8.1 Operational planning and control
This week, we change gears from higher level planning of the quality management system overall, to the nitty gritty of operational planning and control. In Week 7 of this challenge, we identified the processes necessary to maintain full control of the quality (or business) management system. There is some overlap between that section and this new one, so be sure to cross reference back to the processes initially defined as critical to ensure there is a good symmetry and alignment when pushing forward with this clause.
Back in 4.4, we identified our processes and things like “inputs, sequence, performance indicators, resources, responsibilities, risks and opportunities, methods for monitoring/measuring and opportunities for improvement”. We’re doing much of the same work here, but at a new level of detail as it applies specifically to processes for products and services. For example, there may be a broad brush approach in the QMS overall to address things like order fulfillment or the manufacturing process. And now, there may be more detailed processes specific to different product lines or business units. Just as a business plan may outline main objectives of throughput, acceptable quality levels (AQL), etc, they are later rolled out in greater detail to each department/work cell/operational location with subgoals intended to achieve the overall objectives and desired outputs of the business.
Let’s take a look at the wording in the new revision. And notice both the points back to 4.4 (QMS and its processes) and 6.1 (Actions to address risks and opportunities). In my opinion, this is a critical point, and missing these connections when creating a QMS can basically result in something like a “circular reference” error when writing an equation in a spreadsheet. If the aren’t carefully considered and connected, there’s likely to be a gap in compliance with all of the requirements. I really don’t like the way this whole thing is structured, because there has always been a struggle with a “process approach”, and this is part of the reason. I would have preferred all 3 of these sections be integrated in a clear and understandable way rather than referencing one another pages apart. There, I said it.
“The organization shall plan, implement and control the processes, as outlined in 4.4, needed to meet requirements for the provision of products and services and to implement the actions deteremined in 6.1, by:
a) determining requirements for the product and services;
b) establishing criteria for the processes and for the acceptance of products and services;
c) determining the resources needed to achieve conformity to product and service requirements;
d) implementing control of the processes in accordance with the criteria;
e) retaining documented information to the extent necessary to have confidence that the processes have been carried out as planned and to demonstrate conformity of products and services to requirements.
The output of this planning shall be suitable for the organization’s operations.
The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.
The organization shall ensure that outsourced processes are controlled in accordance with 8.4.”
In addition to circling back to 4.4 and 6.1, the section finishes with a reference to 8.4 (Control of externally provided products and services). So once we’ve looked at the QMS processes, we must break things down to a detailed plan for controlling product and service fulfillment. And finally, we must consider the same for externally provided products and services. So, there you have it.
THIS WEEK’S HOMEWORK
Hopefully, you have created (or reviewed) your QMS thus far with a series of interactive and sequenced processes, and you’ve been able to review each of the processes with the criteria provided. Look at your system so far. Are the processes clearly defined? Are each of the criteria clearly defined and communicated? If this is done well, other requirements like training, competence, process monitoring, corrective action will clearly roll out with each process and the system will be tidy and simple and easy for all users within your organization. Unfortunately, these links can often be severed or missing altogether and this is usually where a QMS can become really challenging to manage.
Do your best to streamline and make the proper connections so that your system is lean, easily understood and easy to use.
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