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 ‘validation’

FDA Upgrades Human Factors and Usability Expectations

Tuesday, August 2nd, 2011

Mark Crawford

Less uncertainty from the FDA, and a smoother 510(k) submission process, is always a good thing.
That’s why most medical device manufacturers (MDMs) support the new FDA guidance document released on June 22 that will improve the safety of medical devices by conducting more human factors engineering.

The 37-page document, entitled “Applying Human Factors and Usability Engineering to Optimize Medical Device Design,” states that its “recommendations are intended to improve the usability of devices to reduce use error, injuries from medical devices, and product recalls.”
The FDA requires that manufacturers conduct risk analyses to determine the risks associated with device use. “If analysis indicates there is a moderate to high risk of use error, then the manufacturer should perform human factors testing,” states the draft document (this testing, however, is required for certain products that are already viewed as higher risk, such as infusion pumps).

According to the document, the sample size for a human factors study may need to be expanded if the device has users with distinctly different characteristics, such as use responsibilities, age ranges, skill sets, or experience levels. If this is the case, validation-testing activities should include 15 from each major user group. “Requiring that sample size for these studies is expected to be a concern for industry, due to the expense and logistics of conducting validation usability studies that test actual users under realistic conditions, user production or pre-production models,” says Virgil Dickson, editor at FDAnews.

Section 8 of the draft document, entitled “Mitigation and Control of Use-Related Hazards,” states that “use-related hazards that are identified through analytical approaches or formative evaluations should be designed out or controlled prior to submitting the device for HFE/UE validation testing. Use-related hazards often require a combination of mitigation and control strategies. The following list presents the order of overall priority for applying strategies to control or mitigate risks of use-related hazards:

• Modify the device design to remove a hazard or reduce its consequences: For example, making the user interface intuitive and ensuring that critical information is effectively communicated to the user can reduce the likelihood of or eliminate certain use-related hazards. If hazards cannot be eliminated, the design should, to the extent possible, reduce their likelihood and the severity of any consequences.
• Make the user interface, including its operating logic, error tolerant: When errors occur during device use, such as users pressing an adjacent key on a keypad, the device should act to preclude a hazardous outcome. Safety mechanisms such as physical safety guards, shielded controls, or software or hardware interlocks will make the design more tolerant of errors that users might make.
• Alert users to the hazard: When neither design nor safety features will eliminate a use-related hazard or adequately mitigate the consequences, the device should detect the condition and provide an adequate warning signal to users.
• Develop written procedures and training for safe operation: If it is impossible to eliminate hazards through any of the previous strategies, or to enhance other control or mitigation strategies, then written procedures, labeling enhancements, and training for safe operation are the remaining options.”
This is good protocol when it comes to redesigning devices and improving user interactions to mitigate possible hazardous situations—it’s also a helpful view of how the FDA expects MDMs to proceed at this sometimes-challenging stage of device development.

The FDA is currently soliciting comments and suggestions on the draft. Send comments to docket No. FDA-2011-D-0469 by September 19, 2011. The complete draft document can be accessed at: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm259748.htm#b.
The final document will replace “Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management,” which took effect in July 2000.
Even though this may be viewed as another layer of regulation by the FDA, it’s a good thing because it presents a clear picture of what the FDA expects regarding the integration of human factors and usability engineering in the design and development process—which also means a smoother and faster 510(k) process and safer medical devices.


The More Things Change… The More They Stay the Same: Best Practices in Change Control

Monday, May 2nd, 2011

Take a trip down the grocery store aisle and you’ll quickly see packages and cans boasting “New and Improved Formula” for everything from soup to soap. It seems that manufacturers are constantly improving their products. But improving is a marketing word. The reality is, they are changing their products. It doesn’t necessarily mean it’s a change for the better; it could be that a vital ingredient is no longer readily available or is suddenly more expensive. It could be that the competition harped about something in their product that they claimed was unsafe/unhealthy, etc. It could be the marketing department’s idea to make news.

Regardless, changes mean work in the Quality Management department. Change Control is a vital part of the quality manager’s job. The FDA has certain expectations of companies and, like it or not, documenting change is one of them. Unfortunately, documenting change isn’t just jotting down “changed from paper to plastic” in a notebook somewhere. Rather, the FDA has a laundry list of things the Quality department must address including: facilities and equipment, materials, production, packaging, labeling, laboratory controls, design controls, components, aseptic/controlled process, viral inactivation/removal, validation, computer systems and preapproval. All must be classified in one of three categories: major, moderate or minor change.

Change Control is a formal process. The challenge for Quality managers is to develop an enterprise-wide system to manage change so that no one is caught off guard when any change is requested. Quality is typically the last department to approve changes, and before doing so, they should review the change for any potential effect on employees or the environment.

But not all changes are planned events. Sometimes, deviations occur because of a host of unexpected factors such as safety hazards, equipment damage, human error, etc. A good quality plan will have an SOP for handling deviations. We all know, stuff happens. It will also plan for corrective and preventive procedures, using trend analysis.

As surely as the sun will rise, eventually an FDA inspector will pay a visit to your Quality department. After exchanging a few niceties and small talk about the weather, you’ll inevitably be asked for your recent Change Control log. What he’ll be looking for is the number of change requests pending, those changes performed without the Quality department’s approval, and a system to ensure a formal system is in place to monitor and evaluate change as well as routinely check trends.

You can prepare yourself for such a visit by following some industry-standard best practices for Change Control and by implementing solution automation to support the collection, tracking, management and reporting for enterprise change control.
A good Change Control system should:
• Identify the needed change
• Justify the change
• Document the change
• Get the appropriate approvals
• Communicate and train
• Implement and evaluate

You should also hold regular Change Control meetings with Quality professionals and other departments that are involved. Discuss issues regarding proposed changes, regulatory requirements, and evaluate trends. Assign responsibility for tracking and monitoring changes, and even enlist a senior manager to this team. Keep everyone in the loop on outstanding requests and stay on top of your system.

The biggest mistake a company can make is to underestimate the value of a Change Control system. It should be a strong aspect of the Quality department, helping to address problems you know about and detect problems early enough.

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