Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions
Recently, we hosted two live demonstrations of SmartSolve Audit Management. The webinar covered a number of topics including how to perform mobile audits, creating audit programs and schedules, working on audits, and managing audit followup. The webinar also included live Q&A during both sessions.
Some key themes emerged during both sessions that helped us understand the challenges you may encounter when carrying out quality audits, and how SmartSolve Audit Management can help.
1. Quality Audits are the Key to Ongoing Compliance
One of the compelling pieces of information presented during the webinar was about the effect of quality audits on overall compliance. In a recent FDA study, manufacturers with an adequate quality audit system were in compliance with approximately 96% of their GMP requirements. However, those that did not have an adequate auditing system in place were in compliance with only 70% of their requirements. (Source www.fda.gov)
In terms of quality processes, managing internal quality audits often gets a lower priority than processes like CAPA or document control. But this simple statistic shows how critical it is to have a consistent audit schedule and processes in place throughout your organization. The focus during the webinar was to demonstrate how easily you can simplify the process of managing internal audits to improve your overall compliance.
2. Risk is Always a Consideration during Quality Audits
Several questions about risk came up during our Q&A session. Some of our attendees were interested in moving toward a risk-based audit program, while others wanted to assess risk during the follow-up process. We discussed how risk is built into the SmartSolve platform so that a finding’s risk assessment can be captured based on severity, occurrence, and detection ratings. This data can be used to improve decision making about how to plan and schedule future audits.
Even prior to creating a CAPA, the normal quality activities auditors perform in the system can help you make risk-based decisions. Auditors can report on recurring findings and follow-up audits to understand recurring weak areas within processes and sites. This is something that is difficult to do without an automated system in place.
3. External Participants Need to be Included
Quality audits are not limited to internal audits. We had quite a few questions about how to include external auditors or suppliers in the audit preparation and follow up. During the Q&A session, we discussed how SmartSolve allows external parties to enter Pilgrim with limited rights and roles. This would restrict their view to only the records they are allowed to see.
If your organization prefers to keep external parties out of the system but still allow them to be a part of the process, attachments such as email and other files can be added to records as evidence. Audit schedules can also be shared via email to help suppliers or other external auditors plan for their next audit.
4. Consistency is Critical to the Audit Process
Audit Management gives auditors many options for building consistency into the auditing process. We focused on many of these areas during the webinar. For example, the system contains policies that can determine when specific fields, notes, notifications, approvals, and even new records (such as CAPAs) are required during your process. Auditors can set these up once and allow the system to continually enforce them.
The webinar also touched upon other capabilities that help reduce audit planning efforts, including the ability to copy audit plans and reuse audit checklists. Many attendees realized that they could become more efficient by eliminating the need to make these decisions each time an audit is performed.
5. Auditors Need Flexibility
Processes for quality audits can vary across organizations. A process that is handled by a team in one organization might be handled by a single individual in another organization. The system provides the flexibility to support this.
We also discussed how Audit Management can be scaled up or down for different types of audits. For example, there are times when using an audit checklist is helpful (or required) and others when you may simply wish to record findings. Similarly, findings may be approved by multiple individuals or all at once by a single person.
Join us On Demand
Last week’s webinars gave our attendees a deeper look at how SmartSolve Audit Management can help them perform quality audits more efficiently and ultimately improve their compliance efforts. If you would like to see these five tips in action and learn more, please download the on-demand webinar below.
SmartSolve Audit Management Product Showcase Webinar
SmartSolve® Audit Management is a comprehensive solution to plan, manage and conduct internal and external audits. Download this product showcase to learn how Audit Management can help your organization.