February 4, 2012

Congressional Committee to Reduce Waste Eliminates Self

Kim Egan

Kim Egan, Partner, DLA Piper LLP

It turns out that I am not the only one who has noticed that food regulation is sometimes a little, well, silly.  The federal government recently “identified a mother lode of government waste and duplication” and decided that getting rid of it “could potentially save billions of tax dollars annually and help agencies provide more efficient and more effective service.”  This according to Sen. Tom Coburn, R-Okla. and the Government Accountability Office (GAO) in response to the GAO’s first ever audit of federal agency overlap.

One of the biggest culprits is food safety.  There are over 30 food-related laws administered by 15 different federal agencies and still the public lacks confidence in the safety of our food supply.  What to do?

GAO recommends that as “a next step, the Director of the Office of Management and Budget, in consultation with the federal agencies that have food safety responsibilities, should develop a government-wide performance plan for food safety that includes results-oriented goals and performance measures and a discussion of strategies and resources.”  What does that mean?  It sounds an awful lot like the “next-generation-platform-based-information-management-solutions” type stuff we heard about during the tech boom.

GAO insists that “[w]ithout a government-wide performance plan for food safety, decision makers do not have a comprehensive picture of the federal government’s performance on this crosscutting issue.”  In other words, if no-one tells the boss what’s going on, the boss won’t know what’s going on.  Let’s definitely fix that.

GAO also wants Congress to ask the National Academies of Science to ask a blue ribbon panel of experts to come up with some “alternative food safety organizational structures.”  The GAO proposes that Congress ask the NAS to ask the blue ribbon panel to consider the excellent example of Europe.   Somehow I don’t think our Tea Party Congress will cotton to that idea.  Europe has one food safety agency and one, transparent set of food safety rules.  That seems so sensible, no?

The GAO also appears to recommend Food Communism: “a coordination mechanism that provides centralized, executive leadership for the existing organizational structure, led by a central chair who would be appointed by the president and have control over resources.”  The Tea Party won’t like that either.

Because the solution to our food problems is to become more European, we can rest assured that nothing at all will change.  We will stick with our quaintly provincial and silly system of food regulation.  FDA will continue to make sure that shell eggs are properly labeled while the USDA’s Animal and Plant Health Inspection Service will continue to ensure the health of the chicks that hatch from them.  FDA will continue to regulate products made from the shell eggs (that one hopes were properly labeled) while USDA’s Agricultural Marketing Service will continue to grade eggs for beauty and purity.  And it will continue to be the case that nobody at all in the federal government will be making sure that the eggs sold in your local grocery store are free of Salmonella.

The good news is that it’s not just food that gets taken to task in this report.  The GAO says we could probably save some money “defending our northern border” from our staunch Canadian ally as well, ironically, as our efforts to identify government overlap.  No. 14 on GAO’s list of things to de-dupe is “Enterprise Architects,” which it says are “key mechanism for identifying overlap and duplication.”

What a waste.

Kim Egan is Partner in the firm DLA Piper LLP

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Former FDA inspector Miles on What FDA Looks for During Inspections & the Importance of Strong CAPA Systems

Ken Miles, Former FDA Inspector

Ken Miles, Former FDA Inspector

Ken Miles, a 28 year veteran of the FDA, is today a widely-respected industry consultant to the medical device industry. He draws on his extensive experience to help firms effectively and efficiently comply with FDA requirements. Ken’s expertise includes evaluating Good Manufacture Practice (GMP) and Good Laboratory Practice (GLP) compliance, Quality System Regulations, and QSIT certification inspections (Management, Design, Process Controls, and CAPA).

In this multi-part series, we talked with Ken about FDA inspections, CAPA, quality systems, audits, training and more.

Q: When you were with the FDA, what did you look for during onsite inspections at medical device facilities?

A: What I primarily looked for was a robust quality management system that covered all of the key areas: CAPA, internal quality audit findings, training, MDRs and complaints, supplier quality, etc.   Supplier audits are also very important, and they should always tie back into CAPA and management review findings.

Q: You mention training as part of the overall quality management system –  what kind of problems did you see in that area?

A: The most common problem with training is that programs are often inadequate. Oftentimes procedures are either nonexistent or very poorly written. You need to have stringent management commitment and oversight, while also removing irresponsible people who can seriously damage the business. Procedures, management review and training are the primary areas that should generally be addressed through a CAPA program to make it work.

Q: Digging deeper, what were the CAPA-related issues you saw most often during inspections?

A: The one thing I saw often was that companies did not prioritize their CAPA items. You need to prioritize them using a risk-based approach. The highest priority ones should be put at the top of the list. Sounds like an obvious thing, but a lot of companies just throw all CAPA related issues into one bucket with no priority or even closure dates. If you don’t have some sort of prioritization system, you might become weighed down with too many assignments with no end in sight. Prioritize by low, medium and high priority, as well as severity of consequences. That would also imply that you have a target date, or closure date once you implement that program. A lot of companies don’t do that.

Q: You stress the importance of prioritizing and setting due dates for CAPA. Can you give us some examples of what you looked for during your inspections?

A: Medium and serious CAPA issues should be closed out within 30 or 90 days at the most. I’ve seen situations where CAPAs are still hanging out there after two or three years! And I’ve even some that have never closed or resolved! In certain situations, I’ve also seen CAPAs that don’t even have a closure date. Unfortunately, that’s typical of spreadsheet based CAPA systems.

In the next part, we will delve deeper into actual situations, and discuss some of the more egregious things that Ken Miles experienced as an FDA inspector.

Click here for more detailed information about CAPA.

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Keystone Dental Takes Fixing Smiles Very Seriously

keystonelogoMore than 30 million Americans are missing some of their teeth in one or both jaws, and with a growing aging population, that’s estimated to grow substantially. According to the American Academy of Implant Dentistry, an estimated two in three Americans have one or more missing teeth, due to the increase in periodontal disease as the population ages.

Three million people have dental implants and that number is growing by 500,000 per year with an estimated market for implants to reach $1.3 billion by 2010.  Dental implants are permanent fixtures of titanium posts anchored in the jawbone and topped with a replacement tooth. The technology was initially developed in Europe over 30 years ago and the success rate is remarkably high: 97 percent success rate in lower implants and 91% success rate in the upper implants.

Keystone Dental, based in Burlington, MA, was founded in March 2006, and aspires to build a market leading global brand recognized within the dental community for its integrity, trust and commitment to improving the standard of care for patients and their quality of life.

Since then, they have rapidly grown into a diversely skilled, fast-moving team of professionals committed to providing excellent customer service and producing high-quality products and services.

Keystone’s business plan called for an electronic quality management system to be implemented as soon as possible. Being an extraordinarily high volume medical device manufacturer, Keystone’s new system would have to handle an equally large volume of electronic records per year.

According to Richard Jancsy, Manager of Quality Systems, “A critical success factor for us is to effectively and efficiently manage a significant volume of regulatory documentation; in a rigorous and compliant manner…you need a reliable and highly configurable system to meet that challenge.  That’s why we selected CATSWeb.”

Instead of using a manual, paper-based system that tediously captures data, the new electronic system has streamlined the process; it’s focused on capturing the essential and actionable information quickly.  The implementation activity allowed Keystone to critically re-evaluate their current manual complaint handling system and design a robust solution by leveraging CATSWeb’s flexible capability.

“CATSWeb can mirror the process in a way that we get to choose, and not the other way around,” added Jancsy. Keystone will integrate the CATSWeb quality system with Salesforce.com and their IFS ERP.  The first process rolling out is complaint handling and then CAPA, audits, training and change control during 2009.

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