Why QA (quality assurance) shouldn't be in Operations

L

Leanmeister

#1
To all those QA folks out there:
I have been in the Quality Assurances since 1980 and have seen QA organizations go in and out of Operations control. The ISO standard and many other standards talk to independent assessment/verification and validation, objectivity, impartiality, etc.

Background:
We are merging with another division whose organization structure puts QA reporting to Operations. Both divisions are ISO certified. Our division QA was once under Operations but is now independent with a direct report to the GM. I need to make the case against this proposed structure but cannot use ISO to leverage.

The question I pose to all is:

Has anyone ever found a standard, reputable source that specifically states why Quality Assurance (or Product Assurance) is to be separate from Operations?

Aside from the old saying: "...because it's the Fox guarding the henhouse," this is an age old question to which I have never had a good answer.

Help!!!!!

Need ideas by Wednesday 1/25!:ca:
 
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Jim Wynne

Staff member
Admin
#2
Leanmeister said:
Has anyone ever found a standard, reputable source that specifically states why Quality Assurance (or Product Assurance) is to be separate from Operations?
I don't know of a specific standard source, but I've always believed that the requirement for Quality to be separate from Production is firm evidence that someone doesn't trust Production. If this is true--that Production can't be trusted--then there must be a fundamental reason that Production can't be trusted, and that reason will almost always lead back to top management. Why Production has been traditionally singled out for this honor remains a mystery; why are there never any inspectors in sales and marketing, or engineering?
 

Jim Wynne

Staff member
Admin
#4
psyched1 said:
This is a GMP requirement of the FDA that the quality function be seperated.
I'm not surprised. I had thought that perhaps it might be requirement in the old MIL standards (9858, e.g.) but I looked and didn't see anything. Do you (or does anyone) have a direct reference to the FDA requirement that the OP can use?
 
J
#6
Why?

Leanmeister said:
To all those QA folks out there:
I have been in the Quality Assurances since 1980 and have seen QA organizations go in and out of Operations control. The ISO standard and many other standards talk to independent assessment/verification and validation, objectivity, impartiality, etc.

Background:
We are merging with another division whose organization structure puts QA reporting to Operations. Both divisions are ISO certified. Our division QA was once under Operations but is now independent with a direct report to the GM. I need to make the case against this proposed structure but cannot use ISO to leverage.

The question I pose to all is:

Has anyone ever found a standard, reputable source that specifically states why Quality Assurance (or Product Assurance) is to be separate from Operations?

Aside from the old saying: "...because it's the Fox guarding the henhouse," this is an age old question to which I have never had a good answer.

Help!!!!!

Need ideas by Wednesday 1/25!:ca:
Why is it you feel you need to object to this arrangement?
Are there quality issues in the other division that you feel are tracable to this arrangement?
While I agree that Quality needs to be independent, and report to the highest level possible, I am curious as to why you feel this is unworkable?

James
 

psyched1

Involved In Discussions
#7
TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER C--DRUGS: GENERAL


PART 211 -- CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Subpart B--Organization and Personnel Sec. 211.22 Responsibilities of quality control unit.

(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.

(b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products shall be available to the quality control unit.

(c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.

(d) The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed.
 

Jim Wynne

Staff member
Admin
#8
psyched1 said:
TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER C--DRUGS: GENERAL


PART 211 -- CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Subpart B--Organization and Personnel Sec. 211.22 Responsibilities of quality control unit.

(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.

(b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products shall be available to the quality control unit.

(c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.

(d) The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed.
This doesn't say anything about who or at what level the "quality control unit" must report to, or whether it's OK or not for it to report to the same authority as production. What if does say is that the unit must have the responsibility and authority to do certain things, which responsibility and authority could derive from the same executive level as production.
 

psyched1

Involved In Discussions
#10
That is the nail one of our customers used to ding us when they found that our rewind department was managed by Production. So we added a dotted line of responsibility from QM to rewind and now everyones happy now.
 
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