Internal Audits for small organizations
This week, Dr. Simon highlighted the importance of quality audits and especially internal audits. The FDA expects each organization to conduct at least one internal audit per calendar year. Internal audits are usually conducted in parts by independant employees to the part/process being audited. This can be a huge burden on small organization that has only one quality engineer. This quality engineer cannot audit his own work, and the company may not have the resources to hire another quality engineer just for audits.
What is your take on this? have any of you had experience in dealing with such issues?
In my experience, a contractor is usually hired or an external auditor is hired for such occasions. This is standard practice if no resources are made available from within the organization.
Yes usually an outside contractor can come in and perform the audit. Also can't employees be trained? I know it is not the same thing but in my company we have a safety audit team that is composed of just regular employees who were trained and they do audits every now and then to make sure we are in line with regulations.
This situation is evident in smaller companies. Auditing your own work defeats the purpose this is why private auditing firms are hired to access the companies process. However, another practice that seems to be getting more popular is hiring many "defined-term" employees. This means that each full-time employee has a set end date before they are hired, this can be extended or changed to regular status if there is a need. With this method there can be a constant cycle of talent, especially when there is a short-term need; like during an audit or a large scale remediation.
I agree that small companies would most likely hire an outside contractor to perform an audit if they do not have the resources to do their own internal audit. However, sometimes even larger companies hire independent contractors to perform audits, the reason being that having an outsider looking at your documentation, you are much more likely to catch something than if someone from the company is performing the audit. It is good to get an external perspective on your procedures and documentations. Also, many times these audit contractors are ex-FDA auditors or very familiar with what FDA would be looking for in an audit, so it really helps a company prepare for an FDA audit.
Since the quality department can't perform their own audits and internal audits are necessary for companies to find and mediate risks in their quality system before an FDA audit happens. Most companies hire an outside person to complete an internal audit, typically a contractor. The contractor has no ties to the company and is able to review the quality system without having any bias towards it.
Smaller organizations and even entrepreneurs can perform internal audits or sometimes they even have it performed by someone in an efficient and cost-effective way. This way it produces positive change and results. It can improve the overall business, the practices and its underlying processes. In some cases, contrary to popular opinion, it may even make employees happier about the work they do and procedure to achieve it.
There are alternatives to performing a thorough audit when there is not enough time and resources available. It is called a "self-assessment". This involves asking people questions or have them complete a self-evaluation rather than examining huge amount of information. It would not be a thorough audit, but at least it can provide useful information about potential risk areas.
Internal audits are helpful for small businesses. They can be performed relatively easily without much cost, and the end result is a better understanding of the way your business operates. Companies often hire external auditors in addition to audit themselves . An independent auditor is typically used to avoid conflicts of interest and to ensure the integrity of performing.An external auditor is not affiliated with your company and thus can redirect your company's behavior without fear of repercussions if you don't like what he has to say. An external auditor can catch small problems before they become serious and help your business get back on the track. External auditors, however, can observe operations from the outside and determine where the company is wasting time or money. They can recommend behaviors to the company to reduce waste or promote greater efficiency in general as well as tighten accounting practices. External auditors can look at the same factors as internal auditors and double-check their work. They can also train internal auditors in accounting principles by explaining how their analysis differs from the analysis the internal auditor performed.
I am a bit confused about internal audit, if anyone knows, could you please clarify? In the lecture, (slide 9), it's stated that for internal audit the company performed by itself and it's not as serious.
My question is: do companies first do internal audits by the company itself after that a small companies may hire a contractor to do other audits and after that audits from FDA, ISO, or notified bodies?
Based on my experience in industry, internal audits are conducted on a regular basis (usually once a year) by someone who works for the company. This is just a requirement that most companies have in their procedures and makes sure that product DHFs are in conformance with the company procedures. It is a good way to ensure that there is consistency between different projects, that good documentation practices are being followed, and that any mistakes that are found are fixed. Sometimes companies may hire outside contractors to audit them, and this usually does not occur on a regular basis, but is just something that the company does to make sure they are prepared for an audit by FDA, ISO, or a notified body. FDA can come audit at any time, but I do not think that they audit on a regular basis. The important thing is that the company is always ready if FDA were to come knocking on the door unannounced.
Internal audits could be done by the manufacturer itself or by hiring auditor.Both 21 CFR Part 820, the Quality System Regulation (QSR), and ISO 13485:2003 require internal quality audits. In QSR, the audits have two primary purposes: Assure that the quality system is in compliance with the established quality system requirements, and determine the effectiveness of the quality system. Internal audits help highlight opportunities for improvements in the medical device itself (including flagging non-conforming materials). An internal audit can also help uncover non-value added activities, allowing a company to focus on streamlining operations to rationalize workflow, resources and realize strategic cost savings. Manufacturers should apply CAPA systems and internal audits as their best and most trusted assets in promoting quality, safety and reliability. I wish this helpful!.