The FDA continues to signal that food enforcement is back in fashion.

Last week at a press-only briefing the agency tried to demonstrate its proactive side, saying it was “taking steps to protect the public following the early identification of Salmonella Tennessee in one company’s supply of hydrolyzed vegetable protein (HVP) and again last week the agency issued an open letter to the food industry calling for more transparent product labels.

So what’s it all mean?

We spoke recently with Kim Egan, partner in the law firm DLA Piper’s Product Liability practice, and a regular source for us on these and other FDA-related matters.

“The food industry is facing a “perfect storm” — high-profile food-borne illnesses continue to plague the global supply chain, prompting President Obama to create the Food Safety Working Group, and the First Lady has declared war on childhood obesity, including a focus on food industry marketing to children, “junk” food in public schools, and the nutritional content of school lunches,” Kim points out.

I happened to see the harrowing film “A Perfect Storm” at my sister’s house last week and if I am an official in the food industry, an expert like Kim using “Perfect Storm” and “Food Industry” in the same sentence would get my attention.

Kim notes that President Obama said in a March 2009 weekly radio address that “At a bare minimum, we should be able to count on our government keeping our kids safe when they eat peanut butter.  That’s what Sasha eats for lunch.”

The Executive Memorandum announcing the First Lady’s Let’s Move campaign said that “[n]early one third of children in America are overweight or obese — a rate that has tripled in adolescents and more than doubled in younger children since 1980.  “Taken together, the new Administration’s focus on food has in turn pushed FDA to renew efforts to improve food safety and more aggressively enforce existing food labeling regulations,” Kim adds.

It’s all part of a more active FDA across the board, Kim notes.

“FDA has stepped up enforcement of existing regulations.  In August 2009, FDA reorganized its food oversight function and moved the Office of Foods into the Office of the Commissioner, giving food safety and food manufacturing enforcement greater visibility.  FDA appears to be focusing particularly on health claims made by food manufacturers, such as its recent warning letter to General Mills that it had no scientific evidence to support cholesterol claims on Cheerios cereal,” Kim adds.

As Kim explains, FDA said that the General Mills claims that Cheerios reduced cholesterol meant that General Mills was advertising Cheerios as a drug, an unapproved one at that.  FDA has also been focusing on health claims made by dietary supplements, the most notable examples of late being dietary supplement products that purported to be effective against the HINI virus.  There is an effort underway to improve front-of-label nutrition information for all food packages, and Senator McCain introduced legislation in February 2010 to strengthen FDA authority to regulate dietary supplements.

Congress has had food safety legislation in the works for a couple of years now.  Highlights of that bill include:

• The Food Safety Modernization Act that is now making its way through Congress will require foreign suppliers to use “risk-based reasonably appropriate preventative controls” to prevent adulteration and reduce hazards.
• FDA would be required to implement new food safety regulations within a year of enactment.  FDA would also have two years from enactment to “expand the technical, scientific and regulatory capacity of foreign governments,” which could include multilateral agreements and international harmonization of the Codex Alimentarius.  FDA would also be required to expend resources on foreign inspections.
• Having said that, however, the majority of food-borne illness outbreaks since 2006 have been caused by domestic products or other products from North America , including fresh spinach, peanuts, jalapeno peppers, and tomatoes.

“In short, we can expect further pressure on food manufacturers to improve quality control,” Kim says.  “We can also expect continued pressure on food manufacturers to adhere strictly to promotional and nutritional labeling requirements, and we can expect those requirements to change in some possibly meaningful respects in the coming years.”

For more information, request “The New FDA Drive for Food Safety” paper here:

Welcome to the 894,302nd and counting piece about Toyota’s fall from manufacturing grace.

We don’t need to devote a lot of space here to recounting Toyota’s problems. You probably know the story: After months of hemming and hawing, the once-proud carmaker finally acknowledged the obvious this month and said it was recalling a boatload of cars that have accelerator pedal problems.

But it gets worse: Yesterday (February 9, 2010) Toyota added that it was also recalling over 400,000 Prius, Lexus because of a brake problem as well as additional problems with the Camry and possibly the Corolla, too. For now, the jury is still out on exactly what went wrong (beyond how badly Toyota handled the PR side of this).

Yet we’re writing about this today because, even as Toyota’s massive problems are being probed, analyzed and dissected by experts from various industries, the issue of supplier quality management (SQM) doesn’t seem to be coming up much.

That’s too bad, because one of the few good things that could come out of all of this is reminding car manufacturers, medical device makers, pharmaceutical companies, food manufacturers and a host of other businesses that supplier quality management is key to being a profitable, effective company that only gets good headlines (See box below, Sal’s Tips).

“Gone are the days when manufacturers can say suppliers can’t have an impact on their success” or, perhaps in the case of Toyota, a spectacular failure, says Dun & Bradstreet analyst Jim Lawton. He also has a background working on medical device issues with Hewlett Packard.

Lawton’s first lesson gleaned from Toyota is that companies should strongly consider focusing on their core competencies and outsourcing other stuff. For example, companies should work hard with partners to understand risk and develop procedures and programs to mitigate it.

“Unfortunately, the medical device industry is not out in front when it comes to managing supplier quality,” worries Jim. “They are all about taking out costs,” he adds. For more of his excellent insights, check out his recent interview with Industry Week.

That can be a case of being penny wise and pound foolish, agrees Sal Lucido at AssurX. ‘Supplier quality management has not gotten the attention it should, because it’s complicated; involving the processes and politics of other companies. It’s hard enough to manage your own company’s issues let alone those of your global suppliers,” Sal says, adding that he believes lessons can be learned from Toyota’s missteps.

Sal’s Tips: Lessons Learned From The Toyota Fiasco

Toyota’s pain could be others gain, IF they learn from what happened to a once-lauded manufacturer. Sal lists some lessons:

• The costs associated with the loss of your company’s reputation are incalculable.
• Product quality includes both the actual and the PERCEIVED view customers hold of your product.
• Ensure you have visibility to the data you need to detect problems early. Prevention is an order of magnitude less costly than late reaction.
• Don’t rely solely on return on investment calculations to direct your process improvement efforts. Sal states as an example that, “ROI calculations are effective when it comes to making decisions such as purchasing automation equipment, but they can fall short when it comes to upstream process improvement investments such as SQM.”

SQM often also gets short shrift because it is harder to calculate in terms of the return on investment (ROI), Sal notes. “When supplier issues are addressed with band aids and tape, they can be hidden from view – for a while. But the day of reckoning always comes.” This is one of the lessons we all may be able to learn from Toyota’s predicament. “The further back in the supply chain, the less attention it gets,” says Sal.

But the Toyota case might make it easier for others to calculate their return on investment in supplier quality. “Decades of reputation building (not to mention billions of dollars) by Toyota has been washed away in a matter of days! It’s very sobering if you are a manufacturer,” Sal points out.

Some good can come out of Toyota’s very public problem if we use it as a wake up call to look at our own house and make sure the processes are sound throughout, starting with supplier quality.

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.

In a recent FDA presentation Foster City, CA, Mark Roh, Regional Food and Drug Director outlined the most common cited 483 items for both pharma and med device companies:

The most common Drug GMP FDA-483 (observational) items:

• Responsibilities and procedures of the Quality Control unit are not in writing
• Written procedures are not followed
• Control procedures not established
• Inadequate specificatons
• inadequate written procedures
• Inadequate failure analysis

The most common Medical Device GMP FDA-483 (observational) items:

• Deficiencies in complaint file system
• Inadequate CAPA procedures
• Lack of written MDR procedures
• Corrective and preventive actions not documented
• Inadequate process validation

This doesn’t mean you won’t be cited for anything not listed in the bullet items or nabbed for all of the above. These are the most common observations cited by FDA personnel during an inspection. So now you may want to go back and take a good hard look at your SOPs, quality management system, CAPA process, complaint handling/MDRs as well as your validation documentation. Obviously training your personnel in these procedures and processes is also key.

Of course, everyone’s goal is not to end up here…

Also, you may want to check out our previous blog entry “Don’t Ignore 483s…it’s in Your Best Interest to Respond in Writing“

The CATSWeb Measurements feature makes it easy to track performance to goals, monitor trends and automatically send performance-based alerts. Measurements can be added to executive and corporate dashboards to provide important, easy to read, quality metrics information. Not only does this give you feedback about your performance to goal and trends, it also allows you to focus your resources on the areas of the business that need attention. Detailed information can be easily accessed by clicking on the metric of interest. All this is done within CATSWeb without relying on any third party tools or add-ons.

Because most of us don’t have time to look at these dashboards every day, alerts may be configured to automatically send E-mail notifications when the metrics change. Measurements can link to any data source such as internal system data like queries and filters, and with all system reports and graphs in CATSWeb – the source data can even be ‘external’  – such as from ERP and HR systems – or other Oracle and Microsoft databases.

It’s easy to set up a measurement:

1. From the Manage page, click on Measurements and choose “Add” (or copy an existing one)
2. Enter your company goals
3. Then add the measurement to a Dashboard

The CATSWeb Measurements Feature provides an easy way to track progress to goals and alert you when thresholds are crossed. This helps your company to:

• Achieve its corporate goals
• Broaden visibility regarding those goals
• Reduce cycle times
• And ensure that tasks get completed on time

Let us know what corporate goals you are tracking (or would like to track) and how you are using the Measurements Feature in CATSWeb.

How does one achieve five 9’s (99.999%) uptime or better in today’s crazy IT world?  Easy.  Have backups for your backups and have at least two of everything.

Okay, so maybe it’s easier said than done and perhaps that is an egregious oversimplification. The bottom line, however, is basically that’s how AssurX has achieved not five 9’s but a perfect 100% uptime for CATSWeb OnDemand systems for two years running.

We have multiple redundancies in all our critical infrastructure systems: at least two of everything.  We have everything from multiple pipes to the Internet to multiple fire suppression systems.  There are multiples of all server types; web servers, application servers, database servers, backup servers. There are multiples of all components of the servers; multiple drives in RAID arrays, multiple network cards, multiple power supplies, multiple CPUs.   There are redundant monitoring systems, monitoring internally and externally the availability of CATSWeb and we are notified immediately when something is wrong.  Fortunately (knock on wood), we’ve yet to experience this scenario outside of testing.

Our data center is the same way.  There are redundant heating and cooling systems, redundant fire suppression systems, redundant UPS systems, redundant generators and everything is in “hot standby” mode, meaning if one fails, the other takes over without missing a beat.   The network employs at least three major telecom providers for separate and redundant backbones to the Internet.

To someone unfamiliar with the true meaning of “mission critical”, all this sounds like overkill. Doesn’t having two (or more) of everything make life more difficult?  Simple answer is, yes, life is more complicated with two of everything.  There are the requirements of extra space, extra maintenance, extra power consumption, extra time for install/management/decommission of software packages and extra man hours spent working on all these redundant systems.  Does it make financial sense?  Absolutely!  Just the same as one has homeowner’s insurance, car insurance, health insurance or life insurance, what redundancy means to an IT department is data and connectivity insurance.  For hosted systems like CATSWeb OnDemand, it means happy customers who always get to their data, day or night.  For IT guys like me it means peaceful, easy sleep and less hair loss.

At the end of the day, the simple fact is that AssurX has achieved something truly difficult in the IT world; 100% uptime, two years running.  This is something major players, like Yahoo, eBay, Google, Amazon and many others cannot claim.  We are proud of our commitment to hosting CATSWeb for our customers and will continue to implement new and better ways to achieve and maintain the best possible uptime numbers and availability as we forge ahead.

More 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.