Defining Approvals Required for Design Control Documents

C

C Jones

#1
Associates,
I'm generating templates for design controls per ISO 13485:2016 and FDA 820.30, but am struggling to find any guidance on approvals necessary for different document types.

I know there's some flexibility in who the organization identifies as required signatories on documents per their defined colleague's responsibilities, but does the Agency expect specific representation on DHF documents?

For example, my HFE/UE should probably have a medical/clinical approver, and my pFMEA should have a manufacturing lead, but each likely doesn't require signing off on the other document. Is a QC and regulatory lead required for all design control documents? Author? Project lead? Senior director?

For what it's worth, we're a 3 person startup wearing a lot of hats.

Thank you in advance-
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Regs / standards don't prescribe who has to sign what. It's up to you; do what makes sense.

Do note that if changes are required, per 13485: "changes to documents are reviewed and approved either by the original approving function or another designated function that has access to pertinent background information upon which to base its decisions." (and there's something quite similar in 820).

I recommend that the document types be enumerated in the Design & Development Plan and the requirements for review and approval be listed there. Takes away any guess-work.
 
C

C Jones

#3
Yodon, thank you for the timely response. It was precisely in drafting a DDP template that I noticed this gap in my understanding. Thank you for the confirmation.

In your experience, is it generally advisable to maintain a consistent approval list across all documents in a given DHF because of the 13485 context you cited and the linkages between documents -- and their impact as such.
 

yodon

Staff member
Super Moderator
#4
Not the same approvers for each document in the DHF, necessarily. For example, the Design and Development Plan typically has more approvers since it has the most stakeholders. The Risk Management Plan (and Report) pulls in someone from top management since they're signing up for the company on residual risk. Domain-specific documents (e.g., software architecture) generally are limited to the domain experts. I generally prefer to have quality sign off on most docs since they act as compliance monitor (in my situations) and have a quality eye.

It really depends on the situation. Small companies, like yours generally have fewer approvers and large companies seem to prefer to have more.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#5
Auditors might as you how you deliberate which dept is impacted. It isn't important how you do it just that you do it. So we have an "impacted dept" checklist on our ECO request form for evidence.
 
S

snoopy2017

#6
I have worked in very small startups. Sometimes the author may be the approver (e.g. the quality manager is the author of many documents but the quality manager also signs off on all the QMS documents), but at least get a second pair of eyes, e.g. another decision-maker. Hope it helps.
 

John Predmore

Trusted Information Resource
#7
For what it's worth, we're a 3 person startup wearing a lot of hats.
You should identify document signers as roles for adequate design control, rather than individuals. As your management team grows or you have turnover, you will make fewer revisions to your forms.

Examples of a RACI chart (Responsibility assignment matrix - Wikipedia) may help identify different levels of responsibility/accountability/consultation/involvement, for projects of varying magnitude or complexity.
 
Thread starter Similar threads Forum Replies Date
K Defining risk control measures IEC 62304 - Medical Device Software Life Cycle Processes 14
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
J Defining staff competence - Small mechanical workshop Occupational Health & Safety Management Standards 20
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
T Defining sampling plan for different AQL AQL - Acceptable Quality Level 3
M Defining frequency of measurement tools callibration Calibration and Metrology Software and Hardware 3
M Defining and Documenting Record Retention CE Marking (Conformité Européene) / CB Scheme 5
G Defining performance metrics for DFMA implementation Design and Development of Products and Processes 2
S Defining a Quality System from scratch - Preferred system and documentation names Document Control Systems, Procedures, Forms and Templates 4
A Defining Expected Service Life in Risk Management File Reliability Analysis - Predictions, Testing and Standards 5
K Defining Acceptance Quality Level, I need clarity on AQL 1.5, 2.5, 4.0 AQL - Acceptable Quality Level 5
M Defining the lifetime of orthopedic implants joints Other Medical Device and Orthopedic Related Topics 2
C AS9100 rev D 8.5.1 c 2 - Defining the Machine in-process frequency per ANSI/ASQ Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
V Defining Safety Precautions for Category 4,5 Molecules Occupational Health & Safety Management Standards 2
E European Regulations defining the terms Repair and Refurbish EU Medical Device Regulations 5
T Defining Major vs. Minor Changes to Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
GStough Adequately Defining Which Suppliers to Audit and Frequency Supplier Quality Assurance and other Supplier Issues 8
E Quality Techucuan (Technician) in Electronics - Defining Postion Requirements Career and Occupation Discussions 4
moritz Defining a good Scope for Critical SOPs ISO 13485:2016 - Medical Device Quality Management Systems 7
T Standards for defining audible alarms/warnings for OR instruments IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Defining Critical Vs. Non-Critical Suppliers/Service Providers (API Q1, 9th. Ed.) Oil and Gas Industry Standards and Regulations 2
B IEC 60601-2-24 - Defining Storage Volume IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Defining Sub-Disciplines for Chemical Testing Laboratory Employee Proficiency Testing General Measurement Device and Calibration Topics 1
T Defining Nonconformances in a Service Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Defining Reliability and Confidence Levels Reliability Analysis - Predictions, Testing and Standards 8
J Defining Martial Arts and Gymnastics Statistical Techniques Statistical Analysis Tools, Techniques and SPC 4
V Defining the criteria for equipment to be qualified or requalified Qualification and Validation (including 21 CFR Part 11) 2
R Need help on defining scope for Design Verification File for Class III IVD 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J Defining CCP (Critical Control Points) in a Rice Mill Plant Food Safety - ISO 22000, HACCP (21 CFR 120) 9
S Process Map and defining KPIs Misc. Quality Assurance and Business Systems Related Topics 5
5 Major Nonconformance for not "clearly" defining the "device lifetime" ISO 13485:2016 - Medical Device Quality Management Systems 2
E Defining the lifetime of an Implantable Medical Device Other Medical Device and Orthopedic Related Topics 5
B Defining Expected Oxygen Leakage for Safety Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
G Defining Post Mold Cure Ramp-Down Temperature Manufacturing and Related Processes 2
K Audit Nonconformity on Defining 'Outsourced' Infrastructure Maintenance Quality Manager and Management Related Issues 21
G Points to consider while defining the Quality Policy AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
G Defining Quality Objectives for Product Realization and Design and Development AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Developing Documentation and Defining Processes as Subcontractor IATF 16949 - Automotive Quality Systems Standard 6
C Defining ISO 9001:2008 Scope for a Sterilization Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Defining Skilled vs. Semi-Skilled vs. Unskilled Labor Manufacturing and Related Processes 1
I Defining the scope for ISO 9001 Registration - Software, Hardware and Customer Care ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Product Specification vs. Information Defining Product - The differences? 7.3.3.1 IATF 16949 - Automotive Quality Systems Standard 6
R Defining Interaction of Processes in a Software Company Software Quality Assurance 3
N Where to begin defining and monitoring Quality Metrics in a Machine Shop Manufacturing and Related Processes 9
A Testing Process Audit - Defining a Process Compliance Mechanism Software Quality Assurance 2
R Defining the type of Applied Part - Metal Probe (Applied Part) employs Water Cooling IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N Defining Security Interfaces for Scope for ISMS - Need help IEC 27001 - Information Security Management Systems (ISMS) 10
A Defining the differences between Prototype vs. Production Guidelines? Contract Review Process 5
R Help defining Eyewear Customer Complaint Categories Customer Complaints 5
G Quality Objectives - Where to start defining Quality Objectives? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11

Similar threads

Top Bottom