Is it OK to reference a procedure in (or from) another procedure?

[Ingeniero1]

In addition to our 23 standard operating procedures, of which the six ISO 9001:2000 required procedures are part, we have work instructions. Nothing new or unusual here, and we do refer to these instructions in our procedures; sometimes specifically, and others in general terms.

Question 1:
Many of these detailed instructions, however, are much older that the 23 procedures, and when originally created, the word ‘procedure’ was included in their titles.

If things were left as they are, our new procedure number QP017, for Customer Complaints, for example, may reference a detailed instruction on how to archive the subject data and route it, which detailed instruction is presently called Procedure for Customer Complaint Data.

Do I have to or should I replace the word ‘procedure’ with ‘instruction’ or ‘guidelines’ from the existing titles of our numerous detailed instructions, or is it OK to use the word 'procedure'?

Question 2:
As you may imagine, we have generated zillions of work instructions or ‘procedures’ over the years. In some cases, there may be more than one that cover the same task, albeit from different perspectives or as part of something else.

Do we have to list or reference every one of these ‘instructions’ or ‘procedures’ within our 23 operating procedures? How serious of a ‘finding’ or non-conformance would it be if some are left unreferenced, whether on purpose* or by oversight**?

* Perhaps we have an instruction for a task that is not specifically mentioned by an operating procedure, so it really doesn't fit anywhere.
** Perhaps we have a detailed instruction somewhere in the system that we may honestly forget to reference even though it would fit perfectly within a procedure.

Thanks!

Alex

 

[Rachel]

Alex...

I see no problem with referencing procedures in other procedures. In fact, I see it as a necessity - the whole point of the process approach is to ensure that the interactions between processes and departments are captured. How could you do that without referencing other procedures? That's the point - very little is stand-alone.

We don't have references to every work instruction included in procedures. We have an entire set of packaging line instructions that are not specifically referenced - rather, the general packaging procedure gives the common steps in the process, and then says "package the product as per the appropriate packaging line instruction". In addition, we have several pieces of equipment that are used by the R&D and QA departments - these are used on an as-needed basis and are not mandated by any procedure. Makes sense - why would you test viscosity, for example, if it wasn't an important characteristic of your product? Why would you make UV stability testing a requirement if the product will not be used for a purpose that requires UV stability? So, these work instructions exist, yes - but they are not always referenced to a procedure.

Hope this helps.
Cheers,
-R.

 

[Greg B]

Alex,

I agree with Rachel. We don't have a FULL cross reference between all of our procedures, work instructions or forms. A lot of the understanding comes from training and experience. When I am auditing I ask the guys about their documentation and if it is evident that they do not know the parent document or the sister procedure then we may look at either cross referencing them or training the guys in their respective documentation

Greg B

 

[Ingeniero1]

Rachel:

... and then says "package the product as per the appropriate packaging line instruction".

That is exactly what I needed to know! I wondered whether referencing a group of instructions or sub-procedures would be acceptable. It seemed as it would have, as it does, but asking doesn't hurt.

Thanks !!

Alex

 

[Govind]

Ingeniero1:
Iam also in your situation. We have over 11,000 documents.When I took over the QMS responsibility, I found referencing of relevant procedures and Work instruction as one of the legacy issue.
Examples:
There were non relevant document referenced,
Relevant documents (internal,external) not referenced,
Document at level 3 referencing way up to Level 1 manual,etc.

I know that I cannot solve the world hunger. So I started focusing on Level 2 procedure, Core,Supporting Process work instructions (not product build type Work instructions).
Over the last 1.5 years I have been successful identifying and referencing the above. Next step would be to focus on Active products that are "early" in the Life cycle and start working on Work instructions that are Product build based.My estimation is this would cover the majority of business requirement.

Important things to keep in mind while referencing the Procedures and WI:

Maintain a matrix of the relationship between referenced procedures,WI similar to "Parent-Child" "Child-Sibling" relationship.This way when a document changes, we will be able to quickly review the impact on related documents.

If a document identified in the reference list is obsoleted, The "relationship matrix"
will identify the list of documents where this reference should be removed in next possible opportunity.

Regards,
Govind.