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Traceability – Board Risk Contol Paper

Risk Agenda – Issues Your Board Should have a Grip On

This series of notes are released with the aim of putting on to the board agenda of UK Plc important matters which are too often overlooked.

Traceability – Key tools for minimising recall nightmares

Introduction

Recalls are often horrendously expensive.  Yet simple steps in advance can reduce the cost by orders of magnitude.  High up the list of these steps is effective end to end traceability.

Traceability Crucial

Just a few moments thought underlines how very important traceability is to running an effective recall and controlling the cost of the exercise.

If a problem batch of product reaches the field (or just the warehouse) it is essential to be able to separate the good product from the bad.

The defective product returned from the field should have effective "on product" identification to allow the identification of common production factors shared with other examples of faulty product.  These factors may account for the problem or at least help to identify which batches or production periods are affected.

However if good practice has not been followed (or only in part) so that "on product" marking and retained production records do not mesh up (or have not been put in place or retained) then a very serious problem is faced.

Recalling the Good with the Bad

If a product needs to be recalled to avert a serious safety risk then this needs to be done urgently and in a targeted way. If the affected product cannot be narrowed down, then it is frequently the case that huge quantities of unaffected product will need to be recalled too in order simply to achieve a recall of the product actually affected.  But the cost will rise exponentially.

For example, imagine a household cleaner which was found on sale with a dangerously acidic make up compared to its normal formula. If there were no direct means of identifying from the defective product common production factors e.g. relating to a line or batch or certain production period , then a very wide scale recall might be needed . This could make the difference between recalling a batch or a few hours production or recalling  weeks or months of production.

The lesson then is to focus very clearly on having product marking which is permanent and relates back to retained production records.  The production records in turn should identify when and how a product was made, which line it was made on and from which batches of inputs.

Common Mistakes to Avoid

Simple and avoidable mistakes can also make a radical difference to the ability to distinguish affected from unaffected product.  Examples include:-

  1. Not marking product, so that its design , batch and date of production can be easily identified
  2. Rolling destruction/wiping of production data
  3. Production data fails to allow backward tracing of inputs , batch and  production line conditions
  4. Use of interchangeable inputs or different input batches without being able to identify which was used in which batch/production period.
  5. Inability of suppliers of inputs to identify their own batch traceability where the problem is thought to be with a component or raw material but it is unclear  what period is affected
  6. Not liaising with your customers to help them maintain traceability of where particular inputs or products have gone

Key Contacts