There is a great opportunity this Friday (3/22) to hear from Scott Durlacher of Anson Group on preparing for a FDA audit. If you are part of a medical device company, I highly recommend you participate. Having worked with and knowing Scott, he has a ton of experiences and suggestions to assist you in being prepared.
Here is a link to the INpact event page.
FDA issued several 483 observations relating to Management Responsibility in 2012. Here is a list of some of these 483s as reported by enKap Community. Still think FDA can’t see your Management Review minutes?
The reality is that if during the course of a FDA inspection, all documentation and records could come into the scope of the inspection. If your company’s Management is engaged, and documentation and records are in good order, I would doubt that a FDA inspector would go fishing around too much without a reason to do so. However, if Management is not engaged, a FDA inspection could be a more painful than normal process.
Keep in mind too that today’s FDA inspections are a little more aggressive than from just a few years ago. As noted in a previous post, total number of inspections, 483 observations, and warning letters are higher now than ever. As such, FDA and regulators across the world EXPECT Management to be engaged and part of the overall decision making process, especially as it relates to compliance.
One of the most critical roles I play for medical device startup clients is that of educator. And the usual topics for those involved with medical device product development include Design Controls, Risk Management, and Quality Management System. Let me dive a little more into Risk Management with this post. Specifically, I want to help explain hazard, harm, and cause.
First, a few official definitions according to ISO 14971:
While the definitions seem pretty clear, I can assure you from personal experience the concepts because risk management and how to capture the details can sometimes get confusing. Specifically, I’ve seen time and time again where the concepts of hazard, harm, and cause can get a little muddy.
So maybe thinking about it this way might help:
Rob Packard comes through again with another guest post. I think the topic is timely and pertinent, mainly because I have several clients who either recently completed or soon will conduct Management Review. Rob is a Regulatory Affairs and Quality Management System expert whose specialty is helping companies with regulatory submission of a Design Dossiers for CE Marking of high-risk Class III medical devices. You can read more of Rob’s work at QC is Dead and RA Review blogs.
When I meet with a new consulting client, the phrase I dread hearing is “the FDA can’t see that.” It is true that the FDA is not supposed to review the content of internal audit reports and management reviews in order to encourage companies to use these tools to address quality problems without having to worry about the FDA beating them with their own reports.
The problem with this mentality is that it fails every time. The FDA can get to issues in your management reviews and your internal audits by asking, “Can I please see all the CAPAs resulting from internal audits and management reviews.”
One client I spoke with said that they purposely don’t open any CAPAs from internal audits or management reviews for that reason. I was in complete shock, but I managed to keep my poker face and asked the client, “So what do you think the FDA will do when you say that you don’t have any CAPAs resulting from internal audits or management reviews?”
Christine Park wrote a recent blog posting (http://bit.ly/FDATarget2013) about management responsibility being the “FDA’s NEW Inspection Target.”Most companies are subjected to a Level 2, QSIT inspection on a biannual basis. During these comprehensive inspections the inspector reviews the four major subsystems: 1) management controls, 2) design controls, 3) CAPA, and 4) production and process controls. The FDA will ask open-ended questions to determine the effectiveness of the QMS. If the inspector is not going to look at the actual meeting minutes from the management review, you can expect them to look at the following obvious targets:
The inspector could also ask for copies of inputs that are identified in the Management Review procedure, such as: “Could I have a copy of the most recent scrap trend analysis for production?” or “What is your threshold for taking corrective actions for rejects found in receiving inspection?”
One Quality Manager told me a fascinating story about his local inspector. During the visit two years before, the inspector requested a copy of the management review. The Quality Manager showed him the cover page that indicated the agenda and the attendees. The Quality Manager refused to let the inspector see the rest of the meeting minutes. The inspector then proceeded to conduct a brutal 3-day inspection where a myriad of 483’s were written.
Twelve months later the inspector returned to perform a “Compliance Follow-up.” This time when the inspector asked to see the management review, the Quality Manager agreed to let the inspector see the entire meeting minutes. From that point onward, each time the inspector got close to identifying a new 483’s the inspector would stop following the audit trail at the last moment before the nonconformity was identified. The Quality Manager said it was almost like the inspector was showing him that he could find all kind of problems to write-up if he wanted to, but he was taking it easy on the company because the Quality Manager was being cooperative.
My personal philosophy is to create a QMS that is open for review by any customer, auditor and even the FDA. No matter what they find, it’s just another opportunity to improve. This has worked well for me, but you need to follow a few basic rules when writing audit reports and management review meeting minutes:
You can continue to listen to the advice of consultants that think of creative ways to hide things from the FDA or you can follow the above advice. If you follow my advice, then you can spend the rest of your time working on the CAPAs for each area where you identified a weakness—instead of spending your time trying to hide your problems.
If you are interested in learning more about preparing for FDA inspections, and how to respond to FDA 483’s or warning letters, please email Rob Packard (rob@13485cert.com). He will be hosting a 2-day course on this course in two different cities (Denver and Vancouver) on July 25/26 and July 29/30 respectively. The speakers for that course will be ex-FDA inspectors Lori Carr and Steve Yost.
Contact me if this is you. Specifically, I’m interested in connecting with you if you have 5+ years experience with quality systems, regulatory submissions (US and OUS), supplier audits, and internal auditing.
Complaint handling seems to be an issue with medical device companies. I’ve seen a few examples in recent years where the company’s approach is less than stellar. In fact, it seems as though some companies just try to disguise complaints altogether. They will do all the work to correct the issue, but for whatever reason, are reluctant to label these events as complaints. And I’m not sure why. Okay, I guess I am sure why. There is an assumption that complaints require lots of work and documentation. Sure, complaints require thorough investigation. And why wouldn’t you want to do this? It involves your products and your reputation.
There is one client I’ve been working with who could actually be the poster child for how to properly investigate complaints. The entire team is committed to investigating product deficiency claims. The company embraces complaints as opportunities to learn more about their products and as chances for improvements. While their complaint processes and documentation are not fully optimized, the personnel working on complaints are diligent about the investigation, root cause determination, testing, communication, and timely closure of complaints.
I just wish more medical device companies would embrace complaint handling in the same way. I wish all of my clients realized that complaints are opportunities for improvement.
Tips For Startups, Events, Medical Device News, and Regulatory have all been updated with links to new content.
A colleague, Rob Packard is conducting a webinar on October 30, 2012 for those in IVD medical device industry. Specifically, the webinar is titled “Companion Diagnostics: Regulatory Updates for FDA, EU, Canada”. Rob knows his stuff, especially when it comes to analyzing impact changing regulations will have on bringing new medical products to market.
Do you remember a couple years ago when I put the message out there that Creo Quality was looking to meet “garage inventors”? Ever since, we have been making connections with medical device inventors, entrepreneurs, and startups. It’s been fantastic!
In fact, right now, I am working closely with two very early stage medical device inventors. Both ideas are novel and seem to solve a real problem. In both cases, the inventors seem to be great people who are open to suggestion and are not afraid to admit that there are just things about this process they don’t know.
In both cases, I shared the Building a Business Case questionnaire with the inventor and received the completed responses within a few days. The completed questionnaires are very helpful for a couple reasons–the biggest of which is the fact that the inventor actually took the time to provide responses is an indicator that he is willing to see this thing through. A leap of faith–maybe. But I’ve had plenty of so-called inventors whom I have not heard from since sending the questions.
And for an aspiring medical device inventor who wants a little help and guidance on what to do and when to do it, I’m telling you now you will get some of my time for FREE if you are willing to complete the Buidling the Business Case questionnaire. The links above should guide you to downloading the survey and you can email it to me if you want a little help.
I’m investigating an issue for a client on a medical device of theirs which appears to have been reprocessed by a third party vendor. A sales rep recently discovered that one of the company’s products had been reprocessed because it had reached expiration date. The reprocessor took the product and repackaged and re-sterilized it and charged the hospital.
Here are some immediate concerns I had when discovering this:
I realize that FDA allows reprocessors to do their thing, with one significant caveat. The reprocessor is required to receive 510(k) clearance first.
So I checked the 510(k) clearances for this particular reprocessor. They have not received 510(k) clearance to reprocess this product.
I’m completing my investigation and will be making several recommendations to my client.
Frankly, as a potential patient, reprocessed medical devices scare me. Maybe it’s because I know too much about the process for bringing medical devices to market. I mean single-use medical devices are designed and tested prior to reaching hospitals. The packaging, sterilization, shelf-life, performance, and so on have all been proven. For a third party who does not have access to any of this data on the product to come in and repackage, re-sterilize, and suggest that the single-use device is as good as new is just preposterous.
The rest of the year is jam packed with a variety of events from medical device investing, to 510(k) workshops, to events focusing on innovation.
Check out the Events Page for a complete listing.
What do you do when you find out your medical device is being used slightly differently than you intended? What about when your product is being used on a patient population where you don’t have much data? What about when you learn that the instructions for use and the procedural steps you identified are not being followed?
What do you do? What are you required to do? These are NOT easy questions to answer.
I recently had a client who had to deal with some of these issues. A doctor contacted the company to get a sample device so that he could become more familiar with components, techniques, etc. The doctor, a pediatric surgeon, asked for the product to be sent to his residence. I was asked for my opinion on what to do and how to handle the situation.
Here is what I recommended to my client:
I take a fairly conservative approach on matters like this. And I advise my clients to do the same. I recommend that they document objective evidence supporting decisions that are made. Sometimes the clients listen; other times they don’t.
If you find yourself in similar types of scenarios, be sure the decisions you make and the actions you take are supported by rationale, objective justifications which are documented.
What can you do to reduce FDA medical device 510(k) delays? Aptiv Solutions suggests the following:
The article provides some explanation for each of the tips listed above. Of the tips, I emphasize #1 – Do your homework. Doing the homework for your medical device and the 510(k) submission is critical, especially the importance of establishing sound, meaningful predicate devices. In my experience, the BIGGEST delay in FDA 510(k) review is a direct relationship to the strength of the predicate devices.
Recently, we created a few new webpages to provide references and useful information pertaining to medical devices. We make an effort to keep these pages up to date every couple weeks. Just letting you know the following pages have just been updated with fresh content for your reading pleasure:
Conducting Management Reviews is required form medical device companies per FDA 820.20 quality system regulations. Specifically:
Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer’s established quality policy and objectives. The dates and results of quality system reviews shall be documented.
And if you think about it, a periodic review of a company’s systems, processes, procedures, etc. does make very good business sense.
However, most medical device companies seem to treat Management Review as a checkbox activity that must be done because the regulations say so. And in some cases, I’ve witnessed Management Reviews as the time when executive management pays attention to the business. To me, this doesn’t work. In my opinion, executive management should always have their finger on the pulse of their business.
I’ve also rarely witnessed when Management Reviews actually effectively evaluate the suitability and effectiveness of a company’s quality system. Yes, the results of the various QS processes are reviewed and discussed, but executive management seems to be out of touch with QS efficiency.
I’ve also witnessed executive management using Management Reviews to assert their authority and dictate new initiatives that seem to be more of a whim than driven for overall streamlining and improvement.
Okay, I guess I just told you several things that Management Review should not be. So what should it be?
Management Review should critically and methodically evaluate quality data and objectives. To me, it starts with the overall vision and strategy of the company. So if the company lacks vision and strategy, then this must first be defined. With a strategy in place, quality plan and objectives can be defined to align with the overall vision and strategy. Management Review assesses whether these objectives are appropriate. Management Review is a time when course adjustments can be discussed in order to stay in alignment with the vision.
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