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Mock recall exercises as a requirement

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Guest user Created:   Apr 26, 2019 Last commented:   Apr 26, 2019

Mock recall exercises as a requirement

"I have a question regarding clause 8.5.2 under ISO 9001:2015…are mock recall exercises are requirement or it is enough just to be able to demonstrate traceability when requested during an audit?”
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ISO 9001 DOCUMENTATION TOOLKIT

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ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Carlos Pereira da Cruz Apr 26, 2019

Answer:
If legislation in your country demands a mock recall exercise, or if a client demands it, then it will be a requirement. If there is no such demands, mock recall exercises are not mandatory.

The following material will provide you information about recall situations:
- ISO 9001 – The February 2016 Mars Chocolate Bar Recall – A Case Study from an ISO 9001 perspective - https://advisera.com/9001academy/blog/2016/03/15/the-february-2016-mars-chocolate-bar-recall-a-case-study-from-an-iso-9001-perspective/
- GM ignition switch recall vs. sunroof recall: An ISO 9001 case study - https://advisera.com/9001academy/blog/2015/04/14/gm-ignition-switch-recall-vs-sunroof-recall-an-iso-9001-case-study/
- Free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- book - Discov er ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

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Carlos Pereira da Cruz Apr 26, 2019

We've received another question:

> Clause 8.6 reads, “…documented information shall include evidence of conformity with acceptance criteria”. We have several items (width, length, outer diameter, flatness, visuals) that are inspected at one point in our operation. These items have defined specifications; however, the results of the checks are not recorded anywhere. Operations says the record is the ‘G’ grade in the system. I am interpreting that clause (and in consultation to my well-worn ISO 9001:2015 in Plain English) to mean we have to record evidence of both the check and its associated result. What are your thoughts?

Answer:
If your acceptance criteria are a variable, then the associated results should be recorded as evidence. If your acceptance criteria are an attribute, then the result is OK or NOK. I have another issue to mention here: your organization inspects 5 items, imagine that 4 are OK and one is NOK, what is the final decision, is the product as a whole OK or NOK? As auditor I find that some organizations left cases like this in a limbo. That is not ac ceptable, there should be a clear final decision about the conformity or not conformity of the product.

The following material will provide you information about quality control:
- ISO 9001 – ISO 9001: Requirements for the release of the product or service - https://advisera.com/9001academy/blog/2017/03/28/iso-9001-requirements-for-the-release-of-the-product-or-service/
- Free webinar – Measurement, analysis, and improvement according to ISO 9001:2015 - https://advisera.com/9001academy/webinar/measurement-analysis-and-improvement-according-to-iso-9001-2015-free-webinar/
- free course - ISO 9001:2015 Lead Implementer Course - https://advisera.com/training/iso-9001-lead-implementer-course/

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Apr 26, 2019

Apr 26, 2019