A quality plan for the renovation could have included increased management oversight and a more frequent review of quality objectives related to the areas being renovated. The auditor was hesitant to provide advice, but she indicated that management could have been more proactive and taken measures to prevent the shipping complaints in the first place. Furthermore, they failed to modify there planned interval for management reviews to take into account significant changes in the facility that could negatively impact quality.Īt the closing meeting, top management asked what should have been done to avoid this finding. The reason the auditor provided was that top management and the management representative did not maintain the effectiveness of the quality management system during a major renovation, because they did not monitor quality objectives on a sufficient frequency to react to quality issues in a timely manner. The auditor responded that she would be issuing a minor nonconformity against the management review process. Since the corrections appeared to be effective, no further action was warranted. The management representative said that the objective quality performance is evaluated by top management during the management reviews. The auditor then asked when top management was notified of the negative trend and reviewed the spike in the performance of the quality objective. The management representative confidently indicated that they were. The auditor asked if shipping complaints were a quality objective.
The management representative said that no formal CAPA was initiated because the problem did not appear to be a systemic problem due to the small volume of complaints relative to the large volume of shipments. The auditor asked if a formal corrective action was implemented. The trend was confirmed to have reversed in the data from the third quarter. The management representative indicated that the pattern was observed in April, and the warehouse manager made corrections in May. The auditor asked when the trend was first observed. When she asked for an explanation, the management representative explained that the renovations caused some misplacement of inventory that resulted in shipping delays and a few mistakes. When the auditor reviewed data analysis of complaints, she noticed a spike in complaints related to shipping errors that occurred in February through May. The audit reviewed all the required inputs since the previous management review–which was held on Tuesday, December 9, 2014. The company conducted a management review on Tuesday, December 8, 2015. The procedure had not changed since the previous year, so the auditor asked to see the most recent management review. The management representative and the auditor returned to the conference room at 9:40 am, and the auditor began with a review of the management review revisions to the procedure. Next, they took the auditor on a tour of the facility to show her some of the areas of the facility that had been renovated since last year’s surveillance audit. Here’s what happened.įirst, they had an opening meeting with the auditor from 8:30 am – 9:05 am. One of my clients recently had a re-certification audit in December with their Notified Body, and they received a nonconformity in the first couple of hours of the four-day audit.
The article includes links to information about new and revised regulatory requirements, how to write a procedure, and there is a link for downloading a free management review webinar.
The article tells a story about a recent re-certification audit nonconformity and how the revised ISO 13485:2016 Standard will help prevent this type of quality issue in the future. The article explains management review revisions required for ISO 13485:2016 compliance. Management review revisions for ISO 13485:2016