The United States and Canadian governments recognize the importance of the role of third parties in the oversight of the medical device industry. Both countries also recognize the benefits of closer regulatory cooperation, as reflected in the 2003 Memorandum of Understanding between the US Food and Drug Administration (FDA) and the Health Products and Food Branch of Health Canada (HC). The pilot Multipurpose Audit Program (pMAP) is an important outcome of this evolving regulatory cooperation.
Qualified auditing organizations (AOs) are now capable of performing third party audits/inspections of medical device manufacturers’ quality systems that will respectively meet the regulatory requirements of the US and Canada. Multipurpose audits/inspections are already taking place under other programs. Through the pMAP, FDA and HC hoped to increase awareness of the advantages of multipurpose audits/inspections currently made possible by AOs operating in the FDA’s Accredited Persons (AP) program and HC’s Canadian Medical Devices Conformity Assessment System (CMDCAS).
Industry perceives a regulatory burden due to multiple audits disrupting day-to-day operations. In addition to these associated costs is the uncertainty related to the scheduling and the allocation of resources needed for multiple regulatory audits. The pMAP was intended to be a vehicle for further regulatory cooperation between HC and FDA leading to a reduction of regulatory burden on industry. The anticipated benefit of the pMAP was to use a multipurpose type audit to reduce overall time spent on site by an audit/inspection team measured in person-days. FDA and HC also used these multipurpose audits/inspections as a learning opportunity to acquire a better knowledge of each other’s respective auditing/inspection approaches in order to leverage resources.
It was decided that ten audit/inspections would be performed in order to conduct an evaluation of the pMAP This final joint report summarizes what was learned.
The data shows that the majority of manufacturers realized a savings in time on site (Table 1). The table shows the time (in person-days) spent by an audit team at each firm under the pilot and the combined times of a previous FDA and HC CMDCAS audit at the same facilities. Savings of time in person-days was achieved in most instances and ranged from 25% to 58% with an average of 33% less total time spent at the facility as compared to the estimated combined time of previously separate audits/inspections that were performed to satisfy the respective regulatory requirements of HC and FDA.1
|pMAP time on site (person-days)||Previous site time (FDA+HC) (person-days)||Savings (previous time on site - pMAP time on site)||Percent time saved|
Table 1: Time (in person-days) on site for pMAP and previous visits by FDA and HC representatives.
* - Not applicable as HC audit represented a full (renewal) audit compared with the previous surveillance audit.
** - Technical expert was added to the normal audit team to assess software validation requirements thus increasing person-days.
Additional Findings and Recommendations
1. Finding: There were no nonconformities issued related to Part 1 , Canadian Medical Device Regulations nor were there findings related to other FDA regulations outside of the Quality System (QS) regulation 21 CFR 820. This may have been due to the small sample size.
Recommendation: Both regulators need to monitor that those additional regulatory requirements outside of the ISO 13485:2003 standard and the QS regulation are adequately covered during audits/inspections. This is identified as a potential future training issue.
2. Finding: Audits performed for HC were a mix of surveillance audits and re-assessment audits. The audits performed for FDA purposes were all Level 2 (similar to HC re-assessment audit).
Recommendation: Greater time savings could be realized if the type of audit and inspection are similar. In the future, when an audit for HC is a surveillance type then the auditor should also perform a Level 1 type inspection for FDA purposes. When an audit for HC is a re-assessment type then the auditor should also perform a Level 2 type inspection for FDA purposes.
3. Finding: A number of Opportunities For Improvement (OFI) were identified in several audit reports. Many of these OFIs should have been written as nonconformities.
Recommendation: In collaboration with the CMDCAS registrars, it has been agreed that OFIs will be omitted from the written regulatory audit report. This recommendation will be reflected in HC’s “GD 211: Guidance on the content of quality management system audit reports.”
4. Finding: Several responses to nonconformities did not contain a cause analysis, a clear statement of correction of the nonconformity, or a clear statement of the corrective action that the manufacturer intended to take to prevent the recurrence of the nonconformity. This is a regulatory requirement for the manufacturer in ISO 13485:2003 clause 8.5.2 and FDA’s 21 CFR 820.100. In addition, this is an accreditation requirement under ISO /IEC 17021:2006 section 9.1.11 for CMDCAS auditors. This issue is not unique to multipurpose audits and has been identified in the past separately by HC and FDA as an area which needs additional international guidance.
Recommendation: The Global Harmonization Task Force (GHTF) recently developed a guidance document on the handling of nonconformities and corrective/preventive actions. HC and FDA will incorporate the GHTF Study Group 3 guidance document GHTF/SG3/N18 “Quality management system – Medical Devices – Guidance on corrective action and preventive action and related QMS processes” into training programs for both the manufacturers and auditors.
5. Finding: HC and FDA review the audit/inspection reports retrospectively often without the audit plan. The level of detail in the narrative needs to be greater in order for the regulators to have a more complete picture of the audit/inspection and the manufacturer’s organization and operation. The narrative portion of the audit reports under the pMAP varied in length from 20 pages to 3 pages. There was variability in description, level of detail and format across the sample set.
Recommendation: The use of a single audit report format should be adopted. HC and FDA are collaborating in the development of HC “GD 211: Guidance on the content of quality management system audit reports” and associated training for this purpose.
Based on this review of ten multi-purpose audit reports a qualified/competent auditing organization can perform a single audit/inspection of a medical device manufacturer’s quality management system (QMS) in order to satisfy the regulatory requirements of HC and FDA.
In addition, when a manufacturer undergoes a multipurpose type audit, HC and FDA have confidence in the ability of a qualified and competent auditing organization to plan, carry out, and report on the audit/inspection according to basic HC and FDA requirements. Informal and anecdotal comments received by FDA and HC personnel from the participating manufacturers and auditors have been positive.
This pilot program provided both regulatory bodies the chance to compare processes and prepare for future best practices in the area of medical device manufacturing regulatory oversight. There is potential for convergence in the areas of audit/inspection best practices. Potential benefits for manufacturers for a future single audit program include:
- saving of audit/inspection time in person days (and associated costs) and less disruption of the manufacturer’s day-to-day operations; and,
- greater control over the scheduling of regulatory audits/inspections.
The regulators benefit from a single audit process through the leveraging of resources and sharing of information from a single audit process. This was a limited sample size, however, it shows the ability to perform a single audit including not only FDA and HC but potentially other regulatory partners.
1 This analysis relies on an estimate of the previous time spent by CMDCAS auditors.