We're a small medical device manufacturer, but we recently updated our Change Management workflow in Arena PLM to meet the ISO 13485:2016 requirements of integrating risk management into the design change process. We have the workflow set up in 4 sections:
Change Description and Rationale, Change Level Assessment, Risk Management / Validation & Verification, and
Implementation Plan. I've pasted the fields below.
ECO Title
Change Description
Change Rationale
<Provide the rationale for the change, the change level and implementation class. This may include test reports, FMEA, etc. Describe validation or verification plans or provide a rationale for why they are not needed. Additional files can be added in the Files View of the Change later in the workflow, if needed. >
Change Level Assessment
Technology Change Assessment
Control mech/operating principle/Energy type changed? Select one... YES NO
Formula Impact Assessment
Formulation changed? Select one... YES NO
Sterility Impact Assessment
Material/permeability of a sterile barrier changed? Select one... YES NO
Fluid Path / Biocompatibility Assessment
Material of a fluid path component changed? Select one... YES NO
EO Cycle Impact Assessment
Product density changed beyond validated range? Select one... YES NO
Specification Assessment
Release Criteria/Specification changed? Select one... YES NO
Labeling & Claims Assessment
Product claims changed? Select one... YES NO
User/Design Requirements Assessment
Ability to meet User & Design Requirements impacted? Select one... YES NO
Supplier of a critical component or finished good assembly changing? Select one... YES NO
<New suppliers for critical components or finished good assembly may require validation and/or verification.>
Other reason to elevate change to MAJOR? Select one... YES NO
<If YES, document the rationale for elevating the change to MAJOR in the Change Level Notes field.>
Change Level Assessment Notes
<If the change is Major due to some other factor, describe the rationale here.>
Change Level Select one... MINOR MAJOR
<If the answer to any of the above questions is "YES", the change level should be MAJOR.>
Risk Management / Validation & Verification
Risk Management File Review Outcome Select one:
- Minor Change. RMF Review not required.
- RMF Reviewed. No changes required.
- RMF Reviewed. See comments below for required updates.
<Document the review and outcome. If updates are required to the RMF, describe them in the comments section below.>
Risk Management File Notes
<Add notes here if changes are required to the RMF.>
Validation/Verification Assessment Results Select one:
- Minor Change. V&V not applicable.
- No additional V&V required. See rationale below.
- Additional V&V is required as described below. V&V results will be attached to the ECO.
<Review User/Design Requirements as part of the V&V assessment.>
Verification and Validation Notes
<N/A if Minor change. Describe rationale if Major change does not require V&V or describe plan for V&V of Major change.>
Implementation Plan
Customer notification required? Select one... YES NO
<Advance notification of some major changes may be required by some customer contracts.>
Regulatory notification required? Select one... YES NO
<Regulatory Impact Assessment>
Supplier Notification Required? Select one... YES NO
<if needed, SME will contact supplier to share the new drawing or requirement document.>
New Supplier required? Select one... Yes No
<If supplier is not yet approved, complete evaluation and approval per QMS-PR-7401.>
ERP Update required? Select one... YES NO
<Materials Manager will coordinate with Accounting using Form QMS-FR-4203.>
Training Required? Select one... Yes No
<QA will coordinate ORS training unless otherwise specified in the Implementation Notes.>
Implementation Class Select one...
Class 1 Class 2 Class 3 Class 4
<Refer to QMS-PR-4204 for implementation class.>
* Implementation Notes N/A
<Describe the implementation plans. Evidence of implementation can be added to the Items, Files or Implementation tab of the ECO as appropriate.>
------------------------------
Christopher Hill MBA, CQE, RAC
Director of Quality
Bolingbrook IL
United States
------------------------------
Original Message:
Sent: 05-Nov-2018 12:11
From: Anonymous Member
Subject: Change request form/template
This message was posted by a user wishing to remain anonymous
Wondering if there is a best practice for implementing changes in the Medical device/IVD industry. For example a comprehensive change request form that is used to identify, assess and implement a Design change?
Thanks for sharing your input.
A