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The FDA Can’t See That

February 4, 2013 By Leave a Comment

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:

  1. “May I see your procedure for Management Reviews?”
  2. “May I please have a copy of your organization chart?”
  3. “Could I see the agenda and attendees list from your last management review?”

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:

  1. DO NOT write anything inflammatory or opinionated in your documents. My motto is, “Stick to the facts Jack (or Jill).”
  2. I ask other people in the management team to read and review the meeting minutes before they are finalized. The variety of perspectives in top management helps to make sure that the final document is well written and clear—especially to FDA inspectors.
  3. I structure the documents as per a standard template that is a controlled document. This ensures that each report or management review was conducted as per the procedure. In fact, I typically reference the applicable clauses and sub-clauses throughout the document. For example, I will reference ISO 13485:2003, Section 5.6.2h) for the slide titled “New and Revised Regulatory Requirements.” I put the reference next to the slide title just to make it clear what requirement this slide is addressing.
  4. If there is an area that I covered, but there was nothing to discuss, I write “There was no further discussion on this topic.”
  5. If there is an area that I did not cover, I make sure I do the following:
    1. write a justification for not covering the area,
    2. indicate the last time the area was covered (and the result at that time), and
    3. document when the area will be covered in future.

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.

Filed Under: All, Ask CQ, Quality System Tagged With: , , , , ,

Are We Dealing With A New FDA?

August 10, 2012 By Leave a Comment

All recent data points I have observed suggests so. Admittedly, helping clients navigate through FDA related issues has become a huge part of CQ’s business. But in my opinion, some of these cases and observations border a little on the edge of being egregiousness and excessive. Here are some examples:

  • Very small medical device company inspected by FDA. Company has been making low-risk, 510(k) cleared device since late 1970s. FDA issued several page warning letter, with primary concern that company was marketing a device without proper FDA clearance. Company demonstrated otherwise.
  • FDA requests sterilization residual data. Test data proves overwhelmingly and objectively that there are no residual concerns. Despite the data, FDA is still concerned.
  • FDA decides to inspect company that manufactures low-risk class I devices. 483 observations are issued.

I wish I could go into much more detail in each case. If there is a trend I’ve noticed, it seems to be this: All FDA-registered companies need to be ready for a FDA inspection at any time. I would not have predicted FDA to show up with a few of my recent clients, but they did. It seems as though the days when FDA spends the majority of their time and resources only inspecting the “Big Boys” and for cause cases are gone.

Is this the FDA we as patients and consumers want? Do we want FDA inspecting manufacturers of low-risk products which have no history of issues? I don’t know. As a potential patient, I definitely want some assurance that the medical devices which could be used on me are as safe as possible.

Have you have any recent experiences with FDA you’d like to share?

Filed Under: All, Medical Device - General Tagged With: , , ,

Remediating Medical Device Quality System

August 8, 2012 By Leave a Comment

Earlier this week, I was onsite at a medical device client to help them navigate through some recent FDA 483 and warning letter observations. It’s a very small company, and they’ve been manufacturing their products for decades. Unfortunately, though, their business practices, quality system, and record-keeping have not kept up with the times and regulatory expectations. The most notable of the FDA observations were lack of CAPA, lack of nonconformance, and lack of complaint handling processes.

My strategy was to focus on the most pressing issues first. I started by drafting four procedures and accompanying forms:

  • Corrective & Preventive Action
  • Nonconformances
  • Complaint Handling
  • Adverse Events

Prior to showing up at the client site, I emailed the drafts for them to review. When I showed up, I could tell that what I was proposing for them was scaring them to death. As a great friend often says “body language always screams; it never whispers”. And she is right. The looks on the faces of the company personnel was quite telling. I knew I was losing them quickly and had to show them that what I proposed was very similar to their current practices.

So we walked through each of the procedures. You should note, that CQ has a different style and approach when writing QS procedures. We prefer to rely less on words and tell the “story” via a picture or process flowchart. Each of the draft procedures provided was only two pages–one of which was the flowchart. I started with the CAPA process flowchart, walking through each step. One of the people asked a question about a recent scenario and whether it would be an applicable CAPA. I used the flowchart and dialog with the people around the table to decide. I then showed them how the CAPA form created followed the process flowchart.

Ah, their body language softened. I think I even saw a smile and heard a sigh of relief. We repeated these steps for the other processes. And within an hour or so, I could tell the client was much more at ease about remediating their quality system issues FDA had previously identified. But this was only capable by demonstrating to the client that their current practices, although lacking in documentation and record keeping, fits FDA regulations. I had to show them that there is value in the paperwork.

Filed Under: All, Ask CQ, Medical Device - General Tagged With: , , , ,

6 Steps to Prepare for FDA Inspection

July 30, 2012 By Leave a Comment

It seems as though FDA is being more aggressive and active in performing medical device company inspections. We’ve been working with several clients who have gone through this process and a couple who are getting prepared just in case.

If you are a medical device company and it has been a few years since your last FDA inspection, my simple advice to you is to be sure you are ready. FDA could call tomorrow to announce plans for their visit to your facility next week? Don’t think it will happen to you? I can connect you to a couple of clients who had this opinion until it actually happened.

Here are 6 steps you can do to get prepared for a FDA inspection:

  1. Perform a mock FDA QSIT audit and/or gap analysis against 21 CFR 820 regulations. Yes, if you don’t know what QSIT means, you should educate yourself on this first.
  2. Review your CAPA process and records in detail. Pay extra attention to root cause analyses and ensure that CAPAs were in fact effective.
  3. Go through customer feedback and complaint files with a fine tooth comb. Make sure executive management was involved in determining whether MDRs were necessary.
  4. Identify gaps and issues from items 1 – 3 above. Be very critical and establish a realistic and actionable plan for correcting. Yes, use your CAPA process!
  5. Get organized. Make sure documents and records are in their proper locations and don’t have post-its and other extraneous notes on them.
  6. Train your team. Help them understand the audit process and to be at ease if and when it happens. Make sure everyone answers questions truthfully without speculating and offering too much extra information.

FDA inspections can be very stressful. Taking a few proactive steps ahead of time, though, will make the actual inspection a little more tolerable. Plus, it will give you and your team some practice at going through the drill just in case FDA comes calling.

If you need help being proactive in preparing for a potential FDA inspection, find someone who has been through this before. Whether a colleague at another medical device company or a consultant, there are resources available and willing to help.

Filed Under: All, Ask CQ, Medical Device - General Tagged With: , , , , , ,

Medical Device Companies Should Always Be Ready for FDA

July 23, 2012 By Leave a Comment

Within the past year or so, I’ve had several clients go through FDA inspections. While this experience can be very stressful for a company, it shouldn’t ever come as a surprise. If a company is registered with FDA, they should expect a visit every few years. The trouble is that many medical device companies have never had a FDA inspection. And sometimes this can lure a company into a false sense of security.

CQ has had a couple clients hire us recently to be more proactive regarding their quality system and preparations for a potential visit from FDA. We applaud these companies for their approach. While the clients have had some gaps and issues to address, they had enough vision and foresight to realize it was necessary to bring a fresh set of eyes with FDA quality system experience in to review their practices.

Interestingly, one of these clients was called a couple weeks ago by FDA. Guess what? FDA was informing this client that they would be visiting for a QSIT inspection. Although the company had not fully implemented the things CQ identified, the company did have a plan in place and has been actively working on addressing identified issues. This did not prevent them from receiving some 483 observations but might have saved them from receiving a warning letter.

The advice we provide medical device prospects and clients is that they should proactively and objectively evaluate their quality system from time to time to ensure that their practices and procedures are up to speed and in compliance. Medical device companies should always be ready for a FDA inspection too.

Filed Under: All, Medical Device - General, Strategy vs. Tactics Tagged With: , , , ,