医疗器械CAPA指南 质量管理体系(6)

Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010

Identify Root Cause ? The output of the root cause analy-sis should be a clear statement of the most fundamental cause(s) re-sulting in the nonconformity Specify: ? What the action is ? Who will do it ? When it should be done It has been concluded that the root cause of the tubing sur-face finish issue is inadequate line clearance procedures established at the supplier. Planned actions Verification of actions Verification of effective-ness Corrective action: Supplier to add line clearance require-ments to documented procedures by [date]. Preventive action: Not applicable. ? Verification activities are to ensure General examples are included below. Actual documenta-that all the elements of the pro-tion would need to be more specific. posed action (documentation, ? Review and approval of the procedural changes prior training etc) will satisfy the re-to use quirements of the proposed action ? Conduct a pilot of new procedure on a specific project/department/time frame prior to full scale im-? Validation activities generate data plementation and information that confirm the ? Verification that the updated supplier procedure ad-likelihood of the effectiveness of dresses the process that caused the nonconformity the corrective action to eliminate ? Verification that the training materials address the the nonconformity or proposed specific process that caused the nonconformity nonconformity. ? Comparing a new design specification with a similar proven design specification ? Performing calculations using an alternative method ? Perform validation of equipment, software, production processes, test method, component, etc. Specific example: Review and approval of supplier procedure XXX by the supplier and the customer to ensure adequacy of the up-dated line clearance process. Method or data for the determination of X months after implementation: effectiveness with acceptance criteria. ? The improvement goal ? Conduct a query of the electronic manufacturing data ? The evidence (data sources) that system to verify there are zero surface finish rejects will be used to support effective-for this component at finished Product A final inspec-ness (e.g., a data source could be tion. where the problem was initially found) ? Supplier Quality Engineer to conduct on site review at ? The time frame that effectiveness the supplier of the action to confirm the procedures will be monitored (e.g., upon com-are in place, are known to the operators, and there is pletion of actions or three months, evidence that the procedures are being followed. six months as appropriate) OR ? Sample size required to demon-strate effectiveness Winterhufen 1.0 November 4, 2010 Page 26 of 26

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