ISO 13485:2016 ¶ 8.2.1 - How can we obtain feedback for production activities?

#1
Hi everyone,

Can somebody give me examples of feedback from production activities? as opposed to post-production? The latter is customer feedback, comments and suggestions. How can we obtain feedback for production activities?

Thank you!:thanks:
 
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Marcelo

Inactive Registered Visitor
#2
#3
Did you find the answer to this question? I was wondering the same thing in regards to the gathering of data from production. What is difficult to interpret is what the standard means in relation to the first paragraph in 8.2.1. That passage states that organizations shall monitor information "relating to whether the organization has met customer requirements."

Is the feedback obtained from production intended to be simply the gathering of mid-production non-conformances? If so, wouldn't this be redundant since non-conformances should be looked at during the non-conformity review and the CAPA process (see 8.3.3 and 8.5.2 b)? Or does the standard intend to ask for more than that since it was not in the 2003 version and it now the concept of production feedback is now within 8.2.1? Since it is in the feedback section, does the standard intend for organizations to establish a method to survey their production staff?

Ultimately, what I am trying to figure out is if the standard is asking for my QMS to either:
1. the establishment of a separate feedback process to obtain data from production or
2. restate what it has already asked for, but revise my QMS to clarify that non-conformances should be considered as feedback from production.
 

Mark Meer

Trusted Information Resource
#4
...Ultimately, what I am trying to figure out is if the standard is asking for my QMS to either:
1. the establishment of a separate feedback process to obtain data from production or
2. restate what it has already asked for, but revise my QMS to clarify that non-conformances should be considered as feedback from production.
I think it's just referring to analysis of whatever production data you collect (NCs, employee performance, etc.). So, #2 (though I don't think it's necessary to revise the QMS if you've already already got established systems for collection and analysis of this data such that it "feeds back" into the system).

I agree that there's redundancy with other clauses, and framing in the context of "meeting customer requirements" requires a degree of separation -> meeting production requirement developed to meet customer requirements.
 

JoshuaFroud

Involved In Discussions
#5
We have interpreted this to be predominantly analysis of data but also direct verbal feedback from our production staff. Issues seen by the production staff during manufacture are fed back to the production manager that presents a summary of production issues at the Management Review meetings and included in our PMS activities.
 
#6
Thanks for the confirmation. This is very similar to what we do now. We actually have a "production issue" form (also used for improvement suggestions) in which will I will just need to revise our feedback procedure to explicitly state that the review of these will be used to satisfy the production feedback requirement.
 
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