What Do We Mean By “adding value”?
We have heard so much about the importance of “adding value” during quality management systems (QMS) audits, but what does it really mean? Is it possible to add value without compromising the integrity of the audit or providing consultancy? In principle, all audits should add value, but this is not always the case. This article aims to provide guidance on how a QMS audit, particularly within the context of pharmacovigilance (PV) in China, can be valuable to all stakeholders involved.
“Value-added” Quality Management Systems
The term “value” often refers to something of usefulness. Therefore, “adding value” means making something more useful.
Some pharmaceutical organizations in China have leveraged the ISO 9000 series standards to develop QMS that are integral to their business operations and instrumental in achieving strategic goals—thereby adding value. On the other hand, some organizations might have merely created a bureaucratic set of procedures that add little value and increase costs, failing to reflect how the organization truly operates.
Approach Matters
A non-value-added approach asks, “What procedures must we write to achieve QMS compliance?” Conversely, a value-added approach asks, “How can we use our ISO 9001-based QMS to enhance our business operations?” This distinction is critical, especially in the pharmaceutical sector where QMS audits play a vital role in ensuring compliance and maintaining high standards in pharmacovigilance.
Adding Value in the Audit Process
How can we ensure that a QMS audit is beneficial for an organization, particularly in the context of maintaining and improving pharmacovigilance systems in China?
To add value, a third-party QMS audit should:
- Provide top management with insights into the organization’s ability to meet its strategic objectives.
- Identify issues which, if resolved, could enhance the organization’s overall performance.
- Uncover opportunities for improvement and potential risk areas, particularly relevant in the pharmaceutical industry where patient safety and regulatory compliance are paramount.
- By improving the organization’s ability to deliver compliant and high-quality pharmaceutical products.
- By enhancing the credibility of the third-party certification process, which is crucial in a heavily regulated market like China’s pharmaceutical industry.
The approach to “adding value” is influenced by the maturity of the organization’s quality culture and its QMS.
Tips for Auditors on Adding Value:
To maximize the benefits of a QMS audit in pharmacovigilance, the following approach is recommended:
1) Audit Planning:
- Understand the auditee’s expectations, corporate culture, and previous audit findings..
- Address any specific concerns, particularly those highlighted in previous audits.
- Conduct a risk analysis specific to the pharmaceutical industry and the organization.
- Pre-evaluate statutory and regulatory requirements, especially those related to pharmacovigilance in China.
- Pre-evaluate statutory and regulatory obligations related to pharmacovigilance.
- Select an appropriate audit team to meet the audit objectives.
- Allocate sufficient time for the audit process.
2) Audit Technique:
- Focus on process performance, rather than just documented procedures.
- Emphasize results and effectiveness rather than merely checking records. Although records provide evidence of process effectiveness, auditors should also recognize other forms of evidence that demonstrate compliance and performance.
- Adhere to the 7 Quality Management Principles.
- Apply the Plan-Do-Check-Act (PDCA) cycle to assess and improve process outcomes:
- Is the process well-planned?
- Is it being executed as planned?
- Are the desired outcomes being achieved?
- Are improvement opportunities being identified and implemented?
3) Analysis and Decision
- Use risk-based thinking and practical judgment to contextualize findings.
- Relate audit findings to their impact on the organization’s ability to deliver compliant pharmaceutical products.
4) Report and follow-up
- Provide clear and actionable audit reports tailored to the organization’s maturity, risk level, and audit objectives.
- Consider cultural aspects as well.
- Highlight positive findings and ensure that proposed solutions to negative findings will genuinely add value.
- Ensure that reports are objective and tailored to the intended audience, recognizing that senior management and management representatives may have different expectations.
Why Overseas MAHs Should Prioritize PV Audits on Local Representatives in China
For overseas MAHs, conducting QMS audits on local representatives in China is crucial for several reasons:
- Regulatory Compliance: China’s regulatory environment is strict, and non-compliance can lead to significant penalties, product recalls, market access issues, or even brand image.
- Global Alignment: Ensuring that local PV practices align with global standards helps maintain consistency in drug safety monitoring and reporting across all markets.
- Risk Mitigation: Early identification of risks through audits helps prevent compliance issues and enhances overall drug safety.
Conclusion
QMS audits are a powerful tool for overseas MAHs to ensure that their local representatives in China maintain high pharmacovigilance standards. By focusing on value-added practices, these audits can provide insights that go beyond compliance, driving continuous improvement and safeguarding patient health.
Contact Us
For expert support with China GVP and QMS audits, whether online/remote or on-site, contact us at info@accestra.com. For more information, visit China PV Hub.