Identification of Non Conformities and corrective actions

PURPOSE: This SOP explains how a non conformity i.e. deviation from the results in the test runs is noted and rectified. This SOP explains the methods to prevent the occurrence of errors and non conformities and corrective actions to be taken in case of non conformities.

2. STAFF RESPONSIBLE AND AUTHORIZED TO PERFORM THE PROCEDURE: Doctor and technical staff

3. PRINCIPLE OF PROCEDURE USED FOR EXAMINATION: IgM Capture ELISA test method

4. PROCEDURE

POSSIBLE NON CONFORMITIES: The following errors may arise in an ELISA test run.

1. Internal Quality control not appropriate.
2. External QC values not in range
3. Cut off values not in range
4. Test plate showing all the results as negative
5. Test plate showing all the results as positive
6. Too high O.Ds of controls
7. Too low O.Ds of controls
8. Deviation from validation criteria of the kit

REASONS FOR NON CONFORMITIES

1. Specimen problem.
2. Documentation errors
3. Kit problems
4. Technician related problems
5. Equipment problems
6. Environmental problems Corrective measures taken

PRECAUTION TAKEN TO AVOID OCCURRENCE OF NON CONFORMITIES

1. All the Steps of ELISA are done in accordance with kit literature instructions.
2. Protocol is made carefully.
3. Samples and kits are stored at 4*c.
4. Kits and reagents are checked for their expiry date.
5. 1. Samples and kits are taken out from refrigerator half an hour before of the starting of the test.
   2. Samples and Reagents are checked for contamination or turbidity.
   3. Pipettes are calibrated every 3 months.
   4. ELISA reader & washer are checked for their accuracy.
   5. Distill water is used for making reagents or dilutions.
   
   
   CORRECTIVE MEASURES TAKEN:
   
   

   No.		Error	Resolution
   Specimen problems
   1	Insufficient volume/ in appropriate container		Collect 3-5 ml of blood in plain test tube
   3	Haemolytic, lipaemic sample		Collect another sample
   4	Sample contaminated		Refrigerate the sample properly. 4*c for a week and -20*c for longer storage
   5	Aliquoting error		Label properly.
   6	Frequent freeze thaw of sample		Avoid repeated freeze, thaw.
   Documentation error
   1	Mixing of patient’s name, sample no		Set up the log books, record books properly
   2	Result print out: well no on print out & worksheet not matched		Write the result from print out sheet to worksheet properly. Repeat the test for resolution
   3	Errors during translating of result From the worksheet to the report from.		Supervisory review/vigilance of result by a second person can correct the error.

   
   

   No.	Error	Resolution
   Kit dependent problems
   1	Used after expiration date.	Expiry dates should be displayed in bold letters on the kit packing. Regular checks should be made to ensure that it does not remain in the lab after the expiry dates. Stocks should be rotated to ensure that kits with lesser expiry are used before the kits with longer expiry dates.
   2	Mixing of reagents from different kits/lot numbers.	Use reagents for the kits for which they are made. Do not mix reagents from different kits.
   3	Performance characteristics (sensitivity, specificity and delta values) not satisfactory.	Do not use unsatisfactory kits i.e. those which do not meet the quality standards.
   4	Deterioration/contamination of one or more component of reagents of the kit. (faulty transport	Do not use contaminated/deteriorated (control values different from those mentioned in package insert) kits. Store at the optimal temperature and maintain cold chain during transport of kits.

   
   
6. 4.     VALIDATION OF RESULTS TO BE DONE BY – Section In charge
   
   
   5.     REVIEW, RECORDS, REMARKS AND RECOMMENDATION
   
   
   ·       DR 18 – Non Conformity register
   
   
   7. REFERENCE
   1. Lab Manual for Technicians (ICTC, PPTCT, Blood banks and PHC) Of NACO,
   2. NIV Kit literature of DENGUE  ELISA
   3. ELISA washer literature