NQA-1 Quality Manual vs. Standard - How much should they differ

R

rgunn1

#1
In putting together my NQA-1 Quality Manual / Quality Program Description, I am finding that my manual almost directly mirrors the NQA-1 document.

To me, this is the logical approach. Look at the requirement, and then attest to our adherence to the requirement. If there is a question about the regulation, our policy is under the same exact section in our manual. There are several areas where I have to elaborate, especially when defining responsibilities, but there are several areas, such as Lead Auditor Qualifications, where my manual is almost word for word the with the NQA-1 standard. I don't really see much of a way around it, or much of a point in trying to find a way to re-arrange the words.

Is this acceptable or commonplace? To what degree should my quality manual differ from the standard that we are adhering to? At the end of the day, we still have individual procedures to direct our processes.

I almost want to put one of my company stickers on the front of this NQA-1 standard, sign the front page, and call it an early evening.:bigwave:
 
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SteelMaiden

Super Moderator
Super Moderator
#2
The one's that I have seen pretty much spit back the standard, but I do not have the knowledge or the experience to tell you that is the "correct" way. :tg:
 
H

Hemi999

#3
Most auditors for NQA1 look for more then a rewording of the NQA1 document and will more then likely reject it just for that reason. What they want to see is more detailed then what is in the NQA 1 document and for it to be more directed to your orgaization.
I do NQA 1 programs and would be interested in additional discussions.


Moderator note: Jim can be contacted through information in his User Profile: Hemi999.
 
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C

crager34

#4
Yeah... I know I am late into this thread.

My experience has been your QA Manual should closely mirror the NQA-1 standard. Nothing wrong with verbatum compliance and if an auditor doesn't like it, that is their opinion and holds no weight. When you work on your Standard Operating Procedures, that is where the details come out and using the Non-Mandatory section of NQA-1 will help in their development. If more detail is needed, then Work Instructions can be developed.
 
H

Hemi999

#5
As a Lead Auditor for over 30 years and program developer when a supplier wants to be approved by a customer the frist issue is a program that describes the program you have and that it is unique to the prcesses that your program is describing. If it mirrors the NQA 1 document the reviewer is less apt to going to ask for clarification or they may just reject the program all together.
Your program is to comply with the NQA 1 requirement but even more important it is to get your prospective customer to accept your program.
ISO allows for a manual to be a copy of the ISO document NQA 1 is a different pholosipy and requires a discription of how your program will meet the requirements not just copying the NQA 1 document.
 
C

crager34

#6
If the written program meets the standard requirements, whether it be using the closely mirrored verbiage of the standard or by some other descriptive means, it still meets the requirements. If the auditor doesn?t like it, it just doesn?t matter because it meets the standard requirements.

I can?t take NQA-1 and make it the property of XYZ company. I have to write a program that meets it. Again I say: Start with a Manual that closely mirrors the standard, and then develop the procedures. The procedures are where the majority of the company specifics should come out. In other words: "describes the program you have and that it is unique to the prcesses that your program is describing"
 
H

Hemi999

#7
NQA 1 Requirement 2, paragraph100, state in part (a) ? The program shall identify the activities and items to which it applies.
The program shall provide control over activities affecting quality to an extent consistent with their importance.
The program shall include monitoring activities against acceptance criteria in a manner sufficient to provide assurance that the activities affecting quality are performed satisfactorily.
The program shall provide for the planning and accomplishment of activities affecting quality under suitably controlled conditions. Controlled conditions include the use of appropriate equipment, suitable environmental conditions for accomplishing the activity, and assurance that prerequisites for the given activity have been satisfied. The program shall provide for any special controls, processes, test equipment, tools, and skills to attain the required quality of activities and items and for verification of that quality. The organization shall establish and implement processes to detect and correct quality problems.

To meet this requirement copying NQA 1 and using it as your manual will not be sufficient. You must write the manual to reflect the uniqueness of your company and describe how your program meets the NQA 1 requirement.
 
C

crager34

#8
[FONT=HelveticaTo meet this requirement copying NQA 1 and using it as your manual will not be sufficient. You must write the manual to reflect the uniqueness of your company and describe how your program meets the NQA 1 requirement. [/FONT]


Agreed. An organization should not "copy" NQA-1 and use it as their manual. Using the same verbiage as NQA-1 in a QA manual while reflecting the uniqueness of the company and describing how the program meets the requirements (closley mirroring) is acceptable.

Trying to find other words to describe the requirements is akin to reinventing the wheel and could potentially lead to interpretation issues.

NQA-1 = The program shall provide control over activities affecting quality to an extent consistent with their importance.

Company XYZ = Company XYS's QA program shall provide control over activities affecting quality to an extent consisten with their importance.
 
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