Get documents about "Iso Audit Report Quality Management Recommendation - Excel
Description
Iso Audit Report Quality Management Recommendation document sample
Document Sample
Includes the following translations; Chinese-Simple, Chinese-
INTENDED FOR USE WITH EXCEL 2003 OR 2007
Traditional, Dutch, English, French, German, Russian & Spanish. Table of Contents
Revision Level: ESAC 2008-06
Contents
Emerson Supplier Audit Checklist What's new with this revision?
ESAC provides a standardized evaluation of a supplier's quality potential. It is based on ISO Language
9001 & TS16949 and strongly emphasizes manufacturing process/quality control. The audit
process typically reveals opportunities for improvement and corrective actions are Instructions
implemented to help reduce quality risks and improve supply chain reliability. In addition, the Typical Audit Cycle
ESAC Workbook provides a means to upload audit results, corrective actions and audit team
recommendation to a central database. ISO / TS Cross Reference
The Emerson Supplier Audit Checklist is sponsored by the Emerson Quality Council and Supplier Profile & Audit Record
endorsed by Emerson Corporate Procurement. Divisions are encouraged to use the ESAC
Database to view audit results from other Emerson Divisions or Supply Chain Organizations Standard Checklist
to assist in making sourcing decisions. We believe you will find ESAC to be a valuable tool for
both supplier selection and supplier improvement. Audit Scores & Findings
Emerson personnel should be properly trained prior to leading a supplier audit. If auditor Supplier Corrective Actions
training is not available within your Division, we recommend professional organizations, such
as the American Society for Quality (ASQ). The ESAC Core Team has developed a 4-hour RoHS Requirements
training course and ESAC Scoring Guidelines. The "Auditing with ESAC" course provides REACH Compliance
experienced auditors with instructions on how to use the ESAC assessment tool and scoring
guidelines. Added Requirements Checklist
Please follow the "Typical Audit Cycle" specified on the Instructions page. Audit Scores & Findings
(Need more information? Use the Quick Links on this page or go to the Instructions tab.) Supplier Corrective Actions
Key information from each ESAC audit is available on the ESAC Database. Audit Results
Click links below to request access or to sign-in if you have already registered. Audit Team Recommendation
Request ESAC Database Access Sign-in to ESAC Database Final Disposition
General Instructions:
Auditor Notes & Attachments
a.) Set the Excel macro security to medium. Click "Enable Macros" when opening this file.)
b.) Use the "Language" and "Show-Hide" buttons as necessary to facilitate use. Upload Audit Results to Database
c.) Read "Instructions" before using the ESAC Workbook.
d) You must be registered to the ESAC Database to upload audit data. Quick Links
Note: Use Excel 2003 or 2007 (or newer). Using Excel 2000 (or older) will cause malfunctions to occur.
Sign-in to ESAC Database
ESAC Auditor Training Materials
ESAC Help Request
Request ESAC Database Access
Place Division Logo here Sign up for ESAC Training
Workbook Compatibility w/ Excel
EU REACH Documents
Sponsored by the Emerson Quality Council (Emerson Proprietary) Auditor Qualifications
Emerson Proprietary Contents
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What's new with this revision? Here are the highlights ….
1 REACH Compliance requirements added. Five questions are now available on the Std Checklist and included in the Audit Results.
Application Instructions for REACH (Checklist Section 18.0)
Beginning June 1, 2008, ESAC audits must include Standard Checklist Section 18.0, "REACH Compliance" except when Division management has positively verified
that the parts provided by this supplier will not be used in Emerson products sold in European Union countries. Requirement 18.5 may be marked as "n/a" if the
supplier is not currently providing parts to Emerson with Substances of Very High Concern (SVHC) that exceed 0.1% wt./wt.
2 Link to 'EU REACH Documents' added to Quick Links on the Contents page. Also added more links for requesting ESAC database access and sign-in to the
database.
3 Example questions provided on the 'Added Requirements' page for topics like labor relations, business ethics, environmental and quality management in greater
4 detail.
DUTCH is now available on the Instructions, Supplier Profile and Std Checklist tabs. ESAC now supports eight languages.
5 Commodity Family area expanded on the Supplier Profile to allow input of two Commodity Family names when applicable.
Workbook Compatibility with Older Excel Versions
ESAC is no longer compatible with Excel 2000 or earlier versions. What are your options?
1. Upgrade to a more current version of Excel, like Excel 2003 or 2007.
2. Click on the "ESAC Help Request" link (below) to inquire about availability of an ESAC that is compatible with older Excel versions.
ESAC Help Request
The following will occur when using this workbook with older Excel versions.
- "Run Time error 1004" message will appear after using the "Select Language" buttons on "Language" tab. It may appear at other times also.
- Continued use of the file may cause formula malfunctions resulting in miscalculation of scores, etc.
- Filters on the Standard Checklist and Added Requirements tabs may not function.
- May not be able to adjust row or column heights or insert Division logo.
Emerson Proprietary Contents
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Auditor Qualifications
Q: How well trained and experienced should someone be before leading an ESAC audit?
A: See the recommendations below & the "ESAC Auditor Training Materials" link.
The recommendations below help ensure that Emerson auditors are appropriately trained and qualified before leading an ESAC audit. These guidelines are
intended to promote consistency and professionalism. Each Division and Supply Chain Organization should establish their own requirements for auditor qualification
and then monitor auditor performance.
1. Completion of an ISO 9001/TS16949 auditor training course (typ. 3 to 5 days), either lead auditor or internal auditor training, provided by a reputable registrar or
consulting/training provider. Or, attend the ESAC Core Team's "Comprehensive Auditor Training" class (1-day plus ESAC audit participation).
2. Attend "Auditing with ESAC" class to learn about how to use ESAC and to properly apply scoring. Must pass written test to confirm training effectiveness. (This
class is optional if the auditor has attended the "Comprehensive Auditor Training" class.)
3. Participate on one or two ISO based quality system audits of suppliers or Emerson production facilities (ie., internal audits). Recommended that at least one of
the audits be an ESAC audit. (Note: Confirmation to lead an audit must come from the auditor's Division.)
4. It is always advisable to participate in re-training on ESAC or generic quality system auditing or take the ASQ "Certified Quality Auditor" exam. (This would be
monitored by the Division.)
In addition to training, Emerson auditors should have excellent interpersonal skills and general business knowledge.
Source: ASQ.org, "Minimum Expectations for a Certified Quality Auditor"
Must possess the knowledge and ability to effectively conduct different types of audits in a professional, ethical and objective manner using and interpreting
applicable standards/requirements, with an awareness of potential legal and financial ramifications.
Must be able to effectively plan, develop, communicate and execute an audit within a defined scope, including resource scheduling, conducting necessary meetings
in performance of the audit and using appropriate auditing techniques.
Must be able to verify, document and communicate audit results, develop an audit report and evaluate the effectiveness of corrective action/follow-up.
Must possess interpersonal skills to resolve conflict, conduct interviews and make presentations effectively.
Must be able to participate in, lead and facilitate teams. Must understand how quality principles relate to business processes and be able to explain the importance
of aligning the audit function to the organization.
Must be able to select and use a wide variety of quality and auditing tools and techniques in practical applications.
TOC Have technical knowledge of the processes being audited and the ability to effectively use an process audit checklist when required.
Emerson Proprietary Contents
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Language
Available
Languages
Language Selection Instruction Selection
Buttons
Chinese- 供应商指示： Chinese-Simple
中国简单
Simple 点击右边按钮这本作业簿会以您选择语言显示。请填妥在"评审计划&供应商背景"和"标准清单"页浅绿色突出的区域。 (中国简单)
Chinese-
Chinese- 供应商指示：
中國傳統 Traditional
Traditional 點擊右邊按鈕這本作業簿會以您選擇語言顯示。請填妥在““評審計劃&供應商背景”和“標準清單”頁淺綠色突出的區域。 (中國傳統)
LEVERANCIERSINSTRUCTIES: Klik op de knop rechts in de taal die u verkiest om de verschillende onderdelen van deze Dutch
Dutch Nederlands vragenlijst te tonen. Vervolledig de in lichtgroen gekleurde velden op de bladzijden "Leveranciersprofiel & Auditplan" and
(Nederlands)
"Standaard vragenlijst".
SUPPLIER INSTRUCTION: Click button to the right to display portions of this workbook in the language you choose. Complete
English English English
the areas highlighted in light-green on the "Supplier Profile & Audit Plan" and "Standard Checklist" pages.
INSTRUCTIONS FOURNISSEUR : Cliquer sur le bouton de droite pour afficher les différentes parties de ce questionnaire dans French
French Français la langue de votre choix. Compléter les zones repérées en vert clair sur les onglets « Renseignements fournisseur et plan d'audit
(Français)
» et « Questionnaire standard ».
LIEFERANTEN-ANWEISUNG: Knopf rechts anklicken um die Ansicht dieses Arbeitsbuches in der Sprache Ihrer Wahl German
German Deutsch anzuzeigen. Vervollständige die hellgrün unterlegten Bereiche in den Seiten des „Audit-Planes, Lieferanten-Profiles-“ und in den
(Deutsch)
„Standardchecklisten“.
ИНСТРУКЦИЯ ДЛЯ ПОСТАВЩИКА: Щелкните кнопкой справа чтобы данный текст отобразился на выбранном языке. Russian
Russian Русско
Заполните поля , выделенные светло-зеленым на листе "План проверки и Профиль Поставщика" и "Программма оценки". (Русско)
INSTRUCCION AL PROVEEDOR: Haga clic en el boton de la derecha para mostrar partes de este archivo en el idioma que Spanish
Spanish Español
escoja. Llene las areas en verde claro en las paginas "Supplier Profile & Audit Plan" y "Standard Checklist." (Español)
Company Confidential
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1 Supplier to complete as indicated. Answer all questions in the Supplier Quality Capabilities
Supplier to complete Emerson to complete
section. Explain any answered with "No" or "Not Applicable".
light-green cells light-yellow cells
2 Supplier to complete "Self-Audit" on Std Checklist (if requested by Division). Use column
labeled "Supplier Self-Audit Score". Click column heading for guidelines.
Emerson Supplier Audit Checklist
Supplier Profile & Audit Plan 3 Return the ESAC file and any requested documentation to the Division or Supply Chain
Organization within 7 days or per their instruction.
1.0 SUPPLIER PROFILE (Supplier to Complete)
^ Supplier (Company name)
^ Facility Address
^ Facility Address (cont)
^ City
^ State / Province
^ Country
^ Mail Code
^ Remit to Address
^ Remit to Address (continued)
^ Remit to Address (continued)
^ Supplier's Telephone No.
^ Supplier's Fax No.
^ Supplier's E-mail Address
^ Supplier's Web-site
^ Year Started Operations
^ Other Location 1
^ Other Location 2
^ Other Location 3
Name Phone email Address Supplier Contacts
^ President
^ Plant Manager
^ Quality Manager
^ Customer Service Manager
^ Sales Manager
^ Engineering Manager
^ Other - Type Title here.
^ Other - Type Title here.
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1 Supplier to complete as indicated. Answer all questions in the Supplier Quality Capabilities
Supplier to complete Emerson to complete
section. Explain any answered with "No" or "Not Applicable".
light-green cells light-yellow cells
2 Supplier to complete "Self-Audit" on Std Checklist (if requested by Division). Use column
labeled "Supplier Self-Audit Score". Click column heading for guidelines.
Emerson Supplier Audit Checklist
Supplier Profile & Audit Plan 3 Return the ESAC file and any requested documentation to the Division or Supply Chain
Organization within 7 days or per their instruction.
^ Annual Sales (USD)
^ Capacity/Year (Units)
^ Plant Size (total)
^ Actual Capacity
^ Total Employees
^ Management
^ QA Personnel
^ Direct Labor
^ Labor Union
^ Contract Expiration
Quality System Certification Status Quality System Certification Status
^ Quality Standard
^ Location Certified
^ Expiration Date
^ ISO / TS Registrar
^ Accreditation Body
Emerson Proprietary Supplier Profile & Audit Plan
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1 Supplier to complete as indicated. Answer all questions in the Supplier Quality Capabilities
Supplier to complete Emerson to complete
section. Explain any answered with "No" or "Not Applicable".
light-green cells light-yellow cells
2 Supplier to complete "Self-Audit" on Std Checklist (if requested by Division). Use column
labeled "Supplier Self-Audit Score". Click column heading for guidelines.
Emerson Supplier Audit Checklist
Supplier Profile & Audit Plan 3 Return the ESAC file and any requested documentation to the Division or Supply Chain
Organization within 7 days or per their instruction.
2.0 SUPPLIER QUALITY CAPABILITIES (Supplier to Complete)
Supplier to Explain All "No" or "Not
Yes No or N/A Applicable" Responses Place "X" in appropriate column. Explain any "No" or "Not Applicable" answers.
1 Are specifications reviewed and production methods established that ensure applicable
customer and regulatory requirements can be met on a consistent basis?
2 When required, is the customer notified of changes to items that may adversely affect quality
or reliability, such as, manufacturing site, process methods, raw materials, etc.?
3 Is there a documented corrective action system in use that focuses on elimination of problem
root cause?
4 Are defined methodologies used to actively pursue cost containment and other continual
improvement activities? (e.g., Lean, Six Sigma, Kaizen, 5S, etc.)
5 Are control plans (or equivalent) maintained that show the process steps, key inspection
points, inspection/test method, sample size and frequency?
6 Are process capability studies, SPC or other statistical methods used to monitor and control
production processes?
7 Are documented methods used to qualify and approve machinery, process equipment,
inspection/test equipment and production tooling?
8 Is product conformance to specified requirements verified prior to further processing or
shipment and are records maintained?
9 Are precautions taken to control and monitor the condition of product during storage, handling
and shipping to prevent loss or damage? (e.g. shelf-life or ESD sensitive materials, etc.)
10 Are the materials and parts produced in accordance with applicable environmental and
product safety regulations, laws and directives? (ie., RoHS, UL)
Emerson Proprietary Supplier Profile & Audit Plan
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1 Supplier to complete as indicated. Answer all questions in the Supplier Quality Capabilities
Supplier to complete Emerson to complete
section. Explain any answered with "No" or "Not Applicable".
light-green cells light-yellow cells
2 Supplier to complete "Self-Audit" on Std Checklist (if requested by Division). Use column
labeled "Supplier Self-Audit Score". Click column heading for guidelines.
Emerson Supplier Audit Checklist
Supplier Profile & Audit Plan 3 Return the ESAC file and any requested documentation to the Division or Supply Chain
Organization within 7 days or per their instruction.
3.0 AUDIT PLAN (Emerson to Complete)
^ Division Name
^ Supply Chain Organization
^ Supplier Self-Audit Date
^ On-Site Audit Date
^ Corrective Action Verification Date
^ SQA Reference No.
^ Commodity Family (Primary / Secondary)
^ Commodity Codes
^ Supplier Code
^ Purpose of Audit
^ Project Reference
Contact #1 Contact #2 Contact #3 Contact #4 ^ Emerson Contacts
^ Name
^ Title
^ Contact Phone No.
^ Email Address
4.0 DOCUMENTATION NEEDED (Emerson to Complete)
NOTES REQUESTED RECEIVED Requested / Received
x ^ Quality Manual (typically is policy manual - not work instructions)
x ^ ISO / TS Certificate (must state registrar & accreditation body)
x ^ Supplier Profile (or similar form provided by auditing Division)
^ Supplier Self-Audit (ESAC)
^ Supplier Self-Audit (C-TPAT Checklist provided separately)
^ Major Customers & Competitors
^ Test & Inspection Equipment List
^ Quality Organizational Chart
^ Process Quality Control Plan
^ Process Capability Study
^ Reliability Test Plan
^ Marking Descriptions
^ Major Suppliers and Raw Materials List
^ Regulatory Agency Certificates, as applicable
Emerson Proprietary Supplier Profile & Audit Plan
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1 Supplier to complete as indicated. Answer all questions in the Supplier Quality Capabilities
Supplier to complete Emerson to complete
section. Explain any answered with "No" or "Not Applicable".
light-green cells light-yellow cells
2 Supplier to complete "Self-Audit" on Std Checklist (if requested by Division). Use column
labeled "Supplier Self-Audit Score". Click column heading for guidelines.
Emerson Supplier Audit Checklist
Supplier Profile & Audit Plan 3 Return the ESAC file and any requested documentation to the Division or Supply Chain
Organization within 7 days or per their instruction.
5.0 PERSONNEL INVOLVED IN AUDIT (Emerson to Complete)
Emerson Audit Team Emerson Audit Team
First Name Last Name Title First Name / Last Name / Title
^ Lead Auditor
^
^
^
^
^
Supplier Personnel Supplier Personnel Involved in Audit
First Name Last Name Title First Name / Last Name / Title
^
^
^
^
^
Emerson Proprietary Supplier Profile & Audit Plan
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Supplier to complete Emerson to complete
Brown = Revised
light-green cells light-yellow cells
STANDARD CHECKLIST
Not Verified
Applicable
Supplier
0-Jan-00 Supplier Self- On-Site After CAPA CA-PA Completion
Audit Audit Verif. AUDIT FINDINGS & Req'd? Date
Not
Requirements Typical Objective Evidence SCORE SCORE SCORE OBSERVATIONS (Y / N) (mm/dd/yy) Status
1.1 The quality system is Quality manual and all QS
1.0 QUALITY MANAGEMENT
documented, controlled, and procedures show revision
maintained to clearly describe control (sign-offs & dates),
current practice. Documented history of changes, quality
procedures required. Records organization's responsibilities
required.
1.2 Quality reports, trend charts and Product quality yield data, top
data analysis identify areas of problems and corresponding
1.0 QUALITY MANAGEMENT
opportunity and are used by improvement actions, status of
management on a routine basis. preventive/corrective actions
Records required. taken, internal audit results
1.3 Quality performance targets are Strategic and tactical
MANAGEMENT
clearly defined, included in the objectives, goals, action plans,
1.0 QUALITY
business plan and monitored for etc.
improvements.
1.4 Executive management Analysis of field failures,
1.0 QUALITY MANAGEMENT
participates in periodic quality inspection yields, resource
system reviews that address needs, internal audit results,
quality related feedback from corrective action status, etc.
customers and internal quality
metrics. Records required.
2.1 Preventive actions are taken Management review meetings,
based on the analysis of goal setting, performance
2.0 CONTINUOUS IMPROVEMENT
significant business trends, design measurement, internal audits,
reviews, customer satisfaction action plans, customer surveys
surveys or other meaningful
inputs. Documented procedures
required. Records required.
Emerson Proprietary Std Checklist
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Supplier to complete Emerson to complete
Brown = Revised
light-green cells light-yellow cells
STANDARD CHECKLIST
Not Verified
Applicable
Supplier
0-Jan-00 Supplier Self- On-Site After CAPA CA-PA Completion
Audit Audit Verif. AUDIT FINDINGS & Req'd? Date
Not
Requirements Typical Objective Evidence SCORE SCORE SCORE OBSERVATIONS (Y / N) (mm/dd/yy) Status
2.2 A formal approach is used to Employee involvement /
2.0 CONTINUOUS IMPROVEMENT
actively pursue cost containment recognition program, Lean, Six
and other continual improvement Sigma, kaizen, SPC, 5-S, cost
activities throughout the reduction program, preventive
organization. Documented actions
procedures required. Records
required.
2.3 A corrective action system is in Corrective action records, trend
place that provides root cause charts, meeting minutes,
analysis and takes timely and nonconformance frequency &
2.0 CONTINUOUS IMPROVEMENT
effective action to prevent cost analysis. Does CA system
recurrence. Documented cover customer, internal &
procedures required. Records supplier issues?
required.
3.1 The skill and education level Job descriptions, job skills
3.0 TRAINING & EDUCATION
required for each job is assessment, training records,
documented and appropriate training manuals. Look for use
training / re-training is provided. of training aids & work
Records required. instructions at work stations.
3.2 Employee qualification / Qualification records,
certification is maintained where certification history, etc.
3.0 TRAINING & EDUCATION
the quality outcome of the process
cannot be verified and is strongly
dependent upon operator skill.
Records required.
3.3 Suitable methods are used to Records of student testing,
verify training effectiveness. production quality records,
Records required. audit records, interview
3.0 TRAINING & EDUCATION
workers to validate training
records. Look for use of
training aids & work instructions
at work stations.
Emerson Proprietary Std Checklist
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Supplier to complete Emerson to complete
Brown = Revised
light-green cells light-yellow cells
STANDARD CHECKLIST
Not Verified
Applicable
Supplier
0-Jan-00 Supplier Self- On-Site After CAPA CA-PA Completion
Audit Audit Verif. AUDIT FINDINGS & Req'd? Date
Not
Requirements Typical Objective Evidence SCORE SCORE SCORE OBSERVATIONS (Y / N) (mm/dd/yy) Status
4.1 The Occupation Health & Safety Procedure for OHS training,
4.0 OCCUPATIONAL HEALTH &
(OHS) management system communications, emergency
addresses the safety of personnel preparedness and response,
without comprising the monitoring and performance
achievement of product quality measurements
SAFETY
requirements.
4.2 The Occupation Health & Safety Policies and procedures, health
4.0 OCCUPATIONAL HEALTH &
(OHS) policy states the & safety trend charts, accident
organization’s health and safety rate improvement history, etc.
objectives and management's
SAFETY
commitment to continual
improvement of OHS metrics.
4.3 Procedures are used for the on- Safety committee or group
4.0 OCCUPATIONAL
HEALTH & SAFETY
going identification of hazards, the meeting minutes, accident
assessment of risks, and the investigation reports, safety
implementation of necessary audit reports
control measures.
5.1 Customer needs and Market studies, customer/end-
requirements are incorporated into user surveys, technical design
5.0 DESIGN DEVELOPMENT &
product designs and/or reviews, mfg process capability
manufacturing processes. Critical- studies, formal process
to-Quality (CTQ) characteristics qualification plan,
SUPPORT
are identified and understood. manufacturing verification
Records required. tests, pilot runs, etc.
5.0 DESIGN DEVELOPMENT
5.2 Product specifications and Complete product
drawings are generated, characteristics, application
controlled and maintained for new requirements, and other
& SUPPORT
or changed product designs. information essential for its
Records required. safe and proper use and
eventual disposal, etc.
Emerson Proprietary Std Checklist
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Supplier to complete Emerson to complete
Brown = Revised
light-green cells light-yellow cells
STANDARD CHECKLIST
Not Verified
Applicable
Supplier
0-Jan-00 Supplier Self- On-Site After CAPA CA-PA Completion
Audit Audit Verif. AUDIT FINDINGS & Req'd? Date
Not
Requirements Typical Objective Evidence SCORE SCORE SCORE OBSERVATIONS (Y / N) (mm/dd/yy) Status
5.3 Design validation is an integral Design results,
part of the design process and manufacturability, productivity
5.0 DESIGN DEVELOPMENT & SUPPORT
occurs prior to production release. and cost studies, confirmation
Records required. that product fulfills its specified
requirements or intended use
or applications, design-FMEA,
etc.
5.4 Human and technical resources Qualification of technical staff.
5.0 DESIGN DEVELOPMENT &
are adequate to meet Emerson’s Equipment/software
requirements for design capabilities; CAD, PRO-E, etc.
collaboration, tooling design and
SUPPORT
electronic drawing and data
exchange.
6.0 QUALITY PLANNING
6.1 Production samples are inspected Completed PPAP or similar
and provided to customers upon forms, inspection reports,
request. Records required. availability of qualified
resources
6.2 Customer production Procedures, design / process
requirements and quality review minutes, FMEA's, mfg
specifications are reviewed to capacity plans, resource plans
6.0 QUALITY PLANNING
ensure they can be met on a that address all product test,
consistent basis. Records storage, packaging and
required. shipment requirements
6.3 Reliability test plans are Reliability test plans, test
developed and routinely followed. reports,
Testing is used to verify design improvement/corrective actions
6.0 QUALITY PLANNING
spec's, drive design taken, design changes
improvements and provide an on- implemented
going check of materials and
workmanship. Documented
procedures required. Records
required.
Emerson Proprietary Std Checklist
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Supplier to complete Emerson to complete
Brown = Revised
light-green cells light-yellow cells
STANDARD CHECKLIST
Not Verified
Applicable
Supplier
0-Jan-00 Supplier Self- On-Site After CAPA CA-PA Completion
Audit Audit Verif. AUDIT FINDINGS & Req'd? Date
Not
Requirements Typical Objective Evidence SCORE SCORE SCORE OBSERVATIONS (Y / N) (mm/dd/yy) Status
6.4 Product reliability test data is Reliability test summary
available upon request and reports/charts
6.0 QUALITY PLANNING
historical test performance data
shows a highly stable process and
product design. Records required.
7.1 New and revised customer Technical review of methods to
specifications are reviewed and be used, capability studies on
7.0 DRAWINGS &
SPECIFICATIONS
implemented in a timely manner. similar parts, documented
Documented procedures required. review procedure, ie., APQP,
PPAP.
7.2 Current process control Customer specifications,
documents are in place and used engineering drawings, change
for production start-up and notices, work instructions and
7.0 DRAWINGS &
SPECIFICATIONS
continuing production. specifications as applicable.
Documented procedures required.
7.3 Customer notification / approval Customer notification
occurs for changes to Control procedure on major changes &
7.0 DRAWINGS & SPECIFICATIONS
Plans, manufacturing site, product compliance to Jedec standards
transfers, raw material or product JESD 46 and JESD 48 (or
obsolescence. Records required. equivalent, if app.). Signed
material / process change
requests. Customers are
notified of RoHS compliance
status change.
7.0 DRAWINGS & SPECIFICATIONS
7.4 Quality records are maintained. A Procedures, list of records to
record control system is in place be kept with retention periods
for the identification, storage, specified
protection, retrieval, retention
time, and disposition of quality
records.
Emerson Proprietary Std Checklist
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Supplier to complete Emerson to complete
Brown = Revised
light-green cells light-yellow cells
STANDARD CHECKLIST
Not Verified
Applicable
Supplier
0-Jan-00 Supplier Self- On-Site After CAPA CA-PA Completion
Audit Audit Verif. AUDIT FINDINGS & Req'd? Date
Not
Requirements Typical Objective Evidence SCORE SCORE SCORE OBSERVATIONS (Y / N) (mm/dd/yy) Status
8.1 A formal process is used for the Supplier quality system audits
selection, qualification and re- and related corrective actions,
8.0 PROCUREMENT
qualification of suppliers. Records engineering testing and
required. approval records, plant
production trials
8.2 Purchases from unapproved ASL, procedures for control
8.0 PROCUREMENT
suppliers are prevented by a and use of ASL, production
properly controlled and available material receipt records
Approved Supplier List (ASL).
Records required.
8.3 Preventive actions are taken to Supplier quality performance
continuously improve performance analysis, performance trends,
8.0 PROCUREMENT
of the supplier base. Records supplier audit reports, Inflation
required. Model, documented goals
regarding raw material cost
containment
8.4 A supplier quality assurance Receiving inspection, supplier
system ensures that all purchased audits, source inspection,
product or material conforms to qualification testing, Certificate
8.0 PROCUREMENT
defined specifications and of Compliance (COC),
applicable regulatory or customer component marking, labeling,
requirements. Records required. etc.
8.5 A system exists for the Procedures, segregation during
identification, verification and storage, limited and controlled
8.0 PROCUREMENT
protection of customer supplied access to stored inventories
product that includes notifying the
customer if product is damaged or
lost. Records required.
9.1 Receiving inspection is performed Procedures, inspection
9.0 INCOMING
per documented procedures and instructions resources
MATERIAL
detailed work instructions. (manpower and equipment)
Records required. allocated for incoming
inspection
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STANDARD CHECKLIST
Not Verified
Applicable
Supplier
0-Jan-00 Supplier Self- On-Site After CAPA CA-PA Completion
Audit Audit Verif. AUDIT FINDINGS & Req'd? Date
Not
Requirements Typical Objective Evidence SCORE SCORE SCORE OBSERVATIONS (Y / N) (mm/dd/yy) Status
Inspected material is adequately Quality Control label, marking
9.0 INCOMING MATERIAL
9.2
identified as to acceptance or or use of designated hold area
rejection and traceable to as indicated in the procedure
receiving inspection report.
Records required.
9.3 Supplier corrective action Availability of written procedure,
requests require root cause standardized Corrective Action
9.0 INCOMING MATERIAL
investigation and records show form, analysis of corrective
responses are analyzed. action cycle time and closure
Documented procedures required. measurements
Records required.
10.1 There is a formal method used to Qualification plan that includes
10.0 MANUFACTURING QUALITY
qualify new or rebuilt production established goals for process
equipment prior to production use. yields/up-time, etc. and record
of process capability, review
and approval, etc.
10.2 Control Plans are used to plan and Process flow diagram,
deploy inspection and test statistical tools to be used, key
10.0 MANUFACTURING QUALITY
functions throughout the inspection points, inspection
production process. frequency, records, control
responsibility, inspection/test
method, gaging used,
acceptable yield rates
10.3 Appropriate work instructions are Sample size, frequency,
10.0 MANUFACTURING
available where needed that method, document control
accurately describe all work dates/revision level, etc.
methods including inspections and Handling procedures for
QUALITY
tests to be done during Electro-Static Discharge
production. (ESD), RoHS compliant
materials & other process
conditions.
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STANDARD CHECKLIST
Not Verified
Applicable
Supplier
0-Jan-00 Supplier Self- On-Site After CAPA CA-PA Completion
Audit Audit Verif. AUDIT FINDINGS & Req'd? Date
Not
Requirements Typical Objective Evidence SCORE SCORE SCORE OBSERVATIONS (Y / N) (mm/dd/yy) Status
10.4 Appropriate inspections, tests and Records of inspections
10.0 MANUFACTURING QUALITY
process adjustments are made performed at incoming, first
per applicable work instructions to piece, in-process and/or final
verify conformance at key points inspection or test. Capability
throughout the process and prior study, material test, RoHS and
to shipment. Records required. other regulatory tests, etc.
10.5 The inspection and process status Batch records, travelers, tags,
10.0 MANUFACTURING
of product is identified and labels, product markings or use
maintained throughout the of designated & identified
QUALITY
production process. Records areas.
required.
10.0 MANUFACTURING QUALITY
10.6 Customers are notified of low yield Corrective actions, records of
production lots or issues that customer notifications,
affect product reliability. reliability test data, etc.
Documented procedures required.
Records required.
11.1 Key part characteristics and Histograms, run charts, SPC
process parameters are reviewed charts, pareto analysis, cause
11.0 PROCESS CONTROL
and statistically based controls & effect diagrams, DOE,
and/or problem solving tools are mistake proofing, documented
used to control variation. reaction plan & process
corrections.
11.2 Written improvement plans are Documented reaction plan &
implemented to reduce sources of process corrections. SPC trend
PROCESS CONTROL
11.0 STATISTICAL
variation. charts showing current status
vs. goals. Improvement plan.
11.3 Process capability is measured Documented process
PROCESS CONTROL
11.0 STATISTICAL
and actions are taken to maintain capability studies and results
established minimum Cpk/Ppk (actual vs target Cpk/Ppk)
targets.
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STANDARD CHECKLIST
Not Verified
Applicable
Supplier
0-Jan-00 Supplier Self- On-Site After CAPA CA-PA Completion
Audit Audit Verif. AUDIT FINDINGS & Req'd? Date
Not
Requirements Typical Objective Evidence SCORE SCORE SCORE OBSERVATIONS (Y / N) (mm/dd/yy) Status
11.4 Out of control conditions are noted Control charts
11.0 STATISTICAL PROCESS
on charts and documented
corrective action is taken to bring
the process back into control.
CONTROL
Documented procedures required.
Records required.
12.1 Nonconforming materials, parts Tags, marking, controlled
and assemblies are segregated staging areas, etc. Look for
(where practical) and identified to mixing of RoHS compliant &
prevent unapproved use. non-compliant materials.
NONCONFORMING
Documented procedures required.
MATERIAL
Records required.
12.0
12.2 Reworked material, parts and Inspection record, tag, stamp,
12.0 NONCONFORMING
assemblies are re-inspected or re- etc.
tested to confirm compliance to
MATERIAL
requirements. Records required.
12.3 Use of nonconforming material is Written procedure, waiver or
12.0 NONCONFORMING
documented under a formal concession records
waiver or concession system.
MATERIAL
Records required.
12.4 Product traceability is maintained Serial number records, lot
12.0 NONCONFORMING MATERIAL
(to the extent required by number, date of manufacture,
Emerson) to facilitate problem labeling and marking of
evaluation and corrective action. containers or product, etc.
Documented procedures required. Look for mixing of RoHS
Records required. compliant & non-compliant
materials.
12.5 There is a positive recall system Documented procedure and
to notify customers of review of system
12.0 NONCONFORMING
nonconforming product that has
already been shipped. Records
MATERIAL
required.
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STANDARD CHECKLIST
Not Verified
Applicable
Supplier
0-Jan-00 Supplier Self- On-Site After CAPA CA-PA Completion
Audit Audit Verif. AUDIT FINDINGS & Req'd? Date
Not
Requirements Typical Objective Evidence SCORE SCORE SCORE OBSERVATIONS (Y / N) (mm/dd/yy) Status
13.1 Gage Repeatability & GR&R studies, reports
13.0 MEASUREMENT EQUIPMENT
Reproducibility studies are
conducted to verify suitability of
measuring devices for their use in
checking product quality or control
of processes. Records required.
13.2 Measuring devices, gaging and Gage calibration stickers,
test equipment are routinely calibration records, positive
calibrated and controlled per identification or segregation of
documented procedures. Records out-of-calibration devices, and
13.0 MEASUREMENT EQUIPMENT
required. inventory, location & status
records, etc.
13.3 Gages and test equipment are Calibration procedures, and
calibrated against standards calibration stickers and other
13.0 MEASUREMENT
traceable to a recognized records.
EQUIPMENT
regulatory body or agency.
Records required.
13.4 Assessments are made to check Assessment records,
the validity of previous corrective actions, etc.
13.0 MEASUREMENT
measurements done on products
EQUIPMENT
where out-of-calibration measuring
devices were used. Records
required.
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STANDARD CHECKLIST
Not Verified
Applicable
Supplier
0-Jan-00 Supplier Self- On-Site After CAPA CA-PA Completion
Audit Audit Verif. AUDIT FINDINGS & Req'd? Date
Not
Requirements Typical Objective Evidence SCORE SCORE SCORE OBSERVATIONS (Y / N) (mm/dd/yy) Status
13.5 Appropriate controls are in place Verification methods and
to verify the suitability and records, revision levels,
13.0 MEASUREMENT EQUIPMENT
accuracy of computer software distribution/use control, etc.
prior to initial use in checking
product quality or control of
processes. Software is re-verified
when revised. Records required.
14.1 Tools are stored in an appropriate, Review of storage area,
14.0 PREVENTIVE MAINTENANCE
clearly defined area, with labeling, tooling records
systematic tracking that provide
traceability, particularly of
customer-owned tools and
equipment. Records required.
14.2 A formal Preventive Maintenance Review of system, PM plans,
14.0 PREVENTIVE
MAINTENANCE
system exists for production PM schedule and compliance
equipment, tools and fixtures. results
14.3 Preventive Maintenance schedule No equipment, tools, or fixtures
14.0 PREVENTIVE MAINTENANCE
is followed. Product cannot be are in use that are outside TPM
made with tools that are outside of schedule, or have unclear
maintenance period. Performance status
is audited
15.1 A documented environmental Environmental policy statement
policy exists that includes a document
commitment to comply with
relevant environmental legislation
and regulations and to continual
15.0 ENVIRONMENTAL
improvement and pollution
prevention.
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Not Verified
Applicable
Supplier
0-Jan-00 Supplier Self- On-Site After CAPA CA-PA Completion
Audit Audit Verif. AUDIT FINDINGS & Req'd? Date
Not
Requirements Typical Objective Evidence SCORE SCORE SCORE OBSERVATIONS (Y / N) (mm/dd/yy) Status
15.2 There is an environmental Records of agency/gov
management system that ensures inspection or certification, doc'd
compliance to all applicable procedures for measuring and
government regulations and there monitoring environmentally
15.0 ENVIRONMENTAL
are no outstanding, unresolved sensitive activities w/ list of
violations of these regulations. mtl's and areas where used,
tracking of hazardous mtl's or
waste.
15.3 A system is in place to minimize Record of purchases, waste
the use, disposal and emissions of stream and consumption;
15.0 ENVIRONMENTAL
hazardous chemicals and to inventory control procedures.
ensure that Class I ozone
depleting chemicals are not used
in the manufacturing process.
15.4 An on-going emphasis is placed Records/use of; non-hazardous
on using materials that are; (RoHS/WEEE compliant)
compliant with applicable materials in production,
15.0 ENVIRONMENTAL
regulations like RoHS & WEEE, biodegradable materials,
biodegradable, recyclable, re- returnable containers or
usable, reduces pollutant packaging, recycling program,
emissions at the point of use. packaging materials made of
recycled materials.
16.1 Areas around the facility are clean Observe production, office &
and orderly. Tools and equipment product storage areas for use
16.0 STORAGE & PACKAGING
are properly stored and readily of 5S/6S principles (Sort, Set-in-
available for use. Lighting and air order, Shine, Standardize,
quality are adequate. Sustain + Safety)
16.2 Proper equipment and methods Observe handling and transit of
are used to prevent product raw material, work-in-process,
16.0 STORAGE &
PACKAGING
damage or loss in all phases of and finished goods.
the material handling process.
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STANDARD CHECKLIST
Not Verified
Applicable
Supplier
0-Jan-00 Supplier Self- On-Site After CAPA CA-PA Completion
Audit Audit Verif. AUDIT FINDINGS & Req'd? Date
Not
Requirements Typical Objective Evidence SCORE SCORE SCORE OBSERVATIONS (Y / N) (mm/dd/yy) Status
16.3 Documented procedures are FIFO practices are defined,
16.0 STORAGE & PACKAGING
followed to ensure proper control packaging specifications, test
and preservation of handling, results, handling and storage
storage (FIFO), packaging, and procedures.
delivery of product.
16.4 Suitability of product packaging is Technical review,
16.0 STORAGE & PACKAGING
reviewed and any concerns are packaging/shipping tests,
communicated to the customer packaging work instructions,
prior to initial production shipment. carton strength tests
Packaging tests if required.
Records required.
16.5 Stored product/material is Doc'd list of shelf-life sensitive
periodically inspected, and where products/materials (e.g.,
applicable, actions are taken to sealants, adhesives, solder
prevent deterioration per paste, paint/varnish, o'rings).
16.0 STORAGE & PACKAGING
documented procedures. Look for poor storage
conditions & damage (e.g., rust
or water damage). Handling
procedures for Electro-Static
Discharge (ESD) & other
sensitive conditions.
16.6 Contingency plans have been Process covering utility
developed that describe actions to interruptions, labor shortages,
16.0 STORAGE & PACKAGING
be taken in the event of a major key equipment failures, major
interruption of the manufacturing production issues.
process.
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STANDARD CHECKLIST
Not Verified
Applicable
Supplier
0-Jan-00 Supplier Self- On-Site After CAPA CA-PA Completion
Audit Audit Verif. AUDIT FINDINGS & Req'd? Date
Not
Requirements Typical Objective Evidence SCORE SCORE SCORE OBSERVATIONS (Y / N) (mm/dd/yy) Status
17.1 A RoHS compliance policy is Documented procedures that
17.0 RESTRICTION OF HAZARDOUS
documented and maintained that set requirements for planning,
defines the requirements for verification, on-going control,
SUBSTANCES (RoHS)
material and process qualification, record keeping & customer
on-going compliance verification, communications. Supplier's
manufacturing controls, management support.
declaration of compliance and
records.
17.2 Technical & customer Records, plans, updates,
17.0 RESTRICTION OF
SUBSTANCES (RoHS)
requirements for RoHS presentations, meeting
HAZARDOUS
compliance are reviewed and minutes.
communicated prior to production
start-up.
17.3 Test methods are established for Assessment of risk by part-type
HAZARDOUS SUBSTANCES
each RoHS controlled hazardous or manufacturing process used.
17.0 RESTRICTION OF
substance. Test sampling plan is Procedures, test methods,
based on analysis of risk for each sampling plan, control plan.
(RoHS)
commodity and/or manufacturing
process used.
17.4 Qualified personnel are available Training & education records.
17.0 RESTRICTION OF HAZARDOUS
to implement and sustain all Interview engineering,
aspects of RoHS compliance. technical, quality control
SUBSTANCES (RoHS)
personnel. Number of qualified
personnel is adequate to
prevent unacceptable delays.
17.5 RoHS technical requirements and Test methods/procedures, tin
17.0 RESTRICTION OF
SUBSTANCES (RoHS)
inspection criteria are documented whisker analysis instructions,
HAZARDOUS
and available where needed, e.g. XRF work instructions, QC
solder fillet, tin whiskers.. audits, etc. Ref to Jedec/IPC
Joint publication JP-002.
17.6 Test methods and acceptance Acceptance limits do not
17.0 RESTRICTION OF
SUBSTANCES (RoHS)
limits follow recognized standards exceed RoHS limits.
HAZARDOUS
and RoHS requirements. References to recognized
standard test protocols, such
as, ISO, IEC, EPA.
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STANDARD CHECKLIST
Not Verified
Applicable
Supplier
0-Jan-00 Supplier Self- On-Site After CAPA CA-PA Completion
Audit Audit Verif. AUDIT FINDINGS & Req'd? Date
Not
Requirements Typical Objective Evidence SCORE SCORE SCORE OBSERVATIONS (Y / N) (mm/dd/yy) Status
17.7 Incoming materials and finished RoHS testing procedure,
17.0 RESTRICTION OF HAZARDOUS
goods are periodically tested with sampling plan/frequency, test
appropriate equipment to confirm records. Use of XRF analyzer,
SUBSTANCES (RoHS)
RoHS compliance. Compliance atomic absorption analyzer, UV-
declarations and test records are VIS equipment, etc.. Qualified
maintained for a minimum of 5 independent chemical lab
years. w/A2LA accreditation or
equivalent
17.8 Effective identification and Documented procedures.
handling methods are in place to Observation of handling /
17.0 RESTRICTION OF HAZARDOUS
prevent commingling or labeling techniques in use.
inappropriate use of both RoHS Production operators are aware
SUBSTANCES (RoHS)
non-compliant and RoHS in distinguishing RoHS
compliant items. materials and processes
versus non-RoHS. Look for
mixing of RoHS compliant &
non-compliant materials.
17.9 There are documented Observation of handling /
17.0 RESTRICTION OF HAZARDOUS
procedures in handling the labeling techniques in use.
screening, rework or refurbishing Production operators are aware
SUBSTANCES (RoHS)
of finished goods returned from in distinguishing RoHS
the field and customers. materials and processes
versus non-RoHS.
Documented procedures.
17.10 A spreadsheet or equivalent Database or other means is
17.0 RESTRICTION OF
SUBSTANCES (RoHS)
system is used to monitor the maintained to track RoHS
HAZARDOUS
status of RoHS compliance and compliance status by part
the declarations for each part number & declarations to
number effected. customers.
18.1 REACH compliance policy is Policy statement or procedure.
18.0 REACH Compliance
documented and maintained that
defines the requirements for
REACH compliance and on-going
verification.
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STANDARD CHECKLIST
Not Verified
Applicable
Supplier
0-Jan-00 Supplier Self- On-Site After CAPA CA-PA Completion
Audit Audit Verif. AUDIT FINDINGS & Req'd? Date
Not
Requirements Typical Objective Evidence SCORE SCORE SCORE OBSERVATIONS (Y / N) (mm/dd/yy) Status
18.2 Responsibilities for REACH have Look for identification of an
18.0 REACH Compliance
been clearly defined and assigned individual or individuals (i.e..,
to appropriate personnel. naming an entire department is
not acceptable). Record the
names and titles of the
responsible individuals.
18.3 REACH Compliance Documents Compliance Plan, Supplier
18.0 REACH
Compliance
and instructions for their use are Letters, Customer Letters
established and followed.
18.4 Supplier must have a system in Database/files. Records of
place to communicate safe communication to customers of
18.0 REACH Compliance
handling information (such as a the Material Safety Data Sheet
Material Safety Data Sheet) for (MSDS) or Safety Data Sheet
any dangerous substances (SDS) in the EU which may
contained in or on it's products. include Exposure Scenario
(ES) and/or Risk Management
Measures (RMM).
18.5 The supplier has informed If the official candidate list has
Emerson if they are providing (or been published by the ECHA
will be providing) Emerson with (European Chemicals Agency),
products that contain Substances then look for records of
18.0 REACH Compliance
of Very High Concern (SVHC) that communication to Emerson of
exceed 0.1% wt./wt. the presence of SVHC, if
applicable. Traceability of
chemical identification.
Additional Findings
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STANDARD CHECKLIST
Not Verified
Applicable
Supplier
0-Jan-00 Supplier Self- On-Site After CAPA CA-PA Completion
Audit Audit Verif. AUDIT FINDINGS & Req'd? Date
Not
Requirements Typical Objective Evidence SCORE SCORE SCORE OBSERVATIONS (Y / N) (mm/dd/yy) Status
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Not Applicable
After
Not Verified
Supplier On-Site CAPA
TOTAL SCORES FOR THIS CHECKLIST ONLY Self-Audit Audit Std Verif. Std
Std Chklst Chklst Chklst
SCORE SCORE SCORE On-Site Audit Findings
Sum of Scores (excluding Corrective Action plans will be submitted on
"n/a" & "Not Verified"): 0 0 0 (date):
Maximum Total Score Available: 0 0 8100 8100 8100 Emerson Audit Leader (name & title):
p Standard Checklist Score: 0% 0% 0% Supplier QA Representative (name & title):
Dates: CA-PA Verification & Finding Closure Date:
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STANDARD CHECKLIST
0-Jan-00 ROOT CAUSE REMEDIAL ACTION CORRECTIVE ACTION PREVENTIVE ACTION CONTROLS
& Scope of Problem Including Immediate Actions Taken to Taken to Address Root Cause Actions Taken to Prevent Deployed to Monitor CA/PA
Requirements Typical Objective Evidence Other Areas Address Issue / Finding & Prevent Recurrence Similar Issues in Other Areas Effectiveness
1.1 The quality system is Quality manual and all QS
1.0 QUALITY MANAGEMENT
documented, controlled, and procedures show revision
maintained to clearly describe control (sign-offs & dates),
current practice. Documented history of changes, quality
procedures required. Records organization's responsibilities
required.
1.2 Quality reports, trend charts and Product quality yield data, top
data analysis identify areas of problems and corresponding
1.0 QUALITY MANAGEMENT
opportunity and are used by improvement actions, status of
management on a routine basis. preventive/corrective actions
Records required. taken, internal audit results
1.3 Quality performance targets are Strategic and tactical
MANAGEMENT
clearly defined, included in the objectives, goals, action plans,
1.0 QUALITY
business plan and monitored for etc.
improvements.
1.4 Executive management Analysis of field failures,
1.0 QUALITY MANAGEMENT
participates in periodic quality inspection yields, resource
system reviews that address needs, internal audit results,
quality related feedback from corrective action status, etc.
customers and internal quality
metrics. Records required.
2.1 Preventive actions are taken Management review meetings,
based on the analysis of goal setting, performance
2.0 CONTINUOUS IMPROVEMENT
significant business trends, design measurement, internal audits,
reviews, customer satisfaction action plans, customer surveys
surveys or other meaningful
inputs. Documented procedures
required. Records required.
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STANDARD CHECKLIST
0-Jan-00 ROOT CAUSE REMEDIAL ACTION CORRECTIVE ACTION PREVENTIVE ACTION CONTROLS
& Scope of Problem Including Immediate Actions Taken to Taken to Address Root Cause Actions Taken to Prevent Deployed to Monitor CA/PA
Requirements Typical Objective Evidence Other Areas Address Issue / Finding & Prevent Recurrence Similar Issues in Other Areas Effectiveness
2.2 A formal approach is used to Employee involvement /
2.0 CONTINUOUS IMPROVEMENT
actively pursue cost containment recognition program, Lean, Six
and other continual improvement Sigma, kaizen, SPC, 5-S, cost
activities throughout the reduction program, preventive
organization. Documented actions
procedures required. Records
required.
2.3 A corrective action system is in Corrective action records, trend
place that provides root cause charts, meeting minutes,
analysis and takes timely and nonconformance frequency &
2.0 CONTINUOUS IMPROVEMENT
effective action to prevent cost analysis. Does CA system
recurrence. Documented cover customer, internal &
procedures required. Records supplier issues?
required.
3.1 The skill and education level Job descriptions, job skills
3.0 TRAINING & EDUCATION
required for each job is assessment, training records,
documented and appropriate training manuals. Look for use
training / re-training is provided. of training aids & work
Records required. instructions at work stations.
3.2 Employee qualification / Qualification records,
certification is maintained where certification history, etc.
3.0 TRAINING & EDUCATION
the quality outcome of the process
cannot be verified and is strongly
dependent upon operator skill.
Records required.
3.3 Suitable methods are used to Records of student testing,
verify training effectiveness. production quality records,
Records required. audit records, interview
3.0 TRAINING & EDUCATION
workers to validate training
records. Look for use of
training aids & work instructions
at work stations.
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STANDARD CHECKLIST
0-Jan-00 ROOT CAUSE REMEDIAL ACTION CORRECTIVE ACTION PREVENTIVE ACTION CONTROLS
& Scope of Problem Including Immediate Actions Taken to Taken to Address Root Cause Actions Taken to Prevent Deployed to Monitor CA/PA
Requirements Typical Objective Evidence Other Areas Address Issue / Finding & Prevent Recurrence Similar Issues in Other Areas Effectiveness
4.1 The Occupation Health & Safety Procedure for OHS training,
4.0 OCCUPATIONAL HEALTH &
(OHS) management system communications, emergency
addresses the safety of personnel preparedness and response,
without comprising the monitoring and performance
achievement of product quality measurements
SAFETY
requirements.
4.2 The Occupation Health & Safety Policies and procedures, health
4.0 OCCUPATIONAL HEALTH &
(OHS) policy states the & safety trend charts, accident
organization’s health and safety rate improvement history, etc.
objectives and management's
SAFETY
commitment to continual
improvement of OHS metrics.
4.3 Procedures are used for the on- Safety committee or group
4.0 OCCUPATIONAL
HEALTH & SAFETY
going identification of hazards, the meeting minutes, accident
assessment of risks, and the investigation reports, safety
implementation of necessary audit reports
control measures.
5.1 Customer needs and Market studies, customer/end-
requirements are incorporated into user surveys, technical design
5.0 DESIGN DEVELOPMENT &
product designs and/or reviews, mfg process capability
manufacturing processes. Critical- studies, formal process
to-Quality (CTQ) characteristics qualification plan,
SUPPORT
are identified and understood. manufacturing verification
Records required. tests, pilot runs, etc.
5.0 DESIGN DEVELOPMENT
5.2 Product specifications and Complete product
drawings are generated, characteristics, application
controlled and maintained for new requirements, and other
& SUPPORT
or changed product designs. information essential for its
Records required. safe and proper use and
eventual disposal, etc.
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STANDARD CHECKLIST
0-Jan-00 ROOT CAUSE REMEDIAL ACTION CORRECTIVE ACTION PREVENTIVE ACTION CONTROLS
& Scope of Problem Including Immediate Actions Taken to Taken to Address Root Cause Actions Taken to Prevent Deployed to Monitor CA/PA
Requirements Typical Objective Evidence Other Areas Address Issue / Finding & Prevent Recurrence Similar Issues in Other Areas Effectiveness
5.3 Design validation is an integral Design results,
part of the design process and manufacturability, productivity
5.0 DESIGN DEVELOPMENT & SUPPORT
occurs prior to production release. and cost studies, confirmation
Records required. that product fulfills its specified
requirements or intended use
or applications, design-FMEA,
etc.
5.4 Human and technical resources Qualification of technical staff.
5.0 DESIGN DEVELOPMENT &
are adequate to meet Emerson’s Equipment/software
requirements for design capabilities; CAD, PRO-E, etc.
collaboration, tooling design and
SUPPORT
electronic drawing and data
exchange.
6.0 QUALITY PLANNING
6.1 Production samples are inspected Completed PPAP or similar
and provided to customers upon forms, inspection reports,
request. Records required. availability of qualified
resources
6.2 Customer production Procedures, design / process
requirements and quality review minutes, FMEA's, mfg
specifications are reviewed to capacity plans, resource plans
6.0 QUALITY PLANNING
ensure they can be met on a that address all product test,
consistent basis. Records storage, packaging and
required. shipment requirements
6.3 Reliability test plans are Reliability test plans, test
developed and routinely followed. reports,
Testing is used to verify design improvement/corrective actions
6.0 QUALITY PLANNING
spec's, drive design taken, design changes
improvements and provide an on- implemented
going check of materials and
workmanship. Documented
procedures required. Records
required.
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STANDARD CHECKLIST
0-Jan-00 ROOT CAUSE REMEDIAL ACTION CORRECTIVE ACTION PREVENTIVE ACTION CONTROLS
& Scope of Problem Including Immediate Actions Taken to Taken to Address Root Cause Actions Taken to Prevent Deployed to Monitor CA/PA
Requirements Typical Objective Evidence Other Areas Address Issue / Finding & Prevent Recurrence Similar Issues in Other Areas Effectiveness
6.4 Product reliability test data is Reliability test summary
available upon request and reports/charts
6.0 QUALITY PLANNING
historical test performance data
shows a highly stable process and
product design. Records required.
7.1 New and revised customer Technical review of methods to
specifications are reviewed and be used, capability studies on
7.0 DRAWINGS &
SPECIFICATIONS
implemented in a timely manner. similar parts, documented
Documented procedures required. review procedure, ie., APQP,
PPAP.
7.2 Current process control Customer specifications,
documents are in place and used engineering drawings, change
for production start-up and notices, work instructions and
7.0 DRAWINGS &
SPECIFICATIONS
continuing production. specifications as applicable.
Documented procedures required.
7.3 Customer notification / approval Customer notification
occurs for changes to Control procedure on major changes &
7.0 DRAWINGS & SPECIFICATIONS
Plans, manufacturing site, product compliance to Jedec standards
transfers, raw material or product JESD 46 and JESD 48 (or
obsolescence. Records required. equivalent, if app.). Signed
material / process change
requests. Customers are
notified of RoHS compliance
status change.
7.0 DRAWINGS & SPECIFICATIONS
7.4 Quality records are maintained. A Procedures, list of records to
record control system is in place be kept with retention periods
for the identification, storage, specified
protection, retrieval, retention
time, and disposition of quality
records.
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STANDARD CHECKLIST
0-Jan-00 ROOT CAUSE REMEDIAL ACTION CORRECTIVE ACTION PREVENTIVE ACTION CONTROLS
& Scope of Problem Including Immediate Actions Taken to Taken to Address Root Cause Actions Taken to Prevent Deployed to Monitor CA/PA
Requirements Typical Objective Evidence Other Areas Address Issue / Finding & Prevent Recurrence Similar Issues in Other Areas Effectiveness
8.1 A formal process is used for the Supplier quality system audits
selection, qualification and re- and related corrective actions,
8.0 PROCUREMENT
qualification of suppliers. Records engineering testing and
required. approval records, plant
production trials
8.2 Purchases from unapproved ASL, procedures for control
8.0 PROCUREMENT
suppliers are prevented by a and use of ASL, production
properly controlled and available material receipt records
Approved Supplier List (ASL).
Records required.
8.3 Preventive actions are taken to Supplier quality performance
continuously improve performance analysis, performance trends,
8.0 PROCUREMENT
of the supplier base. Records supplier audit reports, Inflation
required. Model, documented goals
regarding raw material cost
containment
8.4 A supplier quality assurance Receiving inspection, supplier
system ensures that all purchased audits, source inspection,
product or material conforms to qualification testing, Certificate
8.0 PROCUREMENT
defined specifications and of Compliance (COC),
applicable regulatory or customer component marking, labeling,
requirements. Records required. etc.
8.5 A system exists for the Procedures, segregation during
identification, verification and storage, limited and controlled
8.0 PROCUREMENT
protection of customer supplied access to stored inventories
product that includes notifying the
customer if product is damaged or
lost. Records required.
9.1 Receiving inspection is performed Procedures, inspection
9.0 INCOMING
per documented procedures and instructions resources
MATERIAL
detailed work instructions. (manpower and equipment)
Records required. allocated for incoming
inspection
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STANDARD CHECKLIST
0-Jan-00 ROOT CAUSE REMEDIAL ACTION CORRECTIVE ACTION PREVENTIVE ACTION CONTROLS
& Scope of Problem Including Immediate Actions Taken to Taken to Address Root Cause Actions Taken to Prevent Deployed to Monitor CA/PA
Requirements Typical Objective Evidence Other Areas Address Issue / Finding & Prevent Recurrence Similar Issues in Other Areas Effectiveness
Inspected material is adequately Quality Control label, marking
9.0 INCOMING MATERIAL
9.2
identified as to acceptance or or use of designated hold area
rejection and traceable to as indicated in the procedure
receiving inspection report.
Records required.
9.3 Supplier corrective action Availability of written procedure,
requests require root cause standardized Corrective Action
9.0 INCOMING MATERIAL
investigation and records show form, analysis of corrective
responses are analyzed. action cycle time and closure
Documented procedures required. measurements
Records required.
10.1 There is a formal method used to Qualification plan that includes
10.0 MANUFACTURING QUALITY
qualify new or rebuilt production established goals for process
equipment prior to production use. yields/up-time, etc. and record
of process capability, review
and approval, etc.
10.2 Control Plans are used to plan and Process flow diagram,
deploy inspection and test statistical tools to be used, key
10.0 MANUFACTURING QUALITY
functions throughout the inspection points, inspection
production process. frequency, records, control
responsibility, inspection/test
method, gaging used,
acceptable yield rates
10.3 Appropriate work instructions are Sample size, frequency,
10.0 MANUFACTURING
available where needed that method, document control
accurately describe all work dates/revision level, etc.
methods including inspections and Handling procedures for
QUALITY
tests to be done during Electro-Static Discharge
production. (ESD), RoHS compliant
materials & other process
conditions.
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STANDARD CHECKLIST
0-Jan-00 ROOT CAUSE REMEDIAL ACTION CORRECTIVE ACTION PREVENTIVE ACTION CONTROLS
& Scope of Problem Including Immediate Actions Taken to Taken to Address Root Cause Actions Taken to Prevent Deployed to Monitor CA/PA
Requirements Typical Objective Evidence Other Areas Address Issue / Finding & Prevent Recurrence Similar Issues in Other Areas Effectiveness
10.4 Appropriate inspections, tests and Records of inspections
10.0 MANUFACTURING QUALITY
process adjustments are made performed at incoming, first
per applicable work instructions to piece, in-process and/or final
verify conformance at key points inspection or test. Capability
throughout the process and prior study, material test, RoHS and
to shipment. Records required. other regulatory tests, etc.
10.5 The inspection and process status Batch records, travelers, tags,
10.0 MANUFACTURING
of product is identified and labels, product markings or use
maintained throughout the of designated & identified
QUALITY
production process. Records areas.
required.
10.0 MANUFACTURING QUALITY
10.6 Customers are notified of low yield Corrective actions, records of
production lots or issues that customer notifications,
affect product reliability. reliability test data, etc.
Documented procedures required.
Records required.
11.1 Key part characteristics and Histograms, run charts, SPC
process parameters are reviewed charts, pareto analysis, cause
11.0 PROCESS CONTROL
and statistically based controls & effect diagrams, DOE,
and/or problem solving tools are mistake proofing, documented
used to control variation. reaction plan & process
corrections.
11.2 Written improvement plans are Documented reaction plan &
implemented to reduce sources of process corrections. SPC trend
PROCESS CONTROL
11.0 STATISTICAL
variation. charts showing current status
vs. goals. Improvement plan.
11.3 Process capability is measured Documented process
PROCESS CONTROL
11.0 STATISTICAL
and actions are taken to maintain capability studies and results
established minimum Cpk/Ppk (actual vs target Cpk/Ppk)
targets.
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STANDARD CHECKLIST
0-Jan-00 ROOT CAUSE REMEDIAL ACTION CORRECTIVE ACTION PREVENTIVE ACTION CONTROLS
& Scope of Problem Including Immediate Actions Taken to Taken to Address Root Cause Actions Taken to Prevent Deployed to Monitor CA/PA
Requirements Typical Objective Evidence Other Areas Address Issue / Finding & Prevent Recurrence Similar Issues in Other Areas Effectiveness
11.4 Out of control conditions are noted Control charts
11.0 STATISTICAL PROCESS
on charts and documented
corrective action is taken to bring
the process back into control.
CONTROL
Documented procedures required.
Records required.
12.1 Nonconforming materials, parts Tags, marking, controlled
and assemblies are segregated staging areas, etc. Look for
(where practical) and identified to mixing of RoHS compliant &
prevent unapproved use. non-compliant materials.
NONCONFORMING
Documented procedures required.
MATERIAL
Records required.
12.0
12.2 Reworked material, parts and Inspection record, tag, stamp,
12.0 NONCONFORMING
assemblies are re-inspected or re- etc.
tested to confirm compliance to
MATERIAL
requirements. Records required.
12.3 Use of nonconforming material is Written procedure, waiver or
12.0 NONCONFORMING
documented under a formal concession records
waiver or concession system.
MATERIAL
Records required.
12.4 Product traceability is maintained Serial number records, lot
12.0 NONCONFORMING MATERIAL
(to the extent required by number, date of manufacture,
Emerson) to facilitate problem labeling and marking of
evaluation and corrective action. containers or product, etc.
Documented procedures required. Look for mixing of RoHS
Records required. compliant & non-compliant
materials.
12.5 There is a positive recall system Documented procedure and
to notify customers of review of system
12.0 NONCONFORMING
nonconforming product that has
already been shipped. Records
MATERIAL
required.
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STANDARD CHECKLIST
0-Jan-00 ROOT CAUSE REMEDIAL ACTION CORRECTIVE ACTION PREVENTIVE ACTION CONTROLS
& Scope of Problem Including Immediate Actions Taken to Taken to Address Root Cause Actions Taken to Prevent Deployed to Monitor CA/PA
Requirements Typical Objective Evidence Other Areas Address Issue / Finding & Prevent Recurrence Similar Issues in Other Areas Effectiveness
13.1 Gage Repeatability & GR&R studies, reports
13.0 MEASUREMENT EQUIPMENT
Reproducibility studies are
conducted to verify suitability of
measuring devices for their use in
checking product quality or control
of processes. Records required.
13.2 Measuring devices, gaging and Gage calibration stickers,
test equipment are routinely calibration records, positive
calibrated and controlled per identification or segregation of
documented procedures. Records out-of-calibration devices, and
13.0 MEASUREMENT EQUIPMENT
required. inventory, location & status
records, etc.
13.3 Gages and test equipment are Calibration procedures, and
calibrated against standards calibration stickers and other
13.0 MEASUREMENT
traceable to a recognized records.
EQUIPMENT
regulatory body or agency.
Records required.
13.4 Assessments are made to check Assessment records,
the validity of previous corrective actions, etc.
13.0 MEASUREMENT
measurements done on products
EQUIPMENT
where out-of-calibration measuring
devices were used. Records
required.
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STANDARD CHECKLIST
0-Jan-00 ROOT CAUSE REMEDIAL ACTION CORRECTIVE ACTION PREVENTIVE ACTION CONTROLS
& Scope of Problem Including Immediate Actions Taken to Taken to Address Root Cause Actions Taken to Prevent Deployed to Monitor CA/PA
Requirements Typical Objective Evidence Other Areas Address Issue / Finding & Prevent Recurrence Similar Issues in Other Areas Effectiveness
13.5 Appropriate controls are in place Verification methods and
to verify the suitability and records, revision levels,
13.0 MEASUREMENT EQUIPMENT
accuracy of computer software distribution/use control, etc.
prior to initial use in checking
product quality or control of
processes. Software is re-verified
when revised. Records required.
14.1 Tools are stored in an appropriate, Review of storage area,
14.0 PREVENTIVE MAINTENANCE
clearly defined area, with labeling, tooling records
systematic tracking that provide
traceability, particularly of
customer-owned tools and
equipment. Records required.
14.2 A formal Preventive Maintenance Review of system, PM plans,
14.0 PREVENTIVE
MAINTENANCE
system exists for production PM schedule and compliance
equipment, tools and fixtures. results
14.3 Preventive Maintenance schedule No equipment, tools, or fixtures
14.0 PREVENTIVE MAINTENANCE
is followed. Product cannot be are in use that are outside TPM
made with tools that are outside of schedule, or have unclear
maintenance period. Performance status
is audited
15.1 A documented environmental Environmental policy statement
policy exists that includes a document
commitment to comply with
relevant environmental legislation
and regulations and to continual
15.0 ENVIRONMENTAL
improvement and pollution
prevention.
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STANDARD CHECKLIST
0-Jan-00 ROOT CAUSE REMEDIAL ACTION CORRECTIVE ACTION PREVENTIVE ACTION CONTROLS
& Scope of Problem Including Immediate Actions Taken to Taken to Address Root Cause Actions Taken to Prevent Deployed to Monitor CA/PA
Requirements Typical Objective Evidence Other Areas Address Issue / Finding & Prevent Recurrence Similar Issues in Other Areas Effectiveness
15.2 There is an environmental Records of agency/gov
management system that ensures inspection or certification, doc'd
compliance to all applicable procedures for measuring and
government regulations and there monitoring environmentally
15.0 ENVIRONMENTAL
are no outstanding, unresolved sensitive activities w/ list of
violations of these regulations. mtl's and areas where used,
tracking of hazardous mtl's or
waste.
15.3 A system is in place to minimize Record of purchases, waste
the use, disposal and emissions of stream and consumption;
15.0 ENVIRONMENTAL
hazardous chemicals and to inventory control procedures.
ensure that Class I ozone
depleting chemicals are not used
in the manufacturing process.
15.4 An on-going emphasis is placed Records/use of; non-hazardous
on using materials that are; (RoHS/WEEE compliant)
compliant with applicable materials in production,
15.0 ENVIRONMENTAL
regulations like RoHS & WEEE, biodegradable materials,
biodegradable, recyclable, re- returnable containers or
usable, reduces pollutant packaging, recycling program,
emissions at the point of use. packaging materials made of
recycled materials.
16.1 Areas around the facility are clean Observe production, office &
and orderly. Tools and equipment product storage areas for use
16.0 STORAGE & PACKAGING
are properly stored and readily of 5S/6S principles (Sort, Set-in-
available for use. Lighting and air order, Shine, Standardize,
quality are adequate. Sustain + Safety)
16.2 Proper equipment and methods Observe handling and transit of
are used to prevent product raw material, work-in-process,
16.0 STORAGE &
PACKAGING
damage or loss in all phases of and finished goods.
the material handling process.
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STANDARD CHECKLIST
0-Jan-00 ROOT CAUSE REMEDIAL ACTION CORRECTIVE ACTION PREVENTIVE ACTION CONTROLS
& Scope of Problem Including Immediate Actions Taken to Taken to Address Root Cause Actions Taken to Prevent Deployed to Monitor CA/PA
Requirements Typical Objective Evidence Other Areas Address Issue / Finding & Prevent Recurrence Similar Issues in Other Areas Effectiveness
16.3 Documented procedures are FIFO practices are defined,
16.0 STORAGE & PACKAGING
followed to ensure proper control packaging specifications, test
and preservation of handling, results, handling and storage
storage (FIFO), packaging, and procedures.
delivery of product.
16.4 Suitability of product packaging is Technical review,
16.0 STORAGE & PACKAGING
reviewed and any concerns are packaging/shipping tests,
communicated to the customer packaging work instructions,
prior to initial production shipment. carton strength tests
Packaging tests if required.
Records required.
16.5 Stored product/material is Doc'd list of shelf-life sensitive
periodically inspected, and where products/materials (e.g.,
applicable, actions are taken to sealants, adhesives, solder
prevent deterioration per paste, paint/varnish, o'rings).
16.0 STORAGE & PACKAGING
documented procedures. Look for poor storage
conditions & damage (e.g., rust
or water damage). Handling
procedures for Electro-Static
Discharge (ESD) & other
sensitive conditions.
16.6 Contingency plans have been Process covering utility
developed that describe actions to interruptions, labor shortages,
16.0 STORAGE & PACKAGING
be taken in the event of a major key equipment failures, major
interruption of the manufacturing production issues.
process.
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STANDARD CHECKLIST
0-Jan-00 ROOT CAUSE REMEDIAL ACTION CORRECTIVE ACTION PREVENTIVE ACTION CONTROLS
& Scope of Problem Including Immediate Actions Taken to Taken to Address Root Cause Actions Taken to Prevent Deployed to Monitor CA/PA
Requirements Typical Objective Evidence Other Areas Address Issue / Finding & Prevent Recurrence Similar Issues in Other Areas Effectiveness
17.1 A RoHS compliance policy is Documented procedures that
17.0 RESTRICTION OF HAZARDOUS
documented and maintained that set requirements for planning,
defines the requirements for verification, on-going control,
SUBSTANCES (RoHS)
material and process qualification, record keeping & customer
on-going compliance verification, communications. Supplier's
manufacturing controls, management support.
declaration of compliance and
records.
17.2 Technical & customer Records, plans, updates,
17.0 RESTRICTION OF
SUBSTANCES (RoHS)
requirements for RoHS presentations, meeting
HAZARDOUS
compliance are reviewed and minutes.
communicated prior to production
start-up.
17.3 Test methods are established for Assessment of risk by part-type
HAZARDOUS SUBSTANCES
each RoHS controlled hazardous or manufacturing process used.
17.0 RESTRICTION OF
substance. Test sampling plan is Procedures, test methods,
based on analysis of risk for each sampling plan, control plan.
(RoHS)
commodity and/or manufacturing
process used.
17.4 Qualified personnel are available Training & education records.
17.0 RESTRICTION OF HAZARDOUS
to implement and sustain all Interview engineering,
aspects of RoHS compliance. technical, quality control
SUBSTANCES (RoHS)
personnel. Number of qualified
personnel is adequate to
prevent unacceptable delays.
17.5 RoHS technical requirements and Test methods/procedures, tin
17.0 RESTRICTION OF
SUBSTANCES (RoHS)
inspection criteria are documented whisker analysis instructions,
HAZARDOUS
and available where needed, e.g. XRF work instructions, QC
solder fillet, tin whiskers.. audits, etc. Ref to Jedec/IPC
Joint publication JP-002.
17.6 Test methods and acceptance Acceptance limits do not
17.0 RESTRICTION OF
SUBSTANCES (RoHS)
limits follow recognized standards exceed RoHS limits.
HAZARDOUS
and RoHS requirements. References to recognized
standard test protocols, such
as, ISO, IEC, EPA.
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STANDARD CHECKLIST
0-Jan-00 ROOT CAUSE REMEDIAL ACTION CORRECTIVE ACTION PREVENTIVE ACTION CONTROLS
& Scope of Problem Including Immediate Actions Taken to Taken to Address Root Cause Actions Taken to Prevent Deployed to Monitor CA/PA
Requirements Typical Objective Evidence Other Areas Address Issue / Finding & Prevent Recurrence Similar Issues in Other Areas Effectiveness
17.7 Incoming materials and finished RoHS testing procedure,
17.0 RESTRICTION OF HAZARDOUS
goods are periodically tested with sampling plan/frequency, test
appropriate equipment to confirm records. Use of XRF analyzer,
SUBSTANCES (RoHS)
RoHS compliance. Compliance atomic absorption analyzer, UV-
declarations and test records are VIS equipment, etc.. Qualified
maintained for a minimum of 5 independent chemical lab
years. w/A2LA accreditation or
equivalent
17.8 Effective identification and Documented procedures.
handling methods are in place to Observation of handling /
17.0 RESTRICTION OF HAZARDOUS
prevent commingling or labeling techniques in use.
inappropriate use of both RoHS Production operators are aware
SUBSTANCES (RoHS)
non-compliant and RoHS in distinguishing RoHS
compliant items. materials and processes
versus non-RoHS. Look for
mixing of RoHS compliant &
non-compliant materials.
17.9 There are documented Observation of handling /
17.0 RESTRICTION OF HAZARDOUS
procedures in handling the labeling techniques in use.
screening, rework or refurbishing Production operators are aware
SUBSTANCES (RoHS)
of finished goods returned from in distinguishing RoHS
the field and customers. materials and processes
versus non-RoHS.
Documented procedures.
17.10 A spreadsheet or equivalent Database or other means is
17.0 RESTRICTION OF
SUBSTANCES (RoHS)
system is used to monitor the maintained to track RoHS
HAZARDOUS
status of RoHS compliance and compliance status by part
the declarations for each part number & declarations to
number effected. customers.
18.1 REACH compliance policy is Policy statement or procedure.
18.0 REACH Compliance
documented and maintained that
defines the requirements for
REACH compliance and on-going
verification.
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STANDARD CHECKLIST
0-Jan-00 ROOT CAUSE REMEDIAL ACTION CORRECTIVE ACTION PREVENTIVE ACTION CONTROLS
& Scope of Problem Including Immediate Actions Taken to Taken to Address Root Cause Actions Taken to Prevent Deployed to Monitor CA/PA
Requirements Typical Objective Evidence Other Areas Address Issue / Finding & Prevent Recurrence Similar Issues in Other Areas Effectiveness
18.2 Responsibilities for REACH have Look for identification of an
18.0 REACH Compliance
been clearly defined and assigned individual or individuals (i.e..,
to appropriate personnel. naming an entire department is
not acceptable). Record the
names and titles of the
responsible individuals.
18.3 REACH Compliance Documents Compliance Plan, Supplier
18.0 REACH
Compliance
and instructions for their use are Letters, Customer Letters
established and followed.
18.4 Supplier must have a system in Database/files. Records of
place to communicate safe communication to customers of
18.0 REACH Compliance
handling information (such as a the Material Safety Data Sheet
Material Safety Data Sheet) for (MSDS) or Safety Data Sheet
any dangerous substances (SDS) in the EU which may
contained in or on it's products. include Exposure Scenario
(ES) and/or Risk Management
Measures (RMM).
18.5 The supplier has informed If the official candidate list has
Emerson if they are providing (or been published by the ECHA
will be providing) Emerson with (European Chemicals Agency),
products that contain Substances then look for records of
18.0 REACH Compliance
of Very High Concern (SVHC) that communication to Emerson of
exceed 0.1% wt./wt. the presence of SVHC, if
applicable. Traceability of
chemical identification.
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STANDARD CHECKLIST
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& Scope of Problem Including Immediate Actions Taken to Taken to Address Root Cause Actions Taken to Prevent Deployed to Monitor CA/PA
Requirements Typical Objective Evidence Other Areas Address Issue / Finding & Prevent Recurrence Similar Issues in Other Areas Effectiveness
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TOTAL SCORES FOR THIS CHECKLIST ONLY
Supplier Corrective & Preventive Action Plan
Sum of Scores (excluding
"n/a" & "Not Verified"): Submitted by (name & title):
Maximum Total Score Available: Date Supplier CA-PA Plan Submitted:
p Standard Checklist Score: Reviewed by (EMR name & title):
Dates: Date Supplier CA-PA Plan Reviewed:
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Emerson Supplier Audit Checklist Supplier:
Audit Results Commodity Family:
Section Scores
Division; S.C. Org.: Supplier On-Site
Total Mandatory Req. Supplier Self- On-Site Audit After CAPA Self-Audit Audit After CAPA
Standard Checklist Section Req'mnts Req'ments (M) No. Audit SCORE SCORE Verif. SCORE SCORE SCORE Verif. SCORE
M 1.1
1.2
1.0 Quality Management 4 1
1.3
1.4
2.1
2.0 Continuous Improvement 3 2 M 2.2
M 2.3
M 3.1
3.0 Training & Education 3 1 3.2
3.3
4.1
4.0 Occupational Health & Safety 3 0 4.2
4.3
M 5.1
5.2
5.0 Design Development & Support 4 1
5.3
5.4
M 6.1
M 6.2
6.0 Quality Planning 4 2
6.3
6.4
M 7.1
7.2
7.0 Drawings & Specifications 4 3
M 7.3
M 7.4
8.1
M 8.2
8.0 Procurement 5 2 8.3
M 8.4
8.5
M 9.1
9.0 Incoming Material 3 3 M 9.2
M 9.3
10.0 Manufacturing Quality 6 3
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Emerson Supplier Audit Checklist Supplier:
Audit Results Commodity Family:
Section Scores
Division; S.C. Org.: Supplier On-Site
Total Mandatory Req. Supplier Self- On-Site Audit After CAPA Self-Audit Audit After CAPA
Standard Checklist Section Req'mnts Req'ments (M) No. Audit SCORE SCORE Verif. SCORE SCORE SCORE Verif. SCORE
M 10.1
M 10.2
1.0 Quality Management 4 1
10.3
10.0 Manufacturing Quality 6 3
M 10.4
10.5
10.6
M 11.1
11.2
11.0 Process Control 4 2
M 11.3
11.4
M 12.1
12.2
12.0 Nonconforming Material 5 2 12.3
M 12.4
12.5
13.1
M 13.2
13.0 Measurement Equipment 5 2 13.3
M 13.4
13.5
14.1
14.0 Preventive Maintenance 3 0 14.2
14.3
15.1
15.2
15.0 Environmental 4 0
15.3
15.4
M 16.1
16.2
16.3
16.0 Storage & Packaging 6 3
M 16.4
M 16.5
16.6
Emerson Proprietary Audit Results
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Emerson Supplier Audit Checklist Supplier:
Audit Results Commodity Family:
Section Scores
Division; S.C. Org.: Supplier On-Site
Total Mandatory Req. Supplier Self- On-Site Audit After CAPA Self-Audit Audit After CAPA
Standard Checklist Section Req'mnts Req'ments (M) No. Audit SCORE SCORE Verif. SCORE SCORE SCORE Verif. SCORE
17.1
1.0 Quality Management 4 1 17.2
17.3
17.4
Restriction of Hazardous Substances 17.5
17.0 (RoHS) 10 0
17.6
17.7
17.8
17.9
17.10
18.1
18.2
18.0 REACH Compliance 5 0 18.3
18.4
18.5
Number of Requirements Possible (including RoHS): 81 27 0% 0% 0% MANDATORY REQUIREMENTS ONLY
Number of Requirements Audited: 0 0 STD REQUIREMENTS (Incl. Mandatory)
0% 0% 0% ADDITIONAL REQUIREMENTS
Overall score is weighted
Revisions (shown in brown text):
OVERALL average of Std Req's &
Added REACH Compliance section 18.0 and updated formulas.
Additional Req's scores
Emerson Proprietary Audit Results
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Emerson Supplier Audit Checklist Supplier:
Audit Results Commodity Family:
Section Scores
Division; S.C. Org.: Supplier On-Site
Total Mandatory Req. Supplier Self- On-Site Audit After CAPA Self-Audit Audit After CAPA
Standard Checklist Section Req'mnts Req'ments (M) No. Audit SCORE SCORE Verif. SCORE SCORE SCORE Verif. SCORE
AUDIT TEAM RECOMMENDATION & FINAL DISPOSITION
1.0 Quality Management 4
Guidelines for Assigning Audit Team Recommendation 1 Final Disposition
&
The Audit Team Recommendation (ATR) and Final Disposition (FD) are assigned by using the three guidelines below. These are guidelines only, not strict rules. The On-Site
Overall Score, the total On-Site Mandatory Requirements Score and auditor experience are all taken into consideration when making the ATR and several additional factors
are reviewed when Division management determines the FD.
Example; Let's say the On-Site Overall Score is between 60 and 69 and the On-Site Mandatory Req's Score is less than 59. According to the guidelines the ATR should be
"Not Acceptable", however the Auditor determines the ATR is "Conditionally Acceptable" and notes the reason in the Auditor Comment box. Then the Division management
considers the audit scores, ATR and the Auditor's Comments when determining their FD. If the FD is "Conditionally Accept", then the Division (or Procurement Office) must
verify the effectiveness of the supplier's corrective actions and develop an improvement plan to raise the supplier's scores above 70. This should take place prior to
production, but circumstances may cause production to start before the corrections can be made. It is the Division's responsibility to take all necessary precautions to
maintain product quality by adjusting their quality plan to offset the increased risk.
In all cases, it is very important that Corrective Actions are verified to ensure the supplier has met the Requirement and the effected scores can be adjusted to 70% or
above prior to production/shipping of Emerson part numbers. The Corrective Action follow-up is typically the responsibility of the Division that will be using the parts/materials.
Guideline: If Total Mandatory Requirements Score AND On-Site Overall Score = 70 or Greater, then
Audit Team Recommendation should be "Acceptable" and Final Disposition should be "Approved"
Guideline: If Total Mandatory Requirements Score OR On-Site Overall Score = 60 to 69, then
Audit Team Recommendation should be "Conditionally Acceptable" and Final Disposition should be "Conditional Approval"
Guideline: If Total Mandatory Requirements Score OR On-Site Overall Score = 59 or Less, then
Audit Team Recommendation should be "Not Acceptable" and Final Disposition should be "Not Approved"
Audit Team Recommendation Complete an On-Site Audit before making Audit Team Recommendation, then upload to ESAC database. Do NOT upload to ESAC
database unless On-Site Audit was completed.
Audit Team Recommendation (ATR): Date: (mm/dd/yy)
Name & Title:
ATR Auditor Comments:
(Required if ATR does not meet guideline)
Final Disposition Verify supplier's CAPA & re-score affected Requirements before making Final Disposition, then upload to ESAC database. Do NOT
upload to ESAC database unless On-Site Audit was completed.
Final Disposition (FD): Date: (mm/dd/yy)
Name & Title:
FD Auditor Comments:
(Required if FD does not meet guideline)
Supplier Evaluation Record Only Check (x) if Final Disposition was based on Supplier Profile, Self-Audit & review of objective evidence only. This Self-
(No On-Site Audit was completed): Audit file should be maintained by the Division or SCO. Do NOT upload to the ESAC database.
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