How do you get ready for a quality audit?

In my experience the regulatory guidelines approach should be embedded into in-house SOP and the actual practices should be inline with the in-house SOP.

*Objective = the purpose of the audit (what you are trying to achieve by doing the audit, what is the aim?) *Scope = Where you are going to start and stop the audit. (this can be broken into the processes, different functions you are auditing) *Criteria = the requirements to audit against the standard. A big tip with any of these is that if we are not sure what they are,seek some input from your auditor or manager before you start the audit.This will ensure that everyone in the organisation is on the same page to runs the audit smoothly.

From an auditor’s perspective, it is essential to send an audit notification with some basic details of the audit including the scope and criteria to help the auditee prepare and confirm their availability for the audit. When the audit is planned over a few days then an auditee can request for an audit agenda which will include the day by day plan. This allows better allocation of staff assigned for the audit. The opening meeting on the day of the audit is an opportunity to clear any doubts the auditee may have with regard to the audit purpose, scope and criteria. This sets the scene for a successful audit.

Create an audit plan.?This plan should detail the scope of the audit, the resources that will be needed, and the timeline for the audit. Conduct a mock audit.?This is a great way to identify areas that need improvement and to test team's readiness for the actual audit. Communicate with your employees about the audit.?Let them know what to expect and how they can help to ensure a successful audit. Be prepared to answer questions.?The auditor will likely ask questions about QMS, procedures, and products or services. Be prepared to answer these questions in a clear and concise way.

As per my point of view, it should be a practice in place or preparation, no any major preparation require prior to any quality audits if you build a good GMP and GDP practice culture by adopting a regulatory guidelines and frequent training’s etc. -same shall be confirmed by internal / mock audit at define interval. -As a part of preparation follow the ALCOA ++ principles during routine practice. -Always updates and make ready all your quality documents like quality manuals, VMP, SMF, layouts etc. -Strictly follow the local FDA requirements too.

In some companies management may think, that Quality system audit (or any other system audit) is just Quality manager's or Quality department's job to handle it. It is not. It is whole managment responsibility, it means, there are many documents and activities to be reviewed before audit. And it is relevant process owner responsibility. Of course, quality staff should support them.

Keep these files organized and always audit ready. Some of your top SOPs will be: quality manual, Site Master File, Deviation management, CAPA management and Change Control management (amongst others). Get your drawings of your facility ready and organized. Having these common documents organized, updated and ready will be so helpful. Also keep electronic files of these as many auditors ask for USB drives now to review records.

Quality audit is a key process in an organization since it will uncover non-conformities and provides effective way of eliminating them.

No one knows your processes better than you and it’s in your best interest to be aware of any weaknesses or gaps in your processes for being successful. If you are aware or during self assessment come to know of such weaknesses best practice is to record them and at least have a plan to address them. It’s not to “pass “ the audit or better outcomes but rather that’s what matters to your business.

The quality of the audit outcome depends on the quality of the of the quality system. For an example, if auditing against a procedure. A proper quality system has regular updates on all procedures at stipulated intervals, then audits are done in reference to each of those documents . If there are gaps/non conformities, these are then attended to improve quality of work and documents. If there are processes that are redundant then that prompts a revision for that particular procedure.

This preparation steps are more applicable to onsite audits. What if it was an online quality audit? Well, it is still important to be familiar with the audit objectives, scope, criteria and plan as described in the previously, but most importantly, the documentation, including records should be made readily available electronically. The auditee needs to ensure that below listed features are available and tested in advance: 1- Laptop/Desktop/Phone equipped with camera and microphone, 2- Internet connection with acceptable speed, 3- Headphones or earplugs are recommended. It is advisable to create a folder and subfolders named with the corresponding standards clauses and keep records related to each clause in its corresponding folder.

- Alignment on audit objective: Trigger for the audit, purpose/goals, expectations. - Clarity on roles and responsibilities before, during and after the audit. - Agreement on potential containment. - Secure prerequisites for effective audit execution. > Required inputs from audit team at first preparation meeting (e.g. current or known issues/developments). > Secured capacity for audit execution and follow-up. > Criteria and timing for GO/NO-GO decision. - Reserve required time slots for the entire audit process. - Secure the logistics for the audit execution (travel/accommodation i.e.).

Main purpose of the Audit is to improve the process from the process efficiency, Defect reduction and Customer satisfaction point of view..

Communications between audit team is very impotant in all audit stages: 1- Pre-Audit: Talk to your team and answer all questions that they need, evaluate their experience, and provide training if necessary. 2- Audit Planning: Discuss audit purpose, scope, criteria and plan with your team to ensue the quality of audit, and to obtain the best results. 3- During audit: You may need more imformation from other departments through other auditor to ensure the actual situation, cross-referencing findings. 4- After Audit: audit report should be constant, so communication and discussion between all audit team should be done.

Purpose of Quality audit is to Validate the Quality system against the set standards.also find out the scope of improvement. Auditee should be fair enough to show the Quality system to enhance the current level of control with open Mind..

I prefer when the auditees do not prepare much. They should show their daily routines and not something prepared for the auditor. If they succeed, it means the quality system was implemented well, if not, it is important to see, if they understand the requirements.

Also make sure that the workplace is safe, equipment and machines are accessible, and the plant will be running during the audit timeframe.

We are in 2023 and almost ready to move in to 2024 so if not already done start planning a move to Electronic QMS which would help your business gain step improvements in efficiency, effectiveness and scalability. In addition it will help you be ready for any audits any time as a good EQMS will host your complete QMS in the cloud including all your KPIs .

Quality is an enabler to your customer experience. In medical devices, it’s a key part of your risk management. So the right approach is to be audit-ready every day. - train your teams in QA and risk management essentials -empower them to suggest improvements and implement them in a continuous improvement culture -create a zero-blame environment: record, review and act on near misses and breaches in your quality standards - understand the root cause of recurring problems - do the 5-whys Whether you have a planned or surprise audit, your team will respond authentically and will embrace the learnings of the auditor as opportunities to be even better. Not treat the audit as theatre. Environments auditors like are great to work in too!

I find it useful to communicate to auditors in advance about site restrictions (eg no open toe shoes in lab tours, gowning..), checking dietary requirements for the all important working lunch. I also like to share housekeeping rules at the opening meeting (fire procedure, security, confidentiality...) in order to make them as comfortable and welcomed as possible.

Role playing audit questions before audits with your colleagues is super helpful and will be beneficial to prepare newcomer SMEs to audits

*As preparation for the Quality audit, explain that auditor questions should be answered truthfully and that the auditor will ask for evidence to support answers. *Nevertheless, staff shouldn't volunteer additional information or steer the auditor towards issues not pertinent to the subject.

Make the auditee aware that the findings of the audit are intended to improve their quality management system. Hence, if nonconformities are identified as part of the findings, they should be seen as ways in which the performance of the quality management system can be improved through addressing same.

In order to ensure the quality of deliverables is critical implement the quality assurance/professional practices function, which should ensure the adherence to standards and compliance in timely manner with expected quality the audit work in each stage.

Audit is evidence based and logical process, and it is orainted by audit objective, scope, and criteria, so questions expectation is not difficult, and it is very important to prepare yourself and your team for audit. you can use these expected questions as: 1- Role play audit: Perform mock audit with your team and ask yourself these questions to ensure that you and your team are capable to give the correct answer . 2- Checklists: Prepare checklists for process related to these questions to ensure its competability with requierment. 3- Record review: Review related records and ensure its integrity because they will be the basics of audit findings.

In addition to this....To assess audit quality post-completion, consider conducting a survey asking stakeholders about communication, thoroughness, and adherence to standards. Include questions on timeliness, transparency, and overall satisfaction to gather valuable feedback.

With my years of experience in the QA/RA Device Industry & Notified Body, the following points should be considered (for any type of audit: Internal/External): 1. Keep your QMS documentation as simple as possible to ensure that all employees, regardless of their competency level, can easily understand. 2. Invest in Staff Training, so that they can understand their role and responsibilities to contribute to QMS compliance. 3. Develop audit culture (Regular Internal Audits & Mock audits) to catch any gap in QMS effectiveness & fill it by raising CAPA. Audit culture also helps in preparing staff for audit. Implementing above habits ensures that your organization is well-prepared for audits, whether they are announced or unannounced.

Focus less on the audit and audit preparation—focus more on the value add, effective implementation of the quality system aligned to the standard, and everyday continual compliance and improvement—live to the standard and zero audit preparation is necessary.

If you must prepare for the audit, there is already a problem. Audit is development tool, and making sure that organization has been taken account demands from standards (base of their own market fields etc.) when build up management systems. If you want to prepare, make sure that personal is aware of the idea of auditing against standards. That′s all.