Thought shower questions

Thought shower questions

Questions

The following list gives you an example of the sorts of questions that might be generated by a thought shower session.

Using the example of Scenario 1 (An operator should have weighed out ingredient A on line 2. However they used ingredient B, leading to rejection of product XYZ) previously given when defining the scope, some of the ideas that might be generated by the thought shower session and considered are listed below.

The incident

  • When did the incident happen?
  • Has this type of issue happened before?

Roles and responsibilities

  • Who was the operator(s)?
  • Was the operator trained / refresher trained?
  • Is the operator experienced / familiar with the job?
  • Who trained / retrained the operator(s)?
  • Is there a responsible deputy(ies) for the operation?
  • Are all roles/duties affecting the operation defined?

Records and procedures

  • Are the correct document(s) version / issue in use?
  • Do weighing procedures / Work Instructions exist?
  • Was the procedure(s) followed?
  • Do weighing records exist?
  • Are the records a true reflection of fact?
  • Who verified / signed off the records?
  • Does an ingredient intake procedure exist?
  • Was the procedure followed?
  • Do intake records exist for ingredients A and B?
  • Are the records a true reflection of fact?
  • Who verified / signed off the records?

The product and ingredients

  • Has all the product(s) been captured / retained?
  • Are any other products affected?
  • Does full traceability of all materials exist?
  • Are all products adequately labelled?
  • Do ingredient A and B look similar?
  • Would the operator(s) visually recognise ingredients A and B?
  • Where else are ingredients A and B used?
  • Are the ingredients from approved suppliers?
  • Are product barcodes used and read?

Other areas of investigation

  • Is line 2 the only area affected?
  • Are the product labels able to be removed?
  • Is there any evidence of product label removal?
  • Is the weighing area well lit?
  • Are any confirmatory identification checks done?
  • Are ingredients decanted into secondary containers?
  • Were the weighing scales calibrated?
  • How could the operator have been distracted?
  • Could cleaning have affected the operation / labels?
  • Was any relevant engineering work taking place locally?
  • Is a non-conformance policy in place and effective?
  • Is the operator aware of the non-conformance policy?
  • Was this policy used and enforced in this incident?