PDCA & RISK BASED THINKING

PDCA stands for Plan-Do-Check-Act.   It is a four-stage approach used in many Continual Improvement (CI) programs.  It was developed by Walter Shewhart and made famous by Edward Deming.  It is one of the easiest quality and management tool to use to improve the quality and effectiveness of processes.

Plan: Defines the process, its requirements and targets that need to be implemented.  Draft these on paper to crystallize the plan that needs to be implemented.

Do: Execute the plan.  Implement the improvements that were identified in the Plan stage.  Document what are being implemented and collect appropriate data as evidence and for analysis.

Check: The validation and evaluation of data are done.   The collected data are validated to ensure they are correct and reliable.  The data must reflect the actual process.   Then an evaluation of these data are done by using quality and management analysis tools.   Conclusions and recommendations are made based on the outcome of these evaluations.

Act: The recommendations are added into documents and data are maintained.  Actions are then taken to implement the recommended changes into the area and processes.   Targets are revised and the PDCA cycle restarts again.

In ISO9001, PDCA is highly recommended as an implementation tool in a process approach improvement program.  This PDCA can be used when;

  • beginning a new implementation project,
  • implementing change or revision of a SOP,
  • developing a new or improving a process,
  • planning to collect data and when analyzing data.

PDCA can be used when implementing all the clauses and at all levels in the ISO9001.  From the planning of ISO9001:2015 system implementation to the establishing of processes and the maintenance of the Quality Management System itself.   PDCA can also be used when performing the Internal Audits and Management Reviews too.

PDCA can also be used to implement the new Risk-Based Thinking requirements of ISO9001:2015:

  1. Plan – identify the QMS processes that exhibit risks that could impact the quality of the product/services and to the customer. Then identify the appropriate process or approach to be used to evaluate, monitor and control the risks in QMS processes.   Such tools could be SWOT, FMEA, Risk-Opportunity Matrix, Risk Register, etc.
  2. Do – Implement the risk tool/s into the processes to evaluate the type and extent of the risks that could impact the quality of the product/services and to the customer. Implement mitigation sub-processes to control these risks when and if these identified risks were to occur.  Document these sub-processes.
  3. Check – Monitor the effectiveness of these sub-processes to mitigate these risks. Maintain records.
  4. Act – Evaluate and review these sub-process mitigation effectiveness. Amend and improve these sub-processes as and when required.

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