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Response Categories

This version of Quality Systems Toolbox is no longer in use. Current documentation for v3 is here.

  1. Describe the problem

Used to further describe the problem, it’s impact, and/or risks.

  1. Contain or temporarily fix the problem

Note that these actions are just damage control – they do not correct the cause of the problem.

  • ’Put out the fire’: This step is where you stop the event from occurring.
  • Assess the damage: Once you have stopped the event from occurring, determine what and how much damage has been done and what can be “repaired / replaced / recovered”.
  • Contain all effects: Upon determination of the amount and extent of damage, prevent everything that was affected from escaping, and determine if anything has escaped.
  • Notify as appropriate: If it is determined that product may have already been released, notify any impacted customers.

These steps are the “remedial actions” or “Immediate Corrective Actions” taken to bring the noncompliance back into compliance.

  1. Investigate the root cause

It is very important to distinguish between the observed symptoms of a problem and the fundamental (root) cause of the problem.

There are many different techniques to assist in determining the root cause. One of the simplest is to ask a series of ‘why?’ questions (ref: 5 WHY technique) to dig deep into the situation until the fundamental reason for the problem is found.

You will need to collect all relevant date, talk to all stakeholders, and investigate all possible contributing causes.

It is important that the investigation is not about finding someone to blame.

  1. Propose a solution to prevent recurrence

The solution proposed should address the root cause. The aim is to stop the incident from occurring again. The solution will often involve a change to the process involved (and associated documentation).

  1. Implement the solution

Record the details on what actions were taken, and when. Supporting evidence may include uploaded files and/or images.

  1. Verify the solution was effective

After some time has elapsed with the solution in place, you need to assess whether it has been effective in preventing the original problem.

This response should provide a record of the objective evidence sighted that shows the solution was effective.

You will need to be an action officer for this issue or a manager user in order for the Issue workflow state to change from ‘In progress’ to ‘Closed’

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