Regarding the design plan: We certainly are required to have that before we begin our work as Naveen says. And FDA's statement about when design controls start (approval of design inputs) can be misleading because the design plan needs to be approved before going into the design input phase. Ultimately, a general chronology of document completion (and thus DHF records) is:
- Concept phase [Not required by the design control regulation but should be part of your SOP and thus should be made mandatory by way of SOP. The systems I build prescribe a Product Concept Document (PCD)].
- Design Initiation Authorization (DIA) form
- Design Plan record and approval
- Design Inputs record and approval
- And so on that is beyond the scope of this post.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 10-Aug-2023 10:05
From: Kevin Randall
Subject: Essential DHF Documentation for Design Control
A key factor is that FDA design control requirements don't apply to the research and concept phase. Think "R" of R&D. But once we reach the "D" step, design controls generally apply. FDA says that design control begins with development and approval of design inputs. FDA tells us to document the flow of the design process so that it is clear to the FDA investigator where research is ending and development of the design is beginning. Accordingly, the general expectation is that once a concept is proven, then the firm's "official" statement of its intent to pursue development is the first required document to begin design controls and thus the first required document for your DHF. Your design control procedures should incorporate these principles and practices.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 10-Aug-2023 06:34
From: Anonymous Member
Subject: Essential DHF Documentation for Design Control
This message was posted by a user wishing to remain anonymous
Can anyone advise on the essential DHF documents that must be approved prior to start of design control (product is class II in US)? Per US FDA, design control should start with the approval of design inputs if the business hasn't determined to formally start sooner, correct? I know approved DDP, Risk Management Plan, and Software Development Plan are essential but are there other DHF deliverables that are hard requirements to start? Thoughts or direction on resources welcome. Thank you!