After purchasing another company, it’s vital for MedTech and pharmaceutical manufacturers to adequately assess quality systems to make sure the best approach of each company is used to create one, unified system, a former US Food and Drug Administration (FDA) official and current QualityHub VP recommends.
“At some point a decision must be made as to whether you’re going to harmonize those two quality systems or not. It’s perfectly viable to let each company independently manage and run their own quality system, but it’s likely there are efficiencies that can be gained by harmonizing those two quality systems,” said Rebecca Fuller, VP of regulatory compliance for QualityHub and an ex-FDA investigator.
But, she added, it’s important for company leaders to not prejudge either quality system.
“The most important thing is not jump to conclusions with regard to one quality system being better than the other,” Fuller said. “Rather, assess both quality systems and understand where there may be gaps in either one and where there are bright spots, where there are very effective processes in place, and then leverage those across the board.”
Fuller recently spoke about training around blended systems, avoiding tunnel vision, building a strong internal audit team, and more. The Q&A below was edited for clarity and brevity.
QualityHub: What’s the best way for a manufacturer to move forward when harmonizing a Quality Management System (QMS) following acquisition?
Rebecca Fuller: It’s about selecting the best of the best and saying, “Hey, I really like the way this company does, for example, their quality data analysis. Let’s bring that over,” or “I like the way this company over here, Company B, is tracking corrective and preventative actions [CAPA]. Maybe they have a better software solution for tracking CAPAs.” So, blend the best of the best. That means issuing new SOPs [standard operating procedures]. It means possibly bringing new technology into one of the companies and upgrading their software systems that are used for documenting and managing quality. Training is a key aspect of this as it is a means of getting every on the same page.
But your question is an interesting one because there are many times when companies say, “If I’m Company A and I purchase Company B, I’m going to tell Company B that they have to implement my quality system” – but that’s not a given. That harmonization effort is going to cost time and money and take concerted effort. It should be carefully thought through, and you should consider leveraging the good things that Company B may have in place and not simply dropping something that Company B has been doing that may represent a best practice that the entire corporation can leverage.
QH: And obviously the purchasing company should make sure their due diligence process and activities are solid.
Fuller: That’s correct. It might be helpful to discuss the acquisition process itself as it impacts downstream decisions regarding the need for QMS improvements and strategy for integration. Part of the acquisition process should include a due diligence audit. While the concept of due diligence is often applied to the financial health of the company to be purchased, it is essential that due diligence audit of quality and compliance risks be considered in the context of M&A [mergers and acquisitions] within the life sciences sector.
A quality and compliance due diligence audit will help the acquiring entity understand what they are buying in terms of potential quality and compliance risk. This means considering recalls and the potential for them, the robustness of the target company’s Quality Management System, product holds and risk to distribution, regulatory inspection history and how this was addressed, backlogs in areas such as complaints and CAPAs, and the robustness of people and other resources applied to quality and compliance. This does not mean that if risks are identified, the acquisition does not move forward; rather, it means the purchasing company can plan ahead in terms of budgetary reserves for integration and strategic plans for mitigating potential compliance risks.
QH: I’m sure many manufacturers have tunnel vision when it comes to their quality system. What recommendations do you have for companies that are doing harmonization efforts after buying another company to make sure they’re not focused on the wrong things?
Fuller: Companies assess the systems they use, including their quality system, through audits, gap assessments, and management review, but there’s an inherent bias they’re going to have in assessing their own system – even if they have an independent function such as a quality assurance team doing those assessments. When that independent function does those assessments over many years, those same internal auditors begin to make assumptions about the systems they’re looking at. They get used to them. They naturally develop a bias.
But to your point: The most common way to answer key quality questions such as, “Do I have the best quality system? Is it meeting all the regulatory expectations? Is there efficiency to be gained? Is there another way to do things?” often means bringing in somebody from the outside who routinely sees other companies’ quality systems, who routinely assesses those and has learned from years and years of doing those assessments, so they can bring a fresh set of eyes and new ideas to you. An independent external assessor is likely going to look at your systems a little differently than you look at them yourself.
QH: It sounds like having a strong internal audit team is a key to success for manufacturers. Am I on the correct path here?
Fuller: Yes, you are. It indeed takes a strong internal audit function – a great group of people that is constantly being trained and retrained on how to look at things and are getting a lot of experience in auditing by, say, auditing suppliers and learning what their suppliers are doing. A company’s internal audit entity can sharpen its skills by supporting their company’s supplier audit functionalities and going out and getting some routine training on new concepts by attending industry conferences to learn how different companies are implementing particular requirements. Industry conferences and ongoing training classes can give an audit team opportunity to casually network with their peers which can lead to new ideas and new solutions to common QMS challenges.
QH: During your career, have you encountered a company that is in denial about their problems despite your recommendations on improving their quality system, and if so, how did that shake out?
Fuller: Many companies are in denial. In some cases, what finally shakes them out of denial is not the consultancy they hired to come in and do an audit; rather, it’s a regulatory agency such as the FDA telling them they have a problem or threatening enforcement action. Sometimes this denial is concurrent with recalls, patient adverse events, and other signals that the quality system needs improvement. If signals in quality data, including trends in audit findings, are proactively addressed, then risks to patients, compliance, and financial well-being can be minimized.
Sadly, until regulatory authorities force the issues, external experts may not be able to convince them of the need for change. Part of that is because implementing new processes, training staff, or making sure the company has the proper resources to sustain a robust QMS, all have an immediate cost. All these things cost money and it’s difficult sometimes in the environment we operate in for companies to justify the expenditure of that money until there’s a problem staring them in the face. But that’s unfortunate because in the long run it’s cheaper to proactively implement improvements before expensive recalls occur or before that implementation must be undertaken in the context of a response to a violative inspection.
But to answer your original question, yes, companies are often in denial. It’s not unusual at all for auditors to go in, conduct an audit, and have the company flat-out disagree with the audit findings. At QualityHub, when we do audits, we issue our initial draft audit reports to our clients so there’s ample opportunity for us to know if we’ve misunderstood something. If they have a valid rebuttal, we certainly take that to heart, and we will modify or clarify a finding so it’s better understood. We really want to get it right. QualityHub works with clients to make sure they understand why something is being written as an audit finding and why it’s a problem, and in cases where maybe we didn’t look at the right objective evidence and the company can provide that evidence, we take the time to consider it before issuing the final report. We go out of our way to make our sure audits provide an opportunity for education and improvement, and after the audit, we’re always open to collaborating on strategies for systemic improvements. We have a vast team of subject matter experts that can provide ideas based on industry best practices and 20-30 years of experience in implementing sustainable solutions.
QH: So, it’s all about having that smooth flow of honest communication between auditor and manufacturer, it appears.
Fuller: If a company is communicating effectively during an audit and giving internal or external auditors ample time to see the right evidence, then audit findings can be avoided, in real time. So, it’s vital keep that line of communication open. One way to do this is to ask questions. If an auditor’s request is not clear, ask for clarity. Often the auditor may ask for a document using terms that aren’t routinely used by the company. It’s important to understand what the auditor is asking for and avoid assumptions. Make sure the context and scope of an auditor’s request is understood before dropping a 200-page report on them that they didn’t really want in the first place.
[Editor’s Note: Is your MedTech or pharma company considering blending quality systems and doesn’t know where to begin? Then contact QualityHub today and learn how our network of consultants can make sure you stay on the path to regulatory excellence.]
