However, the outputs need to include anything required in the inputs if your customer requires a drawing, or your machine shop requires electronic CAD files , be usable by necessary departments such as purchasing and production, have the acceptance criteria for the product, and identify the essential characteristics for proper use. Design and Development Review. Your process needs to include review steps to make sure that the process is working properly.
Do you make sure that the design will meet the requirements, point out any problems, and make necessary changes? Do you include people from all areas of the company that are affected by the design, and do the reviewed results and actions need to be recorded?
Design and Development Verification. Verification is almost always one of the design reviews in a process. Verification is basically taking the design outputs drawings, build instructions, test instructions, etc and making sure that every requirement from the design inputs is included. If government regulations say that the unit needs to be painted orange for safety reason, do the build instructions call for a step to paint orange?
As always, records of the outcome are required. Design and Development Validation. Validation is when you actually build the first product and test to make sure that it meets all the requirements, and intended use. There is a note that this should happen, whenever possible, before you ship or install the first unit for use by the customer.
Again, records of this are to be kept. Control of Design and Development Changes. The last set of requirements talks about changes to the outputs of the design process, or simply how you change your drawings, instructions, etc. The idea is to make sure that not just anyone can make changes without making sure that the change is shown to be good and approved to implement. Included in this is deciding how making this change will affect related parts, and how not making this change to parts already complete will affect their usability.
Of course, records of these changes need to be kept. It is important to ensure that the design process focuses on having proper reviews so that potential problems with manufacture are caught and eliminated early.
It has been said that problems caught in manufacturing are at least 10 times the cost to correct as those caught in design. Click here to see a free preview of the Procedure for Design and Development template. AS still adheres to this thinking, in fact. Without knowing that, the data is meaningless since it makes it difficult to know where which process to apply corrective action.
I take an unconventional interpretation here, as follows:. Again, each process must have at least one objective; each objective must have at least one metric sometimes more and each metric must have a goal, set by management. You will find that your traditional quality objectives, such as yield, scrap rate, etc. Now, when you have a poor yield, you know which process is likely responsible, and thus where to apply corrective action. They also invent a false dichotomy, saying that process auditing is the opposite of clause-based auditing, which is also utterly untrue.
In fact, ISO clause 9. Having said that, conducting internal audits by processes is a good idea , as it makes audits more manageable, and then results in audits that can highlight process inefficiencies or problems. But, as I said, you still have to audit the clauses in some fashion. But this is also why you want to have some processes dedicated to the QMS administrative clauses, like 4 and 5, to ensure they get audited, and that they are measured as part of your processes.
Makes sense! Finally, you will assess the performance of each process, based on its objectives and measurements, in real time as needed. But you must then report this to management during your periodic management review; ISO clause 9. Then, during management review, have the process owners present their data to top management, and if the goals are not met, then management may elect to either change the goal or request corrective action.
Whatever happens, if a goal is not met, something must be done, and this should be captured in the records of management review. Likewise, you will report on the internal audit results, by processes. When done, your top management will know which processes are operating effectively, which are not, and thus be able to make informed decisions aimed at correcting or improving some processes, while leaving the high-performing processes alone to carry on.
The system cannot operate well if one or more of the major processes is stumbling. By adopting a truly robust process approach to the QMS, this enables management to manage by processes, which simultaneously captures the performance against ISO clauses and other requirements. Last tip: our totally free ISO QMS Documentation template kit is still available, constantly updated, and includes sample documentation based on the process approach methods defined herein.
This is the only book on ISO that goes behind the scenes to detail the politics, backstabbing and skulduggery that caused the latest version of ISO to be so terrible, but then provides proven, real world guidance on how to implement each clause. You can grab it by visiting www. Adult language is used, so fair warning; as I said, the new standard is pretty terrible, and it deserves a few f-bombs. Having a process that does not have a procedure is particularly noticeable in processes where you rely heavily on the knowledge and skills of the person doing the job.
When a doctor is performing brain surgery, they do not have a documented procedure to do this because it relies heavily on their experience in dealing with what they find as they go. There may be some procedures that are followed as they go, but there is no documented procedure for this. The discussion of whether you need to document a procedure is yet another step, but also an important one.
In ISO there are six identified documented procedures that are needed for a QMS, but with the new version of ISO there is no mandated documented procedure. It is the responsibility of the company to determine if they need to document a procedure in order to ensure consistent results from the process and the associated procedure.
The process approach is one of the eight quality management principles that are the foundation of ISO , and understanding what a process is and how they interact is an important part of being able to implement and improve your QMS. By knowing your processes, you can better understand which ones need to have a specified way of creating the output, which will let you know when you need to have a procedure to go along with your process. You can then further determine if you need to document that procedure or not to ensure consistent results.
Understand your processes and their interactions, and you will be able to more effectively implement your QMS for better customer satisfaction and improvement. You may unsubscribe at any time. For more information, please see our privacy notice. For full functionality of this site it is necessary to enable JavaScript. Here are the instructions how to enable JavaScript in your web browser. ISO Blog.
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