Bastard Jobseeker From Hell Interviewing On skype

The CAPA Question

The Bastard Jobseeker from Hell had an interview today. It was for his usual role as a contract software tester where the project had a significant risk to human life and required compliance with the US law 21 CFR.

The interviewer was particularly weak and had the demeanour of a man whose professional activities are constantly complained about by everybody who comes into contact with him.

You can guess how it went.

The line manager (LM) starts the interview by asking for a brief summary of one aspect of US regulations on medical devices concerning the manner in which customer complaints are to be addressed and, if necessary, remedial action taken.

Which hasn’t actually got a great deal to do with the aspect of the job our man is being interviewed for, but as it is the only question this hapless interviewer will get to ask it is deserving of a full and frank response.

Here’s the after-action report.

LM: Do You Know CAPAs?
A litle.

Corrective And Preventive Action (CAPA) is defined by sections 90, 100, and another I don’t recall right now of 21 CFR 820. What these regulations require of a firm, in essence, is that the manufacturer is to maintain a dedicated business unit to handle problem reports and customer complaints. What we in IT call “issues”.

These “issues” must be fully documented to the usual standards of traceability and non-repudation and a process must be in place for receiving, reviewing, and evaluating complaints. This is necessary for the preservation of human life where potentially dangerous products are concerned. It dovetails nicely with the GMP “good manufacturing” suite of processes and the two often go together.

The CAPA team is not about fixing issues. The CAPA team documents, assesses and prioritizes. If it is determined that a software fix is required then and only then will it be handed over to the appropriate development team. The dev team’s deliverables to the CAPA team are documented evidence that the fix has been implemented to a standard that will provide a reasonable assurance of the product’s quality – the principle aim of 21 CFR.

The key words for our purposes are “dedicated business unit“. This legal requirement is to prevent ad-hoc self-assessment by research and development teams, which would run the risk of introducing subjective decision making. Thus, CAPA is not the responsibility of the IT team. Although members of the IT team may be consulted to advise CAPA on technical matters. Such advice should be objective and delivered with professional integrity and above all intellectual honesty.

I’m not qualified to give legal advice on this matter, I am simply giving you what my understanding of the law is based on my own experience, studies, and a layman’s review of the relevant case law.

But I thought you intended hiring a software tester. That’s what the advertisement said. Are you suggesting I join the CAPA team and review your business processes and enforce compliance from devs? I’d be delighted to do so. I think I would like to start with the hiring process though, because you did advertise for a test engineer, not a business process engineer.

LM: You’d be working on my development team as a test engineer
Is it the CAPA team you get most of your line-items, sorry, issues, from?

LM: Yes
I see. So it’s fair to say your team spends most of its time working on complaints?

LM: Not all the time, no. We also do some product development
When they are developing do the team mainly produce new products or are they mainly supporting legacy code?

LM: Mainly new products, with a few older applications, but we don’t work on the older ones much
You mainly work on applications that the team has produced themselves?

LM: Yes
And these are the applications that the complaints are getting raised about?

LM: Yes
Complaints from hospitals and laboratories in the health-care industry about inferior quality and perhaps risk to human life?

LM: Well, not all of the issues we handle come from our customers no
Who else does you team support?

LM: We also provide IT services for internal use
Do these internal users also raise quality issues with you?

LM: Yes
And you would like me to come and work for you?

LM: That decision hasn’t been made yet
I can assure you it has. Do you have any more questions?