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    ISO 9001 Drive to ‘Process Thinking’ in Manufacture


    Risk is the ‘Effect of Uncertainty on an Expected Result’ 


    The ISO 9001 drive for Risk Based Thinking started in 2015 and is scheduled to be in place Sept 2018; Risk-based thinking is something we all do automatically in everyday life.

    Electronic manufacturing is one of the most complex processes, and incorporating risk into this process requires something more than a check list mentality. By engaging people in the process we can get much more than a tick yes or no, response, we can get participation in the processes.


    K&S started to look at ways to go beyond traditional pick and place and offer holistic solutions for their customers. I was asked by K&S to design a system that would risk the manufacturing process. The first issue was to establish how we would measure risk. Health and safety for example use a numerical score of 1 to 5, others use 1 to 9, that scale out as high, medium and low risk, appropriate to safety. However, K&S wanted a unique approach to risk, they did not want a cut and paste approach.

    Manufacturing measures the process stages in throughput and yield, throughput is product dependant, but yield is a meaningful measure and quickly translates in a manufacturing environment, so we developed the form around an expected yield risk.

    No matter how detailed you design a system like this, we knew we could not design a system that could capture every single variation in product type. Instead we designed the process around the key common elements of a typical process line.

    But K&S wanted more, they wanted me to find a way of capturing this complexity unique to the product, so we needed a way of capturing the unexpected, we did this by adding a note pad and insert photo function to record the anomalies.

    There is no use in gathering all this information if we can’t use the data, we finally put together a working version (working in the sense of testing in real facilities) that gathers the yield data for each stage and report the results on the front page. We added an export function to export this data to be used in excel allowing data gathering and trend analysis.

    So this is how it was designed and put together, keeping to the key principle of a holistic approach.

    How do we assess the unexpected inform what is important to happen at this location (key criteria), this empowers people by information on the subject under review, informed people can make a powerful impact on unexpected process problems.

    What is the form

    Its cross platform (pdf), it dynamically calculates as you select a score based on key criteria focused questions and presents the results of these selections on the front page.

    How does the form work

    With illustrations relevant to the subject, and detailed text explaining the process (application) at this stage, each text area is designed to accept a maximum of 600 characters (the same as Facebook and executive summaries). This keeps the content manageable (readable), the questions are listed by Number (1, 2 etc.) or Letters (A,B….), we could have made these quick click radio buttons or check boxes, but this encourages people to quickly click through with little thought. We needed the questions to be read in context to the Key Criteria, so we adopted the nudge principles, where a response needs to be read and understood to be selected.

    The front page summarises the selections results, the fact that we have converted these complex processes into a number allows us to compare screen printing to reflow soldering, and of course line to line and site to site. The drawings help in the comprehension of the text which can be difficult when English is not the first language.


    This risk based form concept and design has worked well for Health and Safety forms, and Environmental forms. These forms have now been in use for nearly 4 years by some large multinational companies who foreseen the ISO drive to risk based thinking. This latest version was uniquely developed for electronic manufacturing, although early versions have been trialed within a large high volume manufacturer and some SME, which helped in this final design.


    Mike has been in manufacturing related industries for over 40 years he started in Radar system test before moving into Defect analysis, He started TSI in 1992 and has trouble shot everything from open cast mining through to Subsea electronic failures. He was appointed by the Pentagon Certification Board as a Cat A MIL-STD-2000 Senior Instructor Examiner in the 1980’s.

    With thanks to Jason Boyd, Staff Global Field Application Engineer at Kulicke and Soffa who was a great help in developing this latest form for K&S. Jason has 29+ years in electronics Industry, and assists global clients for K&S on process issues, supplying mentoring and training in all aspects of advanced SMT manufacture.