Nadcap OPERATING PROCEDURE AUDIT FAILURE PROCESS Document Owner: Michael Graham
NOP-011 Page 1 of 16 Issue Date: 05-NOV-03 Revision Date: 17-JUL-2014
EFFECTIVE FOR AUDITS CONDUCTED ON OR AFTER 22-JUN-2014 1.0 SCOPE This procedure defines applicable failure modes/criteria and establishes the policy for evaluating Supplier audit performance involving Failure and Risk Mitigation. 2.0 2.1 DEFINITIONS See Quality Manual Fail/Risk Mitigation: A term that denotes that a Nadcap Task Group has stopped the audit review process becau the supplier did not meet Nadcap requirements. The accreditation process has stopped and the supplier must comply with the re-entry conditions to be readmitted into the Nadcap Program. The supplier requirements of the risk mitigation process are described in Section 4.3. Audits procesd as part of the failure/risk mitigation shall not count towards Audit Report Reviewer delegation, or Board of Director/Nadcap Management Council (NMC) Metrics related to processing of Nadcap Audits (e.g. cycle time, 90 day audits, etc.) 3.0 MODES OF AUDIT FAILURE An audit may be failed for any number of reasons including but not limited to; verity of Nonconformances (NCRs), number of NCRs, any violation of Supplier agreement, failure to pay prescribed fees, etc. 3.1 Audit Failure Mode “A” – Supplier Stops the Audit or Accreditation Process: Audit Failure in this c
a takes place when the Supplier, either by choice or by failure to meet the terms of an agreement, cancels an audit that is in progress, has just been completed or is in the accreditation process. When an initial AC7004 audit fails, the conjoined commodity audit shall be failed per Mode A. If an Initial Commodity Audit fails for a single commodity supplier, the AC7004 audit shall fail per Mode A.
3.1.1 3.1.2
Issued By: Director, Nadcap Program and Aerospace Operations DRAFT <signature on file> Scott R. Klavon Approved By: Nadcap Management Council Chairperson <signature on file> Kevin J. Ward Date: 17-Jul-2014 Date: 17-Jul-2014
Nadcap OPERATING PROCEDURE AUDIT FAILURE PROCESS Document Owner: Michael Graham
NOP-011 Page 2 of 16 Issue Date: 05-NOV-03 Revision Date: 17-JUL-2014
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Audit Failure Mode “B” – Excessive Number of NCRs (Non-conformance Report): An audit shall be balloted for Failure when either the total NCRs or Major NCRs exceed the threshold defined in Appe
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电梯安装验收规范ndix A; trainee auditors do not count towards the calculation of auditor days. Each Task Group shall determine the number of Total and Major NCRs allowed per auditor day (NAD) on an annual basis, typically at the February Task Group Meeting. It is suggested that the threshold be established at a level where 95-98% of the population (bad on Task Group audits for the previous year) fall below that limit. (Task Groups may lect a different threshold bad on size and maturity of the Supplier population.) A Task Group may also define an upper limit (CAP) of NCR’s regardless of the number of auditor days. Appendix A contains the limits defined by each Task Group: Commodity specific audit NCR data will be provided by PRI on an annual basis for audits starting January – December of the previous year. Establishment of or changes to Mode B Failure Criteria require Task Group approval prior to incorporation into this procedure but do not require balloting to Nadcap Management Council. (Task Group approval may be by voice vote at a regularly scheduled meeting as evidenced by the meeting minutes) Changes to the Mode B failure criteria are treated as a possible effect on accreditation per NIP 4-01 and require 90 day effectivity for implementation. NOP-008 “Supplier Merit Program” Appendix B shall be updated as appropriate to reflect any changes to the Mode B Failure Criteria. New Task Groups are requested to define their failure criteria (Mode B) once a statistically valid number of audits (e.g. 32 audits) have been conducted or at the cond anniversary of their checklist publication. For Verification of Corrective Action (VCA) Audits one or m
ore Non-sustaining NCR’s shall result in the VCA audit and its related audit under review being subject to failure per Mode B. Re-entry Audits shall be treated as “Reaccreditation” audits with respect to Mode B failure criteria. For Add Scope Audits Threshold criteria for initial audits shall be ud to determine Mode B failure for an “Add Scope” audit. Where the audit report reviewer identifies significant non-conformances to audit criteria that also apply to the main audit scope, the auditor report reviewer, with concurrence of the Task Group Chair, may ballot Subscriber
3.2.1
3.2.1.1 3.2.1.2
3.2.1.3 3.2.1.4 3.2.1.5
3.2.2
3.2.3 3.2.4 3.2.4.1 3.2.4.2
Nadcap OPERATING PROCEDURE AUDIT FAILURE PROCESS Document Owner: Michael Graham
NOP-011 Page 3 of 16 Issue Date: 05-NOV-03 Revision Date: 17-JUL-2014
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Task Group Members on withdrawal of accreditation and/or failing other open audits in that commodity. 3.3 Audit Failure Mode “C” – Severity of NCRs: Audit Failure in this ca may take place when the Supplier has issues vere enough to warrant failure. Issues that could be considered for Mode C are: • • • • • Potential or Actual Product Impact Gross Systems Breakdown Lack of Management Control Falsification of Documents Others issues vere enough to warrant failure
Note: As quality system issues may be documented in the conjoined commodity audit report, the AQS Task Group may consider the NCRs along with tho in the AQS audit report when evaluating for Mode C failure. 3.4 Audit Failure Mode “D” – Too Many Review Cycles to Complete: Audit Failure in this ca may take place if the audit does not clo by review of the 4th cycle (as indicated in the “cycle count” displayed in eAuditNet). The intent is for the Supplier to be permitted 4 complete rounds of respon to clo the audit. Up to two (2) additional rounds of respon are permitted at the discretion of the Audit Report Reviewer to allow for administrative issues such as where the Supplier may have submitted the audit to the Audit Report Reviewer in error, a missing objective evidence, communication issues, etc. The audit must be balloted for failure when the cycle count in eAuditNet reaches the sixth (6) cycle and respons submitted in that cycle are not sufficient to clo the audit. As part of their review, the Task Group will asss the responsibility for e
xcessive cycles to decide if audit failure is warranted. Note: If the audit is entering either 5 or 6 rounds of respon (as shown in eAuditNet cycle count) and not balloted for failure, the Audit Report Reviewer must include a note with the audit justifying why the failure ballot did not occur. (This must be included for both round 5 and round 6). 3.5 Audit Failure Mode “E” – Non-Responsiveness by Supplier: Audit Failure in this ca may take place when the Supplier is deemed non-responsive by meeting either of the criteria identified below: • • The audit has accumulated greater than 30 days of Supplier Cumulative Delinquency (e NOP-001). The audit reaches 120 days elapd time (starting from the last day of the audit.)
Nadcap OPERATING PROCEDURE AUDIT FAILURE PROCESS Document Owner: Michael Graham
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4.0 4.1 4.2 4.2.1
PROCEDURE Any audit which exceeds the failure criteria (except for Mode A) must be submitted to the Task Group for a failure ballot. Actions (Tho paragraphs below identified with an “*” are not required for Mode A Failures) The audit review process shall be stopped by submitting the audit to Ta
sk Group Review on a failure ballot. (For Mode “A” Failures, no ballot is required; the Task Group does not vote.) *The Task Group has a minimum of 7 calendar days to review the issues and respons to determine if audit failure is warranted and to vote on audit failure. A 2/3 majority of responding Task Group Voting Members is required to fail. Sufficient votes supporting the decision (to fail or not to fail) are required with a minimum of quorum. The ballot shall be extended as necessary to obtain the required quorum. *If the Task Group votes to NOT fail, the audit review process continues. If the Task Group votes to fail the audit or the audit is being failed per Mode A, the following actions shall be taken: The audit shall be classified as “Failed”. A Supplier Advisory shall be issued (e NOP-006). Risk Mitigation activities outlined in 4.3 shall be started. Any current accreditation for the commodity is withdrawn, unless otherwi approved by the Task Group.
4.2.2
4.2.3 4.2.4 4.2.4.1 4.2.4.2 4.2.4.3 4.2.4.4
4.2.4.4.1 Failure of an AC7004 reaccreditation audit shall result in the recommendation of suspension or withdrawal of all Nadcap commodity accreditations at that facility. 4.2.4.4.2 For Initial Commodity Audits who utilize the AC 7004 Quality System: If the failed audit is not a single commodi
ty Supplier, the AQS Task Group shall review the findings to determine whether the existing AC 7004 accreditation shall be withdrawn, if an AC 7004 audit is required to re-evaluate the quality system, or if the AC 7004 shall remain active until the expiration date. This decision shall be documented in the commodity audit by the AQS Task Group. 4.2.4.4.3 For Reaccreditation Commodity Audits who utilize the AC 7004 Quality System: The failure of a commodity reaccreditation audit at a company which utilizes AC7004 accreditation as their quality system may result in a review of the audit findings by the AQS Task Group, at the request of the commodity
Nadcap OPERATING PROCEDURE AUDIT FAILURE PROCESS Document Owner: Michael Graham
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Task Group, to determine if the existing AC7004 accreditation shall be withdrawn or if an AC7004 audit shall be conducted to re-evaluate the quality system. When there is no cau to withdraw, suspend, or revi the existing AC7004 accreditation, the AC7004 accreditation shall remain active until the expiration date. This decision shall be documented in the commodity audit by the AQS Task Group. 4.2.4.5 4.2.4.6 4.3 Other affected Task Groups shall be notified of the audit failure. (Other au
dits conducted in conjunction with the failed audit may be subject to failure.) Formal notification detailing the requirements for re-entry into the system shall be nt to the Supplier. Risk Mitigation Process (See Appendix B for process flow diagram) The purpo of this process is to develop a risk mitigation activity when needed. Subscribers (presumably tho who are the Supplier’s customers) will determine if risk mitigation is required by virtue of volunteering to participate on the Risk Mitigation Team. (If no one volunteers to support the Risk Mitigation Team, the process halts, unless otherwi directed by the Task Group Chair or designee.) This process provides the opportunity for: • • • The Supplier to document their action plans for closing findings. Subscribers to have visibility of the Supplier’s corrective action plan. Providing visibility of corrective action respons to both auditor and Subscriber customers on finding closure by using the normal Root Cau Corrective Action (RCCA) process.
4.3.1
A Risk Mitigation Team of Subscribers shall be formed within 2 calendar weeks of audit failure. If there are no volunteers, the mitigation process is halted, however, the Supplier may still elect to provide respons in eAuditNet. In this ca, the Task Group Chair shall appoint a committee of Subscribers to provide support. Requests are submitted to Task Group Subscriber Voting Members 嘚瑟是什么意思
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and NMC Subscriber Voting Members soliciting volunteers for the Risk Mitigation Team. A Risk Mitigation Team Lead will be appointed. The Team Lead will be responsible for collating team respons and posting replies in eAuditNet within required timeframes. (The Team Lead can be decided among the Volunteering Subscriber Members or by the Task Group Chair.) A notification shall be nt to the Supplier informing them of the risk mitigation process and identifying the review team companies (individual team members names shall not be included) as well as the next respon due date. (Due date shall be 21 calendar days from the date of failure.)
4.3.2
Nadcap OPERATING PROCEDURE AUDIT FAILURE PROCESS Document Owner: Michael Graham
NOP-011 Page 6 of 16 Issue Date: 05-NOV-03 Revision Date: 17-JUL-2014如果蜗牛有爱情电视剧全集免费观看
4.3.3 4.3.4 4.3.5
Suppliers shall provide respons to all open findings. Team review is due back to the Supplier within 14 calendar days; subquent Supplier respons are due within 7 calendar days. A maximu
儿童故事在线m of 3 additional rounds of respon and/or an additional 30 days of cumulative delinquency is recommended, however, the Risk Mitigation Team may decide at any time to: • • Discontinue processing the audit for cau (e.g. significantly delinquent respons, non-responsiveness, inappropriate respons, etc.) Allow additional rounds of respon or delinquency as they deem appropriate.
4.3.6 4.4 4.4.1
Closure of a failed audit by the Failure/Risk Mitigation Process shall not result in accreditation of the audit. Re-entry Requirements for Failed Audits: A re-entry audit may be scheduled only after all corrective actions have been submitted and accepted by the Risk Mitigation Team. For audits scheduled more than 24 months after the date of failure, the Task Group may elect to waive this requirement. For audits where the Risk Mitigation process was halted, the supplier must submit a formal appeal to the Task Group in accordance with NOP-001 to resume the risk mitigation process. Corrective actions shall be demonstrated to the auditor on site at the time of the new/re-entry audit. The Nadcap Management Council shall periodically monitor failure metrics (established by the Metrics Committee) to ensure that failure criteria continue to be consistently enforced. DOCUMENTATION All documentation regarding failure of an audit shall be in eAuditNet. All failure b
allots, appeals, appeal decisions, etc. need to be documented with the appropriate audit to clearly identify actions to fail or rever/overturn the failure of an audit. Audits exceeding failure criteria that are not failed: Where audits exceed the failure criteria and are not failed, the reason for not submitting the audit for failure needs to be documented with the appropriate audit. It is recommended that the above documentation be included on the “Audit Summary” page under “Notes”.
4.4.2
4.4.3 4.5
5.0 5.1 5.2
5.3
5.4
