Published: 10 Nov 2020

Youmna Abboud, Quality Assurance and Regulatory Affairs Associate at Zimmer Biomet, Middle East, explains why internal audits are required during the coronavirus pandemic.

Businesses around the world have been disturbed and had to revise their yearly plans, due to the coronavirus pandemic. The healthcare industry, in particular, witnessed a shift in its priorities, mostly by having to address the worlds’ need to fight the ongoing virus. Consequently, there was an urgent focus on developing vaccines, screening tests, antiviral therapy and ventilation devices. Business plans were revised – including quality audits – which put compliance to quality standards at risk.

So how can organisations maintain quality standards/objectives in these disruptive times where on-site audits are not possible, and the effectiveness of remote audits are still subject to debate? The answer could be through internal audits. Internal audits can fulfil the needs of an organisation by evaluating the effectiveness and compliance of the latter’s systems, ensuring that the organisation is meeting its quality objectives, during these disruptive times.

Coronavirus impact on healthcare

For the healthcare industry, the coronavirus pandemic caused the following problems:

  • Postponement of quality audits from health authorities and certification bodies.
  • Shifting priorities to adapt to changes and new demands. Prior to the pandemic, some priorities for businesses included product launches, but plans such as those at the beginning of the year were either modified or delayed, due to the coronavirus crisis.
  • Restricted travelling which has prevented auditors from conducting audits at facilities on-site.
  • Offices closing and the introduction of remote working (from home).

The aforementioned issues above have caused a disruption to quality management continuity and business plans, thus jeopardising patients’ health. Alternatively, remote audits are still not allowed for all types of audits. For example, efforts are still being deployed to permit notified body virtual audits for medical device manufacturers, under the new Medical Device Regulation (MDR).

Benefits of internal audits

What companies can do to minimise the risk and to ensure their quality system is compliant with applicable standards is to audit their own systems. Having an internal audit programme within an established quality management system can be very beneficial in leading the organisation to achieve quality objectives and improve the quality of the products or services they provide to their customers. Thus, if the internal audit was postponed for this year, there is still room to perform one. Likewise, in the case where external audits are deferred, companies can self-inspect themselves as an evaluation tool to develop their processes/practices in-house.

Having the quality system audited internally might fulfil the gaps of virtual external audits, especially in the case of an on-site visit to check the operating facilities. Communication with the relevant stakeholders in internal audits is also less tense because it is performed within the organisation itself. Internal audits are also required at planned intervals, according to ISO 9001:2015, which is the quality system management standard that is applicable to all types of management systems.

Below are some pointers to help auditors conduct internal audits successfully:

  • Management approval and full support is essential. In order to perform a proper audit, top management has to be aware of the audit’s objective and the impact on business.
  • The auditor, who will be a person within the company, should be independent from the operating managers of the function being audited. This is to ensure that the audit is performed objectively, and the results are free from bias.
  • The scope of the audit needs to be identified and any change(s) impacting the quality of a product or service should to be taken into consideration.
  • The audit plan and date should be set up and communicated to all stakeholders in order to raise awareness and get everybody prepared for the audit.
  • Audit findings have to be addressed properly, in a timely manner and submitted to the senior management team, in order to reduce the risk of any non–conformities.
Implementing an internal audit programme will help businesses to prepare for third party and other external audits

It also allows organisations that are being audited to assess if their quality management system(s) (QMS) is compliant with the relevant requirements to meet quality objectives.

However, businesses without an established QMS might not be able to perform internal audits if the audit criteria to audit against is not available. For example, some health authorities might not require companies to have a QMS. Nonetheless, they might have local regulatory and/or quality requirements to which companies have to comply to and therefore, the authority (or authorities) will perform inspections to check conformity to these standards. From this standpoint, these companies can do the internal audit according to the local requirements, which will be considered as the audit criteria. After all, as the infamous quote from Henry Ford goes: “Quality is doing the right thing when no one is looking”.

Preparing your business in advance through internal audits will help your team(s) to meet quality objectives, by ironing out any issues or non-conformances in good time. More organisations should start embracing this method of auditing sooner rather than later to ensure their businesses remain compliant and maintain their quality standards, during the pandemic.

For further information and updates on auditing during the coronavirus outbreak, visit the CQI's Covid-19 landing page