Risk Management greatly reduces inefficiencies resulting from unanticipated operational disruptions.

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For regulated organizations, quality problems & non-compliance have serious consequences

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An integrated and effective quality system is key to improve efficiency & compliance in manufacturing operations.

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Posts Tagged ‘quality’

SOPs: What You Need to Know

Thursday, December 22nd, 2011

Mark Crawford

According to the FDA, the problem cited in 60 percent of all warning letters is SOP—standard operating procedures.

That’s actually a good thing because it is relatively straightforward (but not always easy) to fix SOPs. Identifying them is one thing—they also need to be concise, clearly written, well-communicated, monitored, and enforced. Taking the time to meet or exceed FDA SOP expectations will not only bring you into compliance but also improve operations and productivity in every department—leading to higher quality, improved profits, lower costs, faster delivery to market, and improved customer satisfaction.

Although you may have staff that can handle the review and overhaul of SOPs in all your departments, chances are they don’t have the time. In addition to being available, experienced SOP consultants in the medical device industry have the advantage of accrued experience from working with multiple companies across the industry. They also know what the FDA wants.

Edwin Wallbusser is an experienced medical device consultant in the greater Philadelphia area and founder of Medical Device SOP Advisors (www.meddeviceadvisors.com), which—you guessed it—specializes in SOP procedures. He offers the following suggestions regarding SOPs:

What is the biggest problem medical device manufacturers (MDMs) have with SOPs?
Wallbusser: The biggest problem is level of detail. If the SOP is too short there may be several interpretations of the procedure. If it is too long and detailed it runs the risk of not being referred to because it is difficult to understand.
When it is the top complaint by the FDA regarding SOPs?

Companies are trying to game the system by quickly restating the regulation in a SOP format. The result is obvious—it is not a system that can be followed to achieve a result.

What is the solution?

The MDM must take the time and the expense to first develop a system that meets the regulations and works (test it!). Then, when everybody involved buys in, document it.

Can you audit SOPs internally?

Definitely. Organizations and procedures evolve and should be changed through a change control process. You do not want the FDA to find that people are following their own version of a procedure and maybe using hidden sticky notes as reminders
What is the advantage of getting a consultant involved?

An experienced consultant knows what to do and how to do it—this saves time and achieves better results. In the long run it saves money by avoiding FDA problems. It is even more cost-efficient to start with proven, generically written SOPs, such as those found at www.meddeviceadvisors.com, and customize as needed. A good consultant customizing generic SOP templates will spend typically 1-2 hours per SOP. SOPs should be audited in detail as part of the companies internal audit process.


Could Your Quality Systems Protect You in a Court of Law?

Wednesday, October 5th, 2011

Author: Mark Crawford

Quality system management and documentation contain a wealth of information (or lack of) that can be used by a regulatory agency like the FDA or a plaintiff in a lawsuit to determine if the company is in compliance with federal regulations or its own internal quality management procedures. Failure to meet these requirements can be highly damaging to a company in litigation.

“Quality manuals and quality system documents are intended to guide the operation of a company’s quality management system, says James Kolka, president of Kolka & Associates in Atlanta and an international legal consultant in regulatory affairs. “Quality system documents are neither intended nor constructed to provide evidence of a company’s concern for patient safety and product safety. If a company wants to prove it cares about patient safety and make safe products, it must build documentation to prove that point.”

The three major areas of product liability litigation—design, manufacturing, and post-market surveillance—are specifically addressed by clauses in each regulatory quality management system.

For example, to design a medical device using FDA’s Quality System Regulation, a company that wants to manufacture Class III, Class II, and certain Class I medical devices must follow 21 CFR 820.30 Design Controls.

“This means that there should be documents and records describing the stages of design development: 820.30 (b) design and development planning, (c) design input, (d) design output, (e) design review, (f) design verification, (g) design validation, (h) design transfer, (i) design changes, and (j) design history file,” Kolka states. “This means records should exist documenting each of those stages, including risk analyses where and as needed. If records don’t exist, the device was not designed in accordance with FDA regulations.”

This knowledge is available to plaintiffs’ attorneys in the event of a product liability lawsuit. Manufacturing a medical device follows its own set of QSR regulatory clauses. To be effective and not be blindsided by plaintiff’s allegations citing quality system breakdowns, corporate counsel must understand regulatory quality management systems in depth and strengthen protocols if necessary to create a stronger legal position.

On his blog at www.jameskolka.typepad.com, Kolka cites a private “in-depth” litigation study conducted by a medical device insurance company of its litigation history. “Since virtually all of their lawsuits have been settled out of court, there is no public record of mistakes to guide other medical device manufacturers, thereby allowing them to repeat the same mistakes over and over,” says Kolka.

The litigation study revealed several key findings regarding weaknesses of medical device manufacturers in product liability lawsuits:

• Several medical device manufacturers constructed quality management systems to satisfy FDA and EU medical device regulatory requirements, but contained no documented methods, processes or procedures for communicating product safety concerns and/or incorporating those concerns into their business processes, thereby demonstrating no commitment to product safety.
• The study found a lack of internal processes and procedures in companies’ QM systems for escalating product safety concerns and a review of those concerns, as well as a lack of any kind of cross-functional committee to deal with product safety issues. Plaintiffs’ attorneys alleged that this demonstrated a lack of due care and concern for product and patient safety.
• The study found several instances of biotech firms failing to protect their documentation by asserting that attorney-client privilege prevented plaintiffs from examining their documentation during discovery, which assertion was not accepted by the court.
• The study found misconceptions by management of medical device manufacturers that compliance with FDA’s quality system regulations was enough to prevent product liability claims.
• The study found that management frequently continued to underestimate the risk of product liability litigation to the success and/or survival of their business.
• The study found that design research documents and agreements often contain hidden product liability exposures—the agreements were not reviewed by legal counsel familiar with clinical research or by insurers or brokers reviewing coverage limits and indemnification clauses.
• The study found a lack of qualified in-house personnel available to integrate product liability avoidance principles into the firm’s quality management system and establish an infrastructure for product safety, resulting in product liability post-production legal defense problems.
• The study found that company postproduction corrective and preventive actions were deemed to be inadequate for the degree of risk presented by individual complaint investigations resulting in both FDA regulatory actions and product liability lawsuits.

These are just some of the problems uncovered by the litigation study.

“The actual list is quite long and quite disturbing,” says Kolka. “The lack of training for product liability exposure is extraordinary. Virtually no firms conduct product liability audits or product safety audits of their operations. The assumption appears to be that compliance with FDA and EU regulations is sufficient. From my experience, quality managers do not see legal issues as their responsibility and therefore will pass them off to regulatory managers, corporate counsel and management. In turn regulatory managers do not focus on product liability exposure.”

Because the focus on product safety and patient safety tends to be inadequate, records are poorly maintained, and the wording of documents pays no attention to the legal consequences of what is said, “it appears that product liability lawsuits will continue to plague medical device manufacturers,” Kolka concludes. “There are steps that can be taken with training personnel to conduct product liability audits, product safety audits, and learn how to write documents so that the words don’t become minefields for litigation.”

Contact Kolka at jameskolka@gmail.com or jim@jameskolka.com.


Lean Is the Cornerstone of Quality

Wednesday, September 14th, 2011

Guest Blogger: Mark Crawford

Eliminating waste in a process is essential for reducing complexity, lowering risk, increase productivity, improving quality, and reducing overall costs—savings that can be passed on to the client through lower pricing. A simpler, more streamlined process also makes reproducibility and validation easier.

There are lots of ways to tackle quality improvement, including monitoring equipment and software. But one of the easiest and least-expensive ways to improve quality and reduce risk is value stream mapping (VSM), one of the key principles of lean manufacturing. In fact, VSM is so simple it just requires a pencil and a piece of paper.

If you aren’t really up on lean and value stream mapping, you’re not alone; many companies in a variety of manufacturing industries, including medical devices, are just catching on to this proven, highly-effective system that the automotive industry has used for decades.

According to the Lean Enterprise Institute (www.lean.org), the five-step thought process for guiding the implementation of lean techniques is:

1. Specify value from the standpoint of the end customer by product family.
2. Identify all the steps in the value stream for each product family, eliminating whenever possible those steps that do not create value.
3. Make the value-creating steps occur in tight sequence so the product will flow smoothly toward the customer.
4. As flow is introduced, let customers pull value from the next upstream activity.
5. As value is specified, value streams are identified, wasted steps are removed, and flow and pull are introduced, begin the process again and continue it until a state of perfection is reached in which perfect value is created with no waste.

Value stream mapping is a good way to give lean a test run. This pencil-and-paper exercise identifies all the actions that take a product through any process. Although it is intended for manufacturing and production, VSM can be applied to any process, including procurement, HR, administration, delivery, customer service, and vehicle maintenance. A process is a process, whether it’s in a factory or a professional office building. Typically every process has some element of waste—eliminating waste from all the processes that drive a business adds up to significant overall savings.

The idea behind VSM is to draw, on one page, a “map” of the flow of material/product through the process, and then identify ways to eliminate the unnecessary steps and waste that suddenly become apparent. Going through this exercise also invariably results in a better understanding of the entire business operation.

Value stream mapping is just the first step of an on-going lean experience. Lean never ends—ideally it becomes part of the corporate culture, a process, a way of thinking. Most lean consultants agree that a process is not really lean until it has gone through at least seven periods of value-stream mapping.

One industry that is relatively new to lean is health care. Under extreme pressure to reduce costs, health care organizations have embraced lean initiatives and are generating impressive results. For example:

• Surgical prep time reduced by 60% at Caldwell Memorial Hospital in Lenoir, NC

• Royal Bolton Hospital in the UK reduced turnaround time for blood test results from two days to 40 minutes

• Henry Ford Health System reduced the number of steps involved in producing test results from 35 to 24, so now 85% of test results are delivered within three hours of specimen arrival time

• Quebec’s provincial health-care costs are projected to drop from 5.7% to 5% over the next three years because of lean

• Barnes-Jewish Hospital has reduced door-to-needle delivery time for delivering clot-busting drugs for stroke victims from 60 minutes to 30 minutes

• Two years of lean implementation at Miami Children’s Hospital resulted in $500,000 in recurring savings and $1 million in avoidable capital

Sometimes impressive gains can be seen within a matter of days of starting lean. Once employees get it, lean starts to snowball and lots of good ideas and advice are received. Every employee should be involved, which creates ownership of the changes and a deeper camaraderie develops for achieving these new goals.

A fully lean operation makes risk management and quality management systems less complicated, less costly, easier to manage, and simpler to validate. Lean can also be applied with equal success across the entire supply chain (and even cleaning out your garage!).


MHRA Looking for Quality Risk Management Systems — Sound Familiar?

Monday, October 25th, 2010

The UK is on to something … British inspectors will be looking for a “risk register” and a defined document management control system including periodic reviews of risk management assessments when inspecting drug manufacturers. It seems both sides of the Atlantic are on board with quality risk management, and for good reason.

 The Medicines and Healthcare products Regulatory Agency (MHRA) was set up in April 2003 from a merger of the Medicines Control Agency and the Medical Devices Agency. According to the website (http://www.mhra.gov.uk), the MHRA is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health. MHRA defines Good Manufacturing Practice (GMP) as “a part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation (sic) (MA) or product specification. GMP is concerned with both production and quality control.”

 Likewise, the Food and Drug Administration (FDA) says that “good manufacturing practices are a quality system that follows certain basic principles that govern the manufacturing process, documentation, employee training, handling of complaints, and management of records. “ They also cite that good manufacturing practices require that domestic or foreign manufacturers have a quality system to do business in the United States.  However, the FDA says that the GMP requirements were established to be flexible in order for each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures.  The flexibility encourages the use of modern technologies to achieve higher quality through continuous improvement.


 Reading through the FAQs on MHRA’s website, you can get an idea of what the agency will be evaluating and enforcing in quality risk management. First of all, quality risk management is required. “All manufacturing authorisation holders, third country manufacturing sites, blood establishments, blood banks and active pharmaceutical ingredient manufacturers must have a system for QRM. Inspectors will review the QRM system as part of the Quality Systems section of the inspection (along with complaints, recalls, deviations, and product quality reviews etc) … It is an expectation of Chapter 1 that companies embody quality risk management. “

 Companies must have a standard operating procedure (SOP) to describe how they approach QRM. SOPs need to define how the management system operates and its general approach to both planned and unplanned risk management. The SOP should include scope, responsibilities, controls, approvals, management systems, applicability, and exclusions.

 Additionally, MHRA requires a “risk register” or similar document to “list and track all key risks as perceived by the organisation and summarise how these have been mitigated. “ It also requires that a management process be in place to review risk management and incorporated into the quality management review process.

 Clearly, the MHRA gave this a lot of thought and the guidance is very detailed. What stands to be seen is whether companies will be able to implement it as well as the requirements suggest. The FDA has seen its challenges with GMP regulations and quality systems. As consumer demand for regulation continues to drive new, more stringent regulations, organizations are forced to look at their quality management systems and ensure that they are following good manufacturing processes. If not now, they will surely be hearing from an auditor from at least one side of the Atlantic.


Quality and Safety Systems Need to Break Out of their Shells

Wednesday, September 22nd, 2010

The Senate reconvened this month with a very important bill on its plate – the Food Safety Modernization Act (S. 510). With the recall of more than 550 million eggs and over 1,500 people sickened from salmonella fresh on their minds, this bill couldn’t be served up at a better time. Many of the backers of this bill feel strongly that this could have prevented or at least minimized the outbreak, and are hopeful that it will “solve” all potential future outbreaks. However, the 483 violations found at the two facilities were mostly facility-focused and clear violations of the Salmonella Prevention Plan. While the FDA has focused on the state of the facility’s environment, where is the focus on the quality and safety systems that are supposed to be in place at the company to prevent it from becoming a national crisis? As food safety issues continue to grow, regardless of whether S.510 is passed or not, manufacturers need to take control of their quality and safety issues in-house to prevent such disasters. 

With 60 percent of fresh fruits and vegetables and 80 percent of seafood coming from outside the U.S., imported food makes up a substantial and growing portion of our food supply. Also, we are increasingly eating foods that are consumed raw and that have often been associated with foodborne illness outbreaks, including leafy greens such as spinach. How are you managing your suppliers? Are you still using paper systems and fragmented IT systems? A recall like the egg recall severely hurts consumer confidence. When consumer confidence in the nation’s food supply is weakened, it often causes a company irreparable damage in reputation and bottom line. 

Yet it continues to happen. Is it really because our laws aren’t strict enough? Do we need to have an FDA inspector on every food manufacturers site? It’s true that food processing companies are faced with the continuous challenge of maximizing food safety while adhering to the growing number of regulations, such as ISO 22000, FDA 21 CFR Part 110, FDA Bioterrorism Act of 2002 and HACCP. But the real problem lies within the organization’s processes. In the majority of cases, they are fragmented and disconnected. Procedures are not always well documented. Required process steps are not always completed. Employees don’t always know or understand their responsibility or authority. Suppliers are not always closely monitored or enforced to continue their own quality process improvements. 

Food processing companies need to take a look into the same principles of industrial automation and apply it to best practices in quality and safety management automation and think of the system as a whole – a global program, trained employees, well-documented SOPs and utilizing technology properly to put global practices and procedures in place. 

The focus should be on continuous process improvement and the implementation of an automated and integrated Safety and Quality system across the enterprise. A well-designed and implemented safety and quality management system can reduce risk and improve performance and profitability. 

By having total automated quality and safety process control, food processing companies can look at achieving consistent yield and uniformity from product to product, and from batch to batch, with increased traceability and trust along your entire production process for complete sustainability. 

September is National Food Safety Education Month. This month-long campaign is held every September and focuses on the importance of food safety education for the restaurant and foodservice industry, while raising awareness of the industry’s commitment to food safety. Perhaps this is a good time to load up your own plate with a Quality and Safety system that will keep you out of the news.

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