Product Quality Personnel and Job Descriptions

[Sylvia16]

I need help understanding the meaning of "product quality" and the need to have Job Descriptions (JDs) for either "personnel who perform work affecting product quality" or for all employees in our company.
I work for a small Medical Device company under FDA part 820 QMS regs and we are ISO 13485:2016 certified. I need to know if I, as the Director of Quality Management, need to maintain Job Descriptions + Resumes for ALL employees or just those who are involved with "product quality".
Do I need to maintain JDs and resumes from the Finance & IT teams who are not directly involved in the quality of our medical device? Or does FDA and ISO requirement extend to Customer Service / Field Service, Manufacturing, Inspection, R&D, & Purchasing groups who are more directly involved with "product quality"?
CFR 820.20(b) Organization states that "each manufacturer shall provide adequate resources ..." and this has been interpreted to be resources for monetary commitment, implying the Finance group.
Thanks!

 

[Tidge]

I need help understanding the meaning of "product quality" and the need to have Job Descriptions (JDs) for either "personnel who perform work affecting product quality" or for all employees in our company.
I work for a small Medical Device company...

This sounds familiar!... but because of my past experience I may give some biased advice so I will jump around a bit, in case I misunderstand.

I worked for a (large) company that had a nuance-free understanding of 21 CFR 820 and QMS. It was the company policy that "every employee is responsible for product quality" and was literally part of every job decsripion and part of the Quality Policy. This was sorta-ok-fine, but it was not true in theory or practice. "Our response to this repeat 483 is that since everyone is responsible for product quality, the 483 clearly can't be applicable!" (my words, distilled from our response). I wouldn't recommend this being in a job description as a panacea, the words belong in the culture!

Now...

Do I need to maintain JDs and resumes from the Finance & IT teams who are not directly involved in the quality of our medical device? Or does FDA and ISO requirement extend to Customer Service / Field Service, Manufacturing, Inspection, R&D, & Purchasing groups who are more directly involved with "product quality"?

Generally... All employees should have job descriptions. If those job descriptions are for people in functions who they will never touch/access/be touched by the QMS, I don't think head of the quality department needs to know if anyone is qualified for their job. I see a few potential issues:

1) If the company is small, it seems very possible that an auditor could literally look through everyone's JD overnight. If folks are "missing", it would burn more fuel to explain why. (it is left as an exercise for the reader to figure out how this might come up)

2) If data is shared with an auditor that is sourced by one of these "non QMS" roles, the person who gives it to the auditor has to attest to the contents and method of derivation. This happens anyway, but "non-quality" IT people can't be thrown under the bus if the spreadsheet is missing data if they aren't supposed to be involved with the QMS.

 

[Ronen E]

@Tidge's reply is accurate; I'll second it with a shorter version:

Since the company is small, most likely EVERYONE in the company is somehow involved with product quality / the QMS, and it would be hard to prove/convince otherwise. So my advice is to just generate JD's for every role. It will most likely be handy/useful from non-QMS aspects as well.

Note: I think you are not obliged to keep everyone's resumes on file, unless by "resume" you meant the list of their relevant qualifications (which can include, on top of certifications etc., relevant previous work experience). You need to have evidence that the individual assigned with a role meets the requirements listed in that role's JD - no more and no less. Additionally, for privacy purposes, it might be better to keep the actual (complete) resume that you might have with HR, and make it clear that this is outside the realm of the QMS. Within the QMS you might have bare-bones versions, as above. You might not want auditors (including internal auditors, who are likely to know their colleagues in person) having access to everyone's full resume.

Cheers,
Ronen

 

[Enternationalist]

A gentle reminder that the idea of a "job description" is not defined in 13485 or 21 CFR 820 - as such, job descriptions are a means to an end. What you need to do with them depends fully on what requirements you intend to fulfil. Usually, people use them to meet certain HR and personnel requirements.

You basically need a way to;

• Track people's competency (training, qualifications, experience, skills, etc.)
• Define what level of competency they need to achieve acceptable product quality
• Drive activities to achieve and meet the required competencies
• Communicate to people these competency requirements, and how their activities affect quality
• Check whether all of the above are actually effective in producing competence and ultimately product quality

The typical job description performs a part of this - it's the communication tool between an employee and management that describes what they do, how it is relevant to and affects product quality, what competency is needed to do that job. Sometimes it'll also include some periodic activities (like recertification for technicians). If you take this approach, one good reason to do it for all staff is because it can act as the place where you assessed whether they affect product quality or not.

That's not the only way to do, it though. One method I quite liked was defining procedural "roles" that each had their own subset of requirements and competencies, along with training and their connection to quality. These roles were documented in their relevant procedures (e.g., a machine operator role would be described in the machine operating procedure). Staff members would then just be assigned various roles (which could be added or removed as needed), and their training requirements calculated by adding all the roles together. This method didn't really look like a traditional "Job Description", but still met the various requirements. We still had a document called a 'job description', but they were a business tool rather than a QMS one.

I would say that the way you document and present these various requirements depends on how you want to communicate with staff regarding their competency and quality requirements. Many people are used to Job Descriptions to do that, and they can be a convenient method if you are already maintaining job descriptions for other business or legal reasons.

 

[Sylvia16]

This sounds familiar!... but because of my past experience I may give some biased advice so I will jump around a bit, in case I misunderstand.

I worked for a (large) company that had a nuance-free understanding of 21 CFR 820 and QMS. It was the company policy that "every employee is responsible for product quality" and was literally part of every job decsripion and part of the Quality Policy. This was sorta-ok-fine, but it was not true in theory or practice. "Our response to this repeat 483 is that since everyone is responsible for product quality, the 483 clearly can't be applicable!" (my words, distilled from our response). I wouldn't recommend this being in a job description as a panacea, the words belong in the culture!

Now...


Generally... All employees should have job descriptions. If those job descriptions are for people in functions who they will never touch/access/be touched by the QMS, I don't think head of the quality department needs to know if anyone is qualified for their job. I see a few potential issues:

1) If the company is small, it seems very possible that an auditor could literally look through everyone's JD overnight. If folks are "missing", it would burn more fuel to explain why. (it is left as an exercise for the reader to figure out how this might come up)

2) If data is shared with an auditor that is sourced by one of these "non QMS" roles, the person who gives it to the auditor has to attest to the contents and method of derivation. This happens anyway, but "non-quality" IT people can't be thrown under the bus if the spreadsheet is missing data if they aren't supposed to be involved with the QMS.

Thank you for sharing your experience and perspective!

 

[Sylvia16]

@Tidge's reply is accurate; I'll second it with a shorter version:

Since the company is small, most likely EVERYONE in the company is somehow involved with product quality / the QMS, and it would be hard to prove/convince otherwise. So my advice is to just generate JD's for every role. It will most likely be handy/useful from non-QMS aspects as well.

Note: I think you are not obliged to keep everyone's resumes on file, unless by "resume" you meant the list of their relevant qualifications (which can include, on top of certifications etc., relevant previous work experience). You need to have evidence that the individual assigned with a role meets the requirements listed in that role's JD - no more and no less. Additionally, for privacy purposes, it might be better to keep the actual (complete) resume that you might have with HR, and make it clear that this is outside the realm of the QMS. Within the QMS you might have bare-bones versions, as above. You might not want auditors (including internal auditors, who are likely to know their colleagues in person) having access to everyone's full resume.

Cheers,
Ronen

Thank you Ronen. Your explanation has helped me realize that everyone in the company is impacted by the QMS, whether they are actually building the actual medical device or not. The procedures, which I inherited, have been written to distinguish "product quality" as those involved in manufacturing and inspection but the term "product quality" is so broad that it can be argued that everyone contributes to "product quality".

 

[Sylvia16]

A gentle reminder that the idea of a "job description" is not defined in 13485 or 21 CFR 820 - as such, job descriptions are a means to an end. What you need to do with them depends fully on what requirements you intend to fulfil. Usually, people use them to meet certain HR and personnel requirements.

You basically need a way to;

• Track people's competency (training, qualifications, experience, skills, etc.)
• Define what level of competency they need to achieve acceptable product quality
• Drive activities to achieve and meet the required competencies
• Communicate to people these competency requirements, and how their activities affect quality
• Check whether all of the above are actually effective in producing competence and ultimately product quality

The typical job description performs a part of this - it's the communication tool between an employee and management that describes what they do, how it is relevant to and affects product quality, what competency is needed to do that job. Sometimes it'll also include some periodic activities (like recertification for technicians). If you take this approach, one good reason to do it for all staff is because it can act as the place where you assessed whether they affect product quality or not.

That's not the only way to do, it though. One method I quite liked was defining procedural "roles" that each had their own subset of requirements and competencies, along with training and their connection to quality. These roles were documented in their relevant procedures (e.g., a machine operator role would be described in the machine operating procedure). Staff members would then just be assigned various roles (which could be added or removed as needed), and their training requirements calculated by adding all the roles together. This method didn't really look like a traditional "Job Description", but still met the various requirements. We still had a document called a 'job description', but they were a business tool rather than a QMS one.

I would say that the way you document and present these various requirements depends on how you want to communicate with staff regarding their competency and quality requirements. Many people are used to Job Descriptions to do that, and they can be a convenient method if you are already maintaining job descriptions for other business or legal reasons.

Thanks for your response. I like the method of defining "roles" in procedures. We currently do something similar .... we use "departments affected", which is broader but works for us now. Funny enough, I am currently updating a procedure on "Supplier Quality", which I had been asked to add "Finance" as one of the affected departments. This alone is justification for the QMS Director (me!) to have their JDs and resumes at the ready.
Thanks agin!

 

[Ed Panek]

This has been a requirement of our company from other giant pharmaceutical companies. They want to make sure we are qualified in education, experience or training and we are not "Learning on the fly." We have created a few HR SOPs that require everyone train on their JD and update their resume.

This has never been demanded from an ISO auditor though but they might ask for credentials of people in the company making technical decisions.

 

[Sylvia16]

This has been a requirement of our company from other giant pharmaceutical companies. They want to make sure we are qualified in education, experience or training and we are not "Learning on the fly." We have created a few HR SOPs that require everyone train on their JD and update their resume.

This has never been demanded from an ISO auditor though but they might ask for credentials of people in the company making technical decisions.

Thank you for reminding me of the perspective that larger pharma / med device companies may need to see evidence of competency.