Understand What is Clause 6.3 | What is Clause 6.3 | What is Failure Mode Effect Analysis | ISO 9001
In this video, we will discuss and understand what is clause 6.3 of the ISO 9001 Standard. The standard requires that:
• We carry out changes in a planned manner and think about
• the purpose of the changes and their potential consequences;
• the integrity of the QMS during changes; and
• the availability of resources, including the allocation of responsibilities
The planning part is easy – we talked about some tools in our previous videos:
• The project plan or a Gantt Chart
• The action lists from management and operational reviews and others
Both these tools allow for defining the purpose of changes, allocation of resources, and responsibilities. Now let’s talk about the crystal ball that may help us to assess the consequences of changes and impacts on our QMS. A typical tool to assess the effects and risks of actions is a failure mode and effect analysis or FMEA process. There are dozens of various FMEA formats out there used by different industries. We will use one of them to assess the impacts or consequences of potential failure modes on a simple example. FMEA tool is very handy when dealing with ISO 9001:2015 clause 6.3 planning of changes and adds to understanding what is clause 6.3.
Let’s say we need to write a procedure. To be successful, our procedure should be clear and easy to follow. Potential failure modes related to these requirements are too wordy and difficult to follow instead of being clear and outdated layout instead of an easy-to-follow format, and others. The next step is to identify the causes of these potential disappointments. Excessive wording – most likely a lack of technical writing skills. Archaic format – may be a result of the use of an outdated document template. Now it is time to talk about the consequences or how an organization will pay for these potential failures. The answer is simple – it is time and money. If a procedure is too long, hard to follow, and full of irrelevant information, it will take more time to train folks and more time for users to follow. To summarize, this video helps us understand what is clause 6.3.
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