Docstoc

Supplier Quality Systems Audit Supplier Quality Systems Audit

Document Sample
Supplier Quality Systems Audit Supplier Quality Systems Audit Powered By Docstoc
					Supplier Quality Systems Audit Operations Quality
Audit Date: Location: Auditor(s):

Audit Participants: Name

Title

Name

Title

Corrective Action Required ? Corrective Action Due Date: Concurrence of Audit Results:

Total Number of Pages: Overall Audit Score:

Auditor

Director Operations

Quality Manager Audit Scoring Rules:

General Manager

Deployment / Execution - The score is 0 unless the following criteria are met: Possible Score, enter 1 point if the audit criteria is applicable to the location / facility being audited Actual Score, enter 1 point if the evidence audited demonstrates compliance to the audit criteria The supplier must obtain a score of 80% or greater for a passing audit score. All non-conformances must be detailed on the "Audit Findings" page. All audit criteria with a "Possible Score" of 1 and an "Actual Score" of 0 must have the specific non-conformance(s) detailed on the "Audit Findings" page for corrective action. This Worksheet is write protected, unprotected cells are identified with this color

Supplier Process Audit Procedure #1005565 Rev.2 - Attachemnt: Audit_Operations.xls

Quality Systems Assessment
Quality System Audit Scoring Summary
Location: Criteria 1.0 Management 2.0 Waste Reduction 3.0 Internal Auditing 4.0 Customer PPAP 5.0 Corrective / Preventive Action Possible Score 9 11 7 10 5 14 10 13 14 13 48 8 7 169 Total Score Actual Score 0 0 0 0 0 0 0 0 0 0 0 0 0 0 % 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

6.0 Engineering / Testing 7.0 Program Management 8.0 Supplier Management - Plant 9.0 Procurement 10.0 Receiving Inspection 11.0 Process Control / Traceability 12.0 Employee Orientation / Training 13.0 Document Control / Records Management Total Score (%)

Supplier Process Audit Procedure #1005565 Rev.2 - Attachemnt: Audit_Operations.xls

Quality Systems Audit Scoring Summary

100%

80%

60%

40%

20% 0.00% 0.00% 0.00% 0.00% 0.00%

0.00% 0% 0.00%

0.00%

0.00%

0.00% 0.00% 0.00% 0.00%

Supplier Process Audit Procedure #1005565 Rev.2 - Attachment: Audit_Operations.xls

Supplier Quality Systems Audit Audit Findings
Audit Section Item Number Action Required Y/N

Audit Finding

* Improvement opportunity Insert additional lines above as necessary to document all findings

Supplier Process Audit Procedure #1005565 Rev.2 - Attachment: Audit_Operations.xls

Supplier Quality Systems Assessment
1.0 - Management
Criteria 1.0 1.1 Management Review Formal Management Review process exists and is conducted semi-annually (at a minimum) and covers all elements of the Quality Systems Manual applicable to the facility. 1 1 1 1 1 1 1 1 Deployment / Execution Possible Score Actual Score

1.2 Results of internal audits including 5S audits reviewed. 1.3 Key measurables are defined, measured, tracked and action plans in place as needed. 1.4 Supplier ppm and on-time delivery is tracked and a reporting system in place. 1.5 Customer ppm and ontime delivery is tracked. 1.6 Customer and supplier ratings are tracked, improvement plans exist where ratings are not 100%. 1.7 Trend charts and action plans posted for all employees to review. 1.8 Customer delivery and PPM issues data posted at assembly lines for employee awareness 2.0 Housekeeping

2.1 Housekeeping (offices, plant, labs warehouse, outside building, yard trailers). Total Score

1 9 0

Supplier Process Audit Procedure #1005565 Rev.2 - Attachment: Audit_Operations.xls

Supplier Quality Systems Assessment
2.0 - Waste Reduction
Criteria 1.0 1.1 Scrap Analysis and Reduction process 1.2 Formal, real time review, analysis champion and corrective action process for scrap - trends positive 1.3 Pareto analysis for scrap with detailed and timely action plans for top pareto issues. 1.4 Downtime analysis and reduction process 1.5 Formal, real time review, analysis champion and corrective action process for downtime / trends positive Waste Reduction 1 1 1 1 1 1 1 1 1 1 1 11 0 Deployment / Execution Possible Score Actual Score

1.6 Pareto analysis for downtime withdetailed and timely action plans for top pareto issues. 1.7 Downtime and scrap issues are fed back to PM process 1.8 COQ Process 1.9 COQ trends meet targets 1.10 Pareto analysis of each COQ element (P, A, IF, EF) 1.11 Detailed and timely action plans for top COQ pareto issues for each element Total Score

Supplier Process Audit Procedure #1005565 Rev.2 - Attachment: Audit_Operations.xls

Supplier Quality Systems Assessment
3.0 - Internal Auditing
Criteria 1.0 Internal Auditing 1 1 1 1 1 1 1 7 0 Deployment / Execution Possible Score Actual Score

1.1 12 month internal audit schedule covering all clauses of TS 16949 or ISO 9000 / 2000 as applies. 1.2 Internal audits conducted by qualified auditors. Auditors do not check their own work. 1.3 Housekeeping / 5S process included in internal audits of all areas / facilities 1.4 Records of audits maintained including objective evidence 1.5 Findings reviewed with responsible department managers 1.6 Corrective actions in place in a timely manner with management sign off approval. Corrective actions address issue/concern

1.7 Follow-up / reassessment of action plan completion / effectiveness and verification Total Score

Supplier Process Audit Procedure #1005565 Rev.2 - Attachment: Audit_Operations.xls

Supplier Quality Systems Assessment
4.0 - Customer PPAP
Criteria 1.0 1.1 1.2 Customer PAPP process PPAP's contain all AIAG required information even if the customer does not require all of the information. All information contained in PPAP meets KSS standards (current revision / released / approved documents, print ballooned, product picture) 1 1 1 1 1 1 1 1 1 1 Total Score 10 0 Deployment / Execution Possible Score Actual Score

1.3 All issues are resolved prior to submission of any PPAP to the Customer 1.4 PPAP Review / Sign-off Process and Checklist (prior to customer submission) 1.5 Completed PPAP's filed in document control 1.6 PPAP approval required prior to first shipment (any saleable vehicle builds) 1.7 No shipment policy prior to PV completion and approval 1.8 1.9 PV build design level. Component sources / revision levels / lot numbers required - subsequent changes re-PPAP'ed and PV'ed Control of Appearance Approval Masters (AAR) for PPAP and ongoing receiving inspection / process control

1.10 Run at Rate process

Supplier Process Audit Procedure #1005565 Rev.2 - Attachment: Audit_Operations.xls

Supplier Quality Systems Assessment
5.0 - Corrective / Preventive Action
Criteria 1.0 Corrective Action 1 1 1 1 Deployment / Execution Possible Score Actual Score

1.1 All customer concerns are tracked, addressed and verified for internal and external closure 1.2 1.3 1.4 2.0 2.1 Repeat concerns are evaluated for management action and problem solving process improvement. CAR kept on file and verified for internal and external closure. Corrective actions for concerns are addressed across similar products, processes and implemented as applicable Both formal and informal customer and supplier concerns are addressed. In process concerns are tracked and verified for closure. Preventive Action Formal continuous improvement program in place with project log and action item register with target and completion dates identified. Total Score

1 5 0

Supplier Process Audit Procedure #1005565 Rev.2 - Attachment: Audit_Operations.xls

Supplier Quality Systems Assessment
6.0 - Engineering / Testing
Criteria 1.0 DFMEA management 1 1 1 1 Deployment / Execution Possible Score Actual Score

1.1 DFMEA's are cross functionally reviewed and approved prior to release 1.2 DFMEA's are released into document control initially and following all revisions 1.3 1.4 2.0 All "hard" or "control level" revisions to products require DFMEA update and release to the new level DFMEA RPN reduction actions are documented and completed where applicable - DFMEA is updated to reflect completion of all RPN reduction actions. DV / PV reporting system for assemblies

2.1 Test plan development and approval process (internal and customer) 2.2 Build level and component suppliers / lot numbers are documented for DV and PV builds 2.3 PV build must be 100% production components (PPAP'ed) and off production processes and tools. 2.4 Standard report format, review, approval and release / document control process 2.5 2.6 Delta DV /PV all changes after initial full DV / PV. Team agrees on modified plan if full DV / PV is not necessary Corrective and preventive action system for testing, including issue resolution and formal closure for all DV / PV / Cert tests. Corrective actions completed within time requirements

1 1 1 1 1 1 1

2.7 All component design changes implemented via KSS SREA 3.0 Engineering change notice system

3.1 Post launch Design Change validation, approval and implementation process 3.2 All effected areas notified of change 3.3 Date of first production run with the change recorded. Total Score

1 1 1 14 0

Supplier Process Audit Procedure #1005565 Rev.2 - Attachment: Audit_Operations.xls

Supplier Quality Systems Assessment
7.0 - Program Management
Criteria 1.0 1.1 Customer Side Program Management Product realization process in place with established phases for completion and checksheets for tracking. 1 1 1 1 1 1 1 1 Deployment / Execution Possible Score Actual Score

1.2 Metrics tracked (% pass on original date, % red programs, attendance) Actions taken 1.3 Evidence books complete with retention controlled. 1.4 Lessons learned recorded and records retained. 1.5 Detailed program timing plans exist, are updated regularly and distributed to all involved persons 1.6 Regular Program Team Meetings held to track and update development / launch timing plans 1.7 Program delay / risk escalation and recovery process 1.8 Phase reviews performed when scheduled 2.0 Supplier Side Program Management

2.1 Supplier product realization process reviewed and tracked for timing. 2.2 Action items registers with follow-up for quality and timing issues. Total Score

1 1 10 0

Supplier Process Audit Procedure #1005565 Rev.2 - Attachment: Audit_Operations.xls

Supplier Quality Systems Assessment
8.0 - Supplier Management - Plant
Criteria 1.0 Supplier PPAP process Supplier PPAP process (review checklist, all PPAP elements addressed, no marked prints, 100% compliance or approved SREA, no statements of conformance without raw data and DFE). Deployment / Execution Possible Score Actual Score

1.1

1

1.2 Distribution of all PPAP Warrants to Receiving Inspection and Purchasing after disposition 1.3 PPAP review / disposition / problem resolution process 1.4 Dimensional verification of supplier data for CC / SC's 1.5 PPAP Filing System and database 1.6 Follow-up system for rejected or interim approved PPAP's 2.0 2.1 Supplier PPAP System SREA process including tracking system, and monitoring of expiration dates and implementation of corrective actions as appropriate.

1 1 1 1 1

1 1 1

2.2 SREA Review / Dispositioning Process (Plant QA and Design Engineering must approve) 2.3 SREA Expiration / Corrective Action Follow-up System 3.0 Supplier Nonconformance Management

MRB Review Process (corrective action responsibility determination, material disposition). MRB 3.1 Process includes NCR dispositioned within 48 hours with BRB tracking follow-up and closure tracking report. 3.2 All supplier concerns are tracked, addressed, Car kept on file and verified for closure. 3.3 Supplier delivery issue resolution process (corrective action, follow-up and closure) 3.4 Supplier Phase Review Process Total Score

1

1 1 1 13 0

Supplier Process Audit Procedure #1005565 Rev.2 - Attachment: Audit_Operations.xls

Supplier Quality Systems Assessment
9.0 - Procurement
Criteria 1.0 Supplier Selection Process: Survey, status determination, business hold, etc. 1 1 1 Deployment / Execution Possible Score Actual Score

1.1 All suppliers must pass initial (Pre-Award) on-site Quality Systems survey before sourcing. 1.2 All suppliers are ISO 9000-2000 certified or TS 16949 compliant or have customer waiver. 1.3 Supplier Directory (supplier status: Approved / Business Hold / Desource, quarterly updates) 2.0 Early Supplier Involvement

2.1 ESI process (cross functional support, initiate ASAP after sourcing) 2.2 ESI meeting minutes / actions tracking, follow-up and closure 2.3 PPAP Date Determination & Communication Process 2.4 PPAP approval required prior to PV and first shipment 2.5 Tooling design / construction standards 2.6 Tool build / approval tracking 2.7 Supplier change / tool move planning, validation & customer approval (supplier and KSS and tooling audit initiated changes).

1 1 1 1 1 1 1 1 1

2.8 Supplier Run @ Rate process (risk determination, witnessed / self certify status) 2.9 Supplier Run @ Rate status tracking, follow-up and resolution process 3.0 3.1 4.0 Supplier Contractual Standards Supplier Quality Requirements Manual (QF) referenced on all Tooling and Component PO's & contracts. Supplier Performance Tracking

1

4.1 Monthly supplier ratings distribution to supply base. Total Score

1 14 0

Supplier Process Audit Procedure #1005565 Rev.2 - Attachment: Audit_Operations.xls

Supplier Quality Systems Assessment
10.0 - Receiving Inspection
Criteria 1.0 Receiving Inspection 1 1 1 1 1 1 1 1 1 1 1 1 1 13 0 Deployment / Execution Possible Score Actual Score

1.1 Receiving Inspection process (all direct material for PV and production are in scope) 1.2 Verification of current PPAP Approval for supplier and revision being received 1.3 Revision level inspected to is revision level ordered 1.4 CC / SC's checked at a minimum 1.5 For heat treated parts each box is verified for correct hardness. Dock-to-stock not allowed. 1.6 Plant component issue feedback to Receiving Inspection criteria 1.7 Inspection files organized by Part Number 1.8 Individual Inspection Files for each Supplier of the same Part Number 1.9 Control Plan & Inspection Records Sheet available. 1.10 Inspection Results Recorded, not just Pass / Fail or Accept / Reject 1.11 Handling and transportation damage resolution process 1.12 All rejected material is identified and moved to a quarantine area 1.13 Dock-to-Stock Program (PPAP approved at current revision, no Open NCR's, acceptable history, QA Mgr. approval, component criticality considered) Total Score

Supplier Process Audit Procedure #1005565 Rev.2 - Attachment: Audit_Operations.xls

Supplier Quality Systems Assessment
11.0 - Process Control / Traceability
Criteria 1.0 Core Documents 1 1 1 1 1 1 1 Deployment / Execution Possible Score Actual Score

1.1 APQP documents cross linked by operation sequence and operation number. 1.2 PFMEA is updated for all process and design changes. RPN's reduction actions are noted and RPN's reduced accordingly. 1.3 PFMEA's are cross functionally reviewed and approved prior to release. 1.4 PFMEA's are released into document control initially and following all revisions. 1.5 Control Plans are complete and followed at all times 1.6 Control Plans include Prototype, Pre-Launch and Production control requirements, as applicable 2.0 Mistake proofing process

2.1 Poke Yoke line control sample verification process (each shift at a minimum) 2.2 Process exists for the application of Statistical Methods, reaction plans and improvement 2.3 SPC used on all CC / SC's or equivalent where possible 2.4 Review process for capability indices and improvement program tracking 3.0 3.1 First Piece / Last Piece Inspection and launch containment First Piece / Last Piece Inspection check sheet used with actual data recorded and sign off approval to begin production.

1 1 1 1

1 1 1

3.2 First piece records and first piece parts are retained and reviewed at next set up. 3.3 Launch Containment process 4.0 4.1 Tooling PM schedule available. 4.2 Tool tracking system with tool number, location, usage, capability and rev. 4.3 Tooling spare parts and perishable tools inventory list available and maintained including spare part location and reorder points. Preventive Maintenance / Tooling

1 1 1 1 1 1 1

4.4 New perishable tools are segregated from reworked perishable tools. 4.5 Tooling work orders show PM is current. 4.6 Tooling condition audits performed, recorded and tools maintained as required. 4.7 Tooling reactive maintenance tracked for feedback for predictive maintenance.

Supplier Process Audit Procedure #1005565 Rev.2 - Attachment: Audit_Operations.xls

Supplier Quality Systems Assessment
11.0 - Process Control / Traceability (continued)
Criteria 5.0 Preventive Maintenance / Equipment 1 1 1 1 1 Deployment / Execution Possible Score Actual Score

5.1 Equipment PM schedule available. 5.2 Equipment tracking system available with equipment number, location, usage, capability and rev. 5.3 Equipment spare parts inventory list available and maintained including spare part location and reorder points.

5.4 Equipment work orders show equipment PM is current. 5.5 Equipment reactive maintenance tracked for feedback for predictive maintenance. 6.0 Management of Nonconformances at the line

6.1 Clear identification of non-conforming and suspect material as well as control to prevent misuse. 6.2 Scrap / Rejected Material is identified at all times. 6.3 Supervisor or Quality (not operators) control keys, remove defects from process and clear faults. 6.4 Scrap is removed from line every shift at a minimum. 6.5 Rejected Material is identified and moved to quarantine area immediately. 6.6 7.0 7.1 Andon light system with audible notification and multiple colors for material, maintenance and quality issues as appropriate. Operator Control Detailed operator Instructions and Visual Aids exist, are visible and followed by all operators. Operators instructions reflect PFMEA and control plan.

1 1 1 1 1 1

1 1 1

7.2 Operators are responsible for the quality of their work. 7.3 Operators have the authority to shut down lines in the event of nonconforming parts. 8.0 Calibration

8.1 All measuring devices have a unique identifying number and an inventory log is maintained. 8.2 Calibration frequencies are established and measuring devices reviewed are current. 8.3 Gages / Test Equipment / Standards are calibrated and the calibration data recorded. 8.4 All standards are traceable to NIST and are current on calibration. 8.5 Measuring devices are calibrated in the range in which the devices are used. 8.6 Calibration instructions are controlled and in use. 8.7 Measuring devices calibrated in inches are used to measure in inches. Devices calibrated in millimeters are used to measure in millimeters.

1 1 1 1 1 1 1 1

8.8 R and R studies are performed for the measuring devices. Outsourced calibrations are performed by accredited laboratories. Calibrations requested to be performed by the accredited laboratories fall within the scope of the outside labs certification.

8.9

1

Supplier Process Audit Procedure #1005565 Rev.2 - Attachment: Audit_Operations.xls

Supplier Quality Systems Assessment
11.0 - Process Control / Traceability (continued)
Criteria 9.0 Lot Traceability / Shelf Life Tracking Deployment / Execution Possible Score Actual Score

Backward Traceability: Lot Traceability System provides traceablity from finished product lot number 9.1 / serial number to all process quality data, component / sub-assembly lot numbers and component raw material lot numbers. Verify system by auditing a random component lot. Forward Traceability: Lot Traceability System provides traceability from component lot number to all 9.2 sub-assembly and finished assembly lot / serial numbers produced, shipped and where / when shipped. Verify system by auditing a random component lot. FIFO (first in first out) used for shipping and for dispersing materials to production. Items used out 9.3 of sequence must have documentation to show reason used out of sequence. Shelf life tracking includes checking shelf life expiration dates prior to production and also checking 9.4 shelf life of inventory on an established schedule. Total Score

1

1

1 1 48 0

Supplier Process Audit Procedure #1005565 Rev.2 - Attachment: Audit_Operations.xls

Supplier Quality Systems Assessment
12.0 - Employee Orientation / Training
Criteria 1.0 1.1 Job descriptions for all positions 1.2 Required skill levels identified. 2.0 Employee Training 1 1 1 Job Skills 1 1 Deployment / Execution Possible Score Actual Score

2.1 Comprehensive training program for employees by job classification 2.2 Training of production operators prior to performing production operations 2.3 Temporary employees trained the same as permanent employees 3.0 Employee Effectiveness

3.1 Effectiveness of training is periodically reviewed and includes all employees / job functions 3.2 Skills matrix available for operators and effectiveness of skills periodically reviewed. 3.3 On line operator has required skills to perform job based on skill matrix and can demonstrate job knowledge. Total Score

1 1 1 8 0

Supplier Process Audit Procedure #1005565 Rev.2 - Attachment: Audit_Operations.xls

Supplier Quality Systems Assessment
13.0 - Document Control / Records Management
Criteria 1.0 Document Control / Records Management Process 1 1 1 1 1 1 1 7 0 Deployment / Execution Possible Score Actual Score

1.1 Document Control / Records Management process 1.2 Change Communication / Review / Signoff process 1.3 Checking process to proofread changes after documents are revised as final check. 1.4 Distribution Process for revised documents. 1.5 Obsolete Documentation Removal Process. 1.6 Engineering change implementation, customer approval process. 1.7 PFMEA, control plan, process flow diagram process information released and controlled document. Total Score

Supplier Process Audit Procedure #1005565 Rev.2 - Attachment: Audit_Operations.xls


				
DOCUMENT INFO
Shared By:
Stats:
views:819
posted:2/6/2008
language:English
pages:20
user002 user002
About