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Product Liability & Recall – Controlling the Risk

A checklist for Action

This sheet is intended to identify a high level  agenda of issues which a business must have well controlled if it is to minimise risk from its products.

Much of it may seem mundane and may be thought to be already in place.

Our experience suggests that this is often an illusion when an audit is undertaken. Systems are often incomplete, or incompletely implemented or observed.

It is no surprise that these are the gateways that allow poor product into the field and product risk to escalate even to the point of causing recalls .

Contracts

  • Review Sale and Purchase Terms at least every 3 years
  • Review your implementation systems to make sure Terms are likely to be incorporated and you know when they are not
  • Have exception reporting where your terms are rejected
  • Audit supplier & customer contracts regularly to check that:
    • Your terms are agreed/incorporated in fact
    • If not agreed what terms you have contracted on
    • Identify key suppliers and customers and focus on these
    • Evaluate the risk posed by given suppliers/customers not contracting on your terms
    • Evaluate supplier credit worthiness/insurance backing

Product

  • Have a responsible manager/team to undertake and document product risk assessments and implement/evaluate risk control systems
  • Regularly assess the risks that your product might pose both to safety and commercially
  • Are there effective and complete  systems addressing the main risk areas posed by the product for safety and recall purposes ?
  • Audit your R & D, suppliers ,goods inward, WIP and finished goods recording, sampling, traceability and QA systems – are they demanding enough?
    • Are they documented in a structured way and for sufficient time periods?
    • Are samples, QA and R & D records retained in a structured way?
    • Are critical suppliers quality  audited at outset and periodically ?
    • Are sampling systems in place and  statistically valid?
    • Is good traceability maintained from supplies , through production and to end customer ?
    • Are processes and product requirements documented and observed in production?

Product Crisis Planning

Plan for a product crisis in advance

  • Have a team
  • Who are familiar with the issues and trained
  • Have a crisis plan with pre-developed materials
  • Think about a PR/communications strategy

Key Contacts