According to the quality assurance assessment of the F-35 Lightning II Programme, dated September 30, 2013, the quality programme did not sufficiently implement or flow down technical and quality management system requirements to external providers in order to prevent the release of nonconforming hardware and software.
Our analysis of the quality assurance assessment suggests that ineffective management reviews and a failure to maintain the required configuration management disciplines were the root-cause of these failures. The results of data analysis and evaluation were not sufficiently used as an input to the management review process.
By not applying the quality management system review criteria and practices prescribed by quality management standards, the management review inputs lacked the required external provider process performance and product conformity data needed to make effective decisions. Without this crucial management review input, inconsistencies between requirements went unnoticed until final assembly commenced.
Also lacking was management's participation in, and documented evidence of the application of design reviews, production readiness reviews, production inspections, documenting programme risks, and configuration management audits. It is likely, if the information were available, analyzed and evaluated, overall negative trends in quality performance would have been identified and corrected sooner and design changes reviewed as required.
In order to determine the effectiveness and to identify overall trends in any quality management system, ensure that your management review inputs include the following quality performance information; customer satisfaction feedback, status of objectives, performance of processes, internal and external issues, risks and opportunities, non-conformities and corrective actions, results of monitoring and measuring audit findings, the performance of external providers, changes to the QMS and additional resource requirements.
To ensure effective management reviews, representation must include, e.g. Top Management, functional management, line management, process owners, process champions, lead process users, action owners, suppliers, and stakeholders.
Ensure that all requirements of the ISO 9001:2015, Clause 9.3.2 Management Review are covered as part of the management review process and ensure that you can show what was discussed at each management review meeting and how the actions recorded were verified. Look into the format that you are using to capture your management review records and make sure that as input requirements from the standard(s) are called out.
Continually improve your organization’s performance by using your quality policy, objectives, audits, data, corrective actions and management review inputs to facilitate improvement!
More information: Quality Assurance Assessment of the F-35 Lightning II Program
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Written: 10th July 2019
Author: Richard Keen
Richard is our Compliance Director, responsible for content & product development.
But most importantly he is ISO's biggest fanboy and a true evangelist of the standards.
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