Stability study- Plastic injection molded parts with fixture gage & digital indicator

B

bayliner

#1
#1
stability studies using gage fixtures

I am hoping that someone can help me out by providing me with some information on performing stability studies on plastic injection molded parts using a fixture gage with digital indicator.

Any help in this area will be greatly appreciated. I have been given the task of creating a method and documenting it in the form of work instructions for this type of study. I am of the opinion that performing a stability study using a fixture gage is not needed, however, we were written up for this during our last audit and it must be done.

------------------
Carla

[This message has been edited by bayliner (edited 09 March 2001).]
 
Highly Rated Gage Tracking - Learn More
Elsmar Forum Sponsor
D

DICKIE

#2
#2
Your fixture gage is no different than any other gage. I assume your audit was for QS-9000 so the AIAG'S MSA (measuring systems analysis) book would be a good place to start. Once you perform this study you'll see it's no big deal and will keep your auditor off your back. Just learning the process will give you some backround and allow you to argue your point.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
D What are the acceptance criteria/requirements for Stability Study? General Measurement Device and Calibration Topics 7
E Use of OQ cleared batch for stability and clinical study use ISO 13485:2016 - Medical Device Quality Management Systems 0
F Extension of a stability study for an API Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
K Food Shelf Life Stability Study Statistical Analysis Tools, Techniques and SPC 1
R Holding time stability study of intermediates of drug substances US Food and Drug Administration (FDA) 2
M Is a Real Time Stability Study required to determine Expiration Date? EU Medical Device Regulations 9
P The correct way to do a Linearity and Stability Study on a Critical Dimension Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
M How to provide Stability Study for micron-precision tool Misc. Quality Assurance and Business Systems Related Topics 2
J How do you perform a S3 Stability Study for a Non-Replicable Measurement System Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
B Interpretation of Stability Study Data Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
J Sampling Method for Stability Study - Implementing MSA Study on Testers Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
A Method S4 Stability Study for Destructive Tests - MSA third Edition page 148 Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
A Do we need to perform Stability, Linearity & Bias study for Attribute data? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
O Stability Study Template wanted Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
H Gage Stability Study Requirements - Gage R&R Study Data Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
N MSA - How do I perform a Stability Study as a part of Measurement Systems Analysis? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
F 1. Suggest a Gage for Checking Rounding of Gears 2. When to conduct Stability Study? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
Nawal Stability Plan US Medical Device Regulations 1
Ed Panek MDR question - Meaning of Stability CE Marking (Conformité Européene) / CB Scheme 6
A Stability Testing of a device with sterile fluid pathway claim Other Medical Device and Orthopedic Related Topics 1
M Stability with min/max sealing parameters? Other Medical Device Related Standards 1
Nihls Quality Control (stability) Chart for CMM's - How the control limits are to be calculated Capability, Accuracy and Stability - Processes, Machines, etc. 2
S Stability sampling for Class 1 medical devices ISO 13485:2016 - Medical Device Quality Management Systems 1
M Device mounted at IV pole - what about mechanical stability testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C Surgical mask stability testing (CE mark) EU Medical Device Regulations 2
G Engineering retest in line - Machine stability issues IATF 16949 - Automotive Quality Systems Standard 8
G Accelerated stability of medical devices Other Medical Device Related Standards 1
R Revalidation machine line and Stability Studies impact. Medical Device and FDA Regulations and Standards News 3
S Stability accelerated vs. real-time Other Medical Device Related Standards 3
S Standards for real time stability for medical devices Other Medical Device Related Standards 2
C Medical Device Stability Studies - Non-validated pilot production Other Medical Device Related Standards 1
B Stability testing of medical devices as per ASTM F1980-16 CE Marking (Conformité Européene) / CB Scheme 0
lilybef Number of lots required for stability testing of a Class II device in the 510(k) Qualification and Validation (including 21 CFR Part 11) 3
V System suitability or stability during continuous usage Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
O New stability - Yes or No - Similar product but for different intended use EU Medical Device Regulations 1
A Accelerated Stability Studies - Class III Medical Gloves Other Medical Device and Orthopedic Related Topics 1
ernieto On going Stability for IVDs Other US Medical Device Regulations 5
A Risks related to Method Validation and Stability Studies Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
N Sampling for stability studies - Class II surgically invasive devices Other Medical Device and Orthopedic Related Topics 1
M Electrosurgical Electrodes - Stability Test Other Medical Device Related Standards 1
C IQ and OQ for a "Dormitory" Refrigerator - Temperature Stability Qualification and Validation (including 21 CFR Part 11) 4
S Stability test - primary packaging EU Medical Device Regulations 7
L MSA - Stability - Part of our PQ (performance qualification) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
C Sample Size for Stability Testing Other Medical Device and Orthopedic Related Topics 2
J EU Medical Device Class I - Stability (Shelf Life) Test EU Medical Device Regulations 2
E EN 13640:2002 or EN23640:2013 For stability testing of in vitro diagnostic reagents ISO 13485:2016 - Medical Device Quality Management Systems 2
P Specification and Tolerance in Stability Control Chart Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
R Convincing Management Cpk without Stability is Meaningless Capability, Accuracy and Stability - Processes, Machines, etc. 7
M A question on Measurement System Analysis - Stability to measure got Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
R Drug Stability Data at the time of Filing US Food and Drug Administration (FDA) 3

Similar threads

Top Bottom