Process Control - The Requirement for listing references in Work Instructions

Scott

S/W QUALITY
#1
What is the requirement for listing references in Operating/Work Instructions?

Just got certified under the 94 standard and there is some confusion as to exactly what is needed and where they should be placed in the document.

Thanks,

Scott
 
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A

Al Dyer

#2
I don't think there is a requirement for placement of references, we just make a notation where ever it seems to fit.

We may be on line 13 of an instruction and say something like:

"Use form number XXX to log this activity"

Just my opinion, but I think 99.9% of work instructions should be totally self sufficient with no need to look for any other information, other than what forms/records need to be filled out as evidence.

I guess what concerns me is that you are asking a question like this after you just got certified.

I'm still a little confused, maybe some more detail on your document structure?

:)
 

Scott

S/W QUALITY
#3
REFERENCES

Thanks for the feedback.

We just got certified/registered last month and the confusion really came from the auditor himself. We had a pre-audit visit in May where he told us that references should be embedded in the Work Instructions (paragraph level) plus be listed at the end of each document. To emphasis this definition of reference we might have one WI that speaks to another so we have to reference the one in the other (according to the auditor). I guess my real question is: Are References Required at all in procedures?

Now he comes back for the audit and says they only have to be at the bottom of each WI. To me, this kinds of defeats the idea of a standard.

Since we will see him every 6 months for a Survelience Visit we want to be ready to argue the standard and not subjecture.

Thanks again,
 
A

Al Dyer

#4
Re: REFERENCES

Originally posted by kempsw
Thanks for the feedback.

We just got certified/registered last month and the confusion really came from the auditor himself. We had a pre-audit visit in May where he told us that references should be embedded in the Work Instructions (paragraph level) plus be listed at the end of each document. To emphasis this definition of reference we might have one WI that speaks to another so we have to reference the one in the other (according to the auditor). I guess my real question is: Are References Required at all in procedures?

Now he comes back for the audit and says they only have to be at the bottom of each WI. To me, this kinds of defeats the idea of a standard.

Since we will see him every 6 months for a Survelience Visit we want to be ready to argue the standard and not subjecture.

Thanks again,

Sorry, I cant find the applicable ISO document number that addresses your situation, but you can find it in the ISO website. (Use the search engine here). I believe it is ISO-11007???

It discusses the structure of documents and what is required. When I find it I will post it.

What worked for us was:

-Policy references related procedures.
-Procedures reference related instructions.
-Instructions referenced related forms and documents which led to records.

There is a certain general structure to be followed for procedures.

I can't post examples as they are too large, but as said before, they are in the PDF site and even better the member access area.

E-mail me if you like, I seem to be rambling at the moment!

Any help out there????

:bigwave:
 

E Wall

Just Me!
Super Moderator
#5
Content Dependent

This issue will have to rely on the structure of your documents. It is always best to link related documents so when any changes are needed you are reviewing all the releveant written information (so nothing is overlooked). Having references is also helpful in audit situations.

We have material and product specs which come from on high (corp office), the plant WI are 'process' outlines that also refer (as needed) to higher spec documents, to other WI and detailed SOPs, and to record (form use) requirements. This is done to avoid redundancy and simplify matters so you are not updating several documents for one change.

We us this general outline format for all WI:
1. Purpose/Scope
2. References
3. Responsibilities
4. General (expands to ther section #'s as needed depending on the complexity of the WI.
X. Revision History (X = last section - apply whatever # is applicable for each WI)

The section 2 is a listing of all references (by name & title) called out in the 4 + sections (by # only).
 
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