Remote audit

Why remote audit?

Due to the Corona virus remote audit – also known as virtual audit – has become the new solution for medical device manufacturers, and also a new challenge. Travel is restricted globally, and nobody knows when it will be back to normal. However, suppliers still need to be audited by the manufacturer to fulfil legal and standards requirements, and internal audits still need to be performed.

But when access to your supplier’s facilities is limited or your company’s sites, how can you assure yourself that the processes and procedures will provide continuity of supply of medical device products? And how can you meet the regulatory requirements and protect the patients? This is where remote supplier audits may prove useful for medical device manufacturers.

Remote audit vs on site audit?

One thing to consider when considering a remote audit vs on site audit is of course: Will it be efficient enough for our purposes?

Remote or virtual audit can provide a lot of information, but due to the approach it also has some limitations. Audit is very much about getting a feeling of who you are talking to. How confident are they? How relaxed are they? Are they telling you what you need to know, or are they holding back? This can be difficult to assess via video as you don’t really get the “feel” for the auditee. Also, there are typically time limitations that may influence the audit. It is not productive to be in a virtual meeting all day, and possibly for more than one day. So, for the Remote Audit to be efficient some front loading is needed. Additionally some extra cooperation from the CMO or supplier is essential, and it is important that a good dialogue is established early in the process.

A four-step approach

Using videoconferencing and a thorough four-step approach to allow for remote auditing can help you meet the requirements and provide confidence in your processes.

A risk-based approach will help provide interim or conditional approval of suppliers during periods of uncertainty or government restrictions.

The approach can be applied to manufacturers of raw materials, components, packaging facilities, warehousing, and distribution along with key outsourced activities such as technical services and R&D engineering contractors.


Step 1 – Risk assessment.

Using a risk-based approach it is determined if a remote audit is feasible and justifiable to enable an interim approval of your supplier, contract manufacturer (CMO) or partner. This step will scope the audit activities and determine how thorough it needs to be.

Activities/key areas that should be evaluated:

  • Site activities
  • Regulatory oversight
  • Licences/registrations
  • Inspection and audit history
  • Recalls
  • Product/material assessment

Step 2 – Remote Review of QMS documents.

Perform a remote review of the quality system, including the supplier’s key policies and procedures vs. internationally recognized quality and cGMP expectations. Depending on step 1 this step could include a video conferencing session with subject matter experts to evaluate the evidence of implementation of the key policies and procedures in place.

Activities/key areas that should be evaluated:

  • Medical Device File/DMR
  • Management oversight and Management review
  • Product review
  • Quality risk management
  • Investigation processes
  • Supplier management
  • Contamination control

Step 3 – Remote Audit.

Based on the scope determined in step 1 and the review of the QMS documentation in step 2, an audit plan is created and sent to the CMO/supplier who will need to identify relevant key personnel that will be present at the virtual audit. This will also provide the opportunity to address any questions in relation to the remote audit; technology to be used, duration, documentation to be ready.

Activities/key areas that should be evaluated:

  • Quality agreements – evidence of implementation
  • Minutes of management review
  • Quality reports – CAPA, NC’s, Complaints, incoming inspection, batch records.
  • Contamination control strategy
  • Audit schedule adherence

Reporting

After steps 2 and 3, prepare a detailed written report of findings and recommendations with an aim of allowing interim approval where justified and warranted.

CAPA Review

Where observations have been raised, review the responses, CAPA plans and effectiveness checks to ensure they are appropriate.


Step 4 – On-Site Assessment

It is highly recommended to perform an on-site audit when travel restrictions are eased, to complete the assessment. Given the comprehensive nature of steps 2 and 3 this can be limited in time and scope.

Activities/key areas that should be evaluated:

  • Physical observation of the facility to ensure appropriate, design, maintenance, hygiene, and compliance to GMP
  • Site culture
  • Follow-up on evidence and CAPA plan implementation

It is highly recommended that manufacturers and suppliers implement procedures to ensure that they are able to use the remote audit as an additional tool to maintain compliance and oversight. The procedures should provide the framework for who and how, and help clarify the methods that will work for the involved. Remote audit can provide some flexibility that is much needed these days, and minimize the audit backlog, but as with all new tools it is a good idea to have the procedures in place.

Quality-Audit can perform your remote audits for you. Check the list of references to see some of the companies that we have helped with this challenge. If you wish to have a discussion about your audit challenges please use the contact information here.

You can find more information on remote audits in this ISO document, it is for ISO 9001 but it does contain some good points.