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 Management’

Pilot Program for ISO 13485 Audits Sounds Promising

Tuesday, April 3rd, 2012

Mark Crawford

On March 19, the FDA announced guidance for a medical device ISO 13485:2003 voluntary audit report submission program. The document provides a strategy for responding to Section 228 of the Food and Drug Administration Amendments Act of 2007, which states that:

“For the purpose of setting risk-based inspectional priorities, the Secretary shall accept voluntary submissions of reports of audits assessing conformance with appropriate quality system standards set by the International Organization for Standardization (ISO) and identified by the Secretary in public notice. If the owner or operator of an establishment elects to submit audit reports under this subparagraph, the owner or operator shall submit all such audit reports with respect to the establishment during the preceding 2-year periods.”

Starting June 5, 2012, the FDA will launch a voluntary pilot program that allows device manufacturers that have been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) using the 13485:2003 standard to voluntarily submit those results to the FDA to be considered for a possible one-year bye from FDA inspection.

“If, based on that report,” the guidance states, “FDA’s analysis or compliance decision meets the requirements of the FDA’s Medical Device Compliance Program 7382.845 for “Situation II,” that there is minimal probability—in light of the relationship between the quality system deficiencies observed and the particular device and manufacturing processes involved—that the establishment will produce nonconforming and/or defective finished devices,then FDA intends to use the audit results as part of its risk assessment to determine whether that establishment can be removed from FDA’s routine inspection work planfor one year from the last day of the ISO 13485:2003 audit.”

If FDA reviewers accept a manufacturer’s most recent ISO 13485 audit report, that company is exempted from FDA quality system inspection for one year from the date of its most recent ISO 13485 audit. 

“The world is using 13485 and many quality-management systems audits are being performed by other regulators and third-party authorized auditing bodies,” says Kim Trautman, associate director for international affairs for the Center for Devices and Radiological Health. “The FDA wants to explore how we can leverage off some of these other audits and utilize some of the trusted partners’ work in auditing manufacturers.”

 The program is only available to manufacturers that have already registered their devices for sale in the U.S.and established FDA GMP-compliant quality systems. Furthermore, qualifying manufacturers must also have ISO 13485 certification in place prior to participation in the program.

Manufacturers should make arrangements with their regulatory third-party auditors prior to the scheduled audit to ensure that the audit and its report will be eligible for the pilot program. The FDA will consider for eligibility under this pilot program ISO 13485:2003 audit reports sent to the FDA within 90 days from the last day of the most recent audit. Reports can be either a full assessment of the establishment’s Quality Management System (QMS) or a surveillance audit of the establishment’s QMS.

“We will use ISO 13485 as a risk-based process for planning and using FDA resources and inspection resources wisely,” adds Trautman. “We are very excited to launch this new program and hope that manufacturers take this opportunity. FDA wants to use this experience to help further develop a medical device single-audit program. We’re excited to possibly use information that’s already available to help us optimize the use of FDA resources and really put those resources toward the places that need the most attention.”

The agency has launched an online video, slide presentation and transcript covering key aspects of the program. See the original guidance at:



Reviving Six Sigma

Monday, February 6th, 2012

Mark Crawford

 There’s been some industry discussion that Six Sigma, the longtime standard of quality implementation, isn’t what it used to be—that in fact, for a growing number of companies, it is actually more of a negative than a positive.

For example, a 2007 study by QualPro revealed that 53 of 58 large companies that use Six Sigma have trailed the S&P 500 since they implemented it.

Others maintain Six Sigma is outdated and being replaced by newer methods, such as the theory of constraints and systems thinking.

However, don’t be too quick to dump Six Sigma—it’s still the same; the difference is in the way companies use it today, especially when dealing with an increasingly fast-paced and competitive global marketplace. Companies simply aren’t taking enough time and attention to implement Six Sigma properly.

A key reason Six Sigma gets disappointing results these days is the lack of leadership strategy and commitment at the top.

“Not enough leaders truly understand that Six Sigma is not an overnight savior,” comments J. Bruce Weeks, a senior business process improvement coach with Quality Engineering Consultants LLC in Charlotte, Michigan, and author of “Is Six Sigma Dead?” (http://asq.org/qic/display-item/index.html?item=32661) in the October 2011 issue of QP, the publication of the American Society of Quality (www.asq.org). “It takes time and work to achieve outstanding results.”

Weeks indicates too many leaders bought into what was called the “latest and greatest fad” in business process fixes, rolled out a Six Sigma program, trained everyone, “and now have up to 80% of their people working on projects to improve processes,” he says. “This sort of Six Sigma undertaking often takes valuable resources away from launching new products and satisfying customers—core processes required to stay in business and make money year after year.”

Another problem occurs when leaders declare victory after using Six Sigma to solve one problem or one set of problems. The organization then moves on to the next hot improvement strategy, usually lean; the Six Sigma process then stalls and the Six Sigma Black Belts are hustled off for training in something else.

Inappropriate accounting methods can also quickly tarnish Six Sigma’s reputation. Companies often use the wrong measure—cost—to determine Six Sigma results, especially early in the process.

Because they focus on cost, “activity-based costing (ABC) and resource-consumption accounting (RCA) practices do not lend themselves to determining the value of a particular activity or resource to the revenue stream or customer satisfaction,” says Weeks.

Therefore key process/production metrics such as quality, throughput, rework, time to market, and customer satisfaction must be measured and factored into the quality equation.

To maximize Six Sigma results, Weeks emphasizes the following points:


  • Leadership commitment. Create strategic business goals and objectives that embrace Six Sigma thinking instead of trying to add it as a separate goal or objective. All Six Sigma projects must be customer-focused, provide value, and be integrated into the larger objectives of the company.
  • Track the right metrics. Key critical-to-quality drivers—such as cost, new product introductions, and market share—must be determined based on the goals and objectives of the program. They should be monitored regularly on a near-real-time or real-time basis.
  • Implement fair accounting methods. A better financial reporting system is required to capture Six Sigma improvements early. Most financial measures are too slow and too aggregated to determine these micro-level (process) improvements.


“When an organization has goals and objectives with appropriate measures that can quickly and accurately reveal the results of improvement efforts, it must determine a project-selection process,” adds Weeks. All improvement projects must meet certain criteria, such as:


  • Have a project charter that clearly defines the scope
  • Have an assigned leader and tentative team
  • Have an expected timeline for completion
  • Have an expected ROI that meets company goals


The addition of lean to the Six Sigma processes to create lean Six Sigma (LSS) makes “so much sense that not doing it seems unimaginable,” says Weeks. “This combination of two methods to reduce waste first, eliminate defects, and improve the remaining necessary processes is powerful. Today’s 110% is tomorrow’s 95%. This will avoid complacency that tends to set in after a goal has been achieved, particularly if it was a difficult project.”

With changes to an organization’s way of thinking, an LSS effort can now be a part of a normative business system for the long haul. “Select key drivers that are customer-focused and have clear key success factors,” advises Weeks. “An organization will be managing to value, not cost. That way, financial reporting will be consistent and timely and global goals and objectives will be supported.”


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!).


Impact of the New 510(k)/PMA Process on Companies for Quality Management

Monday, May 2nd, 2011

The entire medical device community is waiting patiently to see how the U.S. Food and Drug Administration changes the 510(k) clearance process. In January 2011, the Agency announced a plan containing 25 actions it intends to implement during the year to improve the most common path to market for medical devices.

According to a press release, the FDA’s key actions include:
• Streamlining the “de novo” review process for certain innovative, lower-risk medical devices
• Clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process
• Establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making

As it stands right now, manufacturers must register new products with the FDA prior to going on the market. The submission, known as 510(k), must show that the proposed product is “substantially equivalent” to a legally marketed medical device.

In other words, forget innovation if you want a “quick” approval of your new medical device. Instead, think about how your product is “just the same as” another on the market. For many, this doesn’t sit too well, especially when the product their approval is based upon has its clearance rescinded.

Many medical device companies argue that the program doesn’t allow for an increasing complexity of technology. Plus, what was designed as a process to reduce time to market, medical device manufacturers say takes even longer. Although a response is required within 90 days, in almost all cases, that is when the manufacturer receives additional questions, further drawing out the process.

Consumers and health care experts doubt the process, citing that patient safety is at risk. The alternative is the Premarket Approval process, which takes at least 180 days and requires formal clinical data and laboratory studies. It’s more costly for all involved – manufacturer, FDA and the ultimate end user – but some argue that the deadliest recalls involve those that did NOT go through the PMA process.

A Task Force was created to make recommendations on how to incorporate new science into the process to encourage medical device innovation while improving patient safety. The FDA promises us a “smarter medical device program.” All we can do is continue to work on and document our processes for quality management in anticipation of what the FDA will require from quality professionals. Ultimately, whatever the FDA requires, it is the responsibility of the quality management department to evaluate risks and ensure that products are safe.


ISO 9001 – It’s all about continuous improvement

Monday, January 24th, 2011

ISO 9001 was created in response to customers who wanted an assurance of quality. The concept was to limit the risk of delivering defective products to customers, with a focus on prevention, detection and correction. ISO 9001 replaced many customer-specific requirements, which suppliers needed to meet in order to make it easier for them to bid for work.

 But ISO 9001 should be a quest for improving quality in all operations and not simply getting and keeping a certificate. It should be viewed as a guide for a management system to satisfy its customers and stakeholders with continual success.

 ISO 9001 requires organizations to establish a quality management system to meet customer requirements. There are many factors needed to achieve product quality, such as:  quality of management, quality of design and quality of conformity. There are eight quality management principles as another set of factors, such as people, machines, methods, materials, measurement and money.

 What this means is that a whole lot of things have to be right for the organization to produce quality products. It is not sufficient to simply focus on the production or delivery processes as these depend on the processes for their inputs. All organizations depend on a system of managed processes to produce the desired outcomes if they have to satisfy their customers and stakeholders.

 ISO 9001 also requires top management to review the management system and to ensure its continuing suitability, adequacy and effectiveness. What many fail to realize is that there is no right or wrong way to do this. The tendency is to create a system to fit the standard, forgetting what you already do and the “language” of your organization. The problem with this is that the focus is on conforming to the procedures of the standard, and not on improving processes. As a result, management can become preoccupied with documentation, instead of corrective actions. Your goal should be to establish an effective system, without abandoning what you already have in place.

 The question is: Is our management system the way we run our business or is it simply a set of documents we used to show compliance with ISO 9001? There has to be some driving force behind your compliance. It can’t just be a pile of papers. Are you thinking, “I want to get this certification,” or are you thinking, “How can we improve our performance?”

 Standards such as ISO 9001 have been created to address a need for customers but they serve an equal benefit for organizations — Continuous Improvement.


The new year is a good time to think about audits

Monday, January 24th, 2011

From December 26th on, you can’t help but see articles on the best and worst of 2010. We had Toyota, BP and eggs topping the news, and it didn’t shed much of a positive light on quality management. So as the new year kicks in, perhaps it’s time to examine your own products and processes in order to ensure compliance with organizational and industry regulations.

 Internal audits can also be done to ensure compliance with specific regulatory standards and help prepare companies for third-party compliance audits.  Internal audits, whether required or not, are highly recommended for all manufacturers to ensure compliance with industry guidelines. Be prepared for a great deal of advance planning though in order to have an effective audit. It can be time consuming and difficult to track (using Excel) without an automated software solution with solid reporting functions. Your efforts will pay for themselves in the long run because you will have factual, unfiltered data of your quality systems – a true objective assessment of your company’s products and processes. 

 What makes an effective audit? First of all, they should be completed at sufficient intervals of time within an organization. If you use paper-based or partial systems, you may have an even harder time updating and maintaining your records. Plus, it may be harder with these systems to view trends over time.

 The FDA uses QSIT to look at your data. QSIT stands for Quality System Inspection Technique. In short, QSIT looks at whether the quality management system has been implemented effectively. The FDA realizes that quality problems happen, but what they’re looking for is what did you do about it and how are you going to keep it from happening again. QSIT focuses on seven major subsystems of a quality management system – Management, Design Control, Corrective & Preventive Actions, Material Controls, Records/Documents and Change Controls, Equipment and Facility Controls, and Production and Process Controls. If you’re using a paper-based or hybrid system, showing the connectivity of these systems may be difficult. Here are some other challenges you may face with an audit:

  • Global planning and visibility across the entire organization and all product lines provide insight into consistency, quality control, and compliance. Paper-based or partially automated systems can hinder an organization’s ability to provide consistent data from the entire organization. Without connecting to other quality processes, like in non-automated systems, audit data will not link to CAPA or other system controls. This isolation, or islands of information, will prevent effective monitoring of the entire organization.
  • Combined with the limited resources in internal auditors, or having to use costly third-party auditors and scheduling can consume the entire audit process. Once initial schedules have been agreed upon, conflicts and the subsequent need for follow-ups increase the difficulty. An automated system, again, can alleviate some of this trouble.
  • Inconsistent checklists can contribute to varied audit reports. Incompatible data reports which focus on different observations and findings make it difficult to trend production processes and determine where the real issues lie. The lack of fully-automated systems forces auditors to complete their reports individually and manually, adding to the time it takes to complete an audit.
  • Manually prepared audit reports have an increased risk for being late, or not being turned in at all. Audits completed by multiple people may not be properly merged together into one cohesive report. These obstacles increase the chance that high risk areas will be unidentified, which could lead to costly problems or compliance issues.

 All of these issues emphasize the need for companies to manage their risks and meet standards and requirements in an effective and substantial way. In order to stay in business, they must take proactive steps to protect themselves. Implementing an effective, streamlined auditing and assessment process can assist companies in reducing costs, improving quality, and meeting all regulatory requirements.


Get Lean! Using Six Sigma and Lean Strategies to Improve Quality

Friday, October 15th, 2010

The goal of lean is to eliminate waste and non-value-added steps at all points in the manufacturing process. To accomplish this, lean implements continuous improvement practices and eliminating waste across the enterprise. Technology has been successful as key to achieving this end. While saving money might be an initial consideration with lean strategies, customer satisfaction is of utmost importance to any organization. By concentrating on customer satisfaction and value while eliminating waste, a company can build profits as well.

 According to the Lean Enterprise Institute (www.lean.org), there are five principles of lean techniques:

 Specify value from the standpoint of the end customer by product family.

  1. Identify all the steps in the value stream for each product family, eliminating whenever, possible those steps that do not create value.
  2. Make the value-creating steps occur in tight sequence so the product will flow smoothly toward the customer.
  3. As flow is introduced, let customers pull value from the next upstream activity.
  4. 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.

Lean principles can help businesses reduce costs, improve product quality, streamline processes and increase customer satisfaction, says the Institute.

 Six Sigma, on the other hand, focus on defining specific processes to produce an exact level of quality that can be repeated. In order to do so, processes must be documented, monitored and analyzed. Working together, lean initiatives and Six Sigma principles can make an effective organization that eliminates waste, reduces cost and improves profitability.

 According to the Lean Enterprise Institute, to achieve a waste-free production process, organizations must be willing to supervise the flow of products and services through entire value streams that flow horizontally across technologies, assets and departments to customers.  Companies who do so can better respond to changing customer needs, with higher quality and with lower cost. Lean principles can also improve communication and accuracy of data, a definite plus for compliance.

 When you apply these lean and Six Sigma principles to an automated quality management system, you create the ideal foundation for succeeding. Technology makes it easier to view your processes, document them, and measure your success using consistent measurements. You can make more accurate predictions without a try-and-see approach. Technology enables you to be more flexible and respond to customers faster.

 Most importantly, by using an automated quality management system with your lean initiatives, you make the system create the lean environment for the organization, rather than relying on a few people who have learned lean principles. Therefore, lean initiatives continue to thrive and grow in the organization, regardless of personnel changes.

 Lean and Six Sigma aren’t limited to the factory or even the supply chain. All parts of the organization can use these principles to improve processes: train employees, manage documents, monitor suppliers, create audit trails, and meet compliance. Even administrative processes can utilize lean principles to reduce and eliminate waste.

 Going lean isn’t easy and requires an organization to gain commitment from the entire organization, set reasonable goals and monitor improvements. You need to establish common processes and extend them to a common technology platform.  The focus should be on establishing repeatable performance and profitability through customer satisfaction.

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