It’s a routine Monday morning and you’re sitting at your desk, enjoying your first cup of coffee, looking out the window of your office as the sun peeks over the trees. You start planning your week. You’re feeling ambitious and even start looking at what you want to accomplish for the next two to three weeks. You start making some notes on your to-do list: Document reviews to complete, a couple of outstanding items from that meeting you had last week, and that one request from Joe that just seems to fall off the list every week, but this is the week you’re going to get it done. All in all, the list isn’t looking insurmountable, and you think to yourself, “This is the week I can finally get back to that project to streamline our audit process.” You give yourself a mental fist-bump as you open your email. “This is going to be a great day!”
'Request for Audit'
Then there it is… the email that makes any Quality Assurance professional take a deep breath before reading when you see the three little words: Request for Audit. Then you go into overdrive as you begin thinking about what that means for you, your team, your organization. You calmly shut your laptop, reinstate calmness, and say “Ok…so this is what we’re doing this week, huh?”
There is no denying that audits are stressful. They require a high level of cross-functional collaboration and preparation, which is time-consuming in itself. There is also the training that may be needed for colleagues who have never been through an audit.
The role of a Quality Professional during an audit can feel like filling the shoes of a party-planner, a therapist, and a negotiator all at once. But it doesn’t have to be that way, and here’s why:
Four words to help change audits for your organization from a stress-inducing firestorm to a walk in the park with puppies (or something close to that).
Audit preparation begins before you’ve even received a “Request For Audit” email. It starts with making sure your teams are well-versed in how to prepare for and interact with auditors.
Understanding an Audit versus an Inspection:
An audit is the process of evaluating and measuring the performance of a facility, a piece of equipment or a process, and the outcome of the evaluation is compared against the expectations, standards or guidelines that have been established. Take for example a vendor management process. An auditor will review the Standard Operating Procedures (SOPs) for the process and compare it to the outcomes from your organization executing on the processes. The resulting audit of both the SOP and the outcome determines how well the organization is performing. Understanding what an audit actually is, allows for a team to better prepare for the activity.
Understanding Audit Standards:
When an auditor evaluates your organization, they don’t have a stash of secret requirements that you will be reviewed against. All auditors use what are known in the business as audit standards. These are the regional and global guidelines and regulations that govern your industry. Familiarization with your industry’s governance will ensure that your processes meet or exceed industry standards, and in turn, the outputs from those processes also meet or exceed industry standards.
Understanding Auditor – Auditee Communications:
One key method that can be used is to develop training geared towards auditor – auditee communications which can help make the process run as smoothly as possible for your team.
Hosting a mock audit prior to the real deal is also helpful in raising the comfort level of your teams and will give them a sense of what it’s like to be in an actual audit situation.
Awareness
They always say that “knowing is half the battle.” This very true for hosting and successfully executing an audit. It is the role of the Quality Assurance lead to communicate clearly not just with the team and senior management personnel that will be supporting the audit, but also the entire organization. (This is especially true if you are lucky enough to have a face-to-face audit.) As soon as that dreaded email hits your inbox, you should be preparing communication with your teams that includes: the proposed date(s) for the audit; the auditors’ name, affiliation, and credentials (if provided); the processes to be audited; the standards your organization will be audited against; and who your primary contact on the team will be.
Audit Communication Plan
The audit communication plan will be key in ensuring the execution during the audit will be as close to flawless as possible. The worst thing to happen is to be mid-audit and have a communication breakdown equal to that of playing “telephone.”
Audit Preparation Meetings
Audit preparation meetings should be scheduled as soon as possible with the purpose of ensuring that all team members are aware of what their roles are in the audit, what will be needed from them during the audit, and to answer any questions the team may have. These meetings are especially important for team members who have never participated in an audit. If presentations are needed, the audit preparation meetings can be a forum for reviewing those presentations, making edits where needed, and for ensuring that the presenter is comfortable speaking to the topics included.
Some auditors may also choose to have a pre-audit meeting with you, the auditee. This meeting is usually held to set expectations for the audit, submit any standard preliminary audit requests (e.g. SOP table of contents, general company information), and to confirm your list of attendees. These are helpful for both you and the auditor and can help build a successful working relationship for the audit.
Execution
The day of the audit has arrived, the team is ready, and you know that they have prepared the right documents in advance. They have practiced their presentations and are ready to confidently speak to their areas of expertise. Apart from making sure that the auditor(s) have access to documents, there are a couple other key aspects to making sure that your audit goes off without a hitch.
Audit Attendance
Although not every team member will be required for every session of an audit, it’s important that all team members and stakeholders attend both the opening and closing meetings if possible. Attendance at the opening meeting ensures that all audit team members understand the scope and intent of the audit and what the expectations will be during the activities. Meanwhile, attendance at the closing meeting ensures that all team members and stakeholders are aware of the audit outcomes. The closing meeting is also an opportunity to clarify any points where questions from the auditor may remain. Additionally, if the audit resulted in any findings, attending the closing meeting will give the team and stakeholders an opportunity to understand the context of any findings and ask questions if needed.
Ensure Top-Notch Scribing
Having dedicated scribes will ensure that requests and questions from the auditor(s) are logged efficiently and that your audit support staff are able to fulfill those requests in a timely manner. Clear and concise scribe notes can also be helpful when responding to any observations that may come out of the audit.
Establish an Internal Communication Forum
Using an internal messaging platform such as Microsoft Teams for internal discussions during the audit is critical. This ensures that communications continue to flow between the audit team and the subject matter experts as the audit progresses. This forum can also be used to get clarifications when needed, request additional assistance in an interview, and even help reconstruct conversations for reference during the audit response process.
Resolution
Gathering the team for an internal review post-audit can be just as important as all the preparation that went into the audit. The purpose of a debrief meeting is to discuss what went well and areas where the team can improve. If observations were discussed in the closing meeting, these can be reviewed so that an action plan can begin to be drafted to address the deficiencies.
Once the audit report has been received, setting a meeting to review the report in its entirety and assign responsible persons will ensure that meaningful corrective actions are developed and resource support is given where needed. This is especially important if a response requires input and collaboration from multiple functional areas. Once responses have been drafted, they should be thoroughly reviewed by the Quality Assurance lead for the audit to make sure they address the observations and that the corrective actions are logged appropriately for tracking and trending purposes.
Although audits are stressful and time-consuming, they are also an opportunity for improvement. They can provide a (mostly) unbiased review of your organization and its processes, and many times can be the catalyst for much-needed change. So the next time you see a “Request For Audit” email in your inbox, you won’t worry because you remembered to educate your teams, make them aware of the scope and intent of the audit, and you have a plan for the execution and resolution of the audit.
Good Luck!
Author:
Emily Dickinson,
Director, Quality Assurance (Western Region)
Linical