Independence of DQA (Design Quality Assurance)

#1
Ussually the Design Quality Assurance is under the responsibility of the QM organization. Nevertheless I have heard about setups where DQA is under the R&D organization. Is there any larger Company structured like this? What are the measures to ensure Independence?

Any info would be highly appreciated

Thanks

Carsten
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
The setup I'm familiar with is R&D being directly responsible and QA having oversight and being involved hi-level (e.g. participating in SOP development and approving design control documents). Independence is guaranteed through design reviews (where at least one independent reviewer is mandated, many times it's someone from QA not connected to the specific project). I've seen this setup in >90% of the orgs I worked with/for, in all sizes of orgs.
 
Thread starter Similar threads Forum Replies Date
T ISO 13485 - 5.5.1 Responsibility and authority - Small Company Independence ISO 13485:2016 - Medical Device Quality Management Systems 13
J ISO 17020 concerns of independence & impartiality of services Other ISO and International Standards and European Regulations 1
lyobovnik Matters being audited, independence, participation and direct responsibility 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D How to ensure independence and authority necessary to perform QM tasks ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A ISO 13485 - Internal Auditor Independence and Process Owners ISO 13485:2016 - Medical Device Quality Management Systems 3
Ronen E Independence on Notified Bodies, inter alia of Manufacturers they Assess EU Medical Device Regulations 7
P Happy Independence Day - India Coffee Break and Water Cooler Discussions 1
R On Auditing Internal Audit Process - How Independence can be Established Internal Auditing 4
Howard Atkins Happy Indian Independence Day Covegratulations 3
Marc Thomas Jefferson, co-author of the United States Declaration of Independence Coffee Break and Water Cooler Discussions 1
T Quality Staff - Independence (ISO 13485 Clause 5.5.1) ISO 13485:2016 - Medical Device Quality Management Systems 1
Ajit Basrur India celebrates 65th Independence Day World News 6
sagai Organizational Independence of the Quality Division 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
A Mexico is Celebrating 200 years of Independence and 100 of revolution Coffee Break and Water Cooler Discussions 8
Stijloor Charlotte, NC - Our Independence is in trouble... Funny Stuff - Jokes and Humour 17
somashekar Independence Day - India - August 15th Coffee Break and Water Cooler Discussions 8
A Internal auditors independence & integrity Internal Auditing 9
M Internal Auditing Independence Rule - Can someone provide a good interpretation Internal Auditing 20
L Registrar Customer Learning Session-Independence Ohio Coffee Break and Water Cooler Discussions 2
W Happy Independence day America Coffee Break and Water Cooler Discussions 4
E Being IQA Team Leader and auditee - Auditor Independence General Auditing Discussions 9
G 4th OF JULY - USA's Independence Day Coffee Break and Water Cooler Discussions 15
Raffy Internal Auditing - Showing independence of process being audited Internal Auditing 4
P Internal auditor independence Internal Auditing 4
Z Software for design control ISO 13485:2016 - Medical Device Quality Management Systems 3
E Design and Development file Procedure ISO 13485:2016 - Medical Device Quality Management Systems 0
DuncanGibbons Section 8.3 relevant for design organisations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
P DFMEA - Machinery Design Best Practices FMEA and Control Plans 0
R Is a FAIR required on parts that we design? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
A 8.6 Release of products and services, 8.3 Design and development - evidence required ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
C Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
J Significant change related to design and intended use EU Medical Device Regulations 3
S Traceability of requirements to design and risk Design and Development of Products and Processes 3
U NOC - What is considered a "design change" EU Medical Device Regulations 5
Q PPT used as Design Review ISO 13485:2016 - Medical Device Quality Management Systems 3
D Design Verification Sample Size vs Repeats Statistical Analysis Tools, Techniques and SPC 9
A Design and development procedure for API Spec Q2 Oil and Gas Industry Standards and Regulations 6
D Design controls - Inputs, outputs, V&V, DHF, DMR ISO 13485:2016 - Medical Device Quality Management Systems 10
LostLouie Manufacturer divorced from Design process, is he justified in design process deficiencies? ISO 13485:2016 - Medical Device Quality Management Systems 9
R DFA & DFM - Examples for Design for assembly and design for manufacturability Lean in Manufacturing and Service Industries 2
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 6
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
M API 4F/7K/8C Design Package Validation Oil and Gas Industry Standards and Regulations 2
A Design History File - Not ready to share the design drawings or Bill of Material US Food and Drug Administration (FDA) 2
W Need for current design or process control FMEA and Control Plans 2
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom