"Caught between QA and production team"
Sharing my experience: there was a quality judgement discrepancy between production team and QA, referring to the their own version of quality plan checklist which cascaded down by senior members years ago.
None of the production team and QA members can answer why it was written that way and what is the underlying rationale.
After spending some time investigating the matter we finally come to realize that the discrepancy is due to the edition change of the relevant IEC standard, which one referring to the older requirement while the other one did not cite edition source of the requirement.
After this matter a company-wide review of relevant IEC standards is conducted at least annually to align all checklists are up-to-date.
It is therefore citing the relevant standard and its edition helps a lot to minimize misunderstanding across different function.
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Richard Tan Yong Jin NCE
Regulatory Compliance Manager
FBAP
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