Sample Design Plan that complies with FDA QSR, ISO 13485 & 14971.

H

Harry17

Hello, my name is Harry. I am new to the Forum and may not be in the correct place. I have found all of your posts very helpful. I have been given the job of writing a Design Control Procedure for our medical device company. I am having trouble constructing a Design Plan section. Does anyone have an example I could view? I need to comply with the FDA QSR and ISO 13485/ISO 14971. Thank you.
 

harry

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Hello, my name is Harry. I am new to the Forum and may not be in the correct place. I have found all of your posts very helpful. I have been given the job of writing a Design Control Procedure for our medical device company. I am having trouble constructing a Design Plan section. Does anyone have an example I could view? I need to comply with the FDA QSR and ISO 13485/ISO 14971. Thank you.

Any takers for this??
 

WEHTTAM

wehttam
DESIGN AND DEVELOPMENT PLANNING-FROM FDA WEBSITE- http://www.fda.gov/cdrh/comp/designgd.pdf

Developing a new device and introducing it into production are very complex tasks. For many new devices and associated manufacturing processes that use software, these tasks are further complicated because of the importance of software, and the possibility of subtle software errors. Without thorough planning, program control, and design reviews, these tasks are virtually impossible to accomplish without errors or leaving important aspects undone. The planning exercise and execution of the plans are complex because of the many areas and activities that should be covered. Some of the key activities are:


determining and meeting the user/patients requirements;
meeting regulations and standards;
developing specifications for the device;
developing, selecting and evaluating components and suppliers;
developing and approving labels and user instructions;
developing packaging;
developing specifications for manufacturing processes;
verifying safety and performance of prototype and final devices;
verifying compatibility with the environment and other devices;
developing manufacturing facilities and utilities;
developing and validating manufacturing processes;
training employees;
documenting the details of the device design and processes; and,
if applicable, developing a service program.
To support thorough planning, the QS regulation requires each manufacturer to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation.


The plans should be consistent with the remainder of the design controls. For example, the design controls section of the quality system requires a design history file (DHF) [820.30(j)] that contains or references the records necessary to demonstrate that the design was developed in accordance with the:


1. approved design plan, and

2. regulatory requirements.


Thus, the design control plans should agree with, and require meeting, the quality system design control requirements. One of the first elements in each design plan should be how you plan to meet each of the design control requirements for the specific design you plan to develop; that is, the design plans should support all of the required design control activities. Such plans may reference the quality system procedures for design controls in order to reduce the amount of writing and to assure agreement.


Interface


Design And Development Planning section 820.30(b) states:


"The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process..."


If a specific design requires support by contractors such as developing molds, performing a special verification test, clinical trials, etc., then such activities should be included or referenced in the plan and proactively implemented in order to meet the interface and general quality system requirements. Of course, the interface and general requirements also apply to needed interaction with manufacturing, marketing, quality assurance, servicing or other internal functions.


Proactive interface is a important aspect of concurrent engineering. Concurrent engineering is the process of concurrently, to the maximum feasible extent, developing the product and the manufacturing processes. This valuable technique for reducing problems, cost reduction and time saving cannot work without proactive interface between all involved parties throughout all stages of the development and initial production program.


Structure of Plans


Each design control plan should be broad and complete rather than detailed and complete. The plan should include all major activities and assignments such as responsibility for developing and verifying the power supplies rather than detailing responsibility for selecting the power cords, fuseholders and transformers. Broad plans are:


easier to follow;
contain less errors;
have better agreement with the actual activities; and
will require less updating than detailed plans.
Over the years, several manufacturers have failed to follow this advice and opted for writing detailed design control procedures. They reported being unable to finish writing the over-detailed procedures and were unable to implement them.


Regardless of the effort in developing plans, they usually need updating as the development activities dictate. Thus, the QS regulation requires in 820.30(a) that the plans shall be reviewed, updated, and approved as the design and development evolves. The details of updating are left to the manufacturer; however, the design review meetings are a good time and place to consider, discuss and review changes that may need to be made in the design development plan.
 

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R

Roland Cooke

Hi Harry,

Whilst I have seen some some truly excellent R&D operations, my general experience is that R&D and good quality system management are often uneasy bedfellows!

This happens for a variety of reasons:


R&D is full of whacky, paper-hating, scientists and engineers.

Unlike routine manufacturing operations, R&D projects almost always change from the original path before completion.

The lovely step-by-step flowchart that the quality guy foists onto the R&D department fails to take account of the fact that some activities will inevitably run slower or faster than expected.

People fail to handle "design review" in a real-world way

The R&D project is well on the way to completion before someone suggests having a quality system to control design and development might be a good idea...


I am sure this list is not conclusive!

The good news is that all of the above is manageable, if people come together with a realistic understanding of what is expected, and how everything (including the unexpected!) will be handled and overseen.
 
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inquisit

Hi, I;m inquisit from us trying to create a Quality manual from scratch for a medical device importing company.That was very useful as it;s so confusing which to adapt from which.:nope:
Joining this site can be a life saver as I'm sure to have questions & q's as I go to each Sop. Thanks,
 
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