There seems to be a lot of confusion around recognising when design and development is, or is not a part of the management system and with regards to the latter - if the non-applicability of the requirement can be justified. But when broken down into smaller steps, is it really as daunting as it seems?
In such cases, the application of clause 8. Not a particularly useful definition when applied to the standard! Another organization may be defining acceptance criteria through trial and error; again, this is development. You may visit an organization that has an established process but they have needed to tweak it to achieve a different, or better result You guessed it - development. I was at an audit not long ago where the client had excluded clause 8. This is development.
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Controls - A critical step in the process: have the organization determined how results to be achieved are defined - what are the project deliverables, how will they be achieved and how will they be measured acceptance criteria. Have reviews been conducted throughout the project as mentioned above at relevant points in order to to meet the input requirements? Conducting reviews post verification and validation in order to iron out any potential issues - these are all critical requirements of design and development controls and must be documented in some form.
Changes - have the organization established a formal process for controlling design and development changes; throughout the project and during reviews, how have changes been documented, the results of design and development reviews communicated.
How are changes authorized think about the persons of authority, as above , how can most up-to date revisions be identified and mitigate the risk of using superseded versions? Specific documented information is required by the standard at relevant stages of the design and development process in order to demonstrate conformity. As long as we follow our own process - as above, and apply a competent interpretation of the standard, yet flexible in relation to the context of the organization, then this clause is actually a lot more straightforward than what it seems.
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Talk about simple, the documentation only takes about two minutes to read. It has an Azure Artifacts service for package feeds and project tracking via the Azure Boards service. Testing is supported by the Azure Test Plans component.
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With the Rotary Inspector, IBS has pioneered technology which addresses the limitations of current techniques; including automation, dynamic measurement and reduction of the measurement time to under 1 minute.
The Rotary Inspector is a smart tool following ISO-standardised measurement and generating KPIs defining the geometric and dynamic performance of the machine. Information is provided at a group, cell or factory level, in an auditable manner and real time. KMWE is a high tech supplier for mechatronic systems and complex machined components, with over 50 state-of-the art machining-centres.
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Therefore KMWE was looking for a measuring tool which enables them to conduct quick performance tests on machining-centres for both static and dynamic behaviour. At this moment a pilot is running on 5 different types of machining-centres and the results are very promising. A measuring cycle, in only 1 minute, during normal production runs, results in a statement about the accuracy-status of the machine-centre.
Furthermore it will be a big help in process control variation management in our production which can be described as high mix — volume production. Basically it helps us being more pro-active and reliable in our production process.