Kymanox can help you with all of your auditing needs, ensuring cost-effective, solution-based approaches so that your audits are not only compliant, but successful and business-smart. Our responsive, expert-led teams are rich in knowledge and experience spanning all aspects of the life sciences, including biomedical research, academia, executive-level pharmaceutical quality management, and other industry leaders. Kymanox’s experts will have you avoiding the following mistakes made in a CGxP quality audit:
1. Not Using Risk Management
Some on-site audits are not necessary, and a simple risk assessment that is well documented can be a good substitute for a periodic on-site audit, resulting in savings of time and money.
Some audits should be done every 1, 2, or 3 years, while other audits can be done over the phone and email (e.g., “paper” audit). By employing risk management early in the audit planning process, Kymanox ensures the maximum return on auditor time and effort with respect to keeping patients safe and having access to effective products.
2. Using a Checklist to Drive an Audit
Kymanox has a detailed audit checklist that has been used as a guide on a wide array of audits. By reviewing the checklist prior to the audit and then referencing it occasionally during the audit, Kymanox is certain there no major matters that are missed.
While checklists are useful tools to provide standardization to an audit program, the best audits are ones that follow real-time data found during the audit. At Kymanox, this “pulling the thread on the sweater” methodology works well for us and our clients.
3. Inadequate Auditing Fundamentals Training
Even the best SOPs have no benefit without proper implementation and compliance, which cannot be achieved without company-specific training. At Kymanox, we specialize in both train-the-trainer sessions and company-wide educational events that are customized and documented to fit your company’s requirements. Our SMEs have presented at nearly all major industry conferences. These prestigious teaching fellows and prior academic faculty are committed to employing effective and motivational training techniques.
4. Lack of Planning and Preparation
The best audits are planned in advance, have a detailed agenda, and have significant pre-work completed prior to on-site arrival or audit execution. At Kymanox, we send audit notifications including detailed agendas and document requests. We also review company presentations, organizational charts, and master document indices in advance, when they are available.
The audit may go in a different direction based on actual audit findings, but by having a plan and being prepared, the audit is less stressful for everyone involved.
5. Findings are Not Categorized Properly
It takes years of experience, expert judgment, and having a pulse on current FDA, EMA and other regulatory agencies to ensure audit findings are categorized correctly. The four main categories are Critical, Major, Minor, and Recommendations / Opportunities for Improvement.
Auditors can cave into political pressuring to downplay a finding, which may save face for a small few, but will result in undermining the integrity of everyone involved. By using a cross-functional, highly experienced team to act as a sounding board on unclear findings, Kymanox is able to properly mimic agency responses based on current field conditions.
6. Inability to Reproduce Audit Findings at a Future Date
At Kymanox, we use our CGxP Audit Toolkit® and ensure our policies, procedures, and templates are followed closely. This includes writing down every document reviewed during the audit and recording that document’s ID number, title, and version number or version date.
A table of all reviewed documents is included in the final report. With this information, future auditors can reproduce the exact same conditions at the time of the original audit with respect to documentation. Also, Kymanox records all participant names, titles and provides a play-by-play narrative summary of the actual audit as compared to the original audit agenda.
Kymanox provides turn-key global Quality Audit Services using our ASQ certified personnel for biologic, drug, and device firms.