Explaining the Basics of ISO Standards: DO
Quality Management, Quality Improvements, Business Requirements
“Plan-Do-Check-Act” is the basis for the ISO standards. The ‘Do’ phase sounds fairly straightforward. Or is it? There are multiple sub-clauses within the “Operation” clause 8 of ISO 9001:2015 and related standards, to point out areas of control; and we all know that producing even simple products or services can have many steps and possible mis-steps. So let’s look under the hood a bit. You can read more about doing and the PDCA cycle is on our website, Plan-Do-Check-Act.
Clause 8 still includes planning, as the process of producing products or services has to be planned out. For example, where will raw materials will be obtained, received, held for production, released, identified, and finally, how will they be used? What types of processes will be used? What is required for each process? How will the process be controlled – with an oven thermometer, a programmed CNC machine, a trained welder?
What are the steps in the processes? Which comes first? Even in turning a single piece of metal, the order of steps is important; more so with something that moves from one station to another (by way of comparison, in McDonald’s, moving hamburger ingredients is planned and laid out in order).
How will you determine the customer’s requirements? What methods of communication will you use to find out, understand, and record those? How will those be passed on to people ordering raw materials, planning for the actual production techniques and steps, and inspecting? And if some requirement changes during production, or even just before beginning, how will you pass on that information? Here’s an article that addresses planning from the perspective of customer delight.
Design is also critical – even if you produce according to the customer’s specification, blueprint or whatever, the method you use will need some thought. If it’s a new product, so much the more important. Clause 8.3 of ISO 9001:2015 has six criteria/steps for governing design; it’s worth reading and applying even to processes.
The purchasing process, all by itself, has many steps, options – and potential potholes. How is it to be controlled, employees trained, and records kept? How will you find and qualify providers? How will you track their performance, to get the most out of your relationship with them? What lead times are needed and can they be met by current providers? What if one goes out of business? Also, when goods are received, you’ll need to have space, a method and ability to keep track of your inventory (titanium is expensive, right?) and release it at the right time for production. Not only for raw materials, by the way, all these thoughts about risks and controls apply to outsourced processes like plating/painting, heat treating, and many more.
In Production
Tracking the actual production process brings up many tasks. Examples are proper documentation as to what is to be done (like a recipe for banana bread), checking to see if your processing machinery is working properly, and keeping whatever measurements at each stage will assure you of conformity (even a meat thermometer at your backyard grill). How will you ensure the proper raw materials are being used, to start with? How will you record those measurements you’re taking to prove conformity? Will you have to engrave a part number or unique ID number on anything?
Other points to plan include preservation – shelf storage, or packaging for shipment – to keep the result of your work in acceptable condition; and of course, inventory of the finished goods you’re holding for the next order. And if you install, warranty, or repair anything on the customer’s site, you have to allow for that – including costs of doing so.
Quality Improvements
OOOPS – when bad results are found at the end of production: Can they be reworked? At what cost? What methods and tools will you use to find, segregate, and deal with these? Can you work a deal with the customer to accept them anyway? Who makes that decision?
But a far more important question is, what caused the problem? What do you change in the process of production? Properly designing the process, to control the critical factors, is cheaper and more effective than rework or corrective actions. Factors to consider include if training was sufficient; equipment and its use and maintenance; calibration; technique for the materials; programming or step-order errors; and others.
These articles on corrective actions and cause analysis may be of help:
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