From a quality perspective, I will say that I have follow all the rules to make this product and I have all the documents in details from the start to end of the project with good GMPs. The quality person will only be afraid of hopefully he did not miss anything and they don't get bad audit report or a 483 because it is embarrassing for the company in the market, It shows that company has a deficiency which can affect in future when you go to FDA to get your product approved and now they will look at every single thing in detail and give you hard time. So quality people is worried about the companies image and reputation in the market and in front of FDA from this audits.

This is a great question. Prior to FDA or BSI audit, the quality department of the company prepares for the audit in gathering few DHRs (Device History Records). From the auditor’s perspective, he/she ensures that the company meets its own Quality System. The auditor assesses the company’s quality system and compares with the few lots recently manufactured. Some auditors are really challenging as to their mindset is that they must issue an observation or a finding before leaving the plant. However, from the quality perspective, this should help the company in improving their quality system. Overall, audits are means to identify how well the company performs to their QMS and to prevent any significant product failure.

Interesting that you say "some auditors have the mindset that they must issue an observation or a finding before leaving a plant." I believe ALL auditors have this mindset no matter how good your quality system is. From what I have seen, auditors will question everything and listen very closely to what people in regulatory and quality say so they can question the details. From a quality perspective, I believe part of quality is trained to answer these audits by providing just enough information to answer their questions but not enough information to open any further investigating or additional questions.

To be prepared for an audit, you will need to periodically review your quality system records (DHRs) for these areas. While you can’t be certain exactly what an auditor will ask, you can use the objectives and sample questions below to review your quality system the way an auditor will during an inspection.
Also, you need to make sure you are following the FDA Quality System Regulations as defined in 21 CFR part 820
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820
Also Mock FDA audits are important for the identification of gaps in the quality systems related to medical device manufacturing. The mock FDA auditor conducts an exit meeting with the company. During this meeting, the mock auditor provides a review of major and minor findings and suggests actions to improve the issues that he or she found.
http://www.thefdagroup.com/thefdgroup-blog/2015/04/2054/

I have assisted in an audit for the quality department and was honestly amazed in the company’s systematic ability to answer questions correctly and intelligently. The biggest lesson that I have learned from seeing an audit is to never give information unless it is asked. The quality department can give great information and documentation but they are also sure to not offer information that the auditor is not asking about. The quality department is a key aspect to the audit but the production and R&D are often brought in as material specialist to discuss the documents that they are responsible for.

In my one experience with audits, the quality department must all be actively involved. The quality manager creates a detailed plan and assigns a designated role for each member in order to have a seamless system. There were no violations that arose. There are of course minor delays in finding the exact documents to answer the auditor's question. There were personnel from other departments that were brought in as experts on certain subjects. Leading up to the audit, there was a meeting to brief everyone involved as well as a practice run to understand how the process would work.

The main purpose of an audit or inspection is to check if the regulatory standards are being followed in the way and magnitude that they need to be followed by the company. While I was working as a quality control associate in the medical imaging operations of a clinical research company, we were trained twice a year on audits and inspections for various projects. There are two types of regulatory checks in the form of FDA audit and Sponsor audit. Some of the points that need to be kept in mind while facing an audit inspector are: confidentiality and sensitivity of the information being revealed while also not withholding the information that the auditor is seeking. While it is important to assure the auditor that the work is being carried out according to protocol, it is also important to maintain the confidentiality of the company's clients and their project data.

An auditor in my perspective, is looking for two things: to point flaws in the regulatory framework of the project and to identify non-compliance by the employees. While it is at least partially assumed that the project's regulatory guidelines meet the FDA standards (otherwise it wouldn't have been approved in the first place), I think a lot of focus is on how well the regulatory policies are adhered to and the confidence that a company and its team can project to the auditor ensuring the safety and effectiveness of the product.

To outline some of the ways to ensure quality is to:

a. Train all the project members on quality control for all phases of the study to highlight the importance and significance of maintaining quality in their own departments is actually interdependent with regards to overall quality of the project.
b. To discuss corrective measures/actions during possible violations of regulatory policies early on in the study. That way, one can assess the magnitude of impact of the violation and take necessary measures.
I can cite a similar example of quality violation from my previous experience. We received a few scans in between the actual scheduled visits for a few patients who showed different reactions to the drug. As there were not detailed instructions regarding the naming convention for unscheduled visits in the study protocol, the images were saved with varying random naming conventions by different members in the team which lead to a lot of confusion during study close out as to how these images should be sorted out and processed. The study protocol was later amended and a new naming convention for unscheduled visits was laid out. Eventually, these already processed images had to be rolled out again for re-processing which lead to quality issue in the project.

I think quality and proactiveness in ensuring quality go hand-in-hand to identify any possible setbacks of the current regulatory structure of the project.

I have participated in three audits over the past two summers where I have worked in the quality area. From what I have learned about audits is to ensure that everyone in the company is familiar with the company's objective/mission. Another key point where everyone should be aware of is the SOP's for their department. Some auditors may just ask you to pull up a SOP about a certain procedure while others might ask u the steps about a procedure. This is why you must follow the SOP's properly.

Another thing I have learned is to provide only the information that the auditors have been asking for. If you give out too much information, it might come back to hurt you and the company. Auditors are always looking for something to point out flaws in and you might be giving one without knowing.

The last point I have learned was to have all paper work in order for all the lots and batches of the product.It is important to have this in order auditors want to check. Auditing might be annoying but it is very important to ensure everything is going well in the company.

I have not participated in an audit from an audit stand point but I recently attended a weeklong training on the FDA’s Quality System Regulation by AAMI University. The trainings were hosted by FDA, consultants, and at least half the class were FDA employees that were mandated to attend the course. It was a shared learning environment and the course instructors walked us through many example FDA warning letters. Interestingly, many of the 483s we reviewed were a result of companies not following their own procedures, not the lack of having established procedures.
These are a few of the top domestic observation according to 2016 DOC observations presented in training:

CAPA
(710 total)
21 CFR 820.100(a) # of observations 234; Percentage 33%
21 CFR 820.198(a) # of observations 201; Percentage 28%
21 CFR 820.90(a) # of observations 96; Percentage 14%

P&PC
(650 total)
21 CFR 820.50 # of observations 98; Percentage 15%
21 CFR 820.75(a) # of observations 84; Percentage 13%
21 CFR 820.72(a)# of observations 45; Percentage 7%

DES
(294 total)
21 CFR 820.30(g) # of observations 79; Percentage 27%
21 CFR 820.30(i) # of observations 59; Percentage 20%
21 CFR 820.30(a) # of observations 35; Percentage 12%

DOC
(223 total)
21 CFR 820.184 # of observations 101; Percentage 45%
21 CFR 820.40 # of observations 48; Percentage 22%
21 CFR 820.181 # of observations 38; Percentage 17%

MGMT
(280 total)
21 CFR 820.22 # of observations 106; Percentage 38%
21 CFR 820.20(c) # of observations 64; Percentage 23%
21 CFR 820.25(b) # of observations 55; Percentage 20%

I have not been a part of the audit during the the FDA or BSI visits. However, I have been called during the visit regarding the documents that I have written. Their main objective was to clear out the inconsistencies in the reports. The documentation meets the defined quality objective of the organizations The activities performed are in conformity with the documented system. The quality system is effective with respect to documentation and its implementation, in meeting the defined quality objectives, and statutory and safety requirements are being fulfilled.

Both medical device companies I have worked at announce all FDA audits in a company-wide email a few days prior and the day of the audit. This is said to give each department time to prepare the required data/documents for presenting to the FDA, but at the same time it also acts as an alert for the staff to be aware of their actions and operations while the FDA auditor is on the premises. All company emails I've ever received regarding approaching FDA audits were followed up by notification emails of the auditor concluding the audit and leaving the premises, which seems a bit uncanny.

An online search of FDA audits provides a link as to how the FDA decides to go about their inspections and what medical device manufacturers should expect. For obvious reasons, companies that produce high-risk devices (Class II & III) are subjected to audits at least every other year since high risk devices require more scrutiny, while manufacturers of Class I devices may receive an audit every five years. An FDA inspector will carry out what's called a Quality System Inspection Technique (QSIT), which is a validated investigation method by an auditor that involves them reviewing procedures, batch records, basic aseptic techniques, GMPs/GDPs, etc. The auditor may provide any recommendations/requirements, such as a protocol being more defined and understandable, ensuring that all testing and facility equipment is calibrated and up-to-date, and that all device/design records and history files are properly stored and organized. The initial audit may also require a follow-up inspection to ensure compliance to FDA standards along with any other post-inspection findings.

Of all the departments in a medical device company, which do you think the FDA comes down on the most (other than quality)? Do departments such as facilities and shipping/packaging expect an as-thorough inspection as quality and manufacturing? Are there any incidents in the history of the FDA where a medical device company was shut down due to its lack of accordance with FDA standards?

https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM466499.pdf

I work for a company that was audited for several months and it was a very stressful time for not only Quality and Regulatory, but for basically every department. It is a complete effort to comply with the demands of auditors and takes a lot of coordination with representatives of all business functions. From my understanding one of the lead auditors would ask for a particular document or information on a certain process and so the department leaders would need to search for it in the Quality System or hunt down a subject matter exist who may be the only person in the company who could answer that particular question. In the end, there were only some minor non-conformances to address. These can range from a missing form, to operators not following the steps of a Standard Operating Procedure, to poorly qualifying a supplier. Whichever the issue, the appropriate department would have to determine the corrective action to institute and prove the issue was fixed so it does not happen again in the future.

Although I do not have experience working in a medical device company, I do have experience working closely with an EHS specialist (environmental health & safety) during my internship a few years ago. This role ensures the safety of the employees through observing the behaviors and procedures practiced in a laboratory. They also perform audits, making sure everyone and the environment in which the employees are working in, are meeting the set requirements put forth by the company.

Most of the issues/violations that arose were issues dealing with safety while in the lab. While working in a chemical lab, it is imperative to be wearing safety googles safety goggles and lab coats whenever working in the lab. Additionally, some had mislabeled hazardous materials, which can be a concern to the environment.

As a person working in the quality department, their priority is to ensure the safety of the workers as well as posing no threat to the environment. This individual must bear in mind that their fellow workers may not necessarily agree with their rules and regulations, however it is vital to the company's success and safety.

The company I intern for has a NADCAP (National Aerospace and Defense Contractors Accreditation Program) certification for some of their tanks. This certification is an industry-managed approach to conformity assessment of special processes that brings together technical experts from prime contractors, suppliers and establish requirements for approval of suppliers using standardized approach. The Performance Review Institute (PRI) administers the NADCAP program. PRI will schedule an audit and assign an approved auditor who will conduct the audit against an industry agreed standard using an industry agreed checklist. To everyone that answered yes it is stressful, yes it is stressful. When the government comes into the building its always a serious tone within the lab. I found myself not worrying so much because I was in charge of keeping the lab clean and since I was an intern theirs not much they can I ask me.