Operational Qualification for injection molding process

S

sebastian12

Hello – I’m working on this operational qualification for this plastic injection molding company, and I’ve been asked to write an OQ and I have no idea how to start. I need help urgent. Can anyone be kind enough to provide me with an example of an OQ protocol for molding?

Thank you very much!
Katy
 
Last edited by a moderator:
J

Juan Dude

The post harry mentions is great, I just want to add that during an OQ you challenge the upper/lower operating settings of the machine.
 
Thread starter Similar threads Forum Replies Date
Z Operational Qualification for Injection Molding Supplier Quality Assurance and other Supplier Issues 6
Stoic Details of Operational Qualification (OQ) test design for plastic extrusion processes, effect of material property noise, and GHTF/SG3/N99-10 US Medical Device Regulations 2
D Determining of sample size for 'Operational Qualification' AQL - Acceptable Quality Level 5
J Installation Qualification (IQ) and Operational Qualification (OQ) for Laser Marking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
L Heated Sealed Packages - Sample Size for OQ (Operational Qualification) and PQ Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
E Operational Qualification of a Drug Box Coding Device in Production Other Medical Device and Orthopedic Related Topics 1
J OQ (Operational Qualification) for Liquid-Water Isotope Analyser Other Medical Device and Orthopedic Related Topics 2
B Usage of Parts from OQ (Operational Qualification) Mold Validation ISO 13485:2016 - Medical Device Quality Management Systems 4
B OQ (Operational Qualification) of a Freeze Dryer Qualification and Validation (including 21 CFR Part 11) 2
S Barcode Scanner IOPQ (Installation/Operational/Performance Qualification) Requirement Qualification and Validation (including 21 CFR Part 11) 9
M Determining Sample Size needed for Operational Qualification (OQ) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 24
L OQ (Operational Qualification) for Electropolish - Orthopedic Cutting Tools Other Medical Device Related Standards 3
W Packaging / Heat Sealer Validation - IOQ (Installation/Operational Qualification) Qualification and Validation (including 21 CFR Part 11) 15
Q Operational Qualification of a CNC machine ISO 13485:2016 - Medical Device Quality Management Systems 4
D Laser Weld Operational Qualification ISO 13485:2016 - Medical Device Quality Management Systems 3
C CNC Machine Operational Qualification Recoverability Testing Other Medical Device and Orthopedic Related Topics 1
W IQ, OQ, PQ (installation, operational & performance qualification) compared to PPAP ISO 13485:2016 - Medical Device Quality Management Systems 5
H Basic questions about Installation, Operational & Performance Qualification - PCBA Qualification and Validation (including 21 CFR Part 11) 11
C ISO 13485 and IQ (Installation Qualification), OQ (Operational Qualification) ISO 13485:2016 - Medical Device Quality Management Systems 30
C Generate IQ, OQ & PQ (installation/operational/performance qualification) Report Document Control Systems, Procedures, Forms and Templates 11
S ISO 14001 Operational Planning and Control - Proving evidence of communicating environmental requirements to suppliers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D AS9100D 8.4.2 Note 2 Significant Operational Risk AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Operational Procedures for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 7
H Operational planning and product and service provision when things happen so fast ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M Operational (free) simulation games for manufacturing and quality Lean in Manufacturing and Service Industries 5
Richard Regalado Top 10 operational risks of 2019 for business continuity planning Business Continuity & Resiliency Planning (BCRP) 6
I ISO 22000:2018 - Operational Prerequisite Program Examples Food Safety - ISO 22000, HACCP (21 CFR 120) 2
C AS9100 Rev D 8.1.1 & APQP - Operational risk management process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L OpEx (Operational Excellence) Documents in QMS? Document Control Systems, Procedures, Forms and Templates 0
O Air Flow - Which is the operational difference between LAF (vertical and horizontal) and RLAF? Manufacturing and Related Processes 2
M Informational UK – Brexit operational readiness guidance for the health and care system in England Medical Device and FDA Regulations and Standards News 3
T Operational setup of how FIFO / Process Map on Lithium Batteries is done Manufacturing and Related Processes 1
C AS9100D, Clause 8.1 - Operational Planning and Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
Q Management control Procedures & Operational Control Procedures ISO 14001:2015 Specific Discussions 1
R AS9100D Cl. 8.4.2 - Identify Raw Material as a Significant Operational Risk AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A Quality Department - Operational Framework Service Industry Specific Topics 2
A Operational Procedure for an IT Service Industry Quality Department Service Industry Specific Topics 1
M Integrated Phased Processes - AS9100D cl. 8.1 Operational Planning - Clarification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
A IT Managed Services Company Quality Department - Operational Document ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
G How have you addressed Cl 4.4.6 Operational Control ISO 14001:2015 Specific Discussions 4
I Quality and Operational Excellence Training Institutes in Europe Training - Internal, External, Online and Distance Learning 1
W ISO 14644 Cleanroom Validation - "Operational" Other Medical Device Related Standards 3
M Quality Manual - ISO 17025 required Mandatory and Operational Procedures ISO 17025 related Discussions 7
J OHSAS 18001 Clause 4.4.6 Operational Control Example Procedure Occupational Health & Safety Management Standards 9
G Evaluation of Training for Operational Staff Training - Internal, External, Online and Distance Learning 8
K Operational Prerequisite Programmes (oPRP) Food Safety - ISO 22000, HACCP (21 CFR 120) 2
S What does "Operational Review" mean as tool - Effectiveness of Internal Control Risk Management Review Meetings and related Processes 3
armani ISO 14001:2004 Clause 4.4.6 - Operational control (in English) ISO 14001:2015 Specific Discussions 2
D Good operational definition for Schedule Variance Software Quality Assurance 2
A Sample Documented Procedures that satisfy 4.4.6 Operational Control wanted ISO 14001:2015 Specific Discussions 2

Similar threads

Top Bottom