ISO 9001 Training

Understanding ISO 9001:2008
Requirements for Quality Management Systems

0.2.3 Process Plan - Do - Check - Act

ISO 9001 Training Key Explanation Points and Tips: 

See Figure 3

PLAN-DO-CHECK-ACT (PDCA) - is a very effective tool for business management and the ISO 9001 standard strongly recommends its use.  PDCA is a dynamic cycle that can be applied to each of the organization’s processes, and also to the system of processes as a whole. It may be used to plan, implement, control and continually improve both product realization and other QMS processes.

Maintenance and continual improvement of QMS processes can be achieved by applying PDCA to processes at all levels within the organization - from the executive high-level strategic processes, such as business planning or management review to operational processes such as product realization or calibration.

(PLAN) - For each QMS process you must establish:

Process owner and his/her accountability

Process inputs, outputs, value adding or conversion activities and sequence/interaction of these activities (sub-processes) within the process. Many of the COP’s and SOP’s may have sub-processes.

Process policies, responsibilities and accountability.

Process objectives and performance indicators and methods to monitor and measure process performance to these objectives and indicators.

Resources needed (e.g. facility, equipment, labor, materials, time, etc).

Preventive and detective controls needed for process activity, input, output and resources used.

Process documentation (e.g. procedures, forms, work instructions, specification, etc.)

The nature, method, frequency and timing of interaction with other processes and where this interaction will occur - input, output, use of resources, conversion activity, etc.

You must pay a lot of attention to this stage of your QMS development. Planning must also consider how you will meet customer, applicable regulatory, and your own organizational requirements, in addition to ISO 9001 requirements. We will look at QMS planning in more detail when we review clause 4.1 requirements. 

(DO) - Deploy and implement your QMS processes and manage and control them according to your plan as documented above. Provide adequate training to staff in on the job and QMS controls.

(CHECK) - Monitor and measure the effectiveness of your QMS processes against policies and objectives that you established under PLAN. Monitoring and measuring activity may focus on any or all of a process’s inputs; outputs; use of resources for conversion; and interaction with other processes. Supervisors should do regular informal audits of their processes to ensure effective compliance to planned controls. Set appropriate measurable process objectives to determine process performance.

(ACT) - Collect and analyze your monitoring and measurement information and use it to determine the effectiveness of each process as well as your overall QMS in meeting requirements. Use your corrective action process to correct problems and continually improve problems that your performance data has uncovered.

As mentioned above PDCA is a dynamic cycle and so continual improvement must be an on-going process for improving your QMS and enhancing customer satisfaction. 

Figure 4 - shows the macro level application of the PDCA model to an entire organization. The organization’s QMS (as depicted by the processes within the circle) is used to PLAN the controls over all inputs, resources, value-adding activities and outputs. We DO - implement our plan by using various resources to convert customer inputs (requirements) into outputs (product) that meet customer requirements. We CHECK - by monitoring and measuring QMS performance and through customer feedback. We ACT - by using this information to continually improve QMS effectiveness. At the micro level, this same model can be applied to each QMS process.

Controls for your processes come from the ISO 9001 standard, customer requirements, your organization or applicable regulatory requirements.. The five clauses of ISO 9001 provide control requirements for PDCA - planning, implementation; monitoring and measurement; and for improvement of each QMS process. The applicable requirements of these five clauses must be applied to each process (inputs; outputs; resources used; transformation activities; interaction with other processes) for effective control. In clause 4.1 we will discuss this in further detail.