Validating a Process Based on Lot Release Criteria

G

GTJunghoon

#1
I'm validating a liquid filling process. The risks associated with the product failure have been assessed and preventative measures have been put in place. So, I am confident that the product will rarely fail the QC inspections.

It appears that the Jefes' want to eventually release a product lot of up to 1400 items after QC inspects and passes 2 items selected from that same product lot. I suppose this means I have to prove that the process is capable of this "lot release criteria".


How do I statistically prove that the defect rate of a process is so low that a lot of 1400 items is released after inspecting 2? :mad:
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#3
I'm validating a liquid filling process. The risks associated with the product failure have been assessed and preventative measures have been put in place. So, I am confident that the product will rarely fail the QC inspections.

It appears that the Jefes' want to eventually release a product lot of up to 1400 items after QC inspects and passes 2 items selected from that same product lot. I suppose this means I have to prove that the process is capable of this "lot release criteria".


How do I statistically prove that the defect rate of a process is so low that a lot of 1400 items is released after inspecting 2? :mad:
Hi,

It seems that according to the AQL-based methodology you would need to sample at least 5 units for a lot size of 1400. If all 5 are pass, the lot passes. If one fails, the lot fails. This regime correlates with an AQL not worse than 2.5 (Normal inspection).

Cheers,
Ronen.
 

somashekar

Staff member
Super Moderator
#4
I'm validating a liquid filling process. The risks associated with the product failure have been assessed and preventative measures have been put in place. So, I am confident that the product will rarely fail the QC inspections.

It appears that the Jefes' want to eventually release a product lot of up to 1400 items after QC inspects and passes 2 items selected from that same product lot. I suppose this means I have to prove that the process is capable of this "lot release criteria".


How do I statistically prove that the defect rate of a process is so low that a lot of 1400 items is released after inspecting 2? :mad:
What is the container made of ... Is it transparent ... Do you have some sort of a scale marked on the container as it gets processed (comes from your design)
How does QC inspect ?
If I had it as said above, I would not be much bothered, as QC can inspect more samples based on your AQL selection easily.
Validation is a exercise done prior to putting the liquid filling process into use. Lot release criteria is more a check of your process effectiveness / Validation effectiveness.
 
Thread starter Similar threads Forum Replies Date
S Validating a Bonding Process Qualification and Validation (including 21 CFR Part 11) 3
Gert Sorensen Validating a Sandblasting Process - Any pointers? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
Q Validating the AOI process (Automated Optical Inspection) Reliability Analysis - Predictions, Testing and Standards 9
A Validating my own application developed with Agile Qualification and Validation (including 21 CFR Part 11) 5
T Risk analysis of QMS software - Validating software we use for QMS ISO 13485:2016 - Medical Device Quality Management Systems 5
H Validating Nondestructive leak testing machine Qualification and Validation (including 21 CFR Part 11) 3
M FDA's expectation for validating OTS software updates Other US Medical Device Regulations 8
R Re-validating revised Medical Device and Aerospace Product COTS software ISO 13485:2016 - Medical Device Quality Management Systems 2
J Validating a stopped test due to never finding any defects Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
J Validating multiple injection molding machines efficiently ISO 13485:2016 - Medical Device Quality Management Systems 5
J Grouping Products and Testing Sterile and Biocompatibility - Validating Products Other Medical Device Regulations World-Wide 3
Q Meeting the Requirement of Clause 7.5.2 on Validating Special Processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Validating a Product through Tool Control and Tool Inspections Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
G Testing and Validating a New Vertical Milling Machine AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
Q Validating Tape Measures used to Measure Product Conformity to Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Protocol for Validating Pull Tester and Force Gage Qualification and Validation (including 21 CFR Part 11) 9
T Validating Supplier Statement - Rusty shield that supplier denied responsibility Manufacturing and Related Processes 7
M Validating 3rd Party Software which Tracks Archived Samples Qualification and Validation (including 21 CFR Part 11) 2
Q Validating ESD (Electrostatic Discharge) Flooring ISO 13485:2016 - Medical Device Quality Management Systems 2
M Procedure for Validating Laser Marking & Electropolishing of Orthopedic Implants Other Medical Device and Orthopedic Related Topics 13
K Validating a gage/fixture in-house under TS 16949 - Need information General Measurement Device and Calibration Topics 2
C Validating Custom adaptations of Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 11
C Validating a Gage R&R spreadsheet - Defining Formulas in spreadsheet cells Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
Gert Sorensen Software Validating Adobe Professional according to Part 11? Quality Assurance and Compliance Software Tools and Solutions 10
D Validating software in materials testing - Integrated system of individual components General Measurement Device and Calibration Topics 3
D Validating Multimeters (how to) General Measurement Device and Calibration Topics 8
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 2
Pau Calvo Quality Management process is mandatory in ISO9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Tagin Template or Checklist for Process Change Document Control Systems, Procedures, Forms and Templates 5
LostLouie Manufacturer divorced from Design process, is he justified in design process deficiencies? ISO 13485:2016 - Medical Device Quality Management Systems 3
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
D Question regarding customer feedback process ISO 13485:2016 - Medical Device Quality Management Systems 3
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
J Process FMEA Template with examples - Cold and Hot Forged components FMEA and Control Plans 4
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 6
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
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 5
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
A Validation of Forced Aeration Process ISO 13485:2016 - Medical Device Quality Management Systems 3
R Error Proofing Label process Manufacturing and Related Processes 4
B New Release of CQI-12 Coatings Process (Revision 3- Release date- 7/2020) Customer and Company Specific Requirements 2
D Layered Process Audits - FCA 9.2.2 - Exemption Clause? IATF 16949 - Automotive Quality Systems Standard 5
B ISO 11607-2 "Critical Parameter" vs. "Process Parameter" Other Medical Device Related Standards 3
Q Example Process orientation to the process leadership, management, goals (tasks of the top management) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S Process Inspection -Sub assembly process inspection sheet Lean in Manufacturing and Service Industries 3
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
T Outsourced process in ISO 45001 Occupational Health & Safety Management Standards 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
T Formal Q Self Assessment - Problem with assigning Product and Process Customer and Company Specific Requirements 1

Similar threads

Top Bottom