Title

Formulate an action plan based on the audit report and monitor its implementation

Why

Nonconformities in examination procedures and the quality management system need to be identified and solved to improve the system.

What

Once the audit report is completed it is submitted to the laboratory manager (see previous activity). The laboratory manager has to develop a SMART action plan to ensure the timely correcting/solving of nonconformities identified during the audit.

How & who

Laboratory Manager:

  1. When the audit report is submitted to you, sign and date it and draft a SMART action plan within 2 weeks. This plan must contain action points for correcting/solving all the nonconformities identified in the audit within the time-frame defined by their score. Formulate corrective actions to eliminate the nonconformity and, if possible, formulate preventive actions that prevent the same nonconformity from occurring again in the future. If possible, implement control steps in the routine laboratory processes to detect if the nonconformity reoccurs.
  2. Discuss the action plan in a weekly staff meeting and inform the staff members of the action points that were assigned to them specifically.
  3. Give the action plan to the Quality Officer who has to monitor its timely and correct implementation.
  4. Once all the action points have been completed, sign and date the action plan for completion. The Quality Officer will subsequently archive the report and action plan.


Quality Officer:

  1. Once the laboratory manager has written and presented the action plan following the Internal Audit Report he will give it to you. Start monitoring timely implementation of the action plan. Do this by adding the action points to the minutes of the weekly staff meeting. This way you can go through the action points every staff meeting and ask for their status of implementation. As the laboratory manager also attends these meetings the staff members that have not yet implemented action points after the deadlines can be forced by the Laboratory Manager to implement the action points as soon as possible.
  2. When an action point is finished ask the responsible person to sign it off with date and signature.
  3. Once all the action points have been implemented completely, give the action plan back to the Laboratory Manager who must sign and date the action plan for completion.
  4. Once signed and dated by the Laboratory Manager, archive the action plan in the folder Action Plans behind the tab "Completed Action Plans".

Back to Roadmap Activity Overview
This activity belongs to the QSE Assessment

 

ISO15189:2007: 4.10.1 4.11.1 4.12.1 4.14.1 4.14.2
ISO15189:2012: 4.10 4.11 4.12 4.14.5
ISO15190:2003: