Completely Lost in QA - Not equipped for QA, QC, ISO, etc.

[Jim Wynne]

Sounds like you'd be happier in an larger organization.

FTFY

 

[Wes Bucey]

Thanks for the question on that. I was just discussing this with someone. there is no plan for what happens if someone leaves. I think that actually reduces salary expenses so that's a good thing for the financial group in the short term. I was just talking to my lab tech about a stability protocol for a product we put together and tested and decided not to go forward with because the material was too expensive. Our quality system and decision tree is so difficult to manage that we decided together it was easier to keep the stability study going for the product we know we are never going to make than to write hte justification for stopping the stability study and throwing away the product. Where does this make any sense at all? I really hate the fact I have been sucked into this kind of decision making. An error like an incorrect signature date can result in a major investigation into my quality ssytem with a major root cause analysis for something like someone signed the wrong year on a signature line. How did I go from being a MD-PhD in orthopedics and biomaterials to figuring out the root cause analysis for why someone didn't follow proper protocols for a signature on a management review meeting? I am so frustrated. I can not see how this is helping me run my clinical studies.

It appears your organization has adopted a complex set of rules for its Quality Management System which is more bureaucratic [and draconian] than the QMS for a major international organization on the order of Abbott Laboratories.

(I've written in the past about Abbott getting slipshod on its documentation practices and getting hammered by the FDA. Even after all the controls mandated by the FDA and Abbott's army of lawyers, their system allows for reason rather than overkill when a typographical error crops up. However, a lapse like one of your examples does trigger an inquiry into error proofing to reduce the possibility of recurrence. Such inquiries turn up previously unsuspected weak links, such as a dyslexic clerk who routinely transposes numbers which "might" create a more egregious error than an easily corrected date.)
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The value of any QMS is limited by how usable the system is for the day-to-day worker. Successful organizations continually evaluate their systems for effectiveness and usability. Management review comes AFTER a systematic evaluation by internal or external auditors to judge whether the system works as planned and laid out in written procedures and processes. Such audits sometimes discover that one or more people do NOT follow the written procedures because each person decides such procedures are "silly" or "impossible." Management's choice is to review and decide if the procedures ARE silly or impossible or if the specific employees are not competent to follow procedures which other employees follow with no problem.

If the procedures are found to be "silly or impossible" (Deming suggests this is often the case in his Red Beads experiment), they need to be changed. If the employee is not competent, he may need to be retrained or reassigned. In any case, nothing happens until the audit is reviewed and a decision made by management whether:

1. system works, no problems, therefore no change
2. system works, problems caused by individuals not competent (by lack of training and understanding or by lack of innate ability to understand and follow instructions, however they are phrased); therefore employee is retrained or reassigned.
3. system has failed and needs to be restructured.

 

[jvstjohntexas]

Thanks again. I think that my problem here is that I, and the company are both not involved in production, we have little marketing, no customers and are pursuing an avenue of work that is very academic and focused on trying to invent materials that may or may not have practical application. Almost like an extension of a true academic lab. We have standards for our lab notebooks, protocols for how to use research equipment and keep it from breaking but I think that right now I and the lab tech would give anything to completely throw away the meager sales product that has CE Mark and iso but no licensing partner, sales of under 100 units per quarter for revenue in less than 5000.00 and no intent to make another batch or change any aspect of the design. I continue to ask how ISO is helping me to complete my quantum mechanics equations and determine new rate constants for nanoparticle and cellular movement. I don't feel it is helping and defining a standard for how I approach each day to do that is not helping, especially when the reviews and nonconformance continuously focus on thigns like training a nonexistent sales force in customer satisfaction when we also don't have any customers. I'm so sick of root cause on things that make no sense. We had 21 customers total in Q1 2011 not that I care, why am I having to write a validation for insuring that I am sampling enough customers when I can prove with very simple math that 100% of 21 customers is the msot sampling I can have and there is no way to have any confidence interval on that few. The solution is to have more customers except that I don't want to do that so I am trapped in this endless loop of a nonconformance just because we have ISO that is supposed to be helping me do my job better.

 

[jvstjohntexas]

I'm well trained for my Job. MD-PhD with multiple successful GCP clnical studies, years of research experience and nearly 40 patents for nanoparticle biological hybrids. I'm a tenured professor of biomedical engineering and I love what I'm supposed to be doing. I hate digging into the quality system for the determination of a root cause for why a sales member was not trained. This stuff trees into massive bureaucracy that right now seems to be feeding on itself. "Why are employees not trained?" root cause, we have no employees, Why do we have no employees, we have no salary money, why do we have no salary money, we are spending massive resources on ISO and not getting our milestones completed. so that feedback looop just keeps going.

 

[MIREGMGR]

We can't tell you that there's a particular provision of the various rules that excepts you or the company for which you work from doing the QS stuff, as long as it sells a medical device of its manufacture.

However, if you didn't work there anymore, or if you still worked there but disposed of the product, or if they'd hire a suitable quality manager, your situation would be improved.

I think that's the bottom line.

 

[Wes Bucey]

Apropos of absolutely nothing except my own curiosity:
I'd like to read some comments from working ISO13485 auditors on how they would deal with the situations described by OP. I have a feeling there is some "wiggle room" for an auditor to avoid becoming a consultant while still providing some "value" for the organization undergoing an audit.

My experience with BSI auditors has always been that they are competent, but not Kwality Kops.

 

[treesei]

I'm well trained for my Job. MD-PhD with multiple successful GCP clnical studies, years of research experience and nearly 40 patents for nanoparticle biological hybrids. I'm a tenured professor of biomedical engineering and I love what I'm supposed to be doing. I hate digging into the quality system for the determination of a root cause for why a sales member was not trained. This stuff trees into massive bureaucracy that right now seems to be feeding on itself. "Why are employees not trained?" root cause, we have no employees, Why do we have no employees, we have no salary money, why do we have no salary money, we are spending massive resources on ISO and not getting our milestones completed. so that feedback looop just keeps going.

There is a conflict between science and product quality. Science by nature requires freedom, creativity, and innovation. Product quality on the other hand requires strick follow-up of procedures and must-do's which to a resesarch scientist make little sense. And all regulatory folks know that in the regulatory world, being the first often means trouble, completely the opposite to scientific discovery.

many research scientists, choosing this profession because they are free spirits by personality, feel frustrated when they hit the walls of ISO.