How a review and revision effort simplified processes and reduced document count.

ISO 9001 continues to evolve, and the 2015 version of the standard has significant differences from the 2008 version. The Quality team at Milwaukee Electronics’ Portland, OR, facility started their journey to better understand those differences in October 2016 by attending a training session presented by BSI.

One key difference is the ISO 9001:2015 quality management system is heavily focused on managing risk by driving accountability and risk analysis throughout the organization. ISO 9001:2015 is focused on leadership responsibility and stronger emphasis on measurement of process inputs and outputs. Customer focus is enhanced, as the new standard requires an understanding of the needs of interested parties, including all potential stakeholders (suppliers, employees, customers, community and the environment). Milwaukee Electronics evolved as an organization in terms of systems, process automation and capabilities over the past several years, so taking a more comprehensive approach to the evaluation made sense from an organizational analysis perspective as well.

The team realized that fully meeting the requirements of the standard required a different approach to documentation construction, and the best way to transition to this new standard was to take a holistic approach in evaluating the gaps between its process documentation and requirements found in the standard. This entailed a paragraph-by-paragraph assessment of the differences between the two standards. Then the differences identified were applied to a Quality Management System (QMS) upgrade plan.

The documentation review and revision effort was completed in April 2017. Each document owner identified subject matter experts (SMEs), and employees were trained on the revised processes and documents. While this may appear to be a complex process, the reality was the process simplified documentation, reducing document count by 10%. Additionally, it drove the creation of results-based documents that focus on outputs that meet requirements, instead of simply outlining a series of tasks for each process. The involvement of document owners and SMEs helps pull everyone toward supporting Quality objectives.

Part of the revised QMS implementation plan was to expand on the existing process failure modes and effects (PFMEA) that were developed for ISO 13485:2003. The PFMEA assessed the risk associated with the new processes created to comply with ISO 9001:2015. The goal was to better help the owners of each process understand the actual impact of each failure mode on their process and the customer and/or end user. The identified risks were addressed in the revised QMS documentation.

To ensure no gaps were present, a full system internal audit was conducted. The approach included paragraph-by-paragraph audits and turtle diagrams for process audits. The turtle diagram exercise did not detect any gaps, but the paragraph audits did determine a few issues requiring correction. Each issue detected during the paragraph audits was assigned a corrective and preventative action (CAPA). The internal audit was deemed closed when the CAPAs were completed and documents were revised.

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Milwaukee Electronics Portland, OR, Quality team members (from left): Jack Tanz, quality engineer; Andrew Hale, lead quality technician; Paul Satryb, quality manager; and Kyle Frank, quality compliance technician.

The registrar conducted a Stage 1 audit, essentially a gap analysis to determine if any areas were missed. Each gap identified during the stage 1 audit was assigned a CAPA. Closure of the CAPA and associated document revisions were the last preparatory action prior to the stage 2 audit. The stage 2 audit resulted in an upgrade certification to ISO 9001:2015 and satisfied the surveillance audit requirement for the current ISO 13485:2003 certification. 

The facility is preparing to upgrade its ISO 13485 certification from 2003 to 2016 next year. The change to ISO 9001:2015 has also impacted that process. The earlier requirements of both standards were aligned. The newer versions do not maintain that alignment, which makes future QMS upgrades challenging. For example, ISO 9001:2015 makes quality the responsibility of the leadership group, and ISO 13485:2016 continues to require a single management representative as the person primarily responsible for quality. An identical plan to upgrade the QMS to comply with ISO 13485:2016 is underway.

The approach the team at Milwaukee Electronics took was time-consuming and generated significant changes. However, these efforts resulted in a single QMS that is in compliance with both standards. Further, it better aligned documentation with scalable capabilities and intensified the company’s focus on eliminating defect opportunities and waste. Longer term, the focus on mitigating inefficiency and defect opportunities will save both the company and its customers money. The focus on inputs and outputs has also helped employees better understand the connection between their activities, customer satisfaction and business success.

Paul Satryb is quality manager at Milwaukee


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