The first presentation of the day ‘The Process Approach: ISO 9001:2015 Certification' was given by Michael Cousins (Triaster). With time ticking towards the deadline for transition to ISO 9001:2015 in September 2018, Michael’s presentation explored what the ISO 9001:2015 ‘process approach’ really means. He explained that although the process approach principle for quality management systems has been around for many years, it has not necessarily been understood or implemented as intended. Process mapping can and should be about predicting the results of change – not just an exercise to achieve ISO certification.
Sarah Ball, in her presentation ‘Effective Issue Resolution on a Global Scale,’ described the Corrective Action Issue Resolution (CAIR) program that Covance have implemented to resolve issues impacting their clients. The CAIR program deals with any issue that is deemed to have a significant impact (e.g. financial, regulatory or time) on clients. Effective root cause analysis is key when investigating issues. Event diagrams are typically used to map out the process and to identify areas of weakness and potential causal factors. Actions can then be targeted towards these potential causal factors to strengthen the process. Sarah stressed that it is critical to have the right people in the room during such investigations. Global teams are brought together at the investigation stage to reduce the opportunity for an error to be repeated across other sites. The CAIR program is supplementary to the regulatory programs, it does not have regulatory oversight and documentation is not subject to regulatory review.
The next presentation ‘Causality and CAPAs – getting to the root of the problem’ looked at critical root cause analysis (RCA) and Corrective and Preventative Actions (CAPAs) in the NHS. Gill Robson (Newcastle Joint Research Office) used case examples to demonstrate why the timely root cause analysis of incidents and issues is important to determine if a full CAPA investigation and action plans are needed in order to prevent ‘death by CAPA’. A review of the case examples showed that there are some situations where a CAPA is not necessary e.g. where the root cause is obvious and the impact is minimal. CAPA actions can add unnecessary complexity which can lead to further non-compliance by trying to implement a quick fix without addressing the cause of the problem.
In the final morning talk, Paul Davidson (Headway Quality Evolution) spoke about ‘Regaining Control of a Runaway CAPA System: A Case Study’. Paul described his experiences after having been tasked with rolling-out an existing clinical CAPA tool in an analytical laboratory. Paul described the missed early red-flags that the CAPA system was failing, the process of regaining control and the ultimate implementation of an effective CAPA management programme. One of the lessons learned from this case study was that full, detailed CAPA should only be used where they will be effective, overuse can eradicate the benefits of the system.
After lunch, Louise Mawer (Mirabilitas) gave a short presentation on methods of root cause analysis that could be used by delegates in the workshop session that followed. The aim of the workshop was to provide a practical approach to RCA and the preparation of a CAPA. Working in groups delegates had the opportunity to evaluate one of two scenarios and to determine the possible root cause(s). Delegates were then asked to identify an appropriate CAPA for the named root cause.
Lisa Heely ended the meeting by thanking both the presenters and the delegates for their participation in the 2018 Northern Regional Forum.