I can say that remediation can pertain to a single CAPA, raised internally, or as a large complex project to remediate Warning and Hearing letter, Consent Decrees, etc.
It can be isolated or global…
I have worked for companies and served clients on global remediation projects, revamping quality systems and developing strong quality cultures. These projects do often take years to bring about the culture change required to support a healthy quality system.
With remediation, it is important to be patient and steadfast. From a collective leadership position, management at all levels has to be committed to fixing the problems.
A robust CAPA system can be the panacea for correcting Quality problems. Validated CAPA systems can provide a solid framework for all the items that go into an effective CAPA:
A thorough, independent investigation Appropriate developed timelines Ownership, accountability and assigned responsibility A repository for objective support evidence to support historical context and traceability
However, as we cover a little later in this presentation, you need to have a game plan in place if you find your organization facing a remediation effort that includes correcting the very CAPA system you are hoping to utilize to resolve the problems.
Often, CAPA is the quality system element that is the vehicle that leads an organization into the change management cycle. Not only are deleterious events captured and investigated, but done well will includes careful analysis of all aspects of the situation that allows for support of appropriate solution.
The conference in February focused on the many aspects of CAPA, as a process, system and philosophy.
Here in the presence of practiced CAPA professionals, I doubt there is anything novel that I can share regarding the CAPA process. What I may however be able to bring are some valuable lessons learned that in the best context can save an organization from wasted time, effort, energy and ultimately, money. Thereby allowing the CAPA system to act as a protector of the bottom line – rather than a risk to the bottom line.
Often times, working in Quality, we can forget about the business end of our organization. Effective use of the CAPA system mitigates the risk of bad product reaching the market – which protects a company’s value on the stock market. For this very reason, top executives should be highly interested in the effectiveness of their overall quality system with special focus on CAPA.
One thing that can be assured, if you don’t focus on Quality, you won’t have to worry about your company’s stock price – eventually, it won’t one.
Often times organizations come to Remediation in light of regulatory action. However, the best scenario is when companies have an internal culture that quality centered and CAPA supportive.
It is far easier for organizations look to stay on top of industry standards and regulations – rather than try to bridge the gap between execution and compliance.
Organizations can suffer from differing philosophies and control over the quality system and metrics.
But it’s important to recognize that CAPAs are good – it is the undocumented and/or un-recognized problems that can have serious repercussions for a company.
What is the goal or the desired result of remediation?
The light at the end of the tunnel:
When you get through remediation, you should have compliant standards established, systemic solutions in place, a greater competency level in personnel, confidence that future evaluations won’t result in any surprises and a corporate culture that embraces CAPA.
Focus on the patient and the solution.
Let’s start with why I love working in this industry…daily I can connect with people who benefit from spirit of innovation, the hard work of development, the long hours of regulatory filings and the celebration of bringing new products to market.
Every day, I would guess that each one of us connects with family, friends, loved ones that have benefitted from the advancements in health care.
I would challenge every person on the webinar today to have story close by – all the time, and ready to be shared. As leaders we have to communicate why we do what we do – and why we do it relentlessly.
I have a history of working in healthcare. First Bio-Tech, then pharma and most recently, med-device. While I have always tried to picture the patient on the other end, recent events in my life have brought this mission to a deeply personal level.
Let me tell you about Jade – Jade is 16 years old, an honor student, plays the clarinet and lives for the first day of school every year.
Every August, Jade goes off to band-camp and comes home with something new. Last year, she got bitten by chiggers, this year, she came home with pneumonia.
On the first day of school, Jade woke up with a fever of 104. She insisted on going to school – it’s the first day after all…like X-mas, easter, thanksgiving, new years and halloween all rolled in to one. So she took advil and went to school. After school, we went to a walk-in clinic – x-rays showed pneumonia….follow-up x-rays showed fractures in her spine.
Mention Training of tools to ensure owners have the appropriate skill set to effectively apply and use techniques.
Move up slide 28 or cover in talking points for Management support of CAPA
CAPA Subsystem includes CAPA, Complaints and Non-Conforming Product Source of the data – FDA’s Turbo Establishment Inspection Reporting (EIR) Database
CAPA is always reviewed because it shows regulators the ability of your system to address what’s wrong.
Work with the end goal in mind – this was stated above in bullet 2 but when we discussed you asked me to note that.
I spoke to Terry about the metrics and his original intent was more for QMS monitoring and trending, which didn’t really apply to this topic. However, I think you could talk through the metrics related to remediation to monitor progress and ensure things are following the plan.
Did you fail to address the problem or was your V of E Criteria unrealistic? Make sure problems and objectives are quantifiable.
You asked me to add a note here about including a bullet about reviewing V of E related to my comment above.
If you have mountains of objective evidence then be organized and summarize results. This will simplify the review of larger CAPAs.
For investigation and RCA - Be sure to document the process and the steps completed, not just the results.
Regulators are likely to look for similar issues at multiple sites so implementing systemic solutions will demonstrate effectiveness of your CAPA and a mature quality system.
The ability to utilize the CAPA system in an effective and compliant manner is a common issue, avoiding these pitfalls can help your organization successfully remediate quality problems and aide in your journey to continuous improvement
Effective Use of CAPA in Remediating Quality Management Systems
Effective Use of CAPA in
February 25, 2016