All Quality Management Systems aim to build processes into the activities and culture of organisations. Simply put, a process is a set of predefined actions or steps that help reach a goal or target. Even when a company is not consciously aware of using a Process approach to tasks and problem solving, they are likely already using some processes. For example, a simple Work Instruction or Standard Operating Procedure (SOP) is a process in itself.
If a company is certified to ISO 9001, ISO 13485 or working to the FDA QS, the process approach is the perfect mind-set to drive consistency and meet targets. A familiar methodology used within many companies is the 5s methodology (Sort, Set-in-order, Shine, Standardise, Sustain) . This methodology is an organisational methodology which is very effective in ensuring a work environment is clean, organised and fit for purpose.
Another powerful methodology (shown above) is PDCA which stands for Plan-Do-Check-Act. A benefit of using this methodology is its design allows a visual representation for each segment. This helps clearly set out the tasks relating to each stage of the project or tasks and when they are to be completed. Below is a brief breakdown of each segment of PDCA.
Plan
The Plan step is used to establish the objectives and desired goals of the proposed changes or modifications. Documenting these goals is important
as it will drive aspects of the next steps in the Process.
Do
Implement the plan and the changes identified. The “Do” step may require data collection and/or analysis prior to the implementation of changes. Training may also be required. Responsibilities should be clearly defined.
Check
Review results and analysis against the planned and expected results or goals.
Act
The “act” step ensures if any further corrective actions or modifications are noticed in the check step, the person will “act” on the findings. However, any proposed changes are better captured by returning to the first step and starting the process again, either way, the application of PDCA will make tasks that little bit more consistent. You can download our PDCA template online. Visit validationresources.ie and go to the “Engineering tools” catalogue.
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