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:

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?

This is a GMP requirement of the FDA that the quality function be seperated.

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?

This is a GMP requirement of the FDA that the quality function be seperated.Where is that in the regulation?

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

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.

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.

You won't find it because the FDA doesn't have that as a requirement.

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.

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.I don't understand how that relates to the issue of the QM not being allowed to report to Operations.

It is considered prudent, by some, that QA be autonomous. This so that they cannot be compromised. I have worked in both environments with QA being autonomous (answering to the President of the company) and where QA answers to production. The concept of course (IMO) is a myth as QA can be compromised in either environment.

I have had the President of a company offer the suggestion that "We will use these non conforming parts and for QA to make it as easy or as hard on themselves as they see fit. But make no mistake! We will use these parts." We of course used the parts and there was never any customer feedback that there was a problem.

It comes down to who is ultimately responsible for quality of product. Once that is established in the procedures the rest is easy.

It is considered prudent, by some, that QA be autonomous. This so that they cannot be compromised. I have worked in both environments with QA being autonomous (answering to the President of the company) and where QA answers to production. The concept of course (IMO) is a myth as QA can be compromised in either environment.

I have had the President of a company offer the suggestion that "We will use these non conforming parts and for QA to make it as easy or as hard on themselves as they see fit. But make no mistake! We will use these parts." We of course used the parts and there was never any customer feedback that there was a problem.

It comes down to who is ultimately responsible for quality of product. Once that is established in the procedures the rest is easy.Been there!

It is considered prudent, by some, that QA be autonomous. This so that they cannot be compromised. I have worked in both environments with QA being autonomous (answering to the President of the company) and where QA answers to production. The concept of course (IMO) is a myth as QA can be compromised in either environment.

I have had the President of a company offer the suggestion that "We will use these non conforming parts and for QA to make it as easy or as hard on themselves as they see fit. But make no mistake! We will use these parts." We of course used the parts and there was never any customer feedback that there was a problem.

It comes down to who is ultimately responsible for the quality of product. Once that is established in the procedures the rest is easy.

I have worked under similar circumstances, fortunately it was during my first job as a young QM. I learned that the President had the authority and responsibility for making management decisions. It was my responsibility to report to him the non-conformances and potential customer effects. Once stated and aknowledged, I supported his decision. Particularly after a couple time when we did not get any negative customer feedback. Also, a couple times I asked him to sign off on a deviatiion to ship NC parts. Once these were done it was over, no complaining or "told you so". These were not functional characteristics, but surface/visual NCs. We always treated each other with respect and professionally. He hired me to be in charge of the quality systems, but he was in charge of the buisness. That's why he got the big bucks:yes:

Good point Jim! It is the organization that decides who QA reports to, how that function is utilized, and why. A well run (managed) organization knows precisely the role of QA and how it is expected to benefit the company, whatever the reporting relationship. A poorly run outfit sticks some poor sap in that unenviable role because some consultant or (perceived) customer mandated standard says they must - and they haven't a clue how to handle him/her. So they hurtle him like a steelie in a pinball machine, to bounce around and cause a lot of sparks.

Also, every organization/industry functions differently, with a different look to the org chart. Who are we to condemn or praise any specific reporting relationship. The real question is: Is the org structure working or not? If not, will changing reporting relationships correct it, or is there some other root cause?

That's why no standard can mandate the pecking order. Jim is right; there is no true autonomy and no complete freedom from potential bias. That lies in the integrity of management and the hearts of the individuals placed in these areas of responsibility (QA or otherwise).

Several people have said it, but I'm going to chime in anyway. It totally depends on your corporate culture whether you can successfully integrate QA into production. We have several "QA functions" and they are all integrated into production. Of course, things like test results that are going to be reported to the customer are signed off by the product metallurgist, so he would communicate closely with the production supervisor and lab personnel if anything was not looking kosher. We don't have a quality dept. at all. Even my job as quality/ISO system coordinator is part of the administration dept. reporting directly to the general manager.

I don't understand how that relates to the issue of the QM not being allowed to report to Operations.

In the customer audit the customer quoted that section of the code stating that production and quality functions must be kept seperate.

I think Quality should actually be the result of production. Where that is not the case QA is neccessary.

In the customer audit the customer quoted that section of the code stating that production and quality functions must be kept seperate.

I think Quality should actually be the result of production. Where that is not the case QA is neccessary.That is not the same issue as the QM reporting to Operations. The QM can report to operations and the production and quality functions can still be separate because Quality does not perform production operations.

Just to clarify:
:truce: I am not opposed to Quality reporting to Operations.

During my 20+ years in defense electronics industry, there have been numerous flip-flops between Operations and direct reporting.

Usually, it occured when there was a change in management and/or reorganization (from downsizing - flattening).

I don't recall that it ever caused a problem related to product conformity or failure to meet customer requirements.

I am beginning to think that it more along the lines of management's budgetary decision.
Still, I was wondering what drives this organization structure.

I think I the situation Leanmeister describes, there's a lot of uncertainty. Big merger, new company cultures, lots of unknowns. I think QA reporting to Ops can work when the culture is solidly supportive of quality, but when it's not, or when you're not sure how it's all going to flush out, it's a recipe for problems.

If I were in Leanmeister's position, I'd be concerned too. Ops is the voice of "Ship it!" Quality is the voice of "Ship it right!". I thinkthey need to be independent of one another for there to be a healthy balance.

And I think the old GMP stated the requirement for QA independence, whereas the cGMP is not as clear.

I have reported directly to Operations Management as Quality Manager at two different companies (both ISO registered). I could (and can) talk to the President any time I feel uncomfortable with what I believe is an "Operations First" decision. In fact, my current desk is closer to the President's office than my boss' office so I usually get there first.:D To paraphrase a Twain remark, "If your quality principles can be compromised, to whom you report is just haggling over the price." In Operations, I'm part of the solution, not the Sheriff.

Icy, it sounds like you work in a good company with its priorities straight. That isn't the case everywhere. I've worked in 5 places. In 2 out of the 5, the QA reporting to Ops thing would not have worked.

In many cases the big guy, (President, GM, Plant Manager, whatever) isn't around to appeal to. He's making customer calls or in corporate meetings, etc. etc. That leaves the opportunity open for QA and Ops to have no higher authority to appeal to. If QA reports to Ops, Ops will win every time. Especially because Ops people are often incentivized on shipments. Don't mess with my compensation, man!

Luckily I'm in a good company now, and do not have this issue. But bad companies are out there, and thus, however it OUGHT to be, many of us have experienced the dark side of this reporting structure and are uncomfortable with it.

In many cases the big guy, (President, GM, Plant Manager, whatever) isn't around to appeal to. He's making customer calls or in corporate meetings, etc. etc. That leaves the opportunity open for QA and Ops to have no higher authority to appeal to. If QA reports to Ops, Ops will win every time. Especially because Ops people are often incentivized on shipments. Don't mess with my compensation, man!I have suppliers like that. I wouldn't work there. Not because it offends my delicate quality sensibilities but because I believe that kind of culture dooms a company to cyclic failure. I want no part of it.

I've got to agree with Rosie - in too many of the companies I've worked for QA (or the department functioning in that role) functioned more as the quality cop rather than as a partner assisting production in assuring quality products to a customer.

I have that feeling at my current employer - too many times I seem to be the lone voice saying wait, we need to do quality planning ahead of new material trials, rather than start them and then decide what planning we want/need to do. (Our system is written for quality planning first, but too many times upper management is in a "**** the torpedoes, full speed ahead" mode of operation. We took a large writeoff on raw material last year due to that mode of thinking (> $750,000 for 1 occurence, and we're still bleeding off the material into production.)

In those instances where QA is the "cop" putting them under production is a recipe for disaster.

I have suppliers like that. I wouldn't work there. Not because it offends my delicate quality sensibilities but because I believe that kind of culture dooms a company to cyclic failure. I want no part of it.

There's another thread here about what an interviewee should ask his interviewer, and my post there contained my thoughts on how to determine if the company is worth working for. Of course, companies can, and DO lie during interviews. You get fired if you lie about your background to an employer. It's a pity that there aren't any repercussions to the employer when they lie.

»GMP Notebook By Efrem H. Zaret, PhD [back to contents]

Revised GMP Legislation in the EU



A new directive requires that all manufacturers operate an effective quality management system.


It is clear that the US pharmaceutical industry is not working alone: The pharmaceutical industry is a worldwide enterprise and is particularly strong in Europe. In the last 10 years, the industry there has grown, and Europe now represents 25% of the world pharmaceutical market.1 The EU will soon represent more than 500,000,000 people.
On October 8, 2003, the EU published Commission Directive 2003/94/EC, which describes the “… principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use.” The publication confirms that all medicinal products manufactured or imported into the EU are to be manufactured in accordance with the GMPs. This includes medicinal products to be exported from the EU.
The EU GMPs were published in 1991 in Commission Directive 91/356/EEC. The new directive indicates that most provisions of 91/356/EEC must be modified for clarity, and also indicates that the 1991 directive is repealed. EU member states are required to promulgate and adopt the regulations in the directive as new laws by April 30, 2004. However, member states need to comply with the new directive as a minimum and may adopt more stringent regulations.


Effective Quality Management

Under the new directive, all manufacturers must operate an effective quality management system. This requires that implementation of a pharmaceutical quality assurance system involve active management participation. The manufacturer must establish principles and guidelines of good manufacturing practice with respect to quality management, personnel, premises and equipment, documentation, production, quality control, contracting out, complaints, product recall and self-inspection. For products made within the EU, the manufacturer needs to ensure that its manufacturing operations are in compliance with GMPs and manufacturing authorization.
For approved products and investigational medicinal products (clinical trial materials) imported into the EU, importers must ensure that the products have been manufactured according to GMP standards that are at least equivalent to the EU GMPs. For approved products, importers must ensure that the manufacturer has been approved by the product’s marketing authorization. For clinical trial materials, the manufacturer has to have been accepted by the competent national health authority of the country where the clinical trial will run.
Manufacturers must have enough competent and qualified personnel to meet the objectives of the quality system, which must be supported by the managerial and supervisory staff, including the qualified person responsible for system implementation. The qualified person is licensed and responsible for the release of each product batch, and also certifies that the batch meets specifications and was manufactured in compliance with the EU GMPs. For product that is imported into the EU, the qualified person must verify the compliance of the foreign manufacturing site.
Responsibilities must be defined in job descriptions approved according to the manufacturer’s procedures. Staff organization, including reporting relationships, must be available on an organization chart, which must also be approved. The directive requires that staff must be given sufficient authority to carry out their responsibilities. Mandated staff training should cover the theory and application of good manufacturing practice and quality assurance as appropriate. The training must include procedures that address health, hygiene practices and clothing of personnel. Training effectiveness must be verified.


Facility Layout and Operation

The manufacturing plant must be “laid out, designed, constructed, adapted and maintained to suit the intended operation.” Facility operation should minimize the risk of error and permit effective maintenance and cleaning to minimize the risk of cross contamination and “any adverse effect on the quality of the product.” All premises and equipment critical to product quality must be appropriately qualified and validated.
Documentation requirements are presented in detail. The documentation should:
1) Form the core of a system based on:
a) Specifications;
b) Manufacturing formulae;
c) Processing instructions;
d) Packaging instructions;
e) Procedures and records that cover the various operations.
2) Be clear, error free and up-to-date.
3) Be based on pre-established procedures kept available with specific batch documentation.
4) Allow the history of manufacture of each batch to be traced.
5) Allow any changes introduced during the development of a clinical trial material to be traced.
6) Be retained for one year after the expiration date or at least five years after certification, whichever is longer, if it describes a marketed pharmaceutical product.
7) Be retained for at least five years after the completion of the clinical trial or formal discontinuation of the last trial in which the batch was used if it describes a clinical trial material.
8) Be readily available in legible form if stored by validated electronic, photographic or other data processing systems.
9) Be protected against loss or damage of data by duplication or back-up and transfered onto another storage system. Audit trails must also be maintained. Production operations are to be carried out according to the pre-established instructions and procedures and in conformance to GMPs. The manufacturer must provide adequate and sufficient resources for in-process controls; any deviations and product defects must be documented and investigated. Critical phases of manufacturing must be validated and regularly revalidated, and any new procedure or important modification of an existing procedure must be validated.
For clinical trial materials, particular care is required after blinding to prevent mix-ups. The manufacturing process for clinical trial materials should be validated completely, if appropriate, taking into account the development stage of the clinical material. Critical steps such as sterilization must be validated, and all steps in the design and development of the manufacturing process must be fully documented.


Quality Control

Someone with the requisite qualifications, independent of production, must be in charge of quality control. Quality control laboratories must be appropriately staffed and equipped to test and examine starting materials, packaging materials, in-process and finished products. Contract laboratories may be used. It is not mandatory to analyze products imported from third countries.
Manufacturers must conduct repeated self-inspections as part of a quality assurance system. Self-inspections should monitor the implementation and conduct of the GMPs and propose corrective actions if needed. The self-inspections and the corrective actions taken must be recorded.
A written contract must describe any manufacturing operation or support performed by contractors. The contract should contain provisions that:
• Define the responsibility of each party;
• Define observance of GMPs by the contractor;
• Define how the qualified person responsible for batch certification is to perform his duties;
• Define conditions under which the contractor may subcontract work; and
• Require the contractor to comply with principles and guidelines of GMP and to allow inspections by regulators.


Evaluating Finished Products

Before release for sale, distribution or clinical trial, finished products must be evaluated to ensure that the manufacturing process conforms to the documentation. The review should consider the in-process control results and product conformance to specifications.
Samples of finished product must be retained for at least one year after the expiration date. Unless a longer retention period is specified by the country of manufacture, starting materials other than solvents, gases and water must be retained for at least two years after the release of the product. These must be available to regulators. In special cases, the marketing approval may include other sample and product retention requirements.
For clinical trial materials, each batch of bulk-formulated product and key-packaging components for finished batches should be retained for at least two years after completion or formal discontinuation of the last trial in which the batch was used, whichever is longer. Labeling of clinical trial materials must ensure patient protection, the proper use of clinical material, and allow traceability and identification of the product and the trial.


Reviewing Complaints

Manufacturers must have a system for recording and reviewing complaints combined with a system for recalling, “promptly and at any time,” any product in the distribution chain. The manufacturer must record and investigate all complaints regarding a product defect. They must also notify regulators of any defect that could result in a recall or abnormal restriction of supply.
For clinical trial materials, the manufacturer and the trial sponsor must have a system of recording and reviewing complaints coupled with a recall procedure for any materials that have entered the distribution network. Manufacturers must notify regulators and provide the location of all trial sites. Trial sponsors must provide procedures for rapidly identifying blinded products to allow for prompt recall if necessary. The sponsor must ensure that the identity of the blinded product is disclosed only as much as is necessary.
The new directive provides high-level regulation of good manufacturing practices for pharmaceuticals in the EU. The details of the GMPs are provided in Volume IV of the Rules Governing Medicinal Products in the European Union. They can be found on the Internet at http: //pharmacos.eudra.org/F2/eudralex/ index.htm. Two sections, sterile products and investigational medicinal products, have been revised this year. Even for those not manufacturing or importing products for the EU, Annex 16 of the GMPs requires special attention, as it covers the responsibilities of the qualified person, a concept not found in the FDA’s GMPs.


Efrem Zaret, PhD consults in GMP compliance and training, quality assurance and control, clinical supplies logistics, regulatory affairs, and product and package development. Reach him at 908-753-8566 or ef@ezassociates.com.

Both Production and Quality along with other groups may report to Operations and the requirement thatSomeone with the requisite qualifications, independent of production, must be in charge of quality control. is still maintained. Not to mention the OP is in the US and not the EU.
Operations is not Production. (http://www.managementhelp.org/ops_mgnt/ops_mgnt.htm#anchor1705482)

Operations is not Production.[/URL]

Maybe so, maybe not. Some companies call the Production Mgr. an Operations Mgr. There's no real standard definition on job titles.

I guess personally, I'd be very wary of taking a QM job in which I reported to whomever is in charge of production, whatever he/she is called.