A process, ISO 9001 tells us is something which changes inputs into outputs but what exactly does this mean? A process may well be a department or a key activity within a department. For example ‘purchasing’ may be described as a process or the ‘production department’ may also be a process.
Processes should always be something that actually adds value to your organisation, but this may not be something that results in a product or service being delivered.
Internal Auditing for instance, is a process and should add value but does not result in your product or service being delivered.
To understand this more easily, when you first decide to do an audit, start by deciding on the following;
- What is the ‘process name’
- What are the ‘outputs’ (what does the process/task actually deliver)
- What are the ‘inputs’ (what do you need to start the process)
This helps to clearly define the process and the scope of the audit. Once this has been done you then need to look at the key factors affecting the process.
Key factors affecting a process…
The process approach to auditing requires you to fully understand not only the inputs, outputs and scope of the process, but also consider six key factors.
The importance of the six factors will vary depending on the individual process; for example, ‘machinery’ is likely to have less importance in an administrative process (e.g. Internal Auditing) than a product realisation process (e.g. Manufacturing or Service Delivery).
When preparing and performing a process based audit, you need to consider each of the following factors;
Manpower: Consider human resources needed including competence and training. This should also include an understanding of any relevant authority and responsibilities.
Machinery: Consider any machinery and equipment required for the process including technical and maintenance requirements. This factor should also consider any monitoring and measurement equipment and relevant calibrations.
Methods: Consider relevant methods and other documentation including records used in the process.
Materials: Consider any materials used in the process and also if relevant, the controls placed on relevant suppliers of materials.
Environment: This factor will include work environment considerations such as temperature, cleanliness, noise etc. and also infrastructure and support requirements for the process.
Measurement: If there are any performance indicators for the process these should be considered but if these are not obvious then always ask:
- How do you know the process is effective and efficient?
- How does the process deal with nonconforming situations?
By thinking about these six key factors before preparing for an audit, you will ensure a true process based audit will be performed.
This makes you a far more effective auditor because although ISO 9001 and your own procedures are important, it is easy to focus on compliance to these procedures and not actually ask the question ‘Is the process effective’.