Solution to Calibration Failure of Liquid Chromatography

T

Tattukolla

#1
Hi all,
happy to share this incident .

Topic is HPLC Calibration:
While running Calibration of LC wavelength accuracy has been failed at minimal absorbance with caffeine.We found that it happen because of out let ball valve of pump in Agilent 1260 infinity model.
My user raised the breakdown request to service engineer as "Wavelength accuracy failed".
At the same time we addressed the same through incident.
Service engineer replaced the out let ball valve with new one .And carried out the calibration by doing Flow test as it required for any ball valve changing.

1.What is the CAPA?
2.Is prevention is required where we proposed only corrective action?
3. Is it required to reanalyze the previously approved batches on same system, and our SOP says to reanalyze three batches on other instrument.
4.0 Any root to not analyse those three batches?
Regards

SATYA
 
Elsmar Forum Sponsor

v9991

Trusted Information Resource
#2
actually your problem-description seems to require further more details...(probably updates - clarifications ...)
here's an quick attempt to provide some thoughts which could correct/clarify your approach...

1. RCA confirmation/clarification :- Try & understand how an “outlet ball valve of pump” is related with the wave-accuracy? (how is flow variation related to wavelength accuracy; as an outsider to the problem, I would have suspected something like, detector, flow thru cell, working standard purity etc.,)

2. INVESTIGATION scope:- Should include the assessment on impact on previous batches; (ascertaining the time&point of impact …from when this problem has been affecting the results/data if any)

3. CORRECTION :- (again, how is it adequate to establish the flow clabiration? even going by your assessment, we must have established the wavelength accuracy as well...right?) anyways, it should suitably addressing the above RCAs and re-establishing the equipment calibrated-status

4. CORRECTIVE ACTION :- addressing the points evaluated during investigation phase, impact on other batches, or disposition of current analysis etc.,

5. PREVENTIVE ACTION (to ensure that problem is not recurred; or atleast finding out the symptons and problems as and when they occur…not waiting for calibration frequency ):- improving the monitoring mechanism viz.,
for a pump, daily monitoring of ensuring the priming, valve-washing etc.;
if it’s a detector, then daily monitoring of noise levels, proper washing/solvents at end of each analysis/ at the end of day.
if its found to be due to particular method...then look at suitable evaluation of procedure of finalizing all current and future methods method...

...
hope that it helps.
 
Last edited:
Thread starter Similar threads Forum Replies Date
O ZenQMS cloud solution? Quality Assurance and Compliance Software Tools and Solutions 0
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Test method validation - Is MSA (MSA1, MSA2, MSA3 and linearity) a good solution? Medical Device and FDA Regulations and Standards News 1
S Validation of eQMS - Cloud based out of the box solution Other Medical Device Related Standards 18
G Saline solution change for soft contact lens potting CE Marking (Conformité Européene) / CB Scheme 0
S EQMS solution (Greenlight Guru and Q-Pulse currently being explored) Medical Information Technology, Medical Software and Health Informatics 8
L Peritoneal dialysis solution is not medical device? EU Medical Device Regulations 0
P Suggestion for QMS platform solution + Business process automation Software Quality Assurance 3
R Re-Use of Diagnostic Reagent Solution Labels - Buffer Solutions for Internal Use ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Greenlight Guru as a Medical Device software solution Medical Information Technology, Medical Software and Health Informatics 62
S What is MSU buffer solution? Manufacturing and Related Processes 1
G Come up with a solution to our CAPA system Nonconformance and Corrective Action 3
E Recommendations for Quality Management Solution in SharePoint Quality Assurance and Compliance Software Tools and Solutions 5
J Want best and effective solution for mouth infection Coffee Break and Water Cooler Discussions 11
C Document Management Solution for Routing Documents for Approval Manually Document Control Systems, Procedures, Forms and Templates 18
Q Is AIAG PPAP section 2.1 waiver a solution? APQP and PPAP 7
F Suggestions for quick & effective solution for Continuous Improvement Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
N Using ISO document number, version number in Software based solution. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Cost Effective Solution for Isolating USB 5V 500mA Power IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T Two job offers, one solution - Automotive vs. Defense Manufacturing Jobs Career and Occupation Discussions 9
M Commercially available software solution for the control of our CNC programs. Records and Data - Quality, Legal and Other Evidence 3
S Six sigma for known solution or unknown solution Six Sigma 1
D Input Requirement Document for developing Product Presentation by Multimedia Solution Document Control Systems, Procedures, Forms and Templates 2
C Simpler Solution to Waste Disposal Site Audits Miscellaneous Environmental Standards and EMS Related Discussions 2
C ANDA (Abbreviated New Drug Application) Filing - Ophthalmic Solution Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
A Cost calculation for solution that should delight the customer Quality Manager and Management Related Issues 3
C Planning & Implementing Solution (book chapter 5 on problem solving) The Reading Room 8
S Easy way to determine % (concentration) of NaOH in an aqueous solution? Manufacturing and Related Processes 1
Q I need a solution to the puzzle... Coffee Break and Water Cooler Discussions 10
A The unit price of the APQP module of MQ1 solution Quality Assurance and Compliance Software Tools and Solutions 2
J EOQ (Economic Order Quantities) - Solution For Parts Manufacturing Nightmare? Lean in Manufacturing and Service Industries 6
S Need solution to AS9100 signature requirements on the plans, and/or changes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
K Medical Devices QC Testing Procedure - Flexible Medical Solution Bags ISO 13485:2016 - Medical Device Quality Management Systems 5
C Pure Tin Plating onto Cu yellowish surface Discoloration - Looking for solution Manufacturing and Related Processes 5
S Identification of Machined Products between Processes - Solution Needed. Manufacturing and Related Processes 7
C Definition Sol. (Solution) Heat Treated - As pertains to stainless steels - Solution Anneal Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 6
S Recommended PPAP Training in the Toronto area or a software solution Training - Internal, External, Online and Distance Learning 3
Wes Bucey Popup ads - new trick! Called by Flash and java - Firefox developers seek 'solution' After Work and Weekend Discussion Topics 6
Q Software solution to manage APQP and PPAP Quality Assurance and Compliance Software Tools and Solutions 3
S Engineering Knowledge Management Solution - Project Management & Database technology Misc. Quality Assurance and Business Systems Related Topics 2
lanley liao Question regarding the calibration of monitoring and measure equipment. Oil and Gas Industry Standards and Regulations 0
N IATF Calibration Lean in Manufacturing and Service Industries 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
T Plug Gage Calibration Calibration and Metrology Software and Hardware 1
M Load Cell Calibration using a totalizer on a flow meter General Measurement Device and Calibration Topics 0
E Calibration Records needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D Limited Range Calibration - 5000 lb Industrial floor scale General Measurement Device and Calibration Topics 3
D Calibration of Small Scales General Measurement Device and Calibration Topics 26
C How to Establish the Calibration & Measurement Capability (CMC)? ISO 17025 related Discussions 1
I IQOQ or just initial calibration required? General Measurement Device and Calibration Topics 3

Similar threads

Top Bottom