8D格式的疑问。。

飞天

The originator will form a problem-solving team as required.
Members should have process/product knowledge, time available, sufficient authority and skills in required technical disciplines.


Define the problem in quantitative terms (what, when, where, how many) and include the customer’s complaint or failure description.
List affected serial numbers and date codes.
Include reference number for related documents (RMA, PO, DMR, etc…
Please use one corrective action request per problem.

Define and implement interim containment actions (i.e., inspection before shipment, etc.) to prevent the problem from growing and to isolate customers from its effects. The customer must be protected until permanent corrective actions can be implemented and verified. The effectiveness of the containment actions must be verified.
Initiate any required Purge Notice or Quality Stop Notice.

Identify all possible causes of problem.
Verify root cause(s) by testing each against problem description and test data.
Determine which potential causes are most significant.
Verify the impact of identified cause(s) and list possible corrective actions.


Evaluate alternative solutions and avoid temporary fixes.
Verify the effectiveness of selected corrective action(s) and lack of undesirable side effects via pre-production testing.
Define contingency actions if necessary, based on risk assessment.
Corrective actions must specify who (individuals responsible), what (action to be taken), and when (deadlines



Implement the selected corrective action(s
List specific action(s) implemented.
Include implementation dates/lot traceability/lot or datecode cut-in for each action.
Formalize all changes (ie. update procedures & instructions, release ECO, etc…
Define ongoing controls to ensure that the root cause is eliminated.
Monitor data to verify that the corrective action(s) are working.
Implement contingency actions as necessary.


Ensure the solution is incorporated into production of future products.
List specific action(s) to modify/revise procedures, practices, systems to prevent reoccurrence of this and all similar problems.
List ECO numbers and release dates. List any required personnel training, responsible individual(s) and implementation dates.

飞天

顶起来。不要留恋






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暗暗一笑

以下仅仅是我个人观点，仅供分享、讨论
5.
Define and verify corrective actions
Evaluate alternative solutions and avoid temporary fixes.
Verify the effectiveness of selected corrective action(s) and lack of undesirable side effects via pre-production testing.
Define contingency actions if necessary, based on risk assessment.
Corrective actions must specify who (individuals responsible), what (action to be taken), and when (deadlines
制定改善措施，并进行前期验证措施是否适宜。措施明确出人，事，时

6.
Implement permanent corrective actions
Implement the selected corrective action(s
List specific action(s) implemented.
Include implementation dates/lot traceability/lot or datecode cut-in for each action.
Formalize all changes (ie. update procedures & instructions, release ECO, etc…
Define ongoing controls to ensure that the root cause is eliminated.
Monitor data to verify that the corrective action(s) are working.
Implement contingency actions as necessary.
执行永久改善措施，列出执行的特记事项，执行日期，涉及的产品批次跟踪，变更标准化（如更新程序文件，指导书，ECO等等）。明确跟踪长期改善措施的控制方式，统计数据监控长期改善措施的有效性。必要时采取预防措施