Establishing an incident management team
It is important to ensure a coherent and consistent approach to any product quality incident across the business.
If you already have a designated IM team, alert its members (subject to potential conflicts of interest) as soon as an "incident" as defined in the IM plan has taken place. If there is no suitable IM team in place, establish an initial working group to help you deal with the incident.
Keep the following points in mind:
- although a thorough knowledge of the business and product will be required, no team member who is personally involved in the production process or sale operations should be given unilateral responsibility for key decision-making
- remind the IM team of the importance of confidentiality, legal privilege and document retention/management, even within the business (please refer to Controlling document creation and securing privilege for more information)
- include at least one senior employee or board director in the IM team, to enable decisions to be taken and acted upon quickly and to secure necessary resources and co-operation from the business
- appoint an IM team leader. Responsibility and reporting lines must be absolutely clear within the IM team
- the IM team should be composed of members of the key relevant business units, including senior management, legal, communications/public relations, IT, compliance, technical/regulatory affairs, human resources and the relevant operational unit(s) (ensuring that the team includes senior technical staff with detailed knowledge of the relevant areas of operation). Ideally, this will include individuals who have been involved in developing and rehearsing the company's IM plan (where one has been put in place)
- all actions related to investigating, mitigating, responding or otherwise dealing with the incident should be coordinated and approved by the IM team (or a majority of them if all are not available)
- in cases of a significant quality/safety issue where the company may be able to recover costs from a third party (for example, a supplier), the IM team should arrange for a log to be kept of time engaged dealing with the issue(s). This may potentially be useful to support a claim for lost management time in the future
