5.3.06 Control of non-compliant results

1 Purpose and objective

To exclude the possibility that products that are identified as defective will continue to be used.edit

2 Scope of application

During the entire process.edit

3 Type and scope

3.1 General information

Products that do not meet the quality requirements may no longer be used. Regulations must be made on labeling, documentation, assessment, segregation, treatment and notification of the bodies concerned. In particular, the responsibility for the assessment of non-conformities and the further treatment of the products (e.g. reworking) must be defined. The identification of defective products is not always identical to the testing of products.

A distinction must be made between the prevention of further processing, which is all the more annoying as the overall production process has progressed, and delivery to the customer.

The error classification should be carried out first for all measures: Only then can the urgency of decisions on how to proceed be assessed. Not all deviations need to trigger an alarm.

3. 2 individual points

The following must be regulated

• how to prevent non-compliant products from being inadvertently reused
• how non-compliant products are labeled
• how the non-compliant products are assessed and how the assessment is documented.
• how the non-compliant products are separated and how they are handled.
• Scope of testing and grading procedure including repeat tests
• Notification of the bodies concerned
• Recording of quality costs due to defective products
• Triggering corrective measures
• Notification of the intended use or repair of the defective product to the client or its authorized representative to obtain a special release
• Records of the actual condition of the accepted fault and of repairs carried out
• Triggering a recall and considering safety, product liability and customer satisfaction
• Special case: "Defective product" on acceptance: If defective products (damaged during transportation) or damaged packaging have to be accepted, the transportation damage must first be checked, identified and documented. The products must be labeled accordingly. The result of the inspection must be communicated to the responsible authorities. This office must then decide on further use.

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4 Documentation

Errors and deviations are divided into critical errors, major errors and minor errors. Further handling must be documented

• Rework (leads to conformity)
• Repair (requires special approval)
• Reclassification (for other uses)
• Warping (scrap)

The findings can be documented in quality deviation reports, possibly test protocols, instructions for repairs, etc.

5 Resources

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6 Notes and comments

In clinical trials, non-compliance with inclusion/exclusion criteria can result in a "defective product". Or the randomization code is broken. Or laboratory values are missing because not enough material was available. Overall, this procedure takes into account that a single error does not always render the entire product unusable, but only limits its usefulness. It is therefore important to consider at an early stage how to deal with (often foreseeable) deviations.

7 Responsibilities

Who carries out the error classification? Who carries out the inspection and makes the disposition decision? Who reports the occurrence of a defective product to the management or to the customer? Who downgrades the product? Who approves the special release?

8 Applicable documents

Literature, regulations

8.7 Control of non-conforming results DIN EN ISO 9001:2015

Terms

Defective products (nonconforming product)

The correct term should actually be "deviating product". What is not meant is the "defective product, which must be sorted out in any case and not allowed to remain in the process".

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