I agree that consistently updating all DHF documents throughout the project is very critical. I have found from my experience that it is very easy to let these things slip, especially in very dynamic projects with frequently changing team members. In fact, I heard of one project where they did not update their project team assignment form, and an auditor noticed that people were signing documents who were not listed as part of the project team, leading to an audit finding. I think that a good way to check that all DHF documents are updated and audit ready is to conduct internal audits regularly throughout the project. This way it forces the team to keep the documentation up to date.

I also agree, the DHF documents should always be updated throughout the project. I have not had experience dealing with DHF files but based on what I have learned so far, I think that updating these documents frequently will be beneficial for the future of the project. This document also gives information on what worked and what didn't through clinical trials. Keeping records of the phases of the project allows for improvement and fresher ideas by reviewing what has already been tested. I think that as soon as new information arises it should be documented as soon as possible. In this way, information isn't forgotten along the way, and when it needs to be audited, its ready.

I recently went through an internal audit in which we reviewed the DHF of one of our product lines. There was heavy debate on information within the Design Specification Document (DID). The DID contains specific specifications and tolerances for drawings of the actual product that is to be manufactured. Each product must be made to the drawing and each measurement must fit within the specs and tolerances and pass QC inspection. Our DID had extremely tight tolerances for one of the measurements in the drawing and the yields for that product were very low since we were failing them at QC inspection due to out of spec measurements. If those out of spec products passed through QC, this error could have potentially led to FDA warning letters.

In retrospect it would have been better to open the tolerances before this drawing was created. We had to go back and open Change Controls to adjust the specs. In addition we had to update the DDP and update the DID again.

To ensure your DHF is audit ready these documents should be reviewed on a consistent basis well before an actual audit occurs. In addition, the DHF should be reviewed by all departments involved which includes Marketing, Engineering, Research and Development, and Regulatory. Each of these departments should provide some level of input on any specific findings or changes that are occurring within the DHF and should be communicating the updates the rest of the team.

There are some important factors to keep in mind in order to have a complete DHF. First we have to keep up with it as you go. Throughout the process, you have to keep an eye on every change you make and update the DHF accordingly. Second factor is to store it separately from your project file, because otherwise it will get messy with all the other notes and things that go into product development. It has to be clean and ready to present whenever you are asked for it. The last factor is to make sure the whole team has access to it. Everyone who contributes to the project should be able to make notes and update the DHF.
Within the DHF lives everything about how you’re meeting Design Controls. Without Design Controls, you won’t be complying with regulations. And lack of compliance means increased exposure during FDA inspections. So make sure you include all design control documents, meeting minutes, all research protocols, clinical and pre-clinical, all notes, and all market research.

Within the medical industry it is crucial to always have the DHF updated as the progress of the project moves forward. A way to make sure that your documents within the DHF are ready for an audit is to have internal audits or a mock FDA audit. At the medical company I work at right now, we already had a mock FDA audit, ISO audit and now an internal audit within the last 3 months. Therefore, we can see our flaws and fix them before we get an FDA audit. One concept that our company instills in terms of documentation is that DHF is a living document, therefore anytime a document is updated it is mandatory for us to update other documents associated with the project. By doing so, the DHF will always be updated. However, people do slack in this category due to time restraints, but it is a great way to prepare for audits. Including a traceability matrix for design controls so that an auditor can see the relationship and flow between the design controls.

One thing to point out about a DHF is that every team member who is involved in the planning/development of a particular medical device should have access to the DHF. Sometimes, new recruits might not be given access just to prevent any mistakes. However, that actually might lead to some missing information that was relayed from the new recruit but not entered in the DHF. In order to keep this as thorough as possible, make sure the whole team has access to it. Everyone who contributes to the project should be able to make notes and update the DHF.

A Design History File (DHF) is part of a regulation that established new standards for medical devices. In the event of an audit by a regulatory body, you will need to provide information from the DHF. Medical design companies need to be prepared for the audits conducted by regulatory agencies such as FDA, and this means that they should understand the strengths and weaknesses of their DHF. I agree with srg36 that conducting internal audits is a good way to check if the DHF documents are updated. I must add that these internal audits should be able to bring to light the strengths and weaknesses of the DHF documents so that it becomes easy to meet the FDA’s requirement. In the company I worked for, there was always an internal audit of the DHF documents, and it was always carried out just before the FDA audit came to inspect the company. The aim is to ensure that ensure the DHF is audit-ready.

Five Tips for Passing Your FDA Audit with Confidence

Passing a regulatory audit is the first priority of any manufacturer of medical devices. It can be an especially scary time for startup firms. All three medical device startups agree that if you take the time to organize your procedures, documents and data in clear, logical order, facing an audit doesn’t have to be so frightening. Here are their five tips to help you prepare for your next audit.

1. Document Your Standard Operating Procedures (SOPs)

Always “say what you do” in your SOPs. Capture the overall requirements of your procedures in sufficient detail to thoroughly document your activities. But do NOT record the specifics of every action within a given procedure — you will trap yourself. Too much detail in your SOPs makes it easy for an auditor to find you in noncompliance with what you say you do. Remember to solicit feedback from your staff regularly and to review and update your procedures often. Frequent reviews will keep your SOPs current and in sync with your processes as you fine-tune them over time.

2. Train Your People

Spend time and effort to thoroughly understand the regulatory standards that govern your business. Then, budget sufficient time and money to train your team so that they understand and comply with the regulatory standards completely. Establish and maintain complete training records for each employee to prove to an auditor that your staff is well trained and that they do what you say they do.

At regular intervals, review the regulatory standards that govern your business and revise and update employee training in response to changing standards as needs require. To prevent complacency from slowly creeping into your process and to demonstrate your on-going commitment to quality, hold occasional training sessions that refresh the skills of your employees.

3. Control, Track and Manage Your Data Electronically

By maintaining complete digital records of your processes, design history file (DHF), device master record (DMR) and bills of materials (BOMs), you demonstrate your commitment to quality, accuracy, and thoroughness. With your SOPs and product data in a secured electronic repository, you can respond to an auditor’s request for any document or record at a moment’s notice. Make sure to implement a proven system for electronic data and document control to maintain data integrity. Auditors will suspect the reliability and security of a home-grown data and document control system.

4. Audit Yourself

Empower your internal auditors to change processes, not just make recommendations. Keep senior management involved in process improvements and ensure that remedial actions happen on time and on schedule. Strengthen your internal auditing processes by hiring external, third-party auditors to perform vigorous mock audits. Not only will this provide you a fully objective analysis of your company’s performance and procedures, your staff will get real-life training in what to expect during a formal audit.

Remember that third-party auditors can have a wealth of experience that can help you improve your company’s processes in many ways beyond passing your audit. Make sure to solicit their input and suggestions for insights on how you can become a better organization.

5. Have the Proof at Your Fingertips

Do not try to evade an auditor’s request for a document or say that you have data you do not have. If you do not have what an auditor wants, admit it. Auditors believe evidence and not people. The faster you can produce evidence that satisfies your auditor, the better the impression he or she will have of your business.

Create complete product history files with all the documents and information — SOPs, BOMs, ECOs, authorizations, reports, reviews, and hurried notes — that prove to an auditor that you “do what you say.” Be able to access your data and documents quickly and easily to demonstrate that your company has tight control over its processes and procedures.

A DHF is a design history file which is a formal document that is prepared for each document. The DHF contains all the documents needs to produce the product. It contains all the design stuff along design review meetings and every small thing required. It should contain all the SOP's required for it and all the documents should have the current revision in the file. To ensure that the DHF is audit ready, make sure all documents are in order and have the updated revision(printed and electronically) and the training for the SOP's is done also. One key factor is for any audits to have everything ready to be given but should not give out too much information. Only give what the auditors are asking for. That is the main thing I have learned from participating in the previous audits. Audits maybe be overwhelming but having everything proper will ease the auditing.

Being preparing for an audit is the best way to tackle an assessment. The first way to prepare is to actively start early. As DHF is being processes starting your traceability matrix from day one will make is a lot easier to prepare for the Audit. An audit can happen at anytime and being ready for it at anytime can save a lot of time and stress. Another thing is transparency of the DHF, everyone involved in the process should have access to the documents so there can be active and fluid updates. Lastly, having internal audits can also be beneficial. With internal audits, the repercussions are not as severe and mistakes can be caught early on. One can never be over-prepared, therefore using all tools can translate to a more successful audit.

Since the DHF is important for both informative purposes and audit it is essential that the file maintain accurate information as a "living document". The best step towards this is having a dedicated team in the product development phase assigned this task. In larger companies the roles that employees have are multi-purpose and there are dedicated teams for reviewing and ensuring that information is accurate. This is true for most lifecycle management roles ranging from design controls to change controls. Therefore, the best course of action is ensuring that employees oversee the accuracy of the DHF file. While an internal audit is a good idea if there is any doubt in the accuracy of design control files, it should be avoided as a last ditch effort. Personally I have been through some internal audits as a preemptive measure and from my experience it drains a lot of resources away from key projects as an internal audit is just as thorough and can take a great amount of time and effort.

Design History file (DHF): Is a file that contains almost all the document from DID,DSD,DOD etc basically when you go back and look at this file you get to know all about the product development. It needs to be necessary that this documents needs to be updated all the time so that anytime even during product development you can refer a DHF. Since DHF is a document which contains so many documents within one document. We needs to make a checklist of all the documents under it and keep an eye on the project development throughout the development stage so that any changes that needs to be updated in the any related document would also be updated in the DHF.

For making sure that DHF is audit ready.
Company needs to make sure they have Mock audits on regular basis and before Mock audit QC should ensure that DIf,DOF have specified all specs in tolerance and if anything needs to be updated they are updated before the mock Inspection. If company has this mock inspection on regular basis rather than few just before inspection that could lead to consequences due to last minute changes and some changes might not be reflected on DHF which would be fatal.

So in order to make sure DHF is audit ready:
Make a checklist of all documnets required in DHF.
Have regular Mock Inspection.
Make QC have reqular inspection of any changes in DIF or DOF.
Make sure department notifies regulatory of any changes in Related documents.
Update DHF with any changes.

According to the FDA, “the design history file shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part (21 CFR Part 820.30). Each manufacturer shall establish and maintain a DHF for each type of device.”
I came across this interesting article on “How to Prepare Your Design History File for an FDA Inspection”. Main points on common mistakes to avoid include:
1. “The Unruly File”
Having a disorganized file folder will mean the company will trouble finding the pertinent information, which may lead the FDA to believe that something else could be missing. So make sure the DHF is organized.
2. “Paper Problems”
The most common format for a DHF is still paper and having multiple papers, you may lose one along the way and sometimes signatures or sections can be left incomplete so the article stresses the importance that DHF should always be accurate and updated.
3. “The Overcompensating DHF”
As the article states, another common mistake are that the company will add everything they possibly can to the DHF including business-related items which do not relate to safety or efficacy. It goes on to say that a DHF should fit with a project file and focus on design control activities that demonstrate you’re following 820.30.
4. “No Traceability Matrices”
One of the key components of the design controls are the traceability matrices, which represent and lay out a roadmap of what’s in your DHF and shows the relationship from design control activities and can act as an important tool to keep team members on the same page. The FDA inspector will appreciate if you have a traceability matrice and can understand how everything works/is related.
5. “Constructing A Traceability Matrix Late in Development”
As the article mentions it’s important to create a traceability matrix at the beginning of a project to create transparency among the company on what needs to be done.
Overall the article states the importance of organization and keeping accurate records and treating the DHF as a “living” document.

I haven't really had experience dealing with DHF documents but in the past we have kept all our important documents in SharePoint and that has been very helpful. It provided us a place to upload and make the latest documents available to rest of the group. I think if DHF document is maintained by the project manager then it would be up-to-date with the his information. We had also hired another audit company who asked us for the financial records time to time to make sure we are on the track, perhaps this task can also be performed with DHF files.