Ensuring that your DHF is constantly updated is the best practice in ensuring that it will have all the necessary documents during an audit. As discussed in the past 2 weeks of class the DHF is a living document and as such everyone involved on the team should have access in editing and updating the document in order to ensure proper inputs. The focus in industry is shifting towards quality management systems that are specifically designed in order to ensure compliance to these FDA mandates in design controls. With quality management systems it becomes easier for a multi functional team across different regions to be updated and follow the guidelines of a DHF as they can upload, review, and sign the necessary documents remotely and everything is logged in the system so that the project manager can have clear visibility on tasks that are completed and remaining. This utilization of QMS is probably the best insurance in maintaining accurate design controls.
This is an interesting discussion topic! In the medical device industry, it is very critical to have the most up to date DHF as the project moves forward with different phases. Many medical device companies have internal audit program, part of the quality system that can help the company identify any gaps and remediate immediately. If the company does not have the internal audit program set up, it is usually outsourced to a third party auditor. Furthermore, any ISO 13485 certified company has an annual surveillance audit, which also helps prepare the company for FDA audit. Any time there is change of any documentation within the DHF, the company must follow their document control procedure for traceability purposes. In this way, the DHF will be updated at all times following the FDA and the ISO regulations and will be audit ready.
The DHF is an integral part of the project design and development aspect. The DHF must be a set of documents that clearly states the intricacies of the product. The DHF must be continually updated in order to have the most optimal product. There should be a team or a specific person in charge of ensuring the DHF is regularly updated. People need to be proactive on the auditing team to ensure that the company never falls behind. The documents must be accessible by all team members so there is not a long process to make changes. Instead, the document can be continually improved by all members of the production team.
Interesting posts. I agree with many of you in regards to the importance to diligent record keeping and constant updating the DHF. It is in fact a "living document" as it was pointed before and will need continuous upkeep to deliver closest expected results to the plan that was laid out. In addition, another good point is the ability to have check points at which the DHF is internally audited not only by the development group itself, but also the quality control team in the company. This will ensure that all items are properly recorded and maintained up to date and ready for the real audit.
I agree that one way to keep the DHF audit ready is to ensure the document is “living” and accurate to the product currently being produced. Although, I would like to bring up some of the risks associated when auditing a document that is constantly being updated.
Maintaining records of document revisions from the initially released version, to the currently issued revision should be considered. Additionally, traceability of changes between revisions is important as well, and commonly referred to as a document “redline.” When updating any document from, for instance, it’s initial release (Rev A) to the second updated revision (Rev B), it is necessary to keep record of what exactly is being changed. In Microsoft Word, this can be done with the simple “Track Changes” feature, however can get a little more complicated in programs such as Excel.
Another risk to be considered is the accessibility to make changes to the living document. More specifically, who has the access to make such changes? How are the changes reviewed and approved prior to be released? For example, If a company has 500 employees, you would not want all 500 of these people to be trained to and have access to make changes to the DHF.
A good way to ensure something is audit ready is to perform internal audits on a regular basis. Also, when findings from an audit arise, an internal corrective action/preventative action (CAPA) system should be followed through an established procedure.
DHF can be audit ready if the organization is ensure a set of checks points are conducted prior. In my organization a living document that we have in my department is for provider rounds documentation for inpatient consults or rounds of medical departments that are coming to assess the patient but they are not the admitting service. This document is literally constantly updating because it changes hands constantly within the organization to ensure that when the patient leaves and the chart is closed it can be sent out to the proper insurance. In regards to how does this fit in as a living document, DHF, even though it is not a medical device, the documentation that is embedded into the patient chart is a legal obligation that is tied to each individual who documents in it so it is imperative that the authors correctly document. Documentation can lead to wrong treatment and the administration of wrongful medications. Both of these things can lead to wrongful death not to mention unlawful billing of incorrect services. Appropriate and accurate inputs and outputs are necessary to make sure that the DHF is always audit ready.
