You can conduct multiple individual process audits or you can conduct one full quality system audit, but which solution is better?
What are individual process audits?
There are 25 processes that require procedures for compliance with the US FDA quality system regulations and ISO 13485:2016 has 28 required procedures. Individual process audits focus on one of these procedures, the process it controls, the equipment and software used by that process, the work environment where the process is performed, the people responsible for the process, the records resulting from that process, and any metrics or quality objectives associated with that process. An individual process audit can be completed in remotely or on-site, and these audits will be much shorter in duration than a full quality system audit. Another way to think of an individual process audit is to realize that a full quality system audit is comprised of many individual process audits scheduled back-to-back. Auditing one process might be as short in duration as 30 minutes (e.g. control of records) but individual process audits can take as long as four hours (e.g. design controls and technical file audits).
What is a full quality system audit?
A full quality system audit is typically a single audit conducted annually to address all the requirements for conducting an internal audit of your quality system. In this type of audit, all of the procedures and processes should be covered. Therefore, full quality system audits are necessarily longer. If the person assigned to conduct the full quality system audit is an employee, that person cannot audit their own work. This can be addressed in two ways: 1) the audit can be a team audit, and the other team members can audit areas the lead auditor was responsible for; and 2) the process(es) that the lead auditor is responsible for can be audited as individual process audits by another auditor at another time.
If the person assigned to conduct the full quality system audit is a consultant from outside the company, there is still potential for conflicts regarding independence. If the consultant audited the company in the previous year, then the auditor cannot audit last year’s internal audit. In our consulting firm we address this issue in two ways: 1) we rotate who is assigned to audits so that the same auditor does not conduct a full quality system audit two years in a row, or 2) we assign another auditor in our company to conduct the audit of internal auditing as a team member.
How do you evaluate auditing effectiveness?
Some companies perceive that auditing is a necessary evil and they want to put as little effort and resources into the audit as possible. In this situation, auditing might be evaluated based upon whether it was completed on-time, by how much the audit cost the company, and the fewer nonconformities identified the better the perceived outcome. This perspective typically results in a single full quality system audit that is three days in duration or shorter if an auditor can manage to complete the audit in less time. Of course the shorter the audit is, the fewer records that an auditor has time to review. Therefore, shorter audits typically have fewer findings and management is pleased at the outcome because the audit required fewer resources and had little or no nonconformities.
The better approach is to look at auditing as a method for identifying areas that need improvement. Identifying areas where your quality system needs improvement is the intent of requiring internal audits. Therefore, the amount of time your company allocates to auditing should reflect the benefits for improvement that are identified. Top management of your company needs to identify which process areas they feel needs improvement. Only then can the audit program manager design an audit schedule that will focus on identifying opportunities for improvement and nonconformities in the process areas where management feels improvement is most needed. Ideally, this approach to auditing will focus on looking for inefficiency and metrics with negative trends. These findings result in preventive actions instead of corrective actions, because the process is not yet nonconforming. In general, the more opportunities for CAPAs that are identified the more valuable the audit was.
What advantages do one full quality system audit present?
Sometimes a single full quality system audit is easier to schedule, because it is only once per year. The rest of the year your company will not need to spend much time discussing audits or even thinking about them. If your company perceives audits as a necessary evil, then the less disruption caused by scheduling an audit the better.
Another advantage of conducting full quality system audits is that you can more easily afford to use external consultant auditors, because the travel costs for auditing are limited to one trip per year. If you had more than twenty individual process audits each year, and external consultant auditors conducted all of the audits, then you would have to pay for travel costs twenty times each year. Unless the consultant lives locally, these travel costs can be substantial.
What advantages exist for individual process audits?
Individual process audits are much easier for the auditor to complete within the time established in the audit agenda, because the auditor does not have another audit process immediately proceeding or immediately after the process they are auditing. There are also fewer people that need to attend an opening or closing meeting for an individual process audit, because only one process is being audited. Managers from other departments are seldom needed for participation in the opening or closing meeting. The combined benefits result in the auditor being more likely to start the opening meeting on-time and to start the closing meeting on-time.
The shorter duration of individual process audits is also an advantage. There are very few times in a year when none of your department managers will be traveling, sick, or on vacation. These rare weeks only happen a few times each year, and sometimes auditors must proceed with an audit even if someone is absent because they have no alternative. If you are preparing for an audit remotely, you face-to-face audit time is only 90 minutes, and your report writing time is also conducted remotely, then finding 90-minutes of available time in an department manager’s schedule is usually quite easy.
Can both approaches to internal audit scheduling coexist?
You can combine both approaches to audit scheduling in several possible ways. First you can schedule one full quality system audit each year in order to make sure that the minimum audit requirements are met, and then top management can review the results of the full quality system audit to decide which processes would benefit from individual process audits.
A second strategy would include conducting individual process audits for each process that resulted in a nonconformity during 3rd party certification audits or during the one full quality system audit. In this scenario, you might have a 3rd party audit in November, a full quality system audit in May, and top management might select 10 other individual processes to audit during the other 10 months of the year.
A third strategy would be to alternate between individual process audits and single full quality system audits each year. During “odd” years the audit program manager would only schedule one full quality system audit, and during “even” years the audit program manager would schedule multiple individual process audits.
A fourth strategy would be for top management to select a few processes that they would like the audit program manager to focus on with individual process audits, and all of the remaining processes would be incorporated into a single audit that covers the remaining 70% of the quality system.
Each of these four strategies for combining the two approaches to audit scheduling is viable and may result in multiple opportunities for improvement being identified. There is no regulation that favors one approach over another, but all four strategies require more time an effort on the part of the audit program manager and top management to discuss and plan the annual audit schedule.
Next steps if you would like to try individual process audits
If your company has always scheduled a single full quality system audit each year, you can test the concept of conducting an individual process audit by selecting just one process to audit. The best choice for this approach is to pick a process that has one or more CAPAs that are in progress or to select a process that top management feels is performing efficiently. The more frustration that top management experiences with a process, the greater the need is to identify opportunities for improvement. If the company has not already identified CAPAs to initiate for that process, you might just need an outsider to state the obvious: “I think we need a CAPA in this department.” The outsider might be a consultant, but it could also be a person from another department. If you would like a quote for an individual process audit, please visit our audit quote webpage.
About the Author
Rob Packard is a regulatory consultant with 25+ years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.