Hello Lamiaa, you have brought up a very good point. In my personal case, I have not dealt with any of those problems, however a close friend who works in the accounting department of a company mentioned to me that they missed a receipt for a minor purchase in the inventory and the government found out about it and they penalized him with a fine of approximately $1500. On the same way, one of my professors told me a story about how one of his coworkers in the industry was applying certain dose into patients for a study involved to ECG signals. The FDA had provided permission to apply 100 grams/ml (I can’t remember the correct unit of the variable) for the study, everything was working well with the dose of a 100, so the engineer decided to change it to 150. This change was not a major change when related to the study, however the FDA found out about it and it almost cost the Engineer his job, career and he also had to go to multiple auditions because of this. I completely agree that every detail of what is being done in a study must be submitted to the FDA, this provides very good control of what’s happening and it helps to go back as a reference when any issue occurs.

Let me know what you think.

Sincerely,
Roberto Pineda.

The FDA is a regulatory institution and therefore can do some serious damage to your company/employees if the audit uncovers irregularities that weren't accounted for. I don't have any examples personally, but the story the person above me sounds exactly like something that could potentially happen during an fda audit. Everything must be logged and everything must be traceable because the FDA will find out and does have the right to prevent you from commercializing your product and could potentially put your company in the red. Making medical devices costs millions of dollars through all the steps from initial design all the way through commercialization. Anything could happen if you fail an audit, like the individual above me described.

Although I do not have personal experience with FDA audits. We are always reminded to adhere to the protocols set forth because they are in place as safeguards for if/when audits do occur. Employees at our company are constantly trained on proper documentation and record keeping of all data and communications so that there is full transparency during any potential audit. Through my experience when I asked my managers about audits, they explained that if there are any small details missing, as Dr. Simon mentioned in his lecture signatures on certain forms, then the FDA would go through a fine tooth comb over the rest of the project in detail. Essentially even the smallest mistakes can prove costly in audits and that is why there is meticulous rules/training on record keeping of all data/communications.

I do not have any personal experience with FDA audits. But i feel its always wise to adhere to the Good Clinical Practices(GCP) to stay on the safer side. Sticking to the proper Standard Operating Procedures(SOP) to maintain the consistency, or proper documentation of the data, receipts, subject consent forms and records keeps one in compliance with FDA. Correcting any unexpected deviation from the protocol, prompt and complete reporting of adverse events and good record keeping are some of the preventive measures followed by the every manufacturing company to gain the approval from FDA.

There are many reasons why tracking time is an important practice for any company or organization. Some include: 1) Following the progress of the project, how much time is needed to complete a certain task, is this time spent wisely, any unnecessary time wasted, can time management be improved? 2) Determining cost of the project, how much should we bill customers, how is time translated to the value of the work? 3) Insights into estimates, completion dates. 4) Insights into employee wages, do they deserves bonuses or raises, keep discipline. I agree with all previous posts that say proper time tracking can ease FDA audits. The FDA is trying to make sure employees are being payed for the work they have put-in, that there is no fraud. Also that paying consumers are not being cheated; i.e. a company claiming compensation for 3 hours of work when only 1 hr was spent on creating the product. Today's employees have more fluidity in their work schedules therefore proper time tracking can become more careless so stricter regulations should be in place. This becomes even more important in med-tech markets where products have direct effect on the welfare of the user.

Keeping work logs and all the proper documentation is important for projects and even after a project is closed and moved on to the next phase. I do not have any personal experience with FDA audits however I do know that any audit is taken very seriously. An auditor can ask for any document from any point in the project timeline and you are expected to be able to find it quickly and have all the proper signatures and is filled out properly. An bad audit can lead to a project shut down or losing people on the project team. This is going to be true for any job associated with a government agency, federal or state. They hold the workers to a standard and you are lucky if you can just get off with a warning sometimes.

There are a lot of bad things that can happen when improper documentation is done. For example, if you do not create a detailed and completed work log when you are creating a product, it might be difficult for you to get approval on filing a patent and getting ownership rights. Also, when in a company, when you forget to add modifications to a product that you are developing e.g. an extra ingredient or a part, and you release that product and you neglect to add that information to the label, you can cause a recall or possible law suit.

For any medical device manufacturer an FDA audit is a necessary and a potentially difficult part. The company should maintains proper documentation . The updated documents like DHF,DMR and dozens of other demonstrates the commitment to quality , accuracy and thoroughness. When the work is properly logged and updated documents one could easily fulfill the auditor's request for any documents or work record because the faster the auditor gets satisfies the better impression he will have about the business. In order to pass FDA audit it is important to organize the procedure, documents and data in clear, logical order. BY going through the documents and work record the FDA inspector will know that company follows the GMP, the staff is knowledgeable and familiar with regulations and GMP, the documents demonstrates the training, monitoring and compliance program. Records should be maintained in a way that is usable and easily accessible.

My field is regulated by The Joint Commission (TJC) and The Centers for Medicare & Medicaid Services (CMS). Every 3 years an on site audit is performed by either TJC, CMS or both. Not having our logs in order when the regulatory bodies arrive can contribute to the overall organization losing it's accreditation. This will financially cripple the organization, and be a leading factor of the organization going out of business.

The FDA is strict on ensuring all guidelines are met when audits are conducted. Works logs are one of the documents auditors must review and reference during their visit. If work logs aren't properly recorded for all employees, it will hinder the auditor's assessment. As a result, high debilitating fines can be handed to the company. In more extreme cases, the FDA can even revoke the patent or license of the company. This will force the company to cease all operations until they apply for and receive the new license, which will delay the finish date. The financial strain of the fines coupled with the unexpected delay can completely kill the project.

I have an example that was thankfully caught by internal QC before any other agency was aware. There was a situation in a diagnostic lab where a new processing technician (non-bench/wet lab position), responsible for accessioning specimen and distributing them to the proper department, was pouring off peripheral blood and bone marrow from original tubes into pour off tubes without indicating if the newly created pour off tube was PB or BM... this left it up to the tech in the wet lab to subjectively try and figure out if it was PB or BM (viscosity, presence of bone shards) which caused problems because testing specifically calling for PB or BM would be halted and turn around time would be delayed because the tech would be unsure by visual inspection and there would be no way to back trace the specimens origin. All patient information was copied over to the pour off tube but not the source type, PB or BM. Something small like missing a piece of information on a label, if caught by a governing agency would be severely detrimental to the company, write ups, fines, deficiencies, etc. This is why QC is so important in catching mistakes and maintaining quality.

Work log itself defines that to maintain a proper record for the product that has been researched, manufactured and various steps involve in the process.
In FDA regulations, the department examines each every record maintained and finds out the error of the product. If any of the record is missed, then the FDA approval is easily rejected.

In the medical device industry there are countless things which need to be documented according to the FDA which may seem monotonous but are all the same mandatory. My company was audited by the FDA for several weeks and they were asking for all sorts of different documents and justification evidence for certain decisions. If you do not have these readily available then you could be hit with a violation and forced to come up without some sort of response to satiate their demands or risk complete production shutdown. Other times you may have documentation but it is done so poorly that you cannot understand why people did the things they did, and it is too long a time period ago that nobody remembers what happened during the project either. This can all get you in trouble if you have inadequate or missing documentation. While the FDA has good intentions it can seem excessive and annoying sometimes but engineers need to remember how important it is to log everything.