コロナウイルスパンデミックにおける遠隔監査Remote auditing during the coronavirus
コロナウイルスのパンデミックのただ中に遠隔監査を実施する監査員に、遠隔監査を経験したシャロン・シャトラー Sharon Shutler, CQP FCQI がアドバイスとガイダンスをお伝えします。(この記事は2020年4月15日にCQI のウェブサイト quality.org に掲載されました)
Sharon Shutler, CQP FCQI, shares her advice and guidance to help auditors carry out remote audits amid the coronavirus pandemic.
In these uncertain times of the Covid-19 pandemic, I am sure many of us are experiencing moments of anxiety and despair. I had such a moment when I was informed, at very short notice, that an audit I was planning must now be performed remotely.
The audit in question was a second-party on-site assessment of a UKAS-accredited testing laboratory that holds a current certification against ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories.
I had been asked to lead the audit for a small biotechnology company that had developed a potentially life-saving immunotherapy product to treat various cancers. My client needed the support of an expert testing laboratory to assure the safety, efficacy and purity of the products, before they could be formally released for administration to human volunteers in a clinical trial.
I panicked at the prospect of leading this audit remotely even though I have been an IRCA-certificated Principal Pharmaceutical Auditor for many years, and led more than 130 audits in 18 countries.
All of the audits I have facilitated in the past were traditional on-site assessments that I had planned and performed in accordance with current guidance in ISO 19011.
The closest I had ever come to a remote audit was the submission of supplier questionnaires or performing ‘desktop’ reviews [of paper or electronic documentation from the organisation] of auditor training courses, when I worked as an IRCA Technical Assessor 10 years ago. Thankfully, my panic was momentary.
I looked at the draft audit plan I had prepared and considered what I really needed to do to transform this audit from an on-site assessment into a remote assessment. I was determined to keep the arrangements as simple as possible and avoid unnecessary downtime during remote meetings. After a quick check with my client, it took me five minutes to make the necessary changes to the planned arrangements (see PDF below).
From the plan I created, I now feel more confident with conducting remote audits, especially during this difficult period we are going through as an industry. The CQI and IRCA have also been very supportive and will continue offering support and guidance to its members through this difficult period, as our profession rapidly adapts to new and more effective ways of working.