快速反应程序：解决质量问题的反应模式.pptVIP

Ask the supplier if they have error proof and detection devices. Do they have a verification procedure? All error proofing and error detection devices with the potential to fail, wear, misalign, or otherwise become out-of-adjustment shall be verified at a minimum of once per day. Each of the flow steps are a SHALL. Use the blue questions to ask the supplier questions regarding their status. Discuss each step of the flow diagram. Emphasize: Is there a list of devices? What is the reaction to non-conformance? Does frequency allow easy containment? Are results written down? This is an example of a verification log used at GMPT. The yellow items require immediate notification of the supervisor, the codes are the reactions to non-conformances which are on the back side of the form. Discuss what forms the supplier uses. This form is used to track any devices that do not correctly identify verification parts. Management can review these results monthly. Ask the supplier if they see a benefit in the strategy and use of the forms. In closing, does the supplier meet the shall requirements? R/Y/G? Show the Layered Audit Video prior to starting the presentation. After the video, ask if the supplier is performing any layered audits. Review the purpose. Is there a section(s) that is particularly related to the supplier? Layered Audits applies to all areas of the plant. This is not a Quality audit, it must be owned and driven by manufacturing. Layered Audits should focus on high risk items. The checklist should be a living document. The workshop team should discuss when and what to add as well as when to remove items from the audit checklist. This is a form a supervisor or auditor might use. This is the second page. Note the sections for total Non-conforming items. Discuss how the supplier responds to nonconformances found during audits. There are different levels of reactions and the auditor must understand what to do. The procedure must address when to