Control of Records - Differences between Controlled Documents and Controlled Records

[Cellardoor]

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

Jim Wynne,

Thank you again for your reply.

"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 was referring to situations where we have a report for about 20 pages about, say, user friendliness, and then realize that we have missed something. So we update the document or add an amendum and then store the documents electronically.
In these cases how do we separate the first version from the updated version, in order to know which one is the latest and is valid?

 

[John Broomfield]

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

Jim Wynne,

Thank you again for your reply.

"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 was referring to situations where we have a report for about 20 pages about, say, user friendliness, and then realize that we have missed something. So we update the document or add an amendum and then store the documents electronically.
In these cases how do we separate the first version from the updated version, in order to know which one is the latest and is valid?

Cellardoor,

Are you talking about work in process or completed, reviewed, approved and issued reports?

What is the status of these documents and records?

John

 

[Cellardoor]

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

I was referring to a record that has been reviewed, approved and issued, where we after its approval realize that something is incorrect and needs to be changed or added.

 

[John Broomfield]

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

Cellardoor,

We've recommended issuing addenda for correcting nonconforming reports.

Are these reports your products and are you planning to use these addenda to improve the reporting process?

If so, you could uniquely number each addendum as nonconforming product with a record of the nature of each nonconformity per clause 8.3. Corrective action may then follow to stop recurrence of the biggest types of report nonconformities (in terms of frequency and impact) per clause 8.5.2.

You would then be able to monitor the effectiveness of your process for stopping recurrence of report nonconformity per clause 8.2.3.

John

 

[Jim Wynne]

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

Jim Wynne,

Thank you again for your reply.

"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 was referring to situations where we have a report for about 20 pages about, say, user friendliness, and then realize that we have missed something. So we update the document or add an amendum and then store the documents electronically.
In these cases how do we separate the first version from the updated version, in order to know which one is the latest and is valid?

Is there a particular reason that the records/reports must be considered complete and final at any stage? If you need to keep track, why not add a table at the end wherein changes/additions are documented, and just discard previous versions? It's hard to say without being more familiar with the context. My thought is that if the current state of the record reflects reality in all significant aspects, and is sufficient to be useful (if need be) in the future, you might be making this more complicated than it needs to be.

 

[Pancho]

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

I was referring to a record that has been reviewed, approved and issued, where we after its approval realize that something is incorrect and needs to be changed or added.

The new version of ISO 9001 (2015) will make no difference between control of records and of other documents.

Records can be changed, but you need to be specially careful with version control so that you don't lose information.

Record changes are very common in my field, construction: Building plans and specs are records. They often have numerous revisions before and after initial client approvals, after construction begins, and occasionally even after the project is done. Traditionally, a table on the record summarizes changes, and bubbles or other markings indicate them in the content. With electronic control, all versions and detailed notes of changes are always available. If upon inspection you discover that something does not meet requirements, having records of changes (the revisions) may allow you to trace the immediate and root causes of the NC. Without them, you'd be lost.

Plan revision annotations are like the addenda mentioned above. You always want to record what will allow you to demonstrate conformance to requirements. That's why they are called "records".

 

[John Broomfield]

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

Pancho,

I've always seen construction specs and drawings as documents subject to revision until they are superseded when they become records.

One set of drawings may be marked-up to record the "as-built" condition for ongoing facilities management.

John

 

[Pancho]

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

Pancho,

I've always seen construction specs and drawings as documents subject to revision until they are superseded when they become records.

One set of drawings may be marked-up to record the "as-built" condition for ongoing facilities management.

John

Yeah, they do straddle the ol' line between docs and records. We think of them as records of the design process, as they provide evidence that the design work was done following the client's requirements. But they are also a "procedure" or "instruction" for the builder. As you say, at the end of the job, the "as-builts" provide evidence of how the building was actually built. When the designer and builder are the same company, then the document is both a record and an instruction.

Same sort of thing applies to "work orders", "material requisitions", "shop drawings" and many other such "documented information". These instructions/records/informations get revised often, provide instruction, and also provide evidence of compliance. Maybe that's why the line between docs and records is being done away with in the new revision of the standard.

 

[John Broomfield]

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

Pancho,

Yes, I had not though of that.

The designer's records become the contractor's documents.

Both are documents of course, as ISO 9001:2008 attempted to clarify by saying records are a special type of document.

I agree that the generic term "documented information" is better.

John