How to evaluate "competency" of consultants ?

[SGquality]

Hello Covers,

So good to be back

I have a question on 21 CFR Part 820.50 (1), that states the below:

Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented

How do organizations evaluate consultants / contractors during FDA inspection ? Would the consultant's Resume or CV be good to demonstrate or any additional documents required ?

Thank you very much !

 

[Ronen E]

Hello Covers,

So good to be back

I have a question on 21 CFR Part 820.50 (1), that states the below:

Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented

How do organizations evaluate consultants / contractors during FDA inspection ? Would the consultant's Resume or CV be good to demonstrate or any additional documents required ?

Thank you very much !

The requirement is that you evaluate (and then select) on the basis of the ability to meet specified requirements. So first, you have to have the requirements specified, specific for that job (or set of jobs). You provide evidence for that by having the requirements documented upfront.

Once you have the requirements specified, you need to show that you tried to evaluate the consultant's / contractor's ability to meet them. I don't think that there's just one way to do that. If a resume provides reasonable assurance that the individual has an acceptable ability to meet the requirements, that'd good. Alternatively you could ask for a reference list, then talk to a few and document the results. Or anything of that sort. Essentially, it needs to make sense (and if you rely solely on a resume I would assess the reliability of what's written there, perhaps even try to verify the important bits independently). If you want to be on the safe side you could attach a 1-pager per candidate, describing your thought process and how you reached the conclusion that the individual meets / doesn't meet the ability threshold.

Finally, you could document how you selected one (or more) consultant(s) based on the results of the previous stage (competency evaluation), and why.

Cheers,
Ronen.

 

[mihzago]

Some auditors may ask about the skills and expertise of the consultant beyond just work experience, so make sure that the CV/resume or another document show that.
Look for certifications (RAC, ASQ CQA/CQE, auditor, etc), or additional training specific to your needs.

 

[Ronen E]

Look for certifications (RAC, ASQ CQA/CQE, auditor, etc), or additional training specific to your needs.

The requirement is to evaluate ability to meet specified requirements. If a requirement for specific certification has been specified, compliance with it should be evaluated (ie is the consultant certified); otherwise it's just an overshoot. The regulation doesn't specify what the requirements should be. It only requires that requirements are specified and evaluated against.

 

[mihzago]

Ronen, I agree, however, just because you don't specify something, does not mean you comply with the requirement.
I'm not saying that specifying certifications is required in all cases, I'm just providing an example of a way to evaluate and show consultant's competency.

I'm also sharing a real-life example for an ISO audit during which I was questioned on how did I evaluate and select a consultant for an internal audit. The auditor made it clear that using work experience is not a sufficient requirement.
Now whether the auditor had any basis for making this statement is something we can debate.

 

[Ronen E]

Ronen, I agree, however, just because you don't specify something, does not mean you comply with the requirement.
I'm not saying that specifying certifications is required in all cases, I'm just providing an example of a way to evaluate and show consultant's competency.

I'm also sharing a real-life example for an ISO audit during which I was questioned on how did I evaluate and select a consultant for an internal audit. The auditor made it clear that using work experience is not a sufficient requirement.
Now whether the auditor had any basis for making this statement is something we can debate.

Let's please separate the FDA context from the ISO one, the requirements are not necessarily the same. The OP asked in an FDA context and my response was in that context too.

The FDA's requirement is not that you evaluate the consultant's competency in general (for which certifications could be a relevant measure), but their ability to meet the requirements specified (it implies that the requirements have to be specified first). My understanding is that if certification wasn't specified (which is easy to show if the job requirements are actually documented in each instance) then it's not something that needs to be looked into in order to comply with the requirement to evaluate. It might still be a good idea to look at certification, but that's a separate issue.

In the ISO context, I sure doubt that that auditor had grounds to make that assertion. This is one of those "Show me the 'shall'" situations. I'm not aware of a formal requirement for certification in order to be an internal auditor (assuming that we're talking about ISO 13485). I tend to agree that work experience alone might not suffice, but the missing element is independence and not certification. The auditor's comment could have also stemmed from some other obscure requirement in your system, rather than in the standard itself. I can't tell because I don't know your system.

Cheers,
Ronen.

 

[v9991]

If you want to be on the safe side you could attach a 1-pager per candidate, describing your thought process and how you reached the conclusion that the individual meets / doesn't meet the ability threshold.

Finally, you could document how you selected one (or more) consultant(s) based on the results of the previous stage (competency evaluation), and why.

Cheers,
Ronen.

We hire consultants because we need expertize (i.e., we are evaluating' competency where we dont have that adequate exposrue!) it might look like synopsis of credentials enquired/submitted to us.

further, is there a way to tie the "success criteria" of the proposed scope of work and get the response from the consultants and then do the comparison / assessment. ( its an attempt to actually move on from qualitative assessment to an comparison of outcomes, or precedence(s) of working in same area etc.,!) (essentially making the experts to respond ...and this actually happens in an another form, discussion on scope, etc.,)

 

[Jen Kirley]

We hire consultants because we need expertize (i.e., we are evaluating' competency where we dont have that adequate exposrue!) it might look like synopsis of credentials enquired/submitted to us.

further, is there a way to tie the "success criteria" of the proposed scope of work and get the response from the consultants and then do the comparison / assessment. ( its an attempt to actually move on from qualitative assessment to an comparison of outcomes, or precedence(s) of working in same area etc.,!) (essentially making the experts to respond ...and this actually happens in an another form, discussion on scope, etc.,)

This is important. Pretty much anybody can learn what the standard says, but a competent consultant needs to be able to guide you in value-added system definition (first), that conforms for certification (second). Too often these objectives are reversed in importance and the client is left with a burdensome or incoherent system.

 

[SGquality]

Thank you all; great points