TOP EVENTS:Print Ver

Winter 2009

Ops A La Carte LLC
Ph: (408) 654-0499
Fax: (408) 986-8154
Website: www.opsalacarte.com

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Theme this newsletter:
MEDICAL RELIABILITY

COURSES/SEMINARS - DfR Asia, CRE Class, Quality Webinar

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EVENTS - BioMed, RAMS, MD&M, CMSE

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SPECIAL OFFERS - $1000 for leads, Free Job Listings

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NEWS - New Consultant in Canada, 2000th proposal

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FEATURED SERVICE - Medical Reliability

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RELIABILITY BLOG - Highlights of Last Quarter's Blogs

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PROBLEM SOLVER - Medical Reliability vs. Regulatory

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ADVERTISEMENTS - Computer Magic

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JOB OPENINGS - Ops A La Carte

The Food and Drug Administration (FDA) http://www.fda.gov/ develops and enforces compliance for safety, effectiveness and reliability. FDA does not develop engineering specifications and standards for Medical Devices. FDA regulations are free for reference.

International Electrotechnical Commission http://www.iec.ch/ Develop regulatory and engineering safety specifications and standards for medical device safety. Medical devices at European market requires CE marking. It is a self declaration process with the compliance of all applicable standards. IEC standards are available for purchase online.

21 CFR Parts 808, 812, and 820 Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Page 2

SUPPLEMENTARY INFORMATION: I. Background  (Design Controls)

“Specifically, in January 1990, FDA published the results of an evaluation of device recalls that occurred from October 1983 through September 1989, in a report entitled ‘‘Device Recalls: A Study of Quality Problems’’. FDA found that approximately 44 percent of the quality problems that led to voluntary recall actions during this 6-year period were attributed to errors or deficiencies that were designed into particular devices and may have been prevented by adequate design controls.”

21 CFR Parts 808, 812, and 820 Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule
A. General Provisions, page 55, § 820.3 Definitions

B. Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for
distribution.

C. Design Controls, page 18, 72.
FDA emphasizes, however, that the section requires the manufacturer to ensure that the design input requirements are appropriate so the device will perform to meet its intended use and the needs of the user. In doing this, the manufacturer must define the performance characteristics, safety and reliability requirements, environmental requirements and limitations, physical characteristics, applicable standards and regulatory requirements, and labeling and packaging requirements, among other things, and refine the design requirements as verification and validation results are established. For example, when designing a device, the manufacturer should conduct appropriate human factors studies, analyses, and tests from the early stages of the design process until that point in development at which the interfaces with the medical professional and
the patient are fixed.”

The purpose of conducting design reviews during the design phase is to ensure that the design satisfies the design input requirements for the intended use of the device and the needs of the user. Design review
includes the review of design verification data to determine whether the design outputs meet functional and operational requirements, the design is compatible with components and other accessories, the safety requirements are achieved, the reliability and maintenance requirements are met, the labeling and other regulatory requirements are met, and the manufacturing, installation, and servicing requirements are compatible with the design specifications. Design reviews should be conducted at major decision points during the design phase.

THE QUALITY SYSTEM AND DESIGN CONTROLS. In addition to procedures and work instructions necessary for the implementation of design controls, policies and procedures may also be needed for other determinants of device quality that should be considered during the design process. The need for policies and procedures for these factors is dependent upon the types of devices manufactured by a company and the risks associated with their use. Management with executive responsibility has the responsibility for determining what is needed.

Example of topics for which policies and procedures may be appropriate are:

• risk management                                                   
• device reliability
• device durability
• device maintainability
• device serviceability
• human factors engineering
• software engineering
• use of standards
• configuration management
• compliance with regulatory requirements
• device evaluation
• clinical evaluations
• document controls
• use of consultants
• use of subcontractors
• use of company historical data

SCOPE AND LEVEL OF DETAIL
Design input requirements must be comprehensive. This may be quite difficult for manufacturers who are implementing a system of design controls for the first time. Fortunately, the process gets easier with practice. It may be helpful to realize that design input requirements fall into three categories. Virtually every product will have requirements of all three types.

• Functional requirements specify what the device does, focusing on the operational capabilities of the device and processing of inputs and the resultant outputs. 
• Performance requirements specify how much or how well the device must perform, addressing issues such as speed, strength, response times, accuracy, limits of operation, etc. This includes a quantitative characterization of the use environment, including, for example, temperature, humidity, shock, vibration, and electromagnetic compatibility. Requirements concerning device reliability and safety also fit into this category. 
• Interface requirements specify characteristics of the device which are critical to compatibility with external systems; specifically, those characteristics which are mandated by external systems and outside the control of the developers. One interface which is important in every case is the user and/or patient interface.

Submitted and approved documents:
1) Corporate Quality System Handbook
2) Product Development Handbook
3) Product Development Management Plan and Report
4) Product development, review and approval record
5) Risk Analysis for both software and hardware
6) Failure Rate Prediction, parts count
7) Failure Mode Effects and Criticality Analysis Report
8) Product Validation test reports both hardware and software
9) Document change procedure
10) Document release procedure
11) Purchase procedure
12) Product serial number system
13) Material Review Board Procedure
14) Finish Goods Procedure
15) Internal Audit Procedure
16) Training Procedure
17) Standard Operations Procedure

The previous case study illustrated how to use regulatory and reliability together in a program.  But what about reliability issues not related to regulatory concerns?

The FDA does not give much guidance in how to develop a reliable product.  Their principle concern is safety!  If the product fails, it must fail safe.  Therefore, we must come up with appropriate methods to ensure reliability.

The next example illustrates how we worked with a company and took them through an entire reliability program to make sure we addressed all major risks to reliability.

The infusion pump was an n+1 design.  We started with a reliability goal statement.  Then we wrote a comprehensive reliability program plan.

RELIABILITY PROGRAM PLAN

• Which areas were the same
• Which areas were new
• Reliability allocations
• Gap analysis
• Reliability Tools Deployed, General for all assys
• Reliability Tools Deployed, Specific to certain assys
• How will tools be used
• Metrics to be used during program
• Reliability Reporting and Issues Management
• Roles and Responsibilities
• Reliability Deliverables
• Contingency Planning
• Ongoing Reliability Assurance

IDENTIFY RELIABILITY RISKS

• Using the Risk Analysis process, we identified as many new risks as possible
• Then we set out to figure ways of mitigating these risks
• Design analysis techniques such as FEA, DOE, and Thermal Analysis
• Accelerated Testing techniques such as HALT, ALT, and RDT
• The important element here is that we always had an eye on our goal.

RESULTS

• Using this process we saved time and money.
• We found out issues during the design analysis that would have required a redesign had we found them later in the design, or worse, out in the field
• We found out issues during the testing that would have set our program back months.
• End result:  We developed and delivered a very reliable product and got it to market faster.

SUMMARY

• Comply with FDA Good Manufacturing Practice , IEC60601-1 Safety, Risk Analysis ISO14971(EN1441) & IEC60601-1-4
• Perform Risk Analysis, Failure Mode Effects and Criticality Analysis,  MTBF prediction, HALT, Accelerated Life Tests, Environmental tests, Validation tests & Safety compliance test.
• Provide adequate confidence for Safe, effective and reliable products and services in product life cycle: Development, Approval, Production, Field services and End of usage.
• Manufacturers should develop the appropriate and practical solutions

THE CHALLENGES

• Need both reliability and regulatory expertise
• Need management of cost, samples and test facility

THE REWARD

Having these will provide you with

•  reliable product
•  timely approval by FDA and other agencies

Below is a summary of the Best of our Blog for last quarter - highlights of the best blog topics we had. If you would like to contribute to our blog, please either

or go to

LED diodes – Life test
HALT Vibration Table in Slow Motion
Green Reliability discussion
Setting Reliability Goals using Benchmarking

MEDICAL RELIABILITY: REGULATORY vs. RELIABILITY

Name In medical devices, we must abide by the rules set out in 21 CFR. What does CFR mean and what is the title for Code 21?

The best response within the next 5 days will receive one free pass to our next Certified Reliability Engineer (CRE) or Certified Quality Engineer (CQE) course.

Computer Magic Training is a computer software and professional development training provider that really makes a difference. Their training works like Magic! What makes them different is that their focus is on the customer, to provide the very best learning experience, whether the class is at Computer Magic or at a corporate location. Their instructors are caring and clear communicators with exceptional knowledge. The training facilities are outstanding - warm, beautiful and comfortable with great computer equipment. The Computer Magic staff and trainers take great care of the students and make sure their needs are met. Students receive helpful after-class support and free class repeats. Computer Magic also provides Tutorial and Consulting Services and a line of Professional Development classes from their Business Magic Training division.

Computer Magic, Inc. | www.computermagictraining.com | sharon@computermagictraining.com | +1.408.261.2600

Ops A La Carte's newsletter goes out to over 18,000 subscribers. If you would like to advertise in next quarter's "Reliability News", email us via our Advertise Contact Form or call at (408) 654-0499.

Given the current economic climate, we know of many talented individuals that are currently looking for work. Therefore, if you are an employer and have a need for any position within reliability, engineering, or operations, we are offering to advertise in our newsletter at no cost. Just doing our part to help stimulate the economy! Below are a few positions that we do know about.

Senior Reliability Consultant

Ops A La Carte is looking for Senior Reliability Consultants around the world to join our team of consultants and work on some of the most exciting and challenging projects in the industry. Whether you have an existing consulting practice or are interested in developing one, please contact us.

If interested, email us via our OPS Job Search Contact Form or call (408) 654-0499.

Ops A La Carte's newsletter goes out to over 18,000 subscribers. If you would like to put a job opening in next quarter's "Reliability News", email us via our Job Openings Contact Form or call at (408) 654-0499.