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:
 

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
G 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
N Validating Software before getting approved as Class 2 device US Food and Drug Administration (FDA) 5
Ed Panek Validating Excel (XLS) formulas 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
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
G 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
Z IA Construction Procurement Process Internal Auditing 3
H Risk Management Plan in agile process ISO 14971 - Medical Device Risk Management 11
DuncanGibbons Process flow & PFMEA for production planning and simulation activities? Process Maps, Process Mapping and Turtle Diagrams 7
N Help with understanding Process Controls Manufacturing and Related Processes 4
M VDA 6.3 – Workshop for Certified Process Auditor VDA Standards - Germany's Automotive Standards 1
C Process Consistency Manufacturing and Related Processes 5
I PFD (Process Flow Diagram) approach. Setup details as part of PFD? APQP and PPAP 5
K Business Process Flowchart Process Maps, Process Mapping and Turtle Diagrams 2
L Looking for Control Plan and FMEA Stamping process FMEA and Control Plans 2
J License renewal process in Iran Other Medical Device Regulations World-Wide 0
J Definition Outsourced process - Clear definition - 13485 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 5
S IS0 13485 process flows ISO 13485:2016 - Medical Device Quality Management Systems 2
H Verification Process for the existing MDS Product IEC 62304 - Medical Device Software Life Cycle Processes 5
C Revalidation of Process Equipment for Equipment Transfered to New Facility. ISO 13485:2016 - Medical Device Quality Management Systems 5
Q Process map Evaluation and Analysis Method Process Maps, Process Mapping and Turtle Diagrams 5
S In process inspection Manufacturing and Related Processes 2
S Brexit 100% inspection during in process inspection Manufacturing and Related Processes 11
A Complaint review as part of the complaint handling process? ISO 13485:2016 - Medical Device Quality Management Systems 3
mustomutlu Process Validation Final Report Other Medical Device and Orthopedic Related Topics 2
Q Process Matrix_Audit Matrix Quality Management System (QMS) Manuals 4
Q Process description for outsourced processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Process matrix examples of ISO 9001 & 14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2

Similar threads

Top Bottom