System suitability or stability during continuous usage

v9991

Trusted Information Resource
#1
before measuring any samples, we have this practice of
* verifying the system precision using an standard material; and
* measuring same standard at a given periodic/frequency ( bracketing standard)
* at a minimum at the end of measuring the standard at the end of analysing the samples. ( bracketing standard)

viz., the system precision is given at NMT 6% or 3% for n=5 ;
the question is about the acceptance criteria for the standard measured at periodic frequency.
option 1 :- the response of bracketing standard is NMT 2% from the average of first 5-standard_measurements.
optioin 2 :- the precision of first 5-standard+1-bracketing standard ( total 6 standards ) - RSD NMT 6%

how to evaluate and simulate above options. pl. guide.
by simple logical representation of values, percentage-difference seems to be better/stringent control of variability of the response of bracketing standard.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
V Selecting System Precision Criteria - System Suitability Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
G How do you determine system suitability and effectiveness of a new system? Miscellaneous Environmental Standards and EMS Related Discussions 3
D Hit for not reviewing System Suitability in Management Review Management Review Meetings and related Processes 6
O Quality Management System Implementation framework and Gap analysis checklist Manufacturing and Related Processes 7
A Applying agile model for Computer system Validation Medical Device and FDA Regulations and Standards News 2
Q Change Control Numbering system Document Control Systems, Procedures, Forms and Templates 6
G RO/DI water system qualification Qualification and Validation (including 21 CFR Part 11) 3
Thee Bouyyy Quality Management System Q1 and Q2 Interpretations Misc. Quality Assurance and Business Systems Related Topics 0
Sidney Vianna Informational ISO/CD 7101 Health Care Quality Management System Standard Hospitals, Clinics & other Health Care Providers 0
G Logging of a decision if a computerized system needs to be validated ISO 13485:2016 - Medical Device Quality Management Systems 5
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
R Quality adjusting inventory in ERP system AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
C Do components of a system require UDIs? Other US Medical Device Regulations 4
R SAP B1 Computer System Validation Qualification and Validation (including 21 CFR Part 11) 0
D Verify Audit Trail of SaaS system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
K System of medical devices EU Medical Device Regulations 0
D Validating Operating system Qualification and Validation (including 21 CFR Part 11) 4
H Article 22 MDR System EU Medical Device Regulations 16
S Searching for TOYOTA Floor Management Development System (FMDS) board Customer and Company Specific Requirements 3
M Procedure for vigilance system according to new MDR EU Medical Device Regulations 0
bobdoering Most typical universal Quality System Funny Stuff - Jokes and Humour 8
G Organizing internal audit program for an Integrated QHSE Management System Internal Auditing 13
K Bioreactor/ incubator system in tissue engineering EU Medical Device Regulations 9
D Integrated Management System Software Quality Manager and Management Related Issues 2
E System&Procedure pack or accessory EU Medical Device Regulations 0
J Informal vs formal scope creep... managing non-medical devices through system processes ISO 13485:2016 - Medical Device Quality Management Systems 2
C Quality Management System Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
V Csv, excel format - audit trail file of HPLC system ( Empower, openlab, EZchrom or any other ) Qualification and Validation (including 21 CFR Part 11) 0
I Class VI certification on seals, o-ring and plastic for a WFI system Qualification and Validation (including 21 CFR Part 11) 0
A System for Supplier Documents Quality Assurance and Compliance Software Tools and Solutions 7
S MDR - System and procedure pack article 22 and all sub processes that apply ISO 13485:2016 - Medical Device Quality Management Systems 0
T Device & Accessory, Components in device, or System EU Medical Device Regulations 0
M Go Live With New ERP System before Recertification Audit General Auditing Discussions 6
John C. Abnet Terms- Different Items in a system ISO 26262 - Road vehicles – Functional safety 0
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
G Management Review (integrated system) Management Review Meetings and related Processes 21
M Unique Quality Management System for 2 sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Orthopedic Implants (Knee system) Sterilization Indicators Manufacturing and Related Processes 6
C Projects in the CAPA system Preventive Action and Continuous Improvement 6
E Insulation diagram for ECG monitoring and diagnosis system. IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R Quality System Functional Safety Checklist / Guidance IATF 16949 - Automotive Quality Systems Standard 0
J Mastercontrol or other system ISO 13485:2016 - Medical Device Quality Management Systems 0
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P MSA - what exactly mean "system" and master sample Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
P MSA study for visual system with artifical inteligence Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
D Big companies suffer from quality management system? ISO 13485:2016 - Medical Device Quality Management Systems 1
qualprod Assign a name to a home-made ERP system? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
H IEC 60601-1 ME equipment or ME system IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K Biological indicator system classification under MDR EU Medical Device Regulations 2
N Chemical Testing on Medical Devices - Solutions in a container closure system (bag) EU Medical Device Regulations 1

Similar threads

Top Bottom