Control of Records - Differences between Controlled Documents and Controlled Records

Cellardoor · May 20, 2014

I have a question regarding the difference between controlled documents and controlled records, and version control of records. I work in a small med tech company (self-care for diabetics), and our production is outsourced.

As far as we understand the standard ISO 13485 wants us to decide one set of rules for how we control documents (?4.2.3), and another set of rules for how we control records (?4.2.4). Controlled documents are documents setting rules and requirements, while records are documents that show evidence that we really do follow rules and fulfil requirements. Records should not be amended. Correct?

However, we sometimes find it difficult to determine if a certain document should be controlled as a document or as a record. For example Quality Policy or Risk Management File or a Quality Agreement with a supplier. They represent decisions made, but may be constantly updated, right?

It should here be mentioned that since our production is outsourced and we sit in our main office, our records are not ?classical? records such as calibration records, but rather longer test reports and decisions made. In these cases it very well can be that we realize that something should be added or changed to the record after its release.

Furthermore, some people in the company also want to be able to version control records, for example if we need to update a record with some information after it has been released.

Is it possible to version control records, or should we rather release a new record with a new date in these cases?

John Broomfield · May 20, 2014

Re: Control of Records - Differences between Controlled Documents and Controlled Reco

Cellardoor said:
I have a question regarding the difference between controlled documents and controlled records, and version control of records. I work in a small med tech company (self-care for diabetics), and our production is outsourced.

As far as we understand the standard ISO 13485 wants us to decide one set of rules for how we control documents (?4.2.3), and another set of rules for how we control records (?4.2.4). Controlled documents are documents setting rules and requirements, while records are documents that show evidence that we really do follow rules and fulfil requirements. Records should not be amended. Correct?

However, we sometimes find it difficult to determine if a certain document should be controlled as a document or as a record. For example Quality Policy or Risk Management File or a Quality Agreement with a supplier. They represent decisions made, but may be constantly updated, right?

It should here be mentioned that since our production is outsourced and we sit in our main office, our records are not ?classical? records such as calibration records, but rather longer test reports and decisions made. In these cases it very well can be that we realize that something should be added or changed to the record after its release.

Furthermore, some people in the company also want to be able to version control records, for example if we need to update a record with some information after it has been released.

Is it possible to version control records, or should we rather release a new record with a new date in these cases?

Cellardoor,

Your current policy and other management system docs are documents subject to revision control.

Superseded docs can be filed/archived as records.

Blank forms are documents (subject to revision control) and completed forms are records controlled for retrievability by a unique identifier recorded on the form.

We do not revise our records. Indeed, organizations have gotten themselves into a lot of trouble revising their records.

Your supplier's docs are subject to revision but you may not receive updates unless you have electronic access or you are on their distribution list per your purchase order. Once the subcontract or purchase order is fulfilled these docs are filed/archived as records.

I hope with these examples you understand that docs are subject to revision and records are not.

John

Cellardoor · May 21, 2014

Re: Control of Records - Differences between Controlled Documents and Controlled Reco

Dear John,

Thank you so much for your reply. However, I have some further questions:

1) You say that companies "have gotten themselves into a lot of trouble revising their records". We would like to know, what troubles exactly? Could you give any examples?

2) What kind of unique identifier do you use to control records for retreivability?

3) How do you solve a situation where you need to file a report (like a study report or test report) and find out after its release that information should be added?

John Broomfield · May 21, 2014

Re: Control of Records - Differences between Controlled Documents and Controlled Reco

Cellardoor said:
Dear John,

Thank you so much for your reply. However, I have some further questions:

1) You say that companies "have gotten themselves into a lot of trouble revising their records". We would like to know, what troubles exactly? Could you give any examples?

2) What kind of unique identifier do you use to control records for retreivability?

3) How do you solve a situation where you need to file a report (like a study report or test report) and find out after its release that information should be added?

Cellardoor,

1) Arthur Andersen in their dealings with Enron
2) Job Number, Sample Number, PO Number, CAR Number etc...
3) File the addendum with the original report but keep the original approved report unchanged

John

Jim Wynne · May 21, 2014

Re: Control of Records - Differences between Controlled Documents and Controlled Reco

John Broomfield said:
<snip>Blank forms are documents (subject to revision control) and completed forms are records controlled for retrievability by a unique identifier recorded on the form.

Blank forms or templates don't necessarily have to be controlled. What needs to be controlled in most instances is the information that gets recorded. This can be controlled by a document that specifies the required information.

John Broomfield said:
We do not revise our records. Indeed, organizations have gotten themselves into a lot of trouble revising their records.

"We" do change records when records are known to contain inaccurate or inadequate information. The method of changing records needs to be strictly controlled.

John Broomfield · May 21, 2014

Re: Control of Records - Differences between Controlled Documents and Controlled Reco

Jim,

Blank forms usually specify the data to be collected and as such they are controlled. A blank form could come with a separate instruction (like the 1040) but the form has to align with the instruction.

As to "changing" records, broadly speaking these strict controls specify that records may be supplemented with other facts provided the original record remains legible or retrievable.

John

Jim Wynne · May 21, 2014

Re: Control of Records - Differences between Controlled Documents and Controlled Reco

John Broomfield said:
Jim,

Blank forms usually specify the data to be collected and as such they are controlled. A blank form could come with a separate instruction (like the 1040) but the form has to align with the instruction.

In many cases a blank form or template can be considered a convenience rather than a necessity so long as the information required is recorded.

John Broomfield said:
As to "changing" records, broadly speaking these strict controls specify that records may be supplemented with other facts provided the original record remains legible or retrievable.

Sometimes what is believed to be factual turns out to be wrong for one reason or another. Records can be altered to show correct information if the recorded information is known to be wrong. Supplementing records with additional information is a separate category, although both the addition of information and the editing of existing information need to be strictly controlled. We need to get past the idea that records can never be changed.

Cellardoor · May 21, 2014

Re: Control of Records - Differences between Controlled Documents and Controlled Reco

Jim Wynne,
Thank you for your reply. I now have a few further questions for you:

If records can be changed, how do you know which one is valid? In case of documents you'll know that if you can find version 5, version 4 is obsolete, but how does that work with records?

I am also curious about how you control the addition/editing of information to existing records?

Jim Wynne · May 21, 2014

Re: Control of Records - Differences between Controlled Documents and Controlled Reco

Cellardoor said:
Jim Wynne,
Thank you for your reply. I now have a few further questions for you:

If records can be changed, how do you know which one is valid? In case of documents you'll know that if you can find version 5, version 4 is obsolete, but how does that work with records?

I can't think of a type of record where the situation you describe might apply. Records are normally dated or somehow linked to something else that's dated. Can you give an example?

I am also curious about how you control the addition/editing of information to existing records?

It's controlled by specifying who may edit or supplement a record, the circumstances under which editing is required or permissible, and the method(s) to use. For example, if a data entry form is found to have an incorrect entry (as the result of a typo, e.g.) you might specify that the incorrect entry is to be ~~lined through~~ such that the original entry is still legible, with the correct data entered next to it, and the correction is initialed by an authorized person.

Bev D · May 21, 2014

Re: Control of Records - Differences between Controlled Documents and Controlled Reco

other ways to revise (not alter) or update or correct an existing record is to add an addendum (this is the approach taken when some revising records that are generated using ERP other software programs...).

the addendum typically has an explanation for why the revision is valid and necessary. hte origianl version and the addendum may be physically attached if they are in paper form or 'linked' if they are in electronic form...

there are other ways that wrok too. the idea is to maintain the visibility of the original data, have a valid documented reason and keeping 'together' somehow (virtually or actually)

Control of Records - Differences between Controlled Documents and Controlled Records

Cellardoor

John Broomfield

Cellardoor

John Broomfield

Jim Wynne

John Broomfield

Jim Wynne

Cellardoor

Jim Wynne

Bev D

Heretical Statistician

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