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Retention of QMS Plans and Reports

contigo123

Starting to get Involved
#1
Hello,
Just wondering if anyone can give advice related to storing plans and reports related to the QMS that don't really fit anywhere else and don't use a standardized template (for example: a plan with activities needed to address a standard change, and a final report summarizing what was done). I'm thinking to create a "report" record type to manage these records, but do I need to have a procedure that governs these reports? Maybe I put together a cover page for each "report", and then keep a log of all the reports? I'm probably overthinking this, but the goal here is just to formally file plans/reports.
Thank you!
 
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indubioush

Quite Involved in Discussions
#4
It seems like you are talking about gap analysis records. You should have a documented method for performing a gap analysis when external standards change. These records should be filed in an organized way. For example, you could organize them based on the external standards number. As an alternative, you can attached the gap analysis to the change record in which the associated quality system documents change. You can also make quality plans controlled documents like any other quality documents. You can assign project numbers and file records under each project number. Many options here. As long as you make the records easily retrievable and protect them from loss, etc., you should be okay.
 

yodon

Staff member
Super Moderator
#5
Sounds like you may be making things a bit too complex. For changes to QMS docs, the change management requirements are outlined in 13485 4.1.4 and 4.2.4. Something simple as a change authorization (capturing the information required by those 2 sections mentioned), a copy of the markup (what was done), review (change verification), and approval should suffice. As @indubioush notes, there are multiple ways to approach this.

Do you have any change request / management software (Jira is pretty typical)? You can set it up to prompt for the required information and capture all the relevant information. If you have an electronic QMS system, it can also help (or take over) here.
 

contigo123

Starting to get Involved
#6
It seems like you are talking about gap analysis records. You should have a documented method for performing a gap analysis when external standards change. These records should be filed in an organized way. For example, you could organize them based on the external standards number. As an alternative, you can attached the gap analysis to the change record in which the associated quality system documents change. You can also make quality plans controlled documents like any other quality documents. You can assign project numbers and file records under each project number. Many options here. As long as you make the records easily retrievable and protect them from loss, etc., you should be okay.
Thanks, that is what I was looking for. I'm totally making this more complicated than it needs to be!
 
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