Fail to control design = designed to fail?

I had a recent and very specific query recently about design process and effectiveness measures for Management Review in a Medical Devices environment.

The question was specifically about demonstrating that outputs of the design process match inputs and whether this was acceptable to present to the Top Management team? The question was also about ISO 13485, the quality management standard for Medical Device Manufacturers but for this article I have broadened the field to cover any organisation looking to implement effective design control measures and many of the points made read across to other sectors. In this article clause references are aligned with ISO 9001: 2015 instead of ISO 13485 but again that the principles apply wherever you use design control and can be applied to any core process.

Generally design control is one of the least understood areas of how organisations go about providing products and services to market. Design plays the fundamental role in determining how well products and services operate and whether they deliver customer satisfaction, both at the point of delivery and throughout their useful life. You only have to follow media stories for product recall and regulator intervention to see that product designers in the automotive, aerospace, consumer goods and other areas as well as service designers, particularly in the financial services sector, have ‘designed in’ risk and failure leading to huge liabilities for their organisations. Individuals involved did not create these liabilities deliberately but didn’t have effective controls implemented for their work.

So, to be able to report on effectiveness to the top team, first you have to be clear what the design process is and what it gives your organisation, all covered in clause 4.4 of the standard, with further detail in clause 8.3. By looking at the design process and identifying criteria and methods needed for effective operation (4.4.1 c) you should be able to identify critical success factors (CSF) for design – generally covering three areas of Quality, Cost, Delivery (QCD), as for any project management activity – but more of this later. You can do this as a quality specialist ‘looking in’ but it is far more effective if you work with those involved in designing products or services and gain their views of what ‘good’ design control looks like.

These CSF requirements are used by your organisation to monitor, measure and analyse the design process (9.1.1) and should help you to establish objectives (6.2.1) and design process measures to demonstrate the process is working effectively.

The original question suggested using the matching of design outputs to design input requirements, covered in clause 8.3.5 – a good starting point but what you actually report at a management review might need careful consideration.

Generally design effectiveness is measured by how well:

  • product meets requirements – covered in clause 8.3.5 of ISO 9001 – the ‘Q’ part of QCD

    Internal (design process) measures:

  • design review results

  • results of component and prototype testing (verification activities),

  • field (including clinical) trials (validation output)

Internal (company) measures but after design:

  • Manufacturing:

  • right first time measures – how easy is it to make the product / deiver the service,

  • scrap and rework at new product / new service introduction – a measure of how robust the new design is

External to the company:

  • Warranty

  • Complaints

  • Field data on product effectiveness (clinical use)

Design process efficiency could be reported by:

  • achievement of budget (The ‘C’ part)

  • on time delivery of new products to market against original timing plan (the ‘D’)

Altogether these measures would demonstrate how well the design process is working.

As far as presenting this to the management review, as for the initial question, with the best will in the world top management (as required by ISO 9001) have limited time to spend on reviewing subjects like quality (not seen by them as “sexy”). Somehow you need to produce an edited highlights version of design measures that will hold their attention, a dashboard using a traffic lights system but with the ability to drill down into the detail should help; if you can assign pound notes to any of the measures that should help even more!

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