Investigating the issue - non-food product
Following the preliminary assessment in relation to whether a trigger event has occurred, the IM team should conduct a thorough investigation of the facts that gave rise to the potential product quality or safety issue, as time permits). For example:
- obtain all available information regarding reported potential problems with the product from the internal quality control department, the consumer helpline, the consumer or the consumer protection or regulatory body that passed on the complaint
- establish whether other similar cases have previously occurred or may exist that have not yet come to light, for example, through a review of any related customer complaints records
- consider putting a ‘hold’ on the release of all product batches that may be affected
- consider tracing product batches which may be affected
- consider performing sampling exercises or spot checks on existing stock items within the company’s control or possession, in the distribution chain and, if necessary, from retailers’ shelves
- obtain a technical analysis of the potential problem with the product, if time permits, in conjunction with in-house technical or quality control staff, and involve a qualified independent expert to review the procedure and the resulting technical analysis where appropriate. It is important that legal privilege is maintained, where available, over such reports. See Controlling document creation and securing privilege
The full implications of the issue may take some time to become apparent. However the team should aim to determine:
- whether the reports or complaints about the issue are genuine and, if so, what the potential issue is and in what circumstances it is likely to arise
- whether any verified problems are isolated incidents (for example, limited to one batch of product or one production base), or whether they are more widespread
- where potentially affected products might be located (ie still in the company’s warehouse, in the distribution chain, or already sold to consumers?)
- the degree and extent of risk the product may pose to consumers (independent experts may be required to assess the risk of the hazard arising and the likely consequences, if it does). For example, whether the issue may potentially threaten any vulnerable groups (such as, for example, children, pregnant women or the elderly)
Although intended to be a non-exhaustive list, consideration of factors such as those listed above should result in an informed assessment of the nature of the risk the product poses to individuals (and/or their property), including the likelihood of the risk materialising and its consequences.
Bear in mind, however, that there may be a legal duty on the company to take action and notify regulators within a short period of time. See Dealing with regulators. There will not always be time to conduct an exhaustive investigation before these obligations bite.
