How to establish a Design History file (DHF)?

C

celia4237

#1
Hello everyone

Nowadays, i am trying to understand what should be included in the DHF because QSR 820 only has one sentence about the requirement of DHF.

Is there anyone who can help me, and give me some practical example about the establishment of DHF?

Thanks a lot.
 
Elsmar Forum Sponsor

harry

Super Moderator
#2
Some of the discussions and attachments in the 'Similar Discussion Threads' box (just scroll down the page) below should be helpful.
 
C

Chris Ford

#3
Hello everyone

Nowadays, i am trying to understand what should be included in the DHF because QSR 820 only has one sentence about the requirement of DHF.

Is there anyone who can help me, and give me some practical example about the establishment of DHF?

Thanks a lot.
It depends on what's practical to include in your DHF. I've seen DHF's that look strikingly like DMR's - simple indexes. All of the various documents and records were spread out in the companies' filing systems.

I don't recommend assembling a DHF in this manner. It's not difficult to determine what to actually put into your DHF binder(s) / files. Basically, include all of your design control records. This will most likely create multiple volumes for your DHF, but it's an easy way to take a walk down memory lane and see every step of the design. In the end, your DHF should be a direct reflection of your design control processes - it makes for a simple validation that your design control process was followed, and it allows quick and easy access to everything you need.

If your device contains components like software, you probably won't include every line of code in your DHF - rather, there may be a disk or a reference to location where the code is maintained and controlled.

Hope that helps.

Chris Ford
 
C

celia4237

#4
Thank you Chris!

I think the way you recommend is practical and makes me feel a little relaxed, because DHF is only a compliation of the record from the process of design control. So i think what i really need to do is to collect all the record of design control in the phase of design validation, is it right?

By the way, there is another point which i get confused about, that is, does the DHF have to include all the version of the design history record? cause you know, in the process of design, it will produce many record, some of them may be replaced by the new one? Do i have to keep the old version?

Thanks a lot!
 
C

Chris Ford

#5
Thank you Chris!

I think the way you recommend is practical and makes me feel a little relaxed, because DHF is only a compliation of the record from the process of design control. So i think what i really need to do is to collect all the record of design control in the phase of design validation, is it right?

By the way, there is another point which i get confused about, that is, does the DHF have to include all the version of the design history record? cause you know, in the process of design, it will produce many record, some of them may be replaced by the new one? Do i have to keep the old version?

Thanks a lot!
You're welcome, Celia. In my experience, the vast majority of the documents in the DHF will change throughout the course of the design. Sometimes, the design control procedure changes along the way, as well. I think no one would disagree that "change" is just a part of everyday life in design and development.

Though, I can't think of a reason that you'd remove anything from a DHF. It's all documenting the life cycle, and that includes the changes. Some items in the DHF will probably be subject to the document control procedure. Others will be controlled by the design control requirements. For example, most companies I've audited don't require the project plan to go through Document Control. But the design control requirement states that the project plan must be reviewed and approved. In some cases, someone creates the plan, and signs it, then sends it to a qualified reviewer for review and approval. Then it's official and they move on. When it's updated along the way, they repeat the same process. You can have just one reviewer/approver or as many as you want. You could (I've seen it several times) make everything subject to Document Control, as well.

But yes, you'll collect the documents for your design validation phase, but you'll also include all of the documents from the other phases, as well. Here's design control in a nutshell - go to the reg for specifics (lots of nuances here).

Define your process
Include the phases of the life cycle, when they're reviewed, who's responsible, etc. This is often done as a set of procedures, because this is a very lengthy requirement encompassing a broad area. We're going from a basic idea to putting a product on the market all in one regulatory requirement.

Follow procedures
The design control system will encompass many procedures. The larger the market, the greater the regulatory requirements. Depending on your product, design methodology, the market and the level of concern of the device, you'll need to alter your design control system periodically. As you follow the procedures, you'll generate records. I typically find that most companies store all of their design control documents in a series of binders labeled with the appropriate design control phase.

Phase reviews
Conduct phase review meetings as defined in your procedures. The phase review is usually placed at the top of the first binder in a set for a phase. It serves as a cover sheet. It doesn't need to be done this way. I've just seen it done a lot, and I think it's a good idea.

Changes
Based on the type of documents that will be generated in the design control system, you'd retain every version in your binders. So, in other words, I'd recommend maintaining a copy of a down-rev validation protocol, even if it weren't executed. Unless, of course, the changes were minor. This is just a personal preference, though.

Retrospective DHR
I can't tell you the number of times I've been retained to create a design control system around a product that was designed under no set of controls, had no approvals, etc. Depending again on the level of concern of the device, I'd approach it differently. If a quality system exists, but the design control procedure wasn't followed or didn't exist, I'd probably document it in the CAPA system, then reference the CAPA number on the DHF records to provide traceability back to a corrective action and demonstrate that it was addressed. If the company doesn't have a quality system at all, I'd probably establish the design control system, and document the rationale on a memo-to-file to the DHF. At any rate, I'd pull all of the documentation necessary to demonstrate design controls were followed, conduct the phase reviews, and file all of it together with the memo-to-file.

So, long story short, I hope this helps you out.

Chris Ford
 
C

celia4237

#6
Thank you Chris!

It is very detail direction with a lot of practical experiences. It is very kind of you to give a lot of help. Thanks again.
 
W

WisdomseekerSC

#8
I have just started a new job and have been tasked with establishing and implementing ISO 13485 for Biomaterial Product line used as components for medical devices. We do a great deal of design & development for implantables. I have reviewed some of the company's DHF that are compliant with ISO 9001. Is there any additional information I need to include in the future for ISO 13485? Do I need to go back and update any of the past files for components to be marketed under the ISO 13485 registration? As a contract manufacturer of components for medical devices, what level of risk management are we responsible for?

Recommendations welcome!
 
C

Chris Ford

#9
I have just started a new job and have been tasked with establishing and implementing ISO 13485 for Biomaterial Product line used as components for medical devices. We do a great deal of design & development for implantables. I have reviewed some of the company's DHF that are compliant with ISO 9001. Is there any additional information I need to include in the future for ISO 13485? Do I need to go back and update any of the past files for components to be marketed under the ISO 13485 registration? As a contract manufacturer of components for medical devices, what level of risk management are we responsible for?

Recommendations welcome!
Hi Wisdomseeker,

If your company is designing and manufacturing FDA Class III medical devices as a contract manufacturer, you're subject to the FDA establishment registration requirements. If you're selling the product internationally, you'll need to conform to the requirements of the appropriate Directive or legislation for licensing and distribution of medical devices in their countries. Depending on the country, there may be additional requirements and/or labeling.

13485 places a greater emphasis on documentation requirements, especially in the areas of verification, validations, clinical trials, risk management, etc. Below are the differences between ISO 9001:2000 and 13485:2003 for design and development.

7.3.1 Design and development planning

The organization shall establish documented procedures for design and development.

Planning output shall be documented, and updated as appropriate, as the design and development progresses (see 4.2.3).

NOTE Design transfer activities during the design and development process ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications.

7.3.2 Design and development inputs

Inputs relating to product requirements shall be determined and records maintained (see 4.2.4).

These inputs shall include
a) functional, performance and safety requirements, according to the intended use,

e) output(s) of risk management (see 7.1). These inputs shall be reviewed for adequacy and approved.

7.3.3 Design and development outputs

Records of the design and development outputs shall
be maintained (see 4.2.4).

NOTE Records of design and development outputs can include specifications, manufacturing procedures, engineering drawings, and engineering or research
logbooks.

7.3.4 Design and development review

Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed, as well as other specialist personnel (see 5.5.1 and 6.2.1).

7.3.6 Design and development validation

Design and development validation shall be performed
in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified
application or intended use. Validation shall be completed prior to the delivery or implementation of the product (see Note 1).

Records of the results of validation and any necessary actions shall be maintained (see 4.2.4). As part of design and development validation, the
organization shall perform clinical evaluations and/or evaluation of performance of the medical device, as required by national or regional regulations (see Note 2).

NOTE 1 If a medical device can only be validated following assembly and installation at point of use, delivery is not considered to be complete until the product has been formally transferred to the customer.

NOTE 2 Provision of the medical device for purposes of clinical evaluations and/or evaluation of performance is not considered to be delivery.
 
W

WisdomseekerSC

#10
More questions...We are developing a new line of tubing that will be absorbable and used as a part of a medical device manufactured by others. If I understand correctly, risk management for us would be mostly focused on our production process and the device manufacturer would be responsible for the risk associated with their final device, including biocompatibility and clinical trials, etc. I do not know what classification their device(s) will be. We are using raw materials that have a proven saftey record for use in humans. We do not install or service our product. Do we need documentation from the final device manufacturer in our DHF? Our material can and will be used by more than one manufacturer (unless, of course, it is a custom make). :read:
 
Thread starter Similar threads Forum Replies Date
C How to Establish the Calibration & Measurement Capability (CMC)? ISO 17025 related Discussions 1
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
O How to establish Datum Planes with two cylinders? Various Other Specifications, Standards, and related Requirements 0
H How to Establish and Document Competence of Employees in a Small Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
shimonv 21 CFR 820.20(d) says: Each manufacturer shall establish a Quality Plan 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K Historical Data to establish Control Limits Manufacturing and Related Processes 4
R Does "establish, implement and maintain a procedure" require a Document - OHSAS 18001 Occupational Health & Safety Management Standards 1
S How to establish a Sampling Plan from the Rework percentage? AQL - Acceptable Quality Level 6
T To establish ISO 9001:2008 in a ISO 17025 accredited Company ISO 17025 related Discussions 4
G Characterization Studies: Analyzing Data to Establish Conclusions Statistical Analysis Tools, Techniques and SPC 1
F FAA Letter of Need to establish Continuing Need Federal Aviation Administration (FAA) Standards and Requirements 1
B Airbus to establish assembly line in United States AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
G NADCAP - How do I establish if a process is covered? Manufacturing and Related Processes 3
D Establish a Documented Procedure (4.2.3) vs. Establish Process (7.6) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Q How to Establish Microbiological Limits in Foods Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
R How to establish Quality Objectives per TS 16949 Clause 5.4.1 Requirements IATF 16949 - Automotive Quality Systems Standard 7
K How to establish critical limit for Critical Control Points (CCPs) Food Safety - ISO 22000, HACCP (21 CFR 120) 7
L Criteria to Establish a Relevant Due Date for Closing Corrective Actions Internal Auditing 8
Z How to Establish a Process in Terms of more Added Value? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Z Can we establish system documents with VIDEO or HUMAN? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T How to Establish Internal Quality Control Planning APQP and PPAP 4
T How to establish KPI Disposal and Follow Up Process Quality Tools, Improvement and Analysis 7
G Quality Policy Requirements - Establish and implement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C How should I establish Quality Systems in my small company Manufacturing and Related Processes 7
C The organisation shall Establish, Implement & Maintain a Procedure(s)? ISO 14001 ISO 14001:2015 Specific Discussions 21
C Do I have to establish a software validation procedure? Qualification and Validation (including 21 CFR Part 11) 11
R Anyone know how to establish one piece flow in apparel industry? Lean in Manufacturing and Service Industries 9
M How to Establish criteria for acceptance of products ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Ajit Basrur FDA on path to establish offices in China US Food and Drug Administration (FDA) 0
H Is it possible to establish a new subforum for TL9000? TL 9000 Telecommunications Standard and QuEST 7
Z How to Establish Quality Manual Not Following the Structure of the Standard? Quality Management System (QMS) Manuals 3
Z How to Establish Quality Policy Based on Vision of Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
Q How can I Establish a New Medical Device Laboratory? ISO 13485:2016 - Medical Device Quality Management Systems 12
Z How to Establish a TS 16949 QMS in an ISO 9001 Registered Company? IATF 16949 - Automotive Quality Systems Standard 2
Z How to Establish Simple and Efficient Procedures and Operating Instructions Document Control Systems, Procedures, Forms and Templates 16
A Establish a New Quality System based on Lean - Starting A Late Career in Quality Lean in Manufacturing and Service Industries 7
R What statistical method to establish a specification? Statistical Analysis Tools, Techniques and SPC 16
T How to establish the 4M (Man Machine Method Material) change control Manufacturing and Related Processes 5
C How to establish an effective ISO/TS16949 System? IATF 16949 - Automotive Quality Systems Standard 2
A How to establish linkage between specs/control plan/FMEA/process flow? Document Control Systems, Procedures, Forms and Templates 10
Douglas E. Purdy Acceptability of Perishable Tooling - How do you establish the standards/requirements Various Other Specifications, Standards, and related Requirements 2
apestate Job Shop Inspection and Test - Where should we establish inspections? Why? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 22
Raffy Do we need to establish Quality Objectives per department? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Geoff Cotton Taguchi quality loss function - How do I establish the 'Consumer Loss' element? Quality Tools, Improvement and Analysis 6
DuncanGibbons Section 8.3 relevant for design organisations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
P DFMEA - Machinery Design Best Practices FMEA and Control Plans 0
R Is a FAIR required on parts that we design? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
A 8.6 Release of products and services, 8.3 Design and development - evidence required ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9

Similar threads

Top Bottom