Keeping the recall from the door is the task that never ends. It depends on a suspenders and belt strategy that prevents noncompliant production with systems in place to reconstruct events if something goes wrong.
While the most dramatic headlines often come from the FDA regulated industries of pharmaceutical and food, recalls are not good for anyone. All manufacturers face recall challenges from regulators, supply agreements and class action lawsuits.
The value chain of raw materials-to-process-to-finished goods-to-customer needs the combined attention of Enterprise Manufacturing Intelligence (EMI) and traceability systems to maintain quality, safety and compliance. During recalls both quality and genealogy systems are critical to characterizing the problem and untangling the mess.
What is at stake?
- In 2012 the FDA had 4,075 recall events (life sciences and food combined).
- In an Ernst & Young study, 77% of respondents estimated an average impact $30,000,000 per incident. 23% of respondents cited even higher costs.
- The cost of poor quality (COPQ) is estimated at 30% of gross pharmaceutical sales.
An integrated IT strategy is critical to combat these challenges. This coordinates existing systems including ERP, WMS, MES, quality management, and traceability. The traceability and process performance data collected directly impact:
- Supplier management
- Logistics & warehousing
- Product recall management
The complimentary roles of EMI and traceability in regulated industry production and supply chains will be the topic of a web conversation with David Miller, President of Mobia Solutions and one of the industry’s leading experts in technology, inventory management and traceability. Register for the complimentary webinar EMI & Traceability –Maintaining quality, safety and compliance and join the discussion November 13.