Do Forms and Templates ALWAYS become Records?

K

KChetzel

We're working on implementing equipment in our QMS.

We have an instance where the User Requirements Specifications (URS) is sometimes outside of the QMS and I'm wondering if we made a QS Doc Controlled template does the output of that template always become a controlled document?

We're working to manufacture combination products in the US, Canada, and EU and follow 21 CFR 11, 210, 211, 820 and ISO 13485:2016 closely among others.
 

jack770214

Involved In Discussions
All "records" classifications must be outlined in your record retention program or schedule. If it falls within the classification it is a record. The key idea is to meet your legal and statutory requirements first and then your QMS requirements for records, but only you can determine which records those are and the process is not easy.
 

Kronos147

Trusted Information Resource
If you have a form that is a phone list, it's not a record, it's a 'tool.'

'Records are special types of documents that provide objective evidence in support of a process...' or something like that.
 

AMIT BALLAL

Super Moderator
Document is one that you'll use as a reference, which can be modified on time to time basis and latest copy has to be available with the user. Once the document is revised, old copy of the document becomes obsolete.

Record on the other hand demonstrates that an activity is completed. For example inspection records will show that inspection is completed, photos of wedding will show that wedding is completed. Records once prepared cannot be tampered (Unchangeable). Records have to be retained.

Question is, whether all formats become records?
No. Some formats / templates become records and some become documents.
For example, the format used for list of telephone numbers will become a document, since you'll use it as a reference and whenever any number gets added / deleted, it has to be revised and latest copy has to be made available with the users.
On the other hand, format used for inspection will become record and has to be retained for a particular period of time based on the rules and regulation, customer requirements, etc.
 

Randy

Super Moderator
Simple question, simple answer....Only when they have been used to record information or have been archived as obsolete in their blank format.
 
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