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Production data in 8.2.1 Feedback

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Guest user Created:   Aug 29, 2019 Last commented:   Aug 29, 2019

Production data in 8.2.1 Feedback

Sec. 8.2.1 feedback- contains a requirement to document the requirement for the feedback process. "This feedback process shall include provisions to gather data from production as well as post-production activities." While customer feedback of post-production activity is well understood, my question is related to the production data. what is expected from production data with regards to the feedback process? Dose is related to how the company react and respond to feedback and trends
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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
Kristina Zvonar Brkić Aug 29, 2019

Answer:
The following production data can be collected as part of a feedback: any non-conformities from the prodution process or any other issues seen by the production staff during manufacturing, measuring different production elements related to production optimization, monitoring of production parameters (eg line speed, percentage of scrap, equipment failure time due to failure and the like). You are responsible for what parameters will be monitored for this purpose.

If you need some more detailes how to implement requirement 8.2, please read the art icle on the following link.
https://advisera.com/13485academy/blog/2018/09/20/how-to-comply-with-section-8-2-monitoring-and-measurement-in-iso-134852018/
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Aug 29, 2019

Aug 29, 2019

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