Resource icon

Development Process: FMEA, Critical Characteristics, Spec Setting and Controls 2023-01-16

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
V Examples of Design and Process FMEA for Pharmaceutical Product Development ISO 14971 - Medical Device Risk Management 7
V Relevance of FMEA in Process Development [Pharma] FMEA and Control Plans 1
M How to apply IEC 62304 Problem Resolution Process for bugs discovered prior to release i.e. during initial development? IEC 62304 - Medical Device Software Life Cycle Processes 2
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
G Strategy for IEC62304 implementation half way into the software development process IEC 62304 - Medical Device Software Life Cycle Processes 9
C IATF 16949 8.3 Exclusion - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 6
M Software Development Company - Who would own the whole process and the certification afterwards? ISO 14001:2015 Specific Discussions 1
S Do we need to validate Software used in Drug discovery and development process? Qualification and Validation (including 21 CFR Part 11) 2
MrTetris Traceability in Medical Sofware Development Process IEC 62304 - Medical Device Software Life Cycle Processes 3
M IATF 16949 Cl. 8.3 - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 1
P ISO 9001:2008 Design and Development Process & Forms examples wanted Design and Development of Products and Processes 3
V Product Development - When to start calculating Process Capability Capability, Accuracy and Stability - Processes, Machines, etc. 3
J Where does process validation fit within design & development? Design and Development of Products and Processes 7
O Design and Development Process - Does one size fit all? ISO 13485:2016 - Medical Device Quality Management Systems 13
L Medical Device New Product Design & Development- How long does this process take you? Other Medical Device and Orthopedic Related Topics 1
V How to Assess Process Capability at the Development or Optimization Phase Capability, Accuracy and Stability - Processes, Machines, etc. 6
W Design and Development, and Assembly Process Quality Metrics AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R Process Development Requirements for a Contract Manufacturer with no Design Design and Development of Products and Processes 5
T Process Validation, NPD (New Product Development), and Supplier Management Qualification and Validation (including 21 CFR Part 11) 7
Manix Automotive Warranty Process at Tier 1 Level Challenges and Development Considerations Quality Manager and Management Related Issues 2
K Process Auditing Clause 7.3 Design and Development Internal Auditing 11
AnaMariaVR2 Pharma ?Quality by Design? (QbD): An Introduction, Process Development & Applications Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
V Production Development Process APQP Methodology APQP and PPAP 9
B 7.3.1 Design & Development Planning related to Process Design IATF 16949 - Automotive Quality Systems Standard 4
T How to link Process Design Changes in Serial Production to Design & Development? Design and Development of Products and Processes 6
D AS9100C PEAR (Process Effectiveness Assessment Report) for Design and Development AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
H Process Development to Validation: What are the steps? Design and Development of Products and Processes 3
kedarg6500 Manufacturing Process Design and Development Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
V Defining Quality Assurance's Role in R&D (Product and Process Development) Design and Development of Products and Processes 11
J Software Development Process - How ISO9001 relates to Software Development ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P PDP (Product Development Process) and APQP Process Map APQP and PPAP 3
P New IATF Communiqu? # 2010-010 - "Auditor Development Process (ADP) ? Process Update" ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
C Product Development Policy and Process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
P Essential List of SOPS for a Medical Device Development & Submission Process? ISO 13485:2016 - Medical Device Quality Management Systems 4
M Manufacturing Process Design and Development Review - TS 16949 Clause 7.3.4 IATF 16949 - Automotive Quality Systems Standard 12
R For ISO/TS 16949 Auditors concerning the Auditor Development Process recertification General Auditing Discussions 4
A What is the Responsibility of QA in the Product Development Process? Design and Development of Products and Processes 8
R Setting Departmental Objectives - Product and Process design & development IATF 16949 - Automotive Quality Systems Standard 2
5 What are your thoughts on my NPD (New Product Development) process map? Process Maps, Process Mapping and Turtle Diagrams 17
J Ford GPDS, APQP, Product & Process Development Plans, Purchasing Department Processes Customer and Company Specific Requirements 1
I Co-Development Process - Separating our development activities from our customer's ISO 13485:2016 - Medical Device Quality Management Systems 13
S Supplier Development Process failed - Question regarding sub-suppiler audits IATF 16949 - Automotive Quality Systems Standard 4
T Scaffolding Service - ISO 9001 Clause 7.3 Design and development process Design and Development of Products and Processes 3
Howard Atkins New IATF Auditor Development Process ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 1
Q Software/Tools to Manage ISO 12207 Audit of Software Development Process Software Quality Assurance 4
ScottK What defines the need for the ISO9001 Design & Development process? Design and Development of Products and Processes 15
J Determining Legal& Statutory requirements while Auditing Design & Development process Design and Development of Products and Processes 8
D ISO 9001 and Process Management and Development ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Design & Development Process - Graphic Design Work Design and Development of Products and Processes 14
A How to Document the Design & Development and Resource Management Process in IT Firm? Design and Development of Products and Processes 2

Similar threads

Top Bottom