8.3 Control of nonconforming product

General :
Version:	1.0

Project :
Author:	Wolfgang Kern
Created:	07.03.2014
Modified:	14.09.2017 15:19:14

Diagram Elements :

Add repair instructions for reoccuring repairs that shall also included into DMR / MMR

Check compliance with legal standards before release of blocked parts

Document and label reason and restrictions for use in case of special release

Manage blocked parts or products

Investigate and document root cause for suspension

Repair blocked parts in-house

Repair on-site

Refurbish modules

Repair device in-house

Manage CAPAs

Manage noncomformities of supplied parts

Block nonconform components or products

8. Measurement, analysis and improvement :8 Measurement, analysis and improvement

8.3 Document rework process if product needs to be reworked (one or more times)

8.3 Take action appropriate to the effects when nonconforming products is detected after delivery

8.3 Re-verification after nonconforming product is corrected

8.3 Records of the nature of nonconformities and subsequent actions

8.3 Ensure that nonconforming product is accepted by concession only if regulatory requirements are met.

8.3 c) Take action to preclude its original intended use of application

8.3 b) Authorizing its use, release or acceptance under concession

8.3 a) Take action to eliminate the detected nonconformity

8.3 Identify products which are not conform to product requirements