William Rankin, CQP FCQI, Management System and Audit Manager at Inmarsat, UK, takes a look at how quality managers and internal auditors can work together to ensure objectivity and integrity is achieved during audits.
A medium-sized pharmaceutical company, with a global presence, recently appointed a new managing director (MD) to turn around a period of poor revenue performance. The newly-appointed MD was hired for this position because of his aggressive but decisive reputation for turning business fortunes around.
With a looming ISO 13485 re-certification audit on the horizon and the business looking for a successful outcome, the quality manager presented to the MD five significant findings, which were raised from a recent internal audit of the manufacturing process. The findings were specific and highlighted significant gaps to basic requirements of the standard, thus requiring a small investment from the business to fund basic calibration equipment. This was to ensure incoming inspection measuring equipment were calibrated effectively by the warehouse team to meet the standard requirements.
The MD wasted no time in trying to enforce his authority by saying there was no investment and challenged the quality manager to close the findings based on poor judgement from the auditors. He demanded the corrective actions to be closed without further delay, ignoring the quality manager’s pleas to conform to the standard. The result of this would mean the business could lose its certification altogether.
What steps should the quality manager take next?
It was apparent that the MD had a lack of knowledge about the specific quality requirements of the standard and the implication of not meeting these versus his reputation for aggressively turning around revenue performance.
It was suggested by the audit team to hold a workshop where the quality manager could help the MD and central leadership team to familiarise themselves with the certification process, including requirements of the standard and impacts of losing the certification, which could impede the business’s chances of winning repeat and new business.
It was clear that the objective of the workshop was to communicate the risks of compromising objective audit evidence gathered from a team of qualified, experienced and capable auditors versus the rush to close out findings that could lead to the business losing its certification and future business.
The quality manager used his experience and tact to objectively illustrate the risks and consequences of not completing the actions raised from the internal audit team to the central leadership team and MD citing specific working examples and tying it back to the requirements of the standard.
Once the workshop was held, there was an agreed consensus from the central leadership team and an acknowledgement from the MD that after presenting logical, objective data and coaching out the requirements of an international quality standard, which cannot be compromised, the duty of the internal audit team was not to obstruct the objectives set by the new MD (to quickly improve revenue performance), but to protect the businesses integrity and opportunities forthcoming, by meeting the requirements of an international quality standard that are non-negotiable.
The MD acknowledged his poor decision making and focused his efforts to support the quality manager. He also thanked the team for their continued support, including his desire to improve his own knowledge and competence with quality and standard requirements in general.
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