Is a nonconformity the "fault" of QA auditors?

[ChristineP - 2006]

An opinion is required please...
An employee issued 3 CARs against Quality Admin, which is responsible for conducting internal audits. In each CAR, he states that he discovered his team has not been following its procedures. He says that the deficiencies do not lie with his team because it is Quality's role to police processes and, had we conducted more frequent audits, Quality would have discovered the problem. His recommended solution is for Quality to conduct audits every month.

I argued that (a) It is the responsibility of each employee to follow their procedures; (b) A CAR is not appropriate to for actions to that are within the employee’s authority or responsibility to implement; (c) Quality cannot be relied upon to ensure employees are meeting very single aspect of their jobs; and (d) We do not have the resources necessary to police, much less increase frequency of audits, which is typically 1-2 times a year for each process, depending on audit result trends.

He feels that we should accept the CARs, perform the audits, and then issue new CARs against the process to correct the problems he pointed out in his original CARs.

He comes from a VERY large company with CMMI Level 3 and thousands of employees. We only have ISO 9001:2000, 70 employees, and 2 auditors (1 (your truly). Still, IS he right?

Thoughts will be appreciated.

Christine

 

[gpainter]

If the procedures are not followed, then CA. Audits should never become a police action, when they do, time to hang up your hat.

 

[Claes Gefvenberg]

Welcome to the Cove, Christine

Still, IS he right?

Um... I was temporarily lost for words there.

Imo, he is most definitely not right. I don't know what planet he is from, but here on Terra we usually assume that people have the responsibility for the actions of their own teams... Short version: You are correct, your points a-d holds and he is wrong.


/Claes

 

[tomvehoski]

Was this the supervisor of the department? Why not just consider his findings an audit, assign the CARs he initiated to the department supervisor, and have them take corrective action? No point in conducting a formal audit if you already know there is a problem and have CARS issued.

"Lack" of internal audits should not be allowed as a root cause, nor should additional audits be considered a preventive action. Something is wrong with their system (training, bad procedures, motivation, etc.), so it should be corrected.

 

[IEGeek - 2006]

I was dealing with a very similar situation here. When I took over the Quality and Engineering Group, I was hailed as the Great White Hope. All the Quality issues would be instantaneously fixed. (Prez's words, not mine).

We had minimal plans, our SOPs were wrong, our control plans were a joke and we even had one engineer tell a customer we would just keep all Certificates Of Conformance here on file, and if they wanted to review they could. Quality was viewed as the bain of manufacturing's existence. Our Production Manager had the best gig in the world, he could approve all of his own product. Our last audit was the day before the auditor arrived. I too, came from a very large company to a small company. The big company stuff just does not work in a small company. That all being said....

In trying to correct all these issues Quality inadvertently became the police department. We were in a downward spiral. Here was our solution, see if this helps.

Quality would conduct our internal audits as scheduled (about once a quarter). CARs and OFIs would be generated. I would then hold a "closing" meeting with all department heads and key personnel. The CARs and OFIs were assigned to the department heads, action plans were generated, dates were set. We even had pizza once. Then I would follow up with the tenacity of a rottweiller. Advising where I could, assisting when I could, guiding where I should. The first two go arounds were difficult.

We clearly delineated who had the responsibility for creating the "system" - Quality

We clearly delineated who had the responsibility for training on the "system" - Human Resources

We clearly delineated who had the responsibility for implementing the "system" - Manufacturing

We clearly delineated who had the responsibility for policing the "system"
ALL TEAM MEMBERS

What threw me a little in your post, is that he (I assume it is a he) wants to genereate CARs, so you can then in turn generate more CARs. That is a lot of paperwork and the true issue would get lost. Lack of internal audits can only be a cause if you have not adhered to your published schedule of internal audits (i.e. policy says once a quarter and you do it twice a year) I agree with all your statements (a-d)

Good luck

Just some thoughts....

 

[Craig H.]

If the guy is the supervisor of the department where he found the items that should have been found in an audit (oh, please), not only is Tom's suggestion a very good one (remember to copy his superiors), but this whole situation should be taken as a warning to keep an eye on this person. What is his function as supervisor, to make sure the coffee is warm?

 

[ChristineP - 2006]

Thank you, everyone, for your responses. What Tom said about "lack" of internal audits not being a valid root cause is a significant argument, as well as "IEGeek's" 4 common sense "rules" concerning responsibilities.

The chap who originated the CARs is not a department supervisor, but he is a chief leader within the process.

I've had further discussions with him and stands his ground. He sent me an e-mail stating that he "...has been looking at the issue of Quality Assurance and the objective evaluation of adherence to processes..." He asked that I review CMMI Level 2 goals for Process and Product Quality Assurance (PPQA), which says "GP2.8 (DI 3) Monitor and control the process and product quality assurance process against the plan for performing the process and take appropriate corrective action." and "GP 2.9 (VE 1) Objectively evaluate adherence of the process and product quality assurance process against its process description, standards and procedures, and address noncompliance."

It is these CMMI specs that he is using as an argument of best practice. I have no knowledge of the standard, but what worries me is, not only for the immediate situation, but if (when) we ever do get CMMI, whether his interpretation (i.e. Quality is responsible to police) is an accepted norm with CMMI practitioners. If so, me thinks I'm going to be spending my entire life doing nothing but audits!

Does anyone have experience with CMMI and how to translate the clauses into practice?

Many thanks,
Christine

 

[surendro - 2009]

Well Christine,

There appears to be low morale in your organisation. May be the gentleman has a complex with you around.

So it is basically a psychological situation, that needs a different handling and CARs have nothing to do.

You need a lot of good wishes to succeed in your undertaking, and here is my contribution - Best of luck!

Surendro :

 

[db]

Christine, This is a most curious situation. My first response is that auditing is nothing more than a sampling. You will not and cannot catch everything. But more importantly, he is correct in that internal audits should have caught his group not following procedures. Since he caught his team not following procedures, here is what I would do.

1) Accept the nonconformances graciously.
2) Schedule an internal audit of his activity.
3) Write him a major nonconformance for not following his procedures.

Use the nonconformances he wrote you as the “objective evidence”.
Now, the reason I say do it this way is not to “get back at him”, but rather place the corrective actions on where they need to be. There are two separate issues. First his group is not following procedures. This is something only he can fix. So, he has to be given the nonconformance. The second issue is that the internal auditors are missing these nonconformances. Your corrective action would be to make your auditors aware of the importance of ensuring the procedures are being followed and making sure that when procedures are not being followed, then corrective actions are being generated.

 

[IEGeek - 2006]

The chap who originated the CARs is not a department supervisor, but he is a chief leader within the process.

I've had further discussions with him and stands his ground. He sent me an e-mail stating that he "...has been looking at the issue of Quality Assurance and the objective evaluation of adherence to processes..." He asked that I review CMMI Level 2 goals for Process and Product Quality Assurance (PPQA), which says "GP2.8 (DI 3) Monitor and control the process and product quality assurance process against the plan for performing the process and take appropriate corrective action." and "GP 2.9 (VE 1) Objectively evaluate adherence of the process and product quality assurance process against its process description, standards and procedures, and address noncompliance."

Many thanks,
Christine

On the surface it appears that this individual feels threatened, and it does not sound like he has the best interests of the company at heart. I am guessing, but he received something like this in a past life, and now he is using it to hang his proverbial hat on with you. Nowhere in your referenced quote does it mention that QA must conduct the audits, nor how frequently.


Here is my solution (take it however it fits) now that I have some more facts. Accept the CARs (against my better judgement) then as your countermeasure conduct training with his team. You mentioned that he discovered that his team was deficient and it was Quality's fault. Well apparently his team needs some training and discipline. Include this person in your training. Training can be simple, I conducted a SOP training once in 20 minutes. Not on the actual SOP itself, but on how to read an SOP. I would not suggest this course if there is any chance it could be seen as retaliatory in nature.


Good luck and keep us posted

Just some thoughts....