Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We currently are a small startup (about 25 people) with 1.5 quality FTEs. We're slightly under-resourced by the 1:10 quality: company FTE rule-of-thumb ratio, but we are managing just fine.

A bit of history. Before my time, there was one QARA person who was not able to maintain the QMS and keep up with the regulatory work which then led to major issues throughout the QMS (they were also not competent to perform that role so that led to all sorts of other issues like requirements not having been interpreted correctly etc.). When I joined, a lot of long hours were spent to get everything to a better state. However, it was clear to the auditor during our certification audits that we were still unable to maintain the QMS and so we had a major NC (the resultant CAPA's root cause was lack of resources). We were able to add 1 FTE (it was a corrective action) and now able to maintain things how it always should have been.

Nine months later since that major finding, and due to a poor money management across the company, now we are at a stage where the company needs to reduce workforce to be able to continue operate. As part of this restructuring plan, and despite pushback from myself (since I am part of leadership team, I have known that this is coming) and showing clear evidence of how lack of resources led to all the past issues which we have now resolved, the proposal is to disestablish the role that was created a result of the CAPA. In terms of QARA resourcing, this is essentially taking the company back to how it was few years ago before my time. I am absolutely certain lack of resources is going to lead to same issues that we had before and it's only a matter of time before we will again start receiving major findings.

Now, coming to what I want input on from this community. We have a continued surveillance audit coming up shortly (the timing seems perfect) and management would obviously like to keep restructuring plans under the wraps due to the lack of resources connection. However, I am increasingly thinking that making the auditor aware of restructure plans within QARA could be a valuable leverage to continue to retain existing role (I have a good rapport with the auditor). This is the last resort for me as I have done all I can (such as, reduce non-people costs in the department elsewhere and showing the consequences of disestablishing the role) so far. 

I would be keen to hear from people who have gone through a similar situation in the past and approaches they have used with success (including using audits as leverage). 

This is not an ideal situation as I have worked extremely hard to get the whole QMS to this stage and moving ahead with the restructuring plans would be undoing all of it. 

First, consider the 1906 FDA Warning Letter to Hammil Manufacturing which includes, "Failure to establish and maintain an adequate organizational structure to assure that quality system requirements are fully met, as required by 820.20(b). For example, your Quality Assurance Department consists of one individual, the Quality Manager, who is responsible for implementation of your CAPA system, quality audits, document control, training, developing procedures, conducting process validations, and all other aspects of your quality system for both medical and non-medical products. During the inspection your quality manager stated that he lacked sufficient time and resources to complete many of the Quality System requirements."

"[FDA has] reviewed your response, which states that you created a CAPA Coordinator position to manage and coordinate all aspects of the CAPA system."

If you were to take the action you propose, telling the auditor of company confidential plans, and I were your manager, then the day after the audit you would no longer have a job with the company.

A better plan is to help the company get through the financial problems. Recognize you will lose an FTE. What should you do with the remaining capacity?

Do a simple analysis of how the people spend their time. Rough estimates will help you understand where the time goes.

In my experience, companies have an overly complex QMS. There is tendency in the industry that says compliance requires complexity. Determine what you are doing that could be simplified or eliminated.

Determine what can be outsourced to part-time people of consultants. For example, an outside person could maintain your quality audit program, especially if it were streamlined, in a few hours per month.

I suspect all managers are asked to prepare a cost-saving plan. Diligently working on your plan will be a better career path than trying to use a third-party auditor for leverage.

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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 17-Aug-2023 23:34
From: Anonymous Member
Subject: Resourcing issues

This message was posted by a user wishing to remain anonymous

We currently are a small startup (about 25 people) with 1.5 quality FTEs. We're slightly under-resourced by the 1:10 quality: company FTE rule-of-thumb ratio, but we are managing just fine.

A bit of history. Before my time, there was one QARA person who was not able to maintain the QMS and keep up with the regulatory work which then led to major issues throughout the QMS (they were also not competent to perform that role so that led to all sorts of other issues like requirements not having been interpreted correctly etc.). When I joined, a lot of long hours were spent to get everything to a better state. However, it was clear to the auditor during our certification audits that we were still unable to maintain the QMS and so we had a major NC (the resultant CAPA's root cause was lack of resources). We were able to add 1 FTE (it was a corrective action) and now able to maintain things how it always should have been.

Nine months later since that major finding, and due to a poor money management across the company, now we are at a stage where the company needs to reduce workforce to be able to continue operate. As part of this restructuring plan, and despite pushback from myself (since I am part of leadership team, I have known that this is coming) and showing clear evidence of how lack of resources led to all the past issues which we have now resolved, the proposal is to disestablish the role that was created a result of the CAPA. In terms of QARA resourcing, this is essentially taking the company back to how it was few years ago before my time. I am absolutely certain lack of resources is going to lead to same issues that we had before and it's only a matter of time before we will again start receiving major findings.

Now, coming to what I want input on from this community. We have a continued surveillance audit coming up shortly (the timing seems perfect) and management would obviously like to keep restructuring plans under the wraps due to the lack of resources connection. However, I am increasingly thinking that making the auditor aware of restructure plans within QARA could be a valuable leverage to continue to retain existing role (I have a good rapport with the auditor). This is the last resort for me as I have done all I can (such as, reduce non-people costs in the department elsewhere and showing the consequences of disestablishing the role) so far. 

I would be keen to hear from people who have gone through a similar situation in the past and approaches they have used with success (including using audits as leverage). 

This is not an ideal situation as I have worked extremely hard to get the whole QMS to this stage and moving ahead with the restructuring plans would be undoing all of it. 

I would be very careful of your next steps.  First, as Dan stated using the audit as leverage is very possibly going to end in the decision to keep your FTE that you hired based on the CAPA and then saving the money by eliminating your position.  That said, there are some things that you could consider not nearly as overtly as telling the auditor of the plan to reorganize the business:

1. Try asking the auditor what the penalty would be if a second occurrence of a similar major NC might be in future audits.  Don't need to specify anything or any major NC in particular - just a question about how recurrent or similar major NC findings are dealt with by the certifier.
2. Look to other sources that can show that people have already gotten into more trouble and agencies/certifiers - FDA has multiple instances where it is noted that the inspectional observations in follow up inspections have been similar to or the same as observations found previously.
3. Take Dan's advice around showing how time is currently used in the group and why it is impossible to eliminate the position.  Or maybe simpler - show that the cost of the FTE currently is less than or equal to the cost of potentially needing to outsource the work or bring in temps to fill gaps while your remaining staff are doing the rest of the daily work that we all have on our plates.
4. SIMPLIFY.  Dan's comment is spot on when it comes to the way things are created.  I have found in more than a few instances when coming into companies that their "systems" or the SOPs that those systems run according to has so much complexity and checks, double-checks, triple-checks, multiple reviews of the same documents, etc. that there is usually hours per week that can be found in simplification.  Take a really good hard look at what you are doing, what the justification is for doing it, how you are doing it, and what the justification is for doing it that way.  If the only justification for either of these is "we've always done it that way" then almost certainly you can reimagine your process to minimize, mitigate or eliminate duplication or effort or non-value-added work.

------------------------------
Victor Mencarelli MS
Global Director Regulatory Affairs
New YorkNY
United States
------------------------------

Original Message:
Sent: 17-Aug-2023 23:34
From: Anonymous Member
Subject: Resourcing issues

This message was posted by a user wishing to remain anonymous

We currently are a small startup (about 25 people) with 1.5 quality FTEs. We're slightly under-resourced by the 1:10 quality: company FTE rule-of-thumb ratio, but we are managing just fine.

A bit of history. Before my time, there was one QARA person who was not able to maintain the QMS and keep up with the regulatory work which then led to major issues throughout the QMS (they were also not competent to perform that role so that led to all sorts of other issues like requirements not having been interpreted correctly etc.). When I joined, a lot of long hours were spent to get everything to a better state. However, it was clear to the auditor during our certification audits that we were still unable to maintain the QMS and so we had a major NC (the resultant CAPA's root cause was lack of resources). We were able to add 1 FTE (it was a corrective action) and now able to maintain things how it always should have been.

Nine months later since that major finding, and due to a poor money management across the company, now we are at a stage where the company needs to reduce workforce to be able to continue operate. As part of this restructuring plan, and despite pushback from myself (since I am part of leadership team, I have known that this is coming) and showing clear evidence of how lack of resources led to all the past issues which we have now resolved, the proposal is to disestablish the role that was created a result of the CAPA. In terms of QARA resourcing, this is essentially taking the company back to how it was few years ago before my time. I am absolutely certain lack of resources is going to lead to same issues that we had before and it's only a matter of time before we will again start receiving major findings.

Now, coming to what I want input on from this community. We have a continued surveillance audit coming up shortly (the timing seems perfect) and management would obviously like to keep restructuring plans under the wraps due to the lack of resources connection. However, I am increasingly thinking that making the auditor aware of restructure plans within QARA could be a valuable leverage to continue to retain existing role (I have a good rapport with the auditor). This is the last resort for me as I have done all I can (such as, reduce non-people costs in the department elsewhere and showing the consequences of disestablishing the role) so far. 

I would be keen to hear from people who have gone through a similar situation in the past and approaches they have used with success (including using audits as leverage). 

This is not an ideal situation as I have worked extremely hard to get the whole QMS to this stage and moving ahead with the restructuring plans would be undoing all of it.