Selecting System Precision Criteria - System Suitability

v9991

Trusted Information Resource
#1
Before analysing the samples on the instrument, it is recommended to evaluate the repeatability/sensitivity specific to the method-parameters.

this requirement could be more relevant&specific for pharmaceutical industry as it handles little more complex samples. (this is in addition to the routine calibration - performance verification steps )

( quick ref... WHO...EP...USP...article...summary)

Question :-
in order to ensure repeatability following methods are currently in use.
1. calculate RSD of consecutive-multiple-measurements (typically 3) of a known standard. (typically <2%) (Yes, I agree that the no. of measurements are proportional to the sensitivity)
2. ratio of two consecutive measurements. (typically the ratio of two measurements to be 0.98 - 1.02 )

which one of above is superior or preferred.

Here's my quick assessment.,
* for RSD (<2%) , the max range possible is +/- 2%
* however for ratio (+/- 0.02), the max range possible is +/- 1%)

is there a way to assess these scenarios of controls.
 
Elsmar Forum Sponsor

v9991

Trusted Information Resource
#2
assessment of precision :- RSD vs similarity factor

I think is more precise and crisp question.,
does the enclosed approach comparison criteria hold any water for preferring similarity factor over %rsd

on left part of the image, is a simulation of possible 3-consecutive values, and the assessment on the range of values (min-max) allowed for given 10% RSD; and similar assessment on the range for possible combinations of values with acceptable similarity factor range.
and point is .... similarity factor allows a 10% difference between 1st and 2nd value; wherein 10% (3 values) allow ~17% range of values.

( yes, there could be other parameters to be considered., viz., no. of replicates for given RSD etc.,)

but, for given RSD vs similarity factor, does the approach sounds an fair step, and are there any other comparison/assessment criteria.


thank you
 

Attachments

Last edited:

v9991

Trusted Information Resource
#3
Re: assessment of precision :- RSD vs similarity factor

are there any more-formal ways to compare the 'control' achieved through "Relative Standard Deviation" versus "ratio of injections" route?

thank you in advance, for your thoughts and feedback.
 
Thread starter Similar threads Forum Replies Date
B Selecting Parts for an MSA (Measurement System Analysis) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
T Selecting which MDD 93/42/EEC Annex to follow - PACS software system CE Marking (Conformité Européene) / CB Scheme 2
M Selecting Samples for an R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
J Selecting factors for screening DoE design Statistical Analysis Tools, Techniques and SPC 8
M Informational How To Avoid Compliance & Timeline Risks When Selecting A Medical Device Supplier Medical Device and FDA Regulations and Standards News 0
O ISO 13485 for software company - Selecting suppliers ISO 13485:2016 - Medical Device Quality Management Systems 3
C Selecting potential internal auditors Internal Auditing 3
Q Advice on selecting an ISO 9001:2015 Lead Auditor Certification Course ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
S Selecting materials for implants to comply with ISO 10993 biocompatibility Other Medical Device Related Standards 4
B Process Control - Selecting Parts - NDC & Study Variation Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
B Selecting components to meet UL 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
B Risk Management while selecting the Supplier Document Control Systems, Procedures, Forms and Templates 3
AnaMariaVR2 5 keys to selecting the right CM (Contract Manufacturer) ISO 13485:2016 - Medical Device Quality Management Systems 1
M Pre-Selecting Materials for ISO 10993-1 Biocompatibility Compliance Other ISO and International Standards and European Regulations 5
P Selecting a Registrar and completing our ISO 9001 Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
S Selecting Wires for Measuring P.D. of Thread Gages General Measurement Device and Calibration Topics 9
M Suggestions for Selecting RF Wireless Components Other US Medical Device Regulations 3
S Selecting weights for daily Calibration Check - Using just one weight? General Measurement Device and Calibration Topics 10
W Selecting a Registration Agent in China China Medical Device Regulations 17
C Selecting Consultants for getting drug approval in USFDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
G Gage R&R Procedures: Selecting parts (sample) to measure Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
W Selecting Non-Conformities to address Nonconformance and Corrective Action 16
C Selecting the Right Problem (book chapter 1) The Reading Room 8
G Gage R&R: Selecting Number of Trials and Appraisers and Parts Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
B Selecting a Sample and Determining the Reference Value for a Bias Study Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
Le Chiffre Selecting a predicate device for FDA 510(k) approval Other US Medical Device Regulations 14
W Question about sample size code letter and selecting sampling plan Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
D Selecting a Tolerance when multiple specifications exist - Different Beers Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
B Optimally Selecting 30 Pieces of Product out of 34 - How do I? Statistical Analysis Tools, Techniques and SPC 9
J Selecting the best Gage - Buy according to production criteria IATF 16949 - Automotive Quality Systems Standard 0
A Is there any kind of Ranking available for selecting the Registrars? Registrars and Notified Bodies 31
L I need a reference for selecting a notified body. Can anyone make a recommendation? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 21
L Selecting ISO 9001:2000 Internal Auditors Internal Auditing 12
Q Criteria for Selecting a Consultant or Consulting Firm Consultants and Consulting 2
B Selecting Six Sigma Black Belts Six Sigma 3
S QOS for Tooling and Equipment - Having difficulty selecting a measurable QS-9000 - American Automotive Manufacturers Standard 2
H A better Lot/bin system Preventive Action and Continuous Improvement 2
S Environment Monitoring System Validation ISO 14001:2015 Specific Discussions 1
R Clinical evaluation for instrument of a navigation system EU Medical Device Regulations 1
A Non-medical device testing in the medical system IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D Repeat Build of a validated system ISO 13485:2016 - Medical Device Quality Management Systems 2
A LEDs in the system to indicate a status or fault IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
F Surveillance Audit for AS9100D and new ERP system incorporated Document Control Systems, Procedures, Forms and Templates 3
A ISO 9001- any advise please with transitioning from a paper based system to eQMS and multi site scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
PQ Systems 10 Ways to Improve Your SPC System Using SQCpack Software 0
R Quality System Software AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
D Integrated Management System (IMS) - Process Vs Clause Based Audits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
I Request for information regarding remote medical monitoring software (its technical documentation and the IUD system) IEC 62304 - Medical Device Software Life Cycle Processes 2
Q The Management system is too much ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Recommendations for affordable CAPA system Preventive Action and Continuous Improvement 4

Similar threads

Top Bottom