Checklist for investigation of out of specification
Sampling:
- Is performance against written procedure carried out?
- Are the cleaned sampling equipments used?
- Are the cleaned containers used for collection of samples?
- Is the sample integrity maintained until testing?
- Is composite sample prepared correctly?
SAMPLE PREPARATION:
- Is correct weighing from correct portion of sample done?
- Is clean and dried apparatus used?
- Are the samples completely transferred?
- Is the sample properly shaken, sonicated or heated / warmed as per specification?
- Are the sample dilutions correctly performed as per specification?
- Are the samples filtered/ centrifuged/membrane filtered properly before introduction into instrument or analysis by classical method?
- Are the samples correctly transferred to auto sampler devices and correctly labelled for traceability?
Testing:
- Are samples / standards correctly prepared for each tests as per speci?cation?
- Are cleaned glassware’s and correct equipment’s used to prepare the sample for analysis?
- Are samples / standards preparations stored under correct environment / time before analysis?
- Are analysis performed on calibrated instrument?
- Is there any possible contamination from syringe or auto sampler carryover?
- Is instrumental setting done as per specification?
- Are the details of method of analysis followed as per specification?
- Is sequence of samples on instrument correct?
- Is the correct column used as per specification?
- Are the correct general analytical method followed for testing?
- Are instruments used as per written procedure (SOP)?
- Is instrument No. identified in test data sheet?
- Are the relevant training records of the analyst available?
- Is there any power supply fluctuation?
- Were there problems during analysis like improper flow or generation of bubbles during HPLC analysis or did one of the paddles fall of during dissolution or was the sample extraction during analysis was incomplete?
Data Collection:
- Is authorized data sheet used?
- Are all the relevant entries in test data sheet filled with correct transcription of raw data?
- Are correct calculations done as per specification / General analytical method?
- Is the interpretation of results of test done correctly?
- Is the data collation from instrument in sequential order?
- Are the formulae used to calculate the results correct?
DATA EVALUTION / REVIEW:
- Is each test in Test Data Sheet /Specification checked for correlation?
- Are all signatures / dates / weights available with report?
- Are all general analytical method numbers / instruments code entered in Test Data Sheet?
- Are all charts / spectra /Instrumental recordings available with the report?
- Is there evidence of who checked the report, and when with signature and date? (Updated on 21/12/2020)
