Documentation – why is documenting your study necessary?

Documentation – why is documenting your study necessary?

documentation

Documentation is essential because it provides Due Diligence evidence that a study has been conducted, considered the appropriate inputs, that tools and techniques have been suitably selected and employed, and that a thorough, balanced and objective study has been completed. It also assists with implementation of corrective actions, legal stipulations and the requirements of commercial Standards.

Be proactive

Once a root cause has been identified it is good practice to consider if any other systems, processes or procedures may be susceptible to the same failure. Time invested at this final stage may minimise the potential for other issues to evolve. For instance:

  • Are any other products made using the piece of equipment that is partially responsible for causing the issue?
  • Are there other areas of the business where staff may not be trained against activities they are performing?
  • Under extreme time pressures or times of high production could the potential arise where staff in other departments take shortcuts and do not follow the procedures as they should?

Report

Any root cause analysis should be documented. All the information used in the investigation should form part of this documentation. It is useful to complete a report that summarises the study that was carried out and detail the actions that were taken.

Advantages to documenting your study:

  • Evidence that action was taken both for internal and external use.
  • Due diligence defence.
  • Reference point for training personnel.
  • May be used to guide future planning, further investigations etc.