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Today's "Got Quality" Blog

Employing Risk-based Audits for Improved Supplier Performance
by Bob Mehta - ASQ Fellow and Principal Consultant


According to the FDA, 21 CFR Part 820.50 (Purchasing Controls) continues to be a significant concern, with the agency issuing Form 483 Observations and Warning Letters citing continued violations by device manufacturers. As shown in below, in 2015, FDA issued a total of 1,002 Forms 483 (between 10/1/2014 and 9/30/2015) and frequency of “Purchasing Controls” element was third highest and a total of 139.  Below is a list of top five CFR Reference Numbers from 21 CFR Part 820 and frequencies of the findings. 


Cite Id

Reference Number

Short Description

Long Description



21 CFR 820.100(a)

Lack of or inadequate procedures

Procedures for corrective and preventive action have not been [adequately] established. Specifically, ***



21 CFR 820.198(a)

Lack of or inadequate complaint procedures 

Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established.  Specifically,*** 



21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been [adequately] established.  Specifically, ***



21 CFR 820.75(a)

Lack of or inadequate process validation 

A process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] validated according to established procedures.  Specifically, ***



21 CFR 803.17

Lack of Written MDR Procedures

Written MDR procedures have not been [developed] [maintained] [implemented].  Specifically, ***



Not only medical device manufacturers have issues with “supplier controls” element but many of their suppliers do not meet all requirements included in ISO 9001:2008 and ISO 13485:2003 section 7.4 titled “Purchasing.” In addition, the new standard (ISO 13485:2016) expects organizations to record their supplier monitoring and re-evaluation activities. 


As we know, suppliers providing non-conforming material are directly related to an increase in medical device recalls, which increases the need for effective quality processes to mitigate risk. With the FDA's increased vigilance, how can device manufacturers better position themselves to achieve and sustain compliance? The answer lies in the establishment of an effective purchasing control procedure that places significant emphasis on supplier controls and the establishment of a value-added supplier audit program. A value-added supplier audit program can help organizations mitigate business and regulatory risk while reducing the Cost of Poor Quality (COPQ).


When intelligently designed, a value-added supplier audit program can provide great benefits to a device manufcturer. Establishing a value-added program begins with the understanding that the program fundamentals expand beyond the phyical performance of supplier audits.


Stay Tuned for Part 2!

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