So you have been practicing 100meter sprint for some time now, in preparation for the big time. But how do you fare against other competitors? You won't unless you put someone next to you on the starting line.


Have you implemented Key Performance Indicators (KPIs)  for your organization? KPI can be considered as a big chunk of the Six Sigma Measure phase, as well as forming the boundary conditions for the Control phase.


Realistic, purposeful KPIs will tell you the following critical health parameters of your business

1. Efficiency
2. Quality
3. Customer Satisfaction

Data collected for KPI will also enable management to benchmark own performance against competitors and industry standard. 


So think competitive; set goals against others and measure KPI honestly.

To Quality or not , that is the question? 
Implementation of a Quality system is often looked upon by smaller businesses as cumbersome, ceremonial process that is non-value adding. Is this really the case?

Consider the following benefits that a well managed Quality program can bring to your business:

1. Lower operating cost, improving margin by reducing production waste (Lean, cost of quality)
2. Certification to ISO standard, or compliance with ISO standard to meet customer expectations
3. Competitiveness, innovation and value of the product
4. Effective Quality Management System that is required and complies with regulatory environment 

Summary of recent warning letters and some fairly amusing inspectional findings.

Warning Letter Analysis: FDA Warning Letters Cite Companies for Marketing, cGMP, Design Deficiencies RAPS News - Article View

It is absolutely essential to establish a robust and effective complaint handling systems for device-related reportable events in compliance with 21 CFR 803. However, the trending of such reportable device complaints is also explicitly required under 21 CFR 820.100, and often overlooked by Regulatory compliance professionals.


Sec. 820.100 Corrective and preventive action

(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:

(1) Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;

Establishing a statistical method to analyze/trend device complaints and other key Quality indicator will be instrumental in maintaining Quality Management of the product, as well as compliance with regulatory requirements.

A Leader...

• Paves the way
• Inspires a vision
• Pushes the envelope
• Encourages others 
• Enables others to act

FDA's report "Understanding Barriers to Device Quality"

FDA's Center of Device and Radiological Health (CDRH) recently published a report addressing the perceived barrier in medical device regulatory bodies and medical device industry.

 It is interesting to see that FDA is taking a much more proactive and collaborative approach in working with industry in "Identifying the barriers" in all areas of medical device market activities, benchmarking best Quality practices in/outside of industry, and improving the transparency of quality data to general public in order make quality a major purchase consideration for HCP and other medical devices customers.

FDA's review on how Industry executive's perceive  inspection activities and how their countermeasures created undesired abrasion between the Agency and Industry, also makes a pretty good read.


You can review the following webcast in the following link ( MS Silverlight required)

http://fda.yorkcast.com/webcast/SilverlightPlayer/Default.aspx?peid=652eaa1108614c6bbc76daf1a9b9d7fb1d

For the FDA report, see the follwing link.

http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM277323.pdf

Quality is defined as conformance to requirements, not “goodness”

-David Crosby