ISO 9001 / ISO 13485 clause 8.3 | ISO 22716 Cosmetics GMP clause 13 – Control of Nonconforming Product / Deviations

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Deviations may arise as a result of but not limited to:

  • material/product – contaminated, out of specification
  • machine/equipment –  failed calibration,  validated operating parameters violated
  • method/procedure – approved process not followed
  • personnel error – not appropriately trained or failing to comply with training requirements,
  • environment – environmental monitoring (temperature/humidity/pressure), water, bioburden etc

There are a number of steps to be performed when Nonconforming product is detected:

1)    Contain the Product 

Affected material must be appropriately labelled and where applicable, controlled electronically immediately to prevent misuse.

2)    Investigate and Determine Root Cause 

The investigation should identify the root cause. Any other potential lots affected should also be identified and contained if required. Tools such as the Five Why’s Analysis and Cause and Effect Diagrams can be used to determine root cause.

3)    Assessing impact 

A risk assessment indicating impact to product quality/patient safety should be performed to determine disposition.

4)    PREPARE ACTION PLAN

Once the root cause has been established, the action plan (corrective action) is developed. Objective evidence of any corrective action must be documented.

5)    VERIFICATION OF ACTIONS

Once the corrective action has been implemented, activities undertaken to verify the effectiveness of the action(s) taken shall be performed. Verification activities may include:

  • Reviewing relevant records (training) etc.
  • Conducting audits
  • Review of data

A final disposition of product is performed following the investigation.

Note: When nonconforming product is identified as rework, a re-verification of the nonconforming product after rework should be performed to ensure that the reworked product meets all applicable requirements. A determination of whether there are any adverse effects of rework on the product should be performed.

Nonconforming product should be reviewed as part of management review.

About CMS:

Compliance Management Solutions is a Melbourne based consultancy assisting organizations in obtaining and maintaining TGA (medicinal products and medical devices ISO 13485) | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 | AS/NZS 4801 (OH&S) | ISO 14001 (Environmental) certification and registration