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Recall Management: A QMS Match Made in Heaven!

  
  
  
Check this out...been working on a few ideas on the concept of Recall Management. something to the tune of 45% of all recalls are medical device and 50% of all other recalls are food-related. That's a whopping 95% (if my math is correct). What I've learned is that recall management is that there is a lot of activities involved to execute a successful recall - dear doctor letters, product traceability, press releases, destruction of product, and it all has to be done within 30 days.

QMS is a prime environment for handling recalls. usually the QA and RA folks are the ones who are tasked with not only executing on recalls, but also running "mock" or desktop recalls to prove the efficiency of their recall process. furthermore, many device manufacturers have a retrieval process whereby they retrieve product for marketing/repackagin purposes.

The QMS can have the document control to assign and execute on any press releases needed, the procedures necessary with escalated workflow to ensure the recall process is completed in a set amount of time, and provide traceability through a nonconformance (NCM) process, as well as the disposition.

There is a match here, methinks. I would like to see whether anyone has been thinking about using their QMS for Recall Management, or if they are using something else (perhaps ineffectively) and see the link between QMS and Recall Management...


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Comments

Hey, very nice site. I came across this on Google, and I am stoked that I did. I will definately be coming back here more often. Wish I could add to the conversation and bring a bit more to the table, but am just taking in as much info as I can at the moment. 
 
iso 9000 
Posted @ Monday, August 01, 2011 9:17 AM by iso 9000
To eliminate or mitigate the cause of a detected nonconformity or other undesirable situations to prevent recurrences during product evaluation require a Corrective Action (CA). Two types of a CA initiated are: 
 
• The Root Cause (RC), which requires root cause analysis to be performed and actions taken to address the analysis  
 
• The Immediate Action (IA) is a type taken to address a direct cause and prevent recurrence of a specific nonconformity. 
 
• The presence of related nonconformities or undesirable situations may indicate a need to address root cause(s) through a RC. 
 
Collective analysis is performed periodically to monitor adverse trends of detected nonconformities and undesirable situations that may not have been addressed by an RC or IA. Results are recorded and provided for senior managers reviews of progress/status and overall process performance. The review may be accomplished through a Corrective Action Board (CAB). 
 
Appropriate reviews of the CA and IA should be conducted regularly to: 
 
 Monitor progress/status and overall process performance (e.g., timeliness, efficiency, effectiveness). 
 
Review adverse indicators and trends. 
 
Resolve issues and/or elevate to the proper forum or level of management for resolution. 
 
Posted @ Friday, May 25, 2012 8:28 PM by Boyd L Summers
I am now taking my management certification class at Project management Academy, and this article really helps me learned things about project management.
Posted @ Wednesday, September 04, 2013 9:17 PM by pmp training course
I want to learn more about recall management, what is this and how can i apply this to my recent project management job.
Posted @ Wednesday, September 04, 2013 9:25 PM by pmp test prep
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