Production and Post Production feedback - ISO 13485

Castaway99

Involved In Discussions
#1
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Would some one have templates for gathering data from production & post production activities.
Even otherwise need help on what to look for.
Also are the words 'Post production' and 'Post market' synonymous?
Thanks.
 
Last edited:
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Tagin

Trusted Information Resource
#2
Would some one have templates for gathering data from production & post production activities.
Even otherwise need help on what to look for.
Also are the words 'Post production' and 'Post market' synonymous?
Thanks.
To me, 'Post production' and 'Post market' are not necessarily synonymous. Post-production could include storage and transport, both of which could impact a product before the customer receives it.

We are 9001, not 13485, so our feedback template may be too simple - it has:
  • feedback date
  • customer information
  • type: positive/neutral/negative
  • feedback description
  • resolution type: escalate to corrective action, resolved immediately, no action required, etc.
  • resolution description
  • any feedback docs (e.g., an email from a customer) are attached to the feedback record.
 

yodon

Staff member
Super Moderator
#4
@Tagin is putting you on the right track. But are you JUST interested in the feedback process or, more broadly, production and post-production information to use in managing risk?

The list provided is good. I'd probably add (or at least consider adding):
  • product in use description (revision, software version running if applicable, etc.)
  • use environment (sometimes asking such questions, you may learn of new use scenarios previously not considered)
  • If the feedback was a complaint (and, if so, linkage to any complaint management)
  • some way to monitor for trends (e.g., if the feedback is relative to a particular component or aspect)
As an aside, feedback should be actively pursued and not just passively received.

The standard also indicates part of the feedback process should gather information on the production side of things as well. Things like scrap rate, percent of / trends in failed in-process or final acceptance tests, trends in rework, etc. should all be considered here.
 

Castaway99

Involved In Discussions
#5
Thanks. That was very useful as well. :agree1:
Especially:
'The standard also indicates part of the feedback process should gather information on the production side of things as well. Things like scrap rate, percent of / trends in failed in-process or final acceptance tests, trends in rework, etc. should all be considered here'.
 
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