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Deviation from requirements for batch identification

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Guest user Created:   Feb 04, 2019 Last commented:   Feb 04, 2019

Deviation from requirements for batch identification

I was wondering if you can tell me about the categorization of a finding regarding batch identification
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Verlene Law Feb 04, 2019
What I mean is: what will happen in an audit if the batch codification does not accomplish the requirements?
can you help me with this?

Answer:

During an audit, when there is a finding, the auditor would first want to know look at your documented procedure and followed by checking with you whether any appropriate justification can be provided for the deviation.

In the case of a minor deviation from the requirement, they would want to know whether any correction has been taken and documented in the form of CAPA. If this has been addressed appropriately, the auditor would likely put it as an observation.

In the case where no corrections are taken, the auditor would require a justification as to why no actions are being taken. A non conformity will be raised in which the auditee would be given a reasonable period of time to perform the corrections.

To know more about corrective actions please look at the following article:
-ISO 13485 continual improvement: Seven-step process for corrective and preventive actions- https://advisera.com/13485academy/knowledgebase/iso-13485-continual-improvement-seven-step-process-for-corrective-and-preventive-actions/
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Feb 04, 2019

Feb 04, 2019