Quality Manager wants Internal Auditor to softgrade the findings - What shall I do?

Golfman25

Trusted Information Resource
#11
Re: Auditing against a procedure you had input to

Hi just completed an internal audit-
  • work order operation out of sequence installing housing at beginning of product assy,
  • date code expiration mssing on labels, no traceability(shelf life nonconformance),
  • increase of part defects 9% from Q1=Q2 (no corrective action addressed)
  • missing product work order
  • solder process not performed to mfg work instruction (special process not documented)
These are some of the samples that I was instructed to record as observations or opportunities for improvement- as far as our internal audit process, Our CB gave it the only positive finding from our re-certification audit in june. We received 1 major, and 9 minor findings, I have been the 3rd lead auditor in 4 yrs, i am undecided on how to deal with this. please advise
I am just wondering if you could go a little further and be more helpful with your findings. Is your job just to be a "cop" and point out other mistakes? Or is it to help the organization improve?

For example, you say work order operation performed "out of sequence." Does it affect the product quality? And defects because of it? Or is it just something where the paperwork "doesn't match?" Could you go futher and point out the actual risk of the problem? Could you suggest possible solutions? Good luck.
 
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Weiner Dog

Med Device Consultant
#12
Re: Auditing against a procedure you had input to

Good day. There are three types of audits:

1. 1st party audits- These are internal audits that are performed either by trained and qualified internal staff or experienced contractors/ consultants to see whether the company has meet internal goals, policies, and requirements.

2. 2nd party audits- These are supplier audits that are performed by trained and qualified internal staff or experienced contractors/ consultants to see whether 1) potential vendors and contractors will meet internal requirements and 2) whether the existing vendors and contractors are still meeting internal requirements.

3. 3rd party audits- These are external audits that are performed by governmental bodies or external contractors/ consultants to see whether the company has met external laws, regulations, directives, or standards.

Typically there are two types of internal audits- 1) formal audits performed by regulatory compliance and quality assurance (such as required by 21 CFR 820.22) and 2) informal audits usually performed by quality assurance and production (i.e. walk-through audits) as quick and periodic quality assurance checks to see whether personnel are familiar with the implemented procedures.

Regulatory compliance and quality assurance are similar in nature, in that both perform audits and analyze nonconforming products and quality problems. However, regulatory compliance is more than the 'quality police' because this department has to make sure that everyone (including people in their own department) are abiding by the external regulations. Quality assurance on the other hand make is making sure that there are not systematic nonconformances and quality problems through data analyses.

Quality control is a sub department of quality assurance. This group does not prevent quality problems (like quality assurance), but detects them by seeing whether products (or services) have met predetermined specifications.

To answer your question, it all depends upon how top management views regulatory compliance and quality assurance.

Regulatory compliance wear 2 hats: a) the 'quality police' and b) the quality mentors and coaches, sot that the company can improve. When they (and quality assurance) perform internal and supplier audits, they are the 'quality police. However, when personnel (i.e. who are directly responsible for the quality problems) correct these quality problems, regulatory compliance is there to mentor and coach (not only to see that they are following internal requirements, but external requirements too).

As such, it depends which role one is playing: regulatory compliance, quality assurance, or quality control. Quality control and quality assurance detect and prevent quality problems respectively. Whereas, regualatory compliance uses risk (i.e. 'so what?") to see whether the noted problems are systematic or minor in nature. It is up to top management to ideally listen to all three departments. If not, bad products will go out the door- eventually with lawsuits and regulators following afterwards.


I am just wondering if you could go a little further and be more helpful with your findings. Is your job just to be a "cop" and point out other mistakes? Or is it to help the organization improve?

For example, you say work order operation performed "out of sequence." Does it affect the product quality? And defects because of it? Or is it just something where the paperwork "doesn't match?" Could you go futher and point out the actual risk of the problem? Could you suggest possible solutions? Good luck.
 

Wes Bucey

Quite Involved in Discussions
#13
Re: Quality Manager wants Internal Auditor to softgrade the findings - What shall I d

It seems to me the primary problem is the QM acting as the final arbiter on this versus top management. It might be helpful to jump the QM to the owner/boss of the organization and say something to the effect:
"Hey. I can certainly write my internal audit reports any way you and the QM want, BUT - if the FDA or a supplier customer or our certifying body comes in and agrees with my original finding or observation, regardless of how WE classify it, we are risking the loss of a customer, the loss of our ISO 13485 certification, or the loss of our FDA approval, which could have a disastrous impact on us and could even incur us penalties and complete shut down by the FDA until/unless we make corrections. So why not concentrate more on correcting the insufficiencies instead of trying to hide them? The classification of major/minor is not as important as the fact they exist and impair our efficiency and efficacy."


Added in edit: Note the use of "we" and "our," NOT "you" and "your" - it is a subtle way to convey solidarity and the sense "this is OUR problem, not YOUR problem."
 
Last edited:

Weiner Dog

Med Device Consultant
#14
Re: Quality Manager wants Internal Auditor to softgrade the findings - What shall I d

Wes-

I totally agree with you- it is ultimately up to top management.

I have been on all 3 sides of the fence- the FDA, as a regulatory compliance specialist working for individual companies, and as a contractor and consultant assisting companies. As you are totally aware of, it is the barriers to quality that is the difficulty.

Certain managers (either because they are not quality savvy and/or are actually egotistical, greedy power-hungry, and manipulative personalities), have their own internal interests at heart. They think they are getting away with it (such as hiding evidence from the FDA), but eventually will get caught (i.e. lawsuits, whistle-blowing, etc.) They do have the 'us v. them' mentality.

On the internal side, there is a balance between morals and ethics v. being fired for confronting the boss + putting up with internal politics. I prefer morals and ethics and quality over making a boss rich, especially when that manager knows of the quality problems, but ignores them. I am not afraid to confront them and go all the way to the top if need be. However, others may not. This is the dilemma working for the regulated industry.

Nevertheless, we as internal regulatory compliance, quality assurance, and external consultants can keep on educating them to the ideas of Juran, Deming, Crosby, and other quality gurus.
 

gpainter

Quite Involved in Discussions
#15
Tough spot. I had one like that and there is not much you can do. Hate to say it but you can only hope that the registrar finds it. My 3rd party auditor would ask me if there were areas that I could use help in and would try to schedule accordingly. That may be able to help you out. Most 3rd party auditors understand what we go thru as the lead auditors.
 
L

lamorenita_QA

#16
Thank You all for your expert advice, I did discuss this with my GM, because another internal auditr was told by this QM to change their audit report. The internal auditor refused, & notified me. We came to the agreement that the QM would assume the responsibility of accepting the finding as an observation/opportunity for improvement, or corrective action with an email that would be filed with the report. I hate to say this but eventually our registrar will see it and probably issue a non conformance against the CAPA process. I tried to reason with my QM that these were not punishment findings, but of value, to improve the processes. we could reduce costs associated with late deliveries, due to increased rework, We have identified the problems, so lets work together to improve them, unfortunately our registrar is going to eat us alive. My QM will probably have to learn the hard way. I will continue to support my QM, with advice & my experience that's just the way I work, but to have the auditor be responsible for alternating a report (with objective evidence in hand) was something I had to do something about. I will update on how this works out.
 
L

lamorenita_QA

#18
Hopefully the registrar will find this and help you put it to bed. Maybe??? How mature is your system?
We received our ISO 13485/9001:2008 3 yr re-certification last month, 1st annual surveillance due by Oct. 2013. the CB almost issued a major finding to our capa system, for sure we'll get one next time.
 

Wes Bucey

Quite Involved in Discussions
#20
Thank You all for your expert advice, I did discuss this with my GM, because another internal auditr was told by this QM to change their audit report. The internal auditor refused, & notified me. We came to the agreement that the QM would assume the responsibility of accepting the finding as an observation/opportunity for improvement, or corrective action with an email that would be filed with the report. I hate to say this but eventually our registrar will see it and probably issue a non conformance against the CAPA process. I tried to reason with my QM that these were not punishment findings, but of value, to improve the processes. we could reduce costs associated with late deliveries, due to increased rework, We have identified the problems, so lets work together to improve them, unfortunately our registrar is going to eat us alive. My QM will probably have to learn the hard way. I will continue to support my QM, with advice & my experience that's just the way I work, but to have the auditor be responsible for alternating a report (with objective evidence in hand) was something I had to do something about. I will update on how this works out.
You wrote I did discuss this with my GM,, but didn't tell us the GM's reaction. That reaction [or lack of reaction] is crucial in determining whether "top management" is involved or apathetic [or even whether the GM is on the same wavelength with the QM.]
 
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