Overwhelmed and Unqualified... Need training...

I work for a medical plastics company who compounds pellets for medical device manufacturers.

I’ve worked there for over 10 years – and started in Production – Running the pellets. As the years went on, I was moved to be a Quality Assurance Technician, and then soon as the QC Manager.

I only went to college for a couple years and still have yet to finish my Associates in Business.

My role then split – and I because the Quality System Manager – handling ISO, our QMS, Complaints, CARs, SCARs, Supplier Approval, Control of NC Material, Arranging Management Reviews, Production Meetings, Specification Reviews, Logging of Production Time Sheets, Control of Documents and Records, Internal Audits (we have several other internal auditors – but I control it all), Customer Audits, Registrar audits, Tracking of Calibration of our equipment, Tracking Scrap of each job, Initial training for all new employees, tracking employee training, etc., etc.

I am the only one in my role – and with all the hats I have to wear – I am also now getting pressure to implement the newest revision of ISO 13485 – Currently we are ISO 9001:2008.

I have gone to my manager and asked for help because I am afraid I could mess something up. We are a company that keeps growing so fast, that I am having a hard time keeping up. Shortly after my meeting, we hired a Director of Quality. I felt so much better – but unfortunately he left the company in 6 months.

No word on if we will hire another.. and that was over a year ago when he got done.

I have Lead Auditor training, but that was 5 years ago. I have no other real training. I have learned everything I know from working here.

I am now also being asked to start auditing our suppliers. Currently we just send out a survey.

I am nervous with the rate we are growing and feel almost helpless being alone in my role.

I am constantly being asked to provide more robust information, and root cause analysis… but being just me – its so hard to ever focus on one thing…


Could someone suggest some training to help me?


- Nikki

 

Andy has a good point. But is sounds like your potential mentor left the company.

Frankly, it sounds like the position is outgrowing your skill base. I'd check with your local mfg. trade associations or community colleges and see if they have some certificate programs. Or even go further and drive yourself to be the Dir. of Quality and hire your replacement for your current job. Good luck.

 

Hopefully recruiting a Quality Engineer/Intern for period of 12 months could help you out, as you have a chance to map out the priorities and accomplish all the tasks in an organized way. The stuff you mentioned will be exciting tasks for someone to learn or internally you could promote someone as a Quality technician to achieve part of your responsibilities.

 

I'm always skeptical of formal training as a necessary path to competence.

Because classrooms necessarily have to generalize, you get a bunch of theoretical concepts that may or may not map to the realities of your company/job. I've taken computing science, economics, business management in formal educational settings, and trust me, only a small fraction of what I learned actually translates into practical skills.

Mind you, if you, like me, simply like learning for the sake of learning, then by all means pursue formal education...but don't expect it to make you an expert at your job!

Judging by your post, I have a feeling that you are under-valuing your own experience/competence:

• You've worked there for 10 years, in multiple departments? You probably already have a good sense of the companies needs and processes.
• You're ISO 9001 certified? You probably already have a good sense of quality management principles, and auditing process (13485 is not much different)

You're in a management position, and it sounds like you've earned it. It's probable that your feeling of being "overwhelmed" is simply due to lack of resources, and NOT due to lack of education, training or experience. Perhaps all you need is some additional personnel to divide the workload...

Best!
MM.

P.S. If I'm wrong here, I'd follow Andy's suggestion: get a mentor (temporary experiences/knowledgeable consultant).

 

Certainly true if your "training" is simple regurgitation of information. Those that get paid the big buck know how to apply that training to the real world.

 

It's true that much formal classroom training has devolved into a valueless "regurgitation of information".

...however, what I was really pointing out is placing mental resources in "generalized" concepts is inherently less economic if you already have a real-world situation by which to constrain and apply mental energies.

I remember taking a course on database management, in which I covered a ton of general situations and applications. Fast-forward to when I'm actually employed to build a database, and the relevant knowledge in this case could have been compacted into a few lectures... If I knew beforehand the real-world applications I'd be confronted with, you could say that most of the course was simply intellectual, and not practical.

In the case of the original poster, Nikki's already got a background, experience, and (presumably) some specific areas that are of concern relating to established constraints within the company...no need to generalize or theorize. In such a case it makes much more sense economically to hire a specialized consultant to help with the specific areas, rather than invest in a general course (much of the content of which Nikki's probably already familiar with the 10-years of practical experience).

(...though I still maintain my hunch that the issue here is likely lack of resources and delegation of responsibilities, not necessarily lack of experience/training/qualification.)

 

The only way I have seen it work is if the training is taken twice. Here's this new concept, I go to the training knowing nothing, and am given a brief overview of how to apply it.

THEN I come back to the real world and try and apply it. Which, since it is no longer ideal, generates a TON of questions.

THEN with a practical understanding of what they were talking about in the first go-round because I have tried to practically apply it in the real world, I go BACK through the training (at a deeper level) armed with real world question I need answered.

Anything other than that, and I am personally better off figuring out for myself.

(and ... that's how this forum works, basically. Sans the face to face.)

 

This is a pretty good concept, but if we're talking straight economics, it doesn't make a lot of sense to re-take an entire training course if only specific areas are relevant.

---OFF TOPIC--- To support your idea, I've realized this in the realm of literature. I'd read a bunch of books as part of English classes but, at the time, without the life experience to really appreciate the profundity of the material. Now, years later, I go back and read, for example, 1984, and get my mind blown! ...oh the value I could have got analyzing the book where I to re-take the class knowing what I know now... (sigh)

 

I agree with Mark that the issue sounds more related to overloading / lack of resources than to lack of knowledge. A mentor sounds like a great idea, regardless.

I suspect that the symptoms described indicate a real problem at the top. If a Director of Quality was hired; left after only 6 months; and was never replaced - there maybe serious quality attitude problems at his boss's level. I guess the DoQ encountered lack of commitment to quality, and did the math. The boss probably realised what it means to have somebody "too knowledgeable" in such a powerful position, and decided that he's better off without it. He probably felt that Nikki is nowhere as near a threat, having grown inside the company and being loyal for so long.

Serious lack of resource allocation to QA is many times a strong indicator of low commitment to quality.

Nikki, a few months ago you shared an event that involved speaking to your boss about an uncooperative colleague who refused to align with acceptable QMS practices. How did it conclude? I see a relevance to the current situation, and I think some insights can be gained from how your boss acted in that instance.

And yes, 1984 is a great book!...

 

Thank you all who responded to this post... As an update (with question to follow) - We are going to move for the ISO 13485:2003 and we are NOT going to continue with ISO 9001:2008 or 9001:2015.

My boss has instructed me to put together any resources I need and present it to him in the next two weeks. I think this is going to be my opportunity and ask for the help / mentor I need.

I want to put together a concise, yet not overly detailed "presentation" of what is required with ISO 13485, and what help I need.

Thoughts / Ideas the best way I can go about this?

 

Much of the work is already done for you. The current version of ISO 13485 has a comparison table of each requirement against the requirements of ISO 9001. It highlights all the differences between the two standards. ..by and large you'll find that much of it is identical.

 

Yes. I am aware and voiced that fact to my boss - who in return stated he did not want to wait... I have heard it is being published next month as well - but again, they all want to move forward with this certification ASAP...

 

Even if you could pull this off on your own as suggested, an opportunity to ask for resources isn't one that should be passed by often.