Design Output

The blog is about design output, another important part of design control. Another concept that should be remembered is

Design Inputs = Design Outputs

There should be a procedure to handle how to deal with design output. Product design output consists of documents, samples, models, math data, software, testing results, specifications etc., that specify the device and its manufacturing, packaging, labeling, installation, and servicing; as well as product acceptance criteria. The following categories of specifications are typically, but not limited to be included in design output:

·       Product specifications,

·       Assembly Drawings,

·       Specifications for purchased products,

·       Manufacturing process specifications,

·       Packaging specifications,

·       Labeling specifications,

·       Installation specifications,

·       Work Instructions,

·       Software Code,

·       Quality Assurance Specifications and Procedures,

·       Maintenance and servicing specifications,

·       Bioburden test results,

·       Biocompatibility test results,

·       Result of Risk Analysis,

·       Product acceptance criteria (purchased, in-process and final)

Design output documents are included in the Device Master Record (DMR). DMR is a compilation of all records that contains procedures and specifications of a FINISHED product.

Per FDA Section 21 CFR 820.181 which states that “Each manufacturer shall maintain device master records”, therefore DMR is part of a requirement.

Design output is expressed in terms that can be verified against design input requirements. Design verification will be blogged later.

Design output documents are reviewed and approved before release during intermediate and final design reviews.

Verification that design output meets the design input requirements is important. When such verification involves calculations or other engineering methods, it is carried out as a design verification activity. When it is a more qualitative evaluation and can be conducted by a design review meeting. 

Ensure that individual design output documents are complete, correct, and are not in conflict with each other. A designated associate shall carry out this checking activities.

Results of reviews carried out by the design review meetings are documented in minutes of the meetings. Results of other reviews and verifications are documented by signoffs on the reviewed documents, memos and reports.

There should be a project manager to oversee all the design control activities. He or she must approve and release design output documents.

Before approving the documents, the project manager verifies that all required reviews have been carried out with satisfactory results, and completes the reviews.

Design output documents are controlled. Their establishment, review, authorization, issue, distribution, and revisions are carried out in accordance with  procedures which handle Control of Documents and Device Master Record.

Approvals of design outputs are evidenced by the project manager dating and signing the Document Change Order releasing the design output documents. Then the manufacturer has a finished product until there are changes which warrant another update of the DMR and slightly change the medical device. The whole or partial process is repeated.

Reference	Criteria
21 CFR 820.30 (d)	Has the company established and maintained procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements?
21 CFR 820.30 (d)	Do design output procedures contain or make reference to acceptance criteria and ensure that those design outputs that are essential for the proper functioning of the device are identified?
21 CFR 820.30 (d)	Is design output documented, reviewed, and approved before release?
21 CFR 820.30 (d)	Is the approval, including the date and signature of the individual(s) approving the output, documented?

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.