Manufacturing Insights

An ERP blog from MAX

Can you cope with a recall?

Posted by Michelle Donaldson on Sep 4, 2013 1:00:00 PM

recall-stampRecalls can behave like tsunamis. Even if you have proper quality and compliance in place, recalls can be initiated at any point along the supply chain. You still need a contingency plan in case you get hit from behind and caught up in another company’s recall party. All manufacturers should address how well current processes would allow them to cope with a recall. Would you be able to respond quickly and efficiently? Could you execute a recall with full confidence? Could your company survive the cost?

The topic of recalls remains red hot. ExpertRECALL by Stericycle released their Recall Index for the second quarter of 2013, and noted:

  • 48 percent of reported medical device recalls had international and U.S. components.
  • Year-over-year food recalls are up 73 percent, and 70 percent of affected food units were considered Class I recalls (the FDA's most serioius classification). 
  • 71 recalls were initiated by the Consumer Product Safety Commission (CPSC) this quarter, the second-lowest number in the past six quarters.

Where there are recalls, new government regulations may soon follow. Earlier this year, the Institute of Food Technologists (IFT) released recommendations on improving food traceability for the U.S. Food and Drug Administration (FDA) as part of the requirements outlined in the Food Safety Modernization Act (FSMA). The intent is to speed up recalls. The reality could become a compliance nightmare if you don’t have the infrastructure in place to adapt. 

At the end of the day, your manufacturing software should be able to tell the story of your business. If recalls are part of that story, expect your technology to support locating and initiating recalls for parts at any level of your assemblies--purchased or manufactured. It’s no longer enough to simply be able the follow the trail of breadcrumbs left by lot and serial numbers; you need to see the complete story of a lot and serial transaction in a visual display. Only then can you take confident action in the face of a recall and manage returns. Make sure that this is a part of your software evaluation process and establish high expectations and standards. The technology is out there that is able to meet your needs.

Topics: Compliance & Regulations, Quality & Control

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Insights, opinions and news relating to the world of manufacturing and ERP software. Read the full introduction here.

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