Guest Column | June 8, 2023

Breeze Through Surprise Audits — Take These 5 Actions Now

By Erika L. Roberts, ELR Lab Services LLC

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Summer is here! Swimming pools, summer camps, outdoor adventures, beaches, and vacation requests all come to mind when we think about summer. However, summertime is also a time when you might hear at your organization the dreaded words, “Surprise! We are coming to audit you!” Whether it’s a client, supplier, or regulatory agency calling for an audit, those words can strike fear in even the most organized and prepared organizations. Is there anything you can do to lessen the dread and even perhaps embrace the surprise audit? There are several steps you can take to ensure that you and your organization are ready for any audit at any time…even in summer!

1. Tune Up Your Standard Operating Procedures (SOP)

SOPs are an integral part of the pharmaceutical organization and one of the most critical quality tools. But when was the last time your quality organization went back through current SOPs and took a good, hard critical look at them? This is not something commonly done at most organizations. SOPs are usually a “set and forget” until there is a critical update needed, or a piece of equipment is retired and the SOP is no longer needed. However, having a system in place to look at your SOPs in an interval that is doable for your organization is a good idea, especially when the surprise audit is called. Taking a critical look at your organization’s SOPs on a routine basis helps to fine-tune them and catch any outdated procedures or mistakes that might be spotted by an auditor during an audit. Doing this within the organization on a timeline that is consistent will help to ensure that your SOPs are current, flow easily, and are up to date with any regulatory or client requirements.

Also, don’t hesitate to enlist the help of any users of the SOPs, and have a system in place to regularly gather feedback on how to improve your SOP writing and process. The users of the SOPs have valuable insights into what works and what doesn’t work in the current set of SOPs. By instituting a system that allows for feedback and regular review of your SOPs on a timeline that works for your organization, you will be more than happy to hand over any requested SOP to an auditor.

2. Invest In A Quality Management System (QMS)

Quality management systems (QMSs) are great tools for any pharmaceutical organization. Large and small organizations can benefit from investing in a QMS system that helps to automate any paper-based system. There are many QMS systems on the market that offer solutions to pharmaceutical companies no matter the size. With all the buzz around artificial intelligence (AI) and how it will change the landscape of how work gets done in the future, now is the time to invest in a more automated system for your organization. Capabilities of QMSs range from managing SOPs and training to fully automating the manufacturing process. These systems can be accessed by any secure device and provide more mobility and visibility than that of a paper-based system. Depending on the size and needs of your organization, many QMS providers offer free consultations and will help you craft a system that is within your budget and helps to solve whatever needs your organization may have when it comes to automating a process.

But how does this help during an audit? Using paper-based systems requires time and resources to gather, print, and provide whatever documentation the auditor needs, which can delay other essential work or take away from time that could be more productively used in the audit process. By automating your paper-based systems with a QMS system, you not only provide instant access and searchability for whatever documentation the auditor is requesting, you also free up personnel to work on other aspects of the audit instead of searching for, printing, and delivering the paperwork to the audit team. By saving time and manpower, this turns document management into something as easy as enjoying a mango smoothie by the pool.

3. Ensure Your Training Programs Are Robust

If you were to ask an auditor what is one of the most important parts of an audit, more than likely they will refer to looking at the training program. Having a robust training program is one of the most critical and crucial aspects of having a surprise audit be a success. Just as with the SOPs, you should be tuning up your training program on an interval that works for your organization. Professional development and diversified training offerings are also an integral part of any robust training program. Does your organization participate in conferences or offer incentives to lab staff to attend? Does your organization have a policy on professional development and how to move into different roles if desired? If not, now might be a time to discuss implementing these types of opportunities.

Also, you can automate your training program through a QMS system and is a great way to ensure compliance with training timelines and due dates. Not only does this help to ensure timely training, but having a QMS system that automates training emails and captures training completion in real time leads to more effective and quality training. Being creative with your training program and fine-tuning your offerings helps to keep everyone engaged and participation high. By having a robust training program, you can be sure your auditor will appreciate your efforts as much as a cold drink on a hot summer day!

4. Perform Internal Audits

Does your organization have a team trained to audit? Do you perform your own internal audits on a regular basis? If not, now is the time to think about implementing a team within your organization that can perform this task. Internal audits are a great way to catch non-compliance issues or gaps that might exist within a particular department or system that wouldn’t be seen otherwise. A successful internal audit team usually will consist of a member of the quality group, a management representative, and laboratory staff. The team needs to be diverse and knowledgeable about your organization. Specific goals and departmental objectives should be defined and a report provided at the end of each internal audit. Having staff participate in these mock audits is also a great way to provide internal professional development opportunities.

Providing greater visibility of the audit process to as many personnel as possible will help everyone in the organization understand how the audit process works, which will lead to more successful surprise audits when they occur. Internal audits can be a breeze if organized in a thoughtful manner and include as many different departments as possible.

5. Invest In Well-Run Corrective Action/Preventative Action (CAPA) Programs & Investigations

It is inevitable that something will not go according to plan or accidents and mistakes will happen, no matter how well trained or automated your process is within your organization. This reality makes having a robust CAPA and investigation program of the utmost importance. CAPA programs help to ensure that when a mistake happens, it doesn’t happen again. CAPA programs are the cornerstone of ensuring that any system is running smoothly. A robust CAPA program will have SOPs in place for investigating out-of-specification data, equipment failures, and gaps in training, just to name a few. It’s not how a mistake happens but how it’s handled that is important to an auditor.

Investigations, just like CAPA programs, are also key to maintaining data integrity and ensuring compliance. A solid investigation program will usually have a team of different individuals who participate in the investigation process and provide recommendations and either approve or reject data based on their findings. This is an important tool in the pharmaceutical industry, especially when it comes to a surprise audit. Most auditors will want to know how and why data was collected, approved, or rejected when something occurs that was not within the scope of work. Investing in a well-run CAPA and investigation process will ensure you sail through this part of your surprise audit.

With summer now here and personnel enjoying their vacation days with family and friends, this is a critical time to be prepared to for any surprise…including the dreaded surprise audit. Of course, these are only a few of the tips to ensuring a successful surprise audit, but implementing and being thoughtful about your processes should help to ease the stress when that call comes through.  So, raise a glass of your favorite summertime drink and kick back by the pool stress-free, knowing that when the call does come, you will be ready.

About The Author:

Erika L. Roberts, MFS, is principal consultant and owner of ELR Lab Services LLC. Having more than 15 years of experience working in many different areas of the pharmaceutical/biotech manufacturing quality environments, she has particular expertise in sterility testing, microbial identification training, HPLC analysis, cGMP training, analytical chemistry, and pharmaceutical regulations. Roberts obtained a master’s in forensic science in 2006 with an emphasis in document examination.