We can probably all agree that the current Corona (COVID-19) pandemic and all measures to control it are having a big impact on us, both from private and business perspective. On the other side though, these disruptive events push us out of our comfort zone and forces us to introduce more significant changes in our ways of working and controlling activities.
This article addresses the ability of the medical device industry to maintain effective control on its processes, subcontractors and suppliers under these conditions.
Travel restrictions and the resulting change to more remote work hamper the ability to effectively control processes, subcontractors and suppliers. The ability to audit our internal processes, outsourced processes and (critical) suppliers is compromised and, if we don’t find a solution, this will affect the core of Quality Management Systems in the medical device industry, which may ultimately affect the safety and performance of medical devices.
The thing is that the solutions to these problems have often already been available for some time but were just not broadly accepted. Where Email has been around for a couple of decades, video conferencing is available at every pc or mobile phone and collaboration tools are almost common practice, our auditing methods are still very traditional. An off-site documentation audit focusing on correctness and completeness of documentation and an on-site audit based on interviews and observation focusing on implementation.
Luckily, a solution is available in the form of remote audits. (a.k.a. eAudits, on-line audits, virtual audits, web-based audits etc.) This method of auditing has been around for quite some time and was finally also explicitly addressed in the 2018 version of ISO 19011 - Guidelines for auditing management systems. (which again is referenced in ISO13485:2016)
So, where the travel restrictions and remote work seem to compromise the “C” for Check in the PDCA cycle, remote auditing (or a hybrid version including it) puts the “r” of remote into PDrCA.
Now where it is defined in ISO19011, that the use of audit methods needs to be suitably balanced, based on, amongst others, considerations of associated risks and opportunities, the reality may be that remote audits will be the prevailing method the coming weeks, months….
To ensure objectivity, trustworthiness and credibility of the audits performed and to effectively conduct these, a number of things should be considered though:
- Can the audit objectives and criteria be adequately accomplished?
- The suitability of remote auditing considering the nature of processes audited. E.g. some agreement on how to handle “difficult areas”, e.g. production processes and environment.Can these maybe be delayed to a later moment?
- Acceptability of remote auditing by both parties.
- The availability of suitable IT infrastructure (e.g. audio and/or video conferencing, ability to share screens, email, document and record management systems…).
- Testing of the IT infrastructure and communications lines prior to the audit
- The availability of electronic documents and records that can easily be shared and how to audit physical (e.g. paper-based) evidence.
- Proper audit preparation, including test of IT infrastructure and backup
- Does you QMS and auditing SOP allow for remote audits?
- The method(s) employed need to be clearly documented in the resulting audit report.
- How to coop with time zone differences of auditors versus auditees…
- Presence auditees, less flexibility to pull-in other auditees, need to be “on-line”, more secure pre-planning of auditees…
- Don’t make it an 8-hour continuous session, like in an on-site audit, permit time for breaks and individual review by the auditors.
- Etc.
Pros and cons of remote auditing:
- +It significant saves travel time and cost. Thus creating the ability to perform more audits in the same time or free up time of auditors for other activities.
- +Avoiding travelling to “difficult” locations.
- +I takes advantage of investments in collaborative IT tools.
- +It better suits global collaborative teams, remote staff members, emerging virtual business processes or virtual sites etc.
- +Specifically suitable for audit follow-up.
- Not ideal or suitable for all processes, e.g. production processes, analytic lab work, physical examinations, production environment etc.
- Less input form auditor from non-verbal communication, body language etc.
- Less favorable if the audited party has a history of (major) non-conformance.
- More dependent on (stability) of technology.
The global Qserve team provides a number of services that can help you in this regard, i.e.:
- A free 1-hour webinar on Internal auditing, where we will also address remote auditing
- Training & certification of auditors (such including remote auditing)
- It’s seasoned consultants can perform (remote or hybrid form) internal and supplier audits.
- Where travel bans between countries exist, the global presence of Qserve auditors may provide a solution.
- Perform MDR, MDSAP mock audits and QSR/QSIT mock inspections or gap analysis
- Witness audits as part of your auditor qualification program
- Qserve can support your Notified Body (CE) or Auditing Organization audit.
All of the above against the well-established audit criteria for the medical device industry, i.e. : against ISO13485:2016, MDSAP, QSR etc.
Just give us a call or drop a message to see how Qserve can support you in these times.