cGMP – Design & Development Review Principles (9)

Rami.Azulay July 1st, 2019 Posted by Rami Azulay( ) Requirements Management Tool

It is quite essential to have a formal design review process. When designs are made or put in place, it is of utmost importance that they are reviewed. A formal review process will help you critically analyze a design in its entirety.

Design Review

This consists of a documented evaluation of the design. It is a comprehensive and also a very systematic process. A design review possesses the data gotten after the proper examination of a design. In a nutshell, it seeks to also carefully evaluate the adequacy and/or capabilities of the design requirements.

One of the most important reasons why a design review is a must is because it will help to identify the problems in the design. While that is really a plus, it is not its only function as it can also help to implement corrective actions to said problems. Design reviews are usually enforced at a more specific/critical stage of the design. However, there are a few other instances that may warrant a design review.

Uses of a Design Review.

The necessity of a design review cannot be overemphasized and this is because it can be used to achieve the following;

  1. Project Progress – In order to formally determine the progress level of a design project, you will need to conduct a design review.
  2. Provide Feedback – A design review helps to provide a comprehensive analysis of the design. This feedback can be used to generate useful data during the design process.
  3. Notification of Emerging Problems – A design review is still your best bet in discovering problems that may arise in a design project. It serves as a check and balance system during the design process.

Orcanos Design Review System

Factors that Influence the Phases of a Design Review.

There are two major things that directly influence the number of phases in a design review. They include;

  1. The Organization – The organization responsible for the design would usually have their own unique parameters or systems in place when making a design. Depending on the bottlenecks in the design process as per the organization’s procedures, a design may have a single or multiple phases in its design review.
  2. The Complexity of the Product – For a simple product with minimal interfaces, it is possible to have a design review with only a single phase. However, if the product is a complex one, it follows that it would generate more than one phase due to its numerous interfaces and sub-systems.

Design Freeze.

This simply refers to a stage in the design review process where design cannot accommodate any more changes. However, this stage will only allow changes if a formal change is made to the design.

Orcanos Freezing Mechisim

Collection of Reviews.

A diverse number of reviewers are typically required when conducting a design review. When orchestrating a review, it should be a collective one where the reviewers are both in-house and external. This would allow for an unbiased examination and final judgment on the design. These reviewers should be in fields such as;

  1. Electrical engineers; a reviewer with a good understanding of electrical appliances and how they work will be essential to a team of reviewers.
  2. Software engineering; one with expertise in this field would be a viable option for a review team.
  3. Manufacturing; this goes without saying as whatever is being designed will eventually need to be manufactured. 
  4. Quality assurance; someone needs to be able to check the quality status of the design.
  5. Regulatory affairs; guidelines must be followed and the necessary rules adhered to and this is where someone with such skill comes in.
  6. Mechanical engineering; this reviewer will be capable of understanding the mechanics of the product.

Others include reviewers in marketing and clinical and also customers (either through direct or indirect participation). Lastly, an important member of the team is the independent reviewer who bears no direct responsibility but has a technical understanding of the device and brings a fresh perspective to the table. 

Systematic Process.

We have said that the design review follows a systematic process that allows for the documentation of the progress of the design. Should there be any need to update the design, the new changes would have to be effected in the design input document. Depending on the level of changes made, there may also be a need to redesign the product or simply change the labeling.

 

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About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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