Control of Records - Retention Time vs. Retention Period

x-files

Involved In Discussions
Hi,

I saw many documentation samples that are addressing Control of Records. When the "retention" is about to be expressed, I saw that someone said something like (sorry for bad translation) "5 last copies/revisions", "Till the IMS exists", etc.

I expected a time period on that place, but I've also found interesting that way of expressing the "retention", when it has sense, of course, not always.

Is that way of expressing retention correct?

Second question. If I have a subtitle called "Records" at the end of every procedure in our IMS, and filled table with all relevant columns for "the identification, storage, protection, retrieval, retention and disposition of records." for the concrete procedure, do I still need a separate documented procedure for Control of Records?

If yes, what is missed?



Best regards,
Vladimir
 

JLyt207

Involved In Discussions
1. We also use number of revisions. I inherited the system so it wasn't my decision but I see the concept. It may be more important to see the history of the changes rather than what it happened to be at a certain date.

2. I will let others answer this one. We use a single written procedure for control of docs. I think it is easier to work with than having it repeated on all other procedures. However, I don't know how auditors feel. It appears you meet the requirement by having the procedure documented.
 

x-files

Involved In Discussions
1. We also use number of revisions. I inherited the system so it wasn't my decision but I see the concept. It may be more important to see the history of the changes rather than what it happened to be at a certain date.
Thanks for sharing your experiences.
2. I will let others answer this one. We use a single written procedure for control of docs. I think it is easier to work with than having it repeated on all other procedures. However, I don't know how auditors feel. It appears you meet the requirement by having the procedure documented.
Note, that I'm referring to "Control of records" not documents. I work in a company with 3000 employees. Processes, procedures and related records are displaced geographically.

In short, my question is - if I ensure that all records related to the process (procedure), are listed (documented) inside that procedure in a table manner, with mandatory data (columns) for "the identification, storage, protection, retrieval, retention and disposition of records.", do I still need a separate documented procedure for Control of records? If yes, what else should that procedure say what is not said in the table header of records' list?

Best regards,
Vladimir
 

Marc

Fully vaccinated are you?
Leader
"Documents" are not "Records" per se. A procedure is a document. Past versions of procedures is one issue where you could call them records, but that is a gray area. Note that in regulated industries (e.g. pharma, medical devices, aerospace, etc.) federal, state and/or local regulations may define to how many revisions of a procedure (or work instruction, etc.) you have to keep and for how long.

Records are a different thing in the normal sense of the word. A Record may have started out as a "document" as a form. It officially becomes a Record when data is entered on it. As above, in regulated industries (e.g. pharma, medical devices, aerospace, etc.) federal, state and/or local regulations may, and often do, define how long you have to keep different records.

For all intents and purposes, Retention Time == Retention Period

Question 2. As long as there is a documented policy or you have written somewhere such as within document(s) you can avoid a specific procedure, in my opinion. BUT - Again, as above in regulated industries (e.g. pharma, medical devices, aerospace, etc.) federal, state and/or local regulations may, and often do, require a documented procedure.

As a last thought, you can have a documented procedure titled something like "Control of Documents and Records" in which both are addressed. My personal "taste" is separate procedures, but that's just me.
 

phoenix2368

Starting to get Involved
I agree with Marc to have separate procedures for control of documents and control of records.
As i see an issue in medical devices, Some times you have to keep the records for a longer time conditioned to when the last batch was sold , how long you kept it. and what is the life time of product. so you are keeping some records for indefinite periods ( Because it depends when your last batch of certain device was sold and you have to retain its record for minimum 2 years as per FDA's requirement.
SO it is better to have separate procedures.
 
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