Understand the Process Approach Methodology
To understand the concept of process approach, one needs first to understand what a process is. Based on the definition in ISO9000, a process is a set of interrelated or interacting activities that use inputs to deliver an intended result. In other words, a process is set of activities which transfer inputs to outputs. Many things a person does with a purpose, such as travelling, dating and cupcake baking, can be regarded as processes. As well, many things a company does with a purpose , such as production, marketing, purchasing, and employees training, can also be considered as processes.
It is also important to understand the input of a process properly. Let's take the cupcake baking process as an example. Many people may regard flour, sugar, water and the other ingredients used to make the cupcakes as the input of the baking process, but actually these are just materials used in the baking process. The input of a process is the set of factors which impact how the process should be carried out. If you want to bake cupcakes, then the taste you desire (requirements on the output), the recipe and the oven you can find (technology available), and the ingredients you can get (resources available), etc. are the factors which affect how the baking process will be carried, and so they're the real inputs to the baking process.
The output of a process, on the other hand, is quite straightforward. It is just the result of the process. In the above cupcake baking process, the cupcakes are the output.
Implement the Process Approach Methodology
When trying to use the process approach methodology in quality management, one needs to take the following steps in order to effectively implement it:
1. Identify the quality processes
2. Plan the processes
3. Implement the process as planned
4. Evaluate the effectiveness of the process
5. Take actions to correct or improve the process
Now let's see what needs to be done and what attention should be paid in each of the above steps.
1. Identify the quality processes:
In this step, one needs to group together the activities with similar inputs and outputs as one process. There are, however, no specific ways to do it. For example, a factory may carry out different types of audit activities, such as system audit, manufacturing process audit and product audit. Each type of these audits can be regarded as an individual process, or they can just be grouped together as one process.
When identifying the processes, one should cover all the activities relevant to the quality management system (QMS). So before doing that, one need to decide whether an activity carried out in the company is within the scope of QMS or not. This can be very obvious for some activities (e.g. failure analysis of defect products), but obscure for the others (e.g. IT system maintenance). A proper decision should be done based on the impact of the activity to the customer satisfaction.
2. Plan the processes
When planning a process, one needs to clearly define:
-Who will be responsible to carry out the process (Man)
-What resources will be needed to carry out the process effectively (Material and Machine)?
-How shall the process be carried out (Method & Environment)?
-How shall the effectiveness of the process be evaluated (Measurement)?
The above aspects are often referred as 5M1E of a process. When defining "man" of a process, one needs to define a sole owner, who's responsible for the overall effectiveness of the process, and the supporters, who're needed to support the carryout of the process. When defining "measurement" of a process, one needs to define targets which can be objectively evaluated. The process owner should be held accountable if the targets are not achieved.
It is a widely used practice in quality management that a documented procedure is established to define the 5M1E of each process, so that the owner and supporters of a process have clear knowledge of their role in the process and how the process should be carried out.
3. Implement the processes
After each process is planned, the owners and supporters shall carry out the process as defined in the documented procedure. Necessary records should be kept as the evidences for the implementation of the required activities, the evaluation of the process effectiveness or future investigation if there's any undesired problem.
4. Evaluate the effectiveness of the process
At a predefined frequency, the effectiveness of each process should be evaluated with the predefined targets, to see whether the process actually achieve its intended results.
Effectiveness evaluation can be done through internal audit, management review and customer satisfaction study as required in ISO9001:2015.
5. Take actions to correct or improve the process
If the process does not achieve the intended result based on the evaluation result, actions should be taken to correct the process. Otherwise, a more challenging target should be set and actions should be proposed to improve the effectiveness of the process.
The corrective and improvement actions taken results in changes in the plan. Hence it goes back to the step 2 (or even step 1 if the processes should be redefined).
The steps explained is just the PDCA cycle. So when using the process approach methodology in quality management, it always has to be paired with PDCA.
It is also important to understand the input of a process properly. Let's take the cupcake baking process as an example. Many people may regard flour, sugar, water and the other ingredients used to make the cupcakes as the input of the baking process, but actually these are just materials used in the baking process. The input of a process is the set of factors which impact how the process should be carried out. If you want to bake cupcakes, then the taste you desire (requirements on the output), the recipe and the oven you can find (technology available), and the ingredients you can get (resources available), etc. are the factors which affect how the baking process will be carried, and so they're the real inputs to the baking process.
The output of a process, on the other hand, is quite straightforward. It is just the result of the process. In the above cupcake baking process, the cupcakes are the output.
Implement the Process Approach Methodology
When trying to use the process approach methodology in quality management, one needs to take the following steps in order to effectively implement it:
1. Identify the quality processes
2. Plan the processes
3. Implement the process as planned
4. Evaluate the effectiveness of the process
5. Take actions to correct or improve the process
Now let's see what needs to be done and what attention should be paid in each of the above steps.
1. Identify the quality processes:
In this step, one needs to group together the activities with similar inputs and outputs as one process. There are, however, no specific ways to do it. For example, a factory may carry out different types of audit activities, such as system audit, manufacturing process audit and product audit. Each type of these audits can be regarded as an individual process, or they can just be grouped together as one process.
When identifying the processes, one should cover all the activities relevant to the quality management system (QMS). So before doing that, one need to decide whether an activity carried out in the company is within the scope of QMS or not. This can be very obvious for some activities (e.g. failure analysis of defect products), but obscure for the others (e.g. IT system maintenance). A proper decision should be done based on the impact of the activity to the customer satisfaction.
2. Plan the processes
When planning a process, one needs to clearly define:
-Who will be responsible to carry out the process (Man)
-What resources will be needed to carry out the process effectively (Material and Machine)?
-How shall the process be carried out (Method & Environment)?
-How shall the effectiveness of the process be evaluated (Measurement)?
The above aspects are often referred as 5M1E of a process. When defining "man" of a process, one needs to define a sole owner, who's responsible for the overall effectiveness of the process, and the supporters, who're needed to support the carryout of the process. When defining "measurement" of a process, one needs to define targets which can be objectively evaluated. The process owner should be held accountable if the targets are not achieved.
It is a widely used practice in quality management that a documented procedure is established to define the 5M1E of each process, so that the owner and supporters of a process have clear knowledge of their role in the process and how the process should be carried out.
3. Implement the processes
After each process is planned, the owners and supporters shall carry out the process as defined in the documented procedure. Necessary records should be kept as the evidences for the implementation of the required activities, the evaluation of the process effectiveness or future investigation if there's any undesired problem.
4. Evaluate the effectiveness of the process
At a predefined frequency, the effectiveness of each process should be evaluated with the predefined targets, to see whether the process actually achieve its intended results.
Effectiveness evaluation can be done through internal audit, management review and customer satisfaction study as required in ISO9001:2015.
5. Take actions to correct or improve the process
If the process does not achieve the intended result based on the evaluation result, actions should be taken to correct the process. Otherwise, a more challenging target should be set and actions should be proposed to improve the effectiveness of the process.
The corrective and improvement actions taken results in changes in the plan. Hence it goes back to the step 2 (or even step 1 if the processes should be redefined).
The steps explained is just the PDCA cycle. So when using the process approach methodology in quality management, it always has to be paired with PDCA.
