Audit Nonconformance - Excel

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Audit Nonconformance - Excel Powered By Docstoc
					                                                                                                  Quality Management System Audit Checklist
                                                                                                                          (a cumulative audit report/summary and management summary)
                                                                                                                                                                                                                                                                                                  Intelex Audit Report #

           LEAD AUDITOR                                                                                                       DEPARTMENT CONTACT INFORMATION/AUDIT PLANNING
                                                    Name:                                                                                                                                              Department:                                                    AUDIT DATE
                                                    (Contact)
                                                                                                                                                                                                                                                                       (RANGE)
               AUDITORS                             Email:                                                                                                                                       Locations Sampled:


                                                   Phone:                                                                                                                                  Audit Scope/Criteria:                                                                  TO
                                                                                                                                                            (e.g., area(s) being audited, applicable clauses from
                                                       Fax:                                                                                                         ISO 9001, applicable Administrative Directive
                                                                                                                                                                  requirements, state or federal regulations, etc.)
                     FINDINGS                                                                                                                                  SUMMARY OF AUDIT RESULTS

                MAJOR
                                                                      Audit Summary:

                Minor
                                                                      System Strength:

               Comment
                                                                      System Weakness:

                                           TYPE OF
               CLAUSE                    EXPECTATION                                           EXPECTATION DEFINED                                                              SYSTEM TRAIL                                    AUDITOR COMMENTS                                FINDING
                                                                                                                                                                                                                                                                                                    Intelex NC # & CA #
                                                                                                                                                         This is where we note the location of the answer to the
                                                                        This is what the standard is requesting we document, define, prove, and/or        EXPECTATION in our system. Grayed out boxes do
                                     Documented




                                                                                                                                                                                                                                                                      Comment
                                                                          record. A description of the types of expectations (shown to the left) is       not require a response, as they will be addressed in          Evidence reviewed and/or issues identified.
                                                           Recorded




                                                                                                                                                                                                                                                                                          MAJOR
                                                                         embedded electronically in the cell for each expectation as a comment.           the sections referenced. When the SYSTEM TRAIL                (black font is comment/evidentiary, blue is
                                                  Proven




                                                                                                                                                                                                                                                                                  Minor
                                                                           (Italics tends to identify a note or summary of what is being covered         entry is BOLD ITALIC , this is a required record for the        opportunity for improvement, and red is a
Relationship with ISO 9001:2008                                                                        somewhere else.)                                      records control procedure addressed in 4.2.4.            nonconformance [issue that must be resolved])                                  NC#              CA#
General questions during all audit                a                   Do you know your Quality Policy? What does it mean?
                                                                      What are the organization quality objectives?
                                                                      How do you contribute to meeting organizations quality objectives?
                                                                      Who is the ISO Management Representative?
                                                                      Do you think you have received adequate training?
4.2.1 Documentation                  a                                Does the Organization have a documented Quality Manual?
Requirements                                                          Does the organization have stated Quality Policy & Objectives?
4.2.2 Quality Manual                                                  Does the organization have the 6 required procedures stated by the
                                                                      standard?
                                                                      What other additional Documents does the organization provide to show
                                                                      effective planning, operation & control of its processes?
                                                                      Does the quality manual describe the scope of the QMS?
                                                                      Does the quality Manual describe the interaction between processes?
                                                                      Does the quality Manual identify exclusions, if any?
4.2.3 Control of Documents           a                                Does the organizations Document Control procedure address the following:
                                                                      - Approval of documents
                                                                      - Review of documents
                                                                      - Revision control of documents
                                                                      - proper identification controls of documents
                                                                      - reapproval of documents, as necessary
                                                                      - control of external documents
                                                                      - control of obsolete documents to prevent unintended use. If so, how?
                                                                      Does the organization have a Master Document list? If so how is it
                                                                      controlled & managed?
                                                                      Does the Master Document List identify all the organizations documents
                                                                      with accurate information?
                                                                      Does the Master Document List include external documents?

4.2.4 Control of Records             a                     a          Does the organization have a documented Records control procedure that
                                                                      addresses the following?
                                                                      - identification controls for records
                                                                      - strorage requirements for records
                                                                      - protection requirements for records
                                                                      - retreival/access controls for records
                                                                      - retention policy for records
                                                                      - define disposition of records after their intended use
                                                                      Are the records legible & identifiable?
                                                                      Do the records have proper revision controls?
                                                                      Does the organization has a records control list? If so, does it address all
                                                                      the required controls for records?

5.1 Management Commitment                         a                   Does the organization have an established Quality Policy?
                                                                      Does the organization have a established Quality Objectives?
                                                                      How does the organization provide effective communication of customer,
                                                                      statutory & regulatory requirements?
                                                                      Does the management conduct Management review meetings?
                                                                      Does the organization provide resources for effective operation of its
                                                                      processes?
5.3 Quality Policy                                a                   Is the documented quality policy appropriate for the purpose of the
                                                                      organization?
                                                                      Does the quality policy include a commitment to comply with requirements?
                                                                      Does the quality policy include a commitment to continual improvement?

5.4 Planning                                      a                   Did the organization establish documented quality objectives, including
                                                                      product-related ones, at all relevant functions and levels?
                                                                      Are the quality objectives measurable & consistant with the quality policy?
                                                                      What QMS planning activities are used to establish the following:
                                                                      - identify processes needed
                                                                      - determine sequence & interaction of processes
                                                                      - methods and criteria needed to show effective operation & control
                                                                      - availability of resources & information ncecessary for support operations
                                                                      - monitor, measure & analyze processes
                                                                      - implement actions necessary to achieve planned results and continual
                                                                      improvement
                                                                      - establish controls for outsourced processes
                                                                      How does the organization plan to maintain the integrity of the QMS when
                                                                      changes occur?

5.5 Responsibility, authority and                 a a                 How are responsibilities & authorities estblished within the organization?
communication                                                         Does it have an ORG chart?
                                                                      Did the organization appoint an Management Representative?
                                                                      What kind of responsibilities & authority does the Management
                                                                      Representative has in achieving the following:
                                                                      - establish, implement & maintain processes needed for effective QMS
                                                                      - report to management on the performance of the QMS & any improvements
                                                                      necessary
                                                                      - promote awareness of customer requirements throughout the organization
                                                                      What kind of communication channels are established regarding the
                                                                      effectiveness of the QMS?

5.6 Management Review                             a a                 Are Management Reviews conducted at planned intervals to ensure the
                                                                      continued suitability, adequecy & effectiveness of its QMS?
                                                                      Are records of Management Review minutes maintained?
                                                                      Does the Management reviews take into account of the following?
                                                                      - results of previous audits
                                                                      - customer feedback/complaints
                                                                      - process performance (Objectives) & product conformity (NCR's)
                                                                      - status of corrective & preventive actions (CA/PA's)
                                                                      - follow-up actions from previous management reviews
                                                                      - changes that could affect the QMS
                                                                      - recommendations/opportunities for improvement
                                                                      Does the result of Management Reviews provide the following:
                                                                      - improvement of the effectiveness of the QMS & its processes
                                                                      - improvement of product/service in relation to its customers
                                                                      - address resource needs
6.0 Resource Management                           a                   Are the resources needed to implement, maintain & continually improve the
6.1 Provision of Resources                                            effectiveness of the QMS & its processes determined & being provided?
                                                                      Are resources needed to enhance customer satisfaction determined & being
                                                                      provided?




                         ee2552e7-6304-4cf6-a444-40a3287c8d83.xls COD-FRM-009                                                                                                                                                                                                              Revision: 4     08/23/10         1 of 4
                                        TYPE OF
            CLAUSE                    EXPECTATION                                           EXPECTATION DEFINED                                                       SYSTEM TRAIL                                      AUDITOR COMMENTS                                FINDING
                                                                                                                                                                                                                                                                                           Intelex NC # & CA #
                                                                                                                                                   This is where we note the location of the answer to the
                                                                     This is what the standard is requesting we document, define, prove, and/or     EXPECTATION in our system. Grayed out boxes do




                                  Documented




                                                                                                                                                                                                                                                              Comment
                                                                       record. A description of the types of expectations (shown to the left) is    not require a response, as they will be addressed in        Evidence reviewed and/or issues identified.




                                                        Recorded




                                                                                                                                                                                                                                                                                  MAJOR
                                                                      embedded electronically in the cell for each expectation as a comment.        the sections referenced. When the SYSTEM TRAIL              (black font is comment/evidentiary, blue is




                                               Proven




                                                                                                                                                                                                                                                                          Minor
                                                                         (Italics tends to identify a note or summary of what is being covered     entry is BOLD ITALIC , this is a required record for the      opportunity for improvement, and red is a
Relationship with ISO 9001:2008                                                                      somewhere else.)                                  records control procedure addressed in 4.2.4.          nonconformance [issue that must be resolved])                                NC#              CA#
6.2 Human Resources                            a a                 Is the competence of the personnel affecting quality of the product/service
                                                                   determined in relation to their education, training, skills and experience?
                                                                   Are the personnel affecting quality are being provided with training?
                                                                   Is the training effective? How is it evaluated?
                                                                   Does staff understand the importance of their training and how their activities
                                                                   contribute to the quality objectives of the organization?
                                                                   Are records of education, training, skills & experience properly maintained
                                                                   and readily available?
6.3 Infrastructure                             a a                 Are necessary infrastructure (buildings; work space & associated utilities;
6.4 Work Environment                                               equipment - both hardware & software; supporting services - transportation,
                                                                   communications…etc) provided & maintained to ensure product/service
                                                                   conformity to requirements?
                                                                   Does the organization determine & manage the work environment
                                                                   (conditions such as lighting, ventilation, clealinesses of work spaces...etc)
                                                                   necessary to achieve conformity of product/service requirements?
7.0 Product Realization                        a a                 Are the processes needed for product/service realization identified, planned,
7.1 Product Planning                                               developed & implemented?
                                                                   Are product related Quality Objectives established?
                                                                   Are the following identified, established & implemented in relation to the
                                                                   product/service:
                                                                   - processes
                                                                   - resources
                                                                   - documents
                                                                   - verifications, validations, monitoring, Inspection & test activities
                                                                   - criteria for acceptance
                                                                   Are the product/service specific records identified, established & maintained
                                                                   (per 4.2.4)?
5.2 Customer Focus                             a a                 How does the organization determine customer requirements, including
7.2 Customer Related Processes                                     delivery & post-delivery requirements?
                                                                   How does the organization address unstated customer requirements?
                                                                   How does the organization determine statutory, regulatory & any other
                                                                   additional requirements determined by the organization?
                                                                   Are all product/service requirements identified, reviewed & confirmed prior to
                                                                   acceptance of order/contract?
                                                                   Does the organizations ability to fullfill the customer requirements
                                                                   established?
                                                                   Show that relevant documents are amended & communicated to all involved
                                                                   parties when product/service requirements have changed after acceptance
                                                                   of order/contract?
                                                                   Are proper records of reviews, changes & customer communication
                                                                   maintained?
                                                                   When the customer provides no documented statement of requirement,
                                                                   does the organization confirm the requirements before acceptance?
                                                                   Are proper communication channels established for handling customer
                                                                   feedback & customer compliants?
7.3 Design                                     a a                 Does the organization has established plan & controls for design &
7.3.1 Design & development                                         development?
planning                                                           Does the design & development plan identify the design changes?
                                                                   Does the design & development plan identify reviews, verifications &
                                                                   validations required at each stage?
                                                                   Does the design & development plan identify the roles, responsibilities &
                                                                   authority?
                                                                   Does the design plan establish effective communication plan?

7.3.2 Design & development                     a a                 Are the design inputs identified & records maintained?
inputs                                                             Does design inputs include the following:
                                                                   - functional & performance requirements
                                                                   - statuatory & regulatory requirements
                                                                   - inputs ffrom previous similar designs, where applicable
                                                                   - any other essectial requirements as needed
                                                                   Are the design inputs reviewed for adequecy (requirements are complete,
                                                                   unambiguous and not in conflict with each other)?
7.3.3 Design & development                     a a                 Are the design outputs reviewed & verified to meet design inputs?
outputs                                                            Are the design outputs approved prior to release?
                                                                   Does the design outputs show appropriate information for purchasing,
                                                                   production and/or service, as applicable?
                                                                   Does the design outputs provide appropriate reference to product
                                                                   acceptance criteria?
                                                                   Does the design outputs specify the characteristics of the product that are
                                                                   essential for its safe & proper use?
7.3.4 Design & development                     a a                 Are systematic design reviews being conducted at planned stages?
review                                                             Does the design reviews evaluate the ability of the results to meet
                                                                   requirements?
                                                                   Does the design reviews identify problems & propose necessary actions?
                                                                   Are appropriate personnel involved in the design reviews? (representatives
                                                                   of functions & stackholders)
                                                                   Are the records of design reviews properly maintained?
7.3.5 Design & development                     a a                 Are design verificaton activities planned & conducted at appropriate stages?
verification                                                       Does the design verification ensure that outputs met design requirements?
                                                                   Are the records of verificaion & any necessary actions properly maintained?


7.3.6 Design & development                     a a                 Are design validation activities planned & conducted at appropriate stages?
validation                                                         Does the design validation ensure that the product/service met its intended
                                                                   purpose?
                                                                   Where applicable, is the design validation conducted & performed prior to its
                                                                   delivery or implementation?
                                                                   Are the records of validation & any necessary actions properly maintained?


7.3.7 Design & development                     a a                 Are design changes reviewed, verified/validated and approved before
changes                                                            implementation?
                                                                   Does the review of design changes include its effect on constituent parts
                                                                   and product already delivered?
                                                                   Are the records of the results of design changes and any necessary actions
                                                                   properly maintained?
7.4 Purchasing                                 a a                 What type and extent of controls does the organization has over its
                                                                   suppliers?
                                                                   Does the organization has controls established for any outsourced
                                                                   processes or products?
                                                                   Is supplier evaluation criteria established? How often are suppliers
                                                                   evaluated?
                                                                   Are records maintained on supplier evaluations?
                                                                   Does the purchaing information describe the product/service to be
                                                                   purchased?
                                                                   Does the purchasing information describe the following:
                                                                   - requirements for approval of product/service, procedures, processes and
                                                                   equipment?
                                                                   - requirements for qualification of personnel?
                                                                   - requirements of Quality Management System? (such as a purchasing
                                                                   procedure or policies)
                                                                   How does the organization verify the adequecy of the purchasing
                                                                   requirements prior to communicating them to supplier?
7.5 Production and Service                     a                   Does the organization has the available information that describes the
provision                                                          characteristics of the product/service?
7.5.1 Control of production and                                    Does the organization have the necessary work instruction needed to
service provision                                                  carryout production and service provsion?
                                                                   Does the organization use suitable equipment for carrying out production
                                                                   and service provision?
                                                                   Does the organization use & maintain measuring & monitoring equipment
                                                                   where needed?
                                                                   How does the organization control the release, delivery and post-delivery
                                                                   activities?




                       ee2552e7-6304-4cf6-a444-40a3287c8d83.xls COD-FRM-009                                                                                                                                                                                                        Revision: 4   08/23/10         2 of 4
                                              TYPE OF
             CLAUSE                         EXPECTATION                                            EXPECTATION DEFINED                                                          SYSTEM TRAIL                                      AUDITOR COMMENTS                                FINDING
                                                                                                                                                                                                                                                                                                     Intelex NC # & CA #
                                                                                                                                                             This is where we note the location of the answer to the
                                                                           This is what the standard is requesting we document, define, prove, and/or         EXPECTATION in our system. Grayed out boxes do




                                        Documented




                                                                                                                                                                                                                                                                        Comment
                                                                             record. A description of the types of expectations (shown to the left) is        not require a response, as they will be addressed in        Evidence reviewed and/or issues identified.




                                                              Recorded




                                                                                                                                                                                                                                                                                            MAJOR
                                                                            embedded electronically in the cell for each expectation as a comment.            the sections referenced. When the SYSTEM TRAIL              (black font is comment/evidentiary, blue is




                                                     Proven




                                                                                                                                                                                                                                                                                    Minor
                                                                               (Italics tends to identify a note or summary of what is being covered         entry is BOLD ITALIC , this is a required record for the      opportunity for improvement, and red is a
Relationship with ISO 9001:2008                                                                            somewhere else.)                                      records control procedure addressed in 4.2.4.          nonconformance [issue that must be resolved])                                NC#              CA#
7.5.2 Validation of processes for                    a a                 Does the organization have any special processes where the output of the
production and service provision                                         process cannot be verified by subsequent monitoring or measurement?If so,
                                                                         how does the organization address the following:
                                                                         - validation of such processes to achieve planned results
                                                                         - defined criteria for review and approval of those processes
                                                                         - approval of equipment or personnel related to those processes
                                                                         - use of methods and procedures for those processes
                                                                         - any requirements for records
                                                                         - revalidation of those processes when changes occur to those processes
                                                                         Are proper records maintained including records of revalidation of any such
                                                                         processes?
7.5.3 Identification and traceability                a a                 Where necessary, does the organizaton address traceability requirements?
                                                                         Is the product/service identified using suitable means throughout its
                                                                         realization process?
                                                                         Is the product status identified with respect to monitoring and measurement
                                                                         requirements?
                                                                         Where traceability is a requirement, are proper records maintained?

7.5.4 Customer property                              a a                 Does the organization identify customer property while it is under the
                                                                         organization's control or use?
                                                                         How is the customer property safegaurded & protected while it is under the
                                                                         organization's control or use?
                                                                         If any customer property is lost, damaged or otherwise found to be
                                                                         unsuitable for use, how is this reported to the customer?
                                                                         How are records maintained in relation to handling of customer property?
7.5.5 Preservation of product                                            How does the organization handle the preservation requirments of the
                                                                         product/service (or its constituent parts) during its internal processing &
                                                                         delivery?
                                                                         Does the preservation process address the following:
                                                                         - identification methods of the product/service
                                                                         - handling methods of the product/service
                                                                         - packaging requirements for the product/service
                                                                         - storage requirements for the product/service
                                                                         - protection requirments for the product/service
7.6 Control of monitoring and                        a a                 Does the organization use monitoring & measuring devices to prove
measuring devices                                                        evidence of conformity?
                                                                         Does the organization establish processes to enable performance of
                                                                         monitoring & measuring activities that are consistent with the monitoring &
                                                                         measuring requirments?
                                                                         Does the organization identify the calibration needs for these measuring &
                                                                         monitoring devices?
                                                                         Does the organization establish the criteria & frequency of calibration for
                                                                         these measuring & monitoring devices?
                                                                         Are the calibration requirements/methods traceable to a known International
                                                                         or national standard?
                                                                         If there is no known standard, how does the organization perform calibration
                                                                         of such devices?
                                                                         Are the measuring or monitoring equipment adjusted or re-adjusted as
                                                                         necessary?
                                                                         What kind of controls are in place to safegaurd adjustments that would
                                                                         invalidate the measurement result?
                                                                         How can the calibration status of these devices be identified? (Is there a
                                                                         calibration log or a calibration sticker on these devices?)
                                                                         How are these calibrated devices protected from damage and deterioration
                                                                         during handling, maintenance and storage?
                                                                         When a device is found to be out-of calibration, how does the organization
                                                                         assess & record the validity of the previous measuring results?
                                                                         How type of actions does the organization take on any equipment or product
                                                                         when a out-of-calibration situation occurs with the measuring device that is
                                                                         used?
                                                                         When using computer software as part of the measuring & monitoring
                                                                         activities, is the ability of this application confirmed prior to initial use and
                                                                         reconfirmed as necessary?
8.0 Measurement, analysis &                          a                   How does the organizaton demonstrate the following:
improvement                                                              - conformity of product/service
8.1 General                                                              - conformity to Quality Management System
                                                                         - continually improve the effectiveness of the Quality Management System
8.2 Monitoring and measurement                                           What methods does the organization use to collect customer perception?
8.2.1 Customer satisfaction                                              How does it use that information?
8.2.2 Internal audits                                a a                 Does the organization has an internal audit procedure?
                                                                         Does the Internal audit procedure define roles, responsibilities & authority for
                                                                         planning, conducting audits, & reporting audit results?
                                                                         Are internal audits conducted at planned intervals to determine the
                                                                         effectiveness of the QMS?
                                                                         Does the internal audit criteria include status, importance & results of
                                                                         previous audits of the audit area?
                                                                         Does the audits define the following: Audit criteria, scope, audit frequency &
                                                                         audit methods?
                                                                         Are the audits conducted in a manner that ensures impartiality and
                                                                         objectivity?
                                                                         Are the audit records properly maintained?
                                                                         Does the audit area take appropriate actions in a timely manner when
                                                                         nonconformities are identified?
                                                                         Does follow-up activities of the audit include verification of actions? Are the
                                                                         results of these verification recorded?
8.2.3 Monitoring and                                 a                   What methods does the organization have in place to measure & monitor
measurement of processes                                                 their processes?
                                                                         Does the organization take necessary corrective actions when its processes
                                                                         are found not to achieve planned results?
8.2.4 Monitoring and                                 a a                 How does the organization measure & monitor product/service
measurement of products                                                  characteristics?
                                                                         Does the organization identify the appropriate stages for monitoring &
                                                                         measuring of product/service?
                                                                         Does the organization maintain proper records to show evidence of
                                                                         conformity of the product/service?
                                                                         Does the organization ensure that all monitoring & measuring activities are
                                                                         completed before the product is released?
8.3 Control of Nonconforming                         a a                 How does the organization identify & segregate nonconforming material?
product                                                                  What measures/controls does the organization have to prevent unintended
                                                                         use or delivery of onconforming product?
                                                                         Does the organization define the responsibilities and authorities in relation to
                                                                         dealing with nonconforming product?
                                                                         Does the organization perform the following:
                                                                         - take action when nonconformace is detected
                                                                         - authorize its use, release or acceptance under concession by relevant
                                                                         authority
                                                                         - take action to preclude its original intended use or application
                                                                         Are proper records for nonconformances maintained including for any
                                                                         subsequent actions taken?
                                                                         Does the organization reverify product/service once the nonconformance is
                                                                         corrected?
                                                                         How does the organization deal if nonconformance is detected after the
                                                                         product/service is delivered?
8.4 Analysis of Data                                                     Does the organization collect & analyze appropriate data to demonstrate the
                                                                         suitability & effectiveness of the QMS?
                                                                         How does the organization utilize this data to evaluate continual
                                                                         improvement in the effectiveness of the QMS?
                                                                         Does the organization collect and analyze data in relation to the follwoing:
                                                                         - Customer satisfaction
                                                                         - conformity of product/service requirements
                                                                         - characteristics and trends of processes & products
                                                                         - suppliers




                         ee2552e7-6304-4cf6-a444-40a3287c8d83.xls COD-FRM-009                                                                                                                                                                                                                Revision: 4   08/23/10         3 of 4
                                          TYPE OF
            CLAUSE                      EXPECTATION                                           EXPECTATION DEFINED                                                       SYSTEM TRAIL                                      AUDITOR COMMENTS                                FINDING
                                                                                                                                                                                                                                                                                             Intelex NC # & CA #
                                                                                                                                                     This is where we note the location of the answer to the
                                                                      This is what the standard is requesting we document, define, prove, and/or      EXPECTATION in our system. Grayed out boxes do




                                    Documented




                                                                                                                                                                                                                                                                Comment
                                                                         record. A description of the types of expectations (shown to the left) is    not require a response, as they will be addressed in        Evidence reviewed and/or issues identified.




                                                          Recorded




                                                                                                                                                                                                                                                                                    MAJOR
                                                                        embedded electronically in the cell for each expectation as a comment.        the sections referenced. When the SYSTEM TRAIL              (black font is comment/evidentiary, blue is




                                                 Proven




                                                                                                                                                                                                                                                                            Minor
                                                                          (Italics tends to identify a note or summary of what is being covered      entry is BOLD ITALIC , this is a required record for the      opportunity for improvement, and red is a
Relationship with ISO 9001:2008                                                                       somewhere else.)                                   records control procedure addressed in 4.2.4.          nonconformance [issue that must be resolved])                                NC#              CA#
8.5 Improvement                                  a                   Does the organization use Quality policy, objectives, audit results, analysis
8.5.1 Continual Improvement                                          of data, management reviews, corrective and preventive actions to
                                                                     continually improve the effectiveness of the QMS?

8.5.2 Corrective action                          a a                 Does the organization have a corrective action procedure?
                                                                     Does the procedure address how to handle the following:
                                                                     - review nonconformities including customer complaints
                                                                     - determine the cause of nonconformities (root cause analysis)
                                                                     - evaluate the need for action to prevent reoccurance
                                                                     - determine and implement necessary actions
                                                                     - maintain records of results of the action taken
                                                                     - review corrective action taken
                                                                     Does the procedure describe the responsibilities & authorities in relation to
                                                                     the corrective action process?
                                                                     Are the corrective actions performed in a timely manner?
                                                                     Are the results of the corrective actions verified & approved by proper
                                                                     authority before they are closed?

8.5.3 Preventive action                          a a                 Does the organization have a preventive action procedure?
                                                                     Does the procedure address how to handle the following:
                                                                     - determine potential nonconformities and their causes
                                                                     - evaluate the need for action to prevent occurance
                                                                     - determine and implement necessary actions
                                                                     - maintain records of results of the action taken
                                                                     - review preventive action taken
                                                                     Does the procedure describe the responsibilities & authorities in relation to
                                                                     the preventive action process?
                                                                     Are the preventive actions performed in a timely manner?
                                                                     Are the results of the preventive actions verified & approved by proper
                                                                     authority before they are closed?




                          ee2552e7-6304-4cf6-a444-40a3287c8d83.xls COD-FRM-009                                                                                                                                                                                                       Revision: 4   08/23/10         4 of 4

				
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