STANDARD OPERATING PROCEDURE FOR HANDLING OF OUT OF SPECIFICATION

1.0 OBJECTIVE

1.1 To lay down the procedure for handling out of specification results obtained during laboratory analysis.

2.0 SCOPE

2.1 This SOP shall be applicable to the results which are out of specification obtained in the Department of Quality assurance (QAD).

3.0 RESPONSIBILITY

3.1 Head- QA

3.2 QA Personnel (QAP)

4.0 DEFINITIONS

4.1 OOS Results – All results that fall outside the specifications or acceptance criteria established or defined for the items described in the scope, shall be categorized as OOS Results.

4.2 An out of specification (OOS) result can be due to:

4.2.1 Laboratory error during analysis.

4.2.2 Mistakes in/following MOA

4.2.3 Use of non-calibrated instruments

4.2.4 Use of incorrect standard

4.2.5 Error in calculation

4.2.6 Contaminated glassware.

4.2.7 Error in sampling, handling, or storage of the sample.

4.2.8 Operator error.

5.0 PROCEDURE

5.1 Analyst shall check the data for compliance with applicable specifications.

5.2 On obtaining an OOS result, the analyst who had conducted the test shall report the OOS result to his/her Reporting Head / Study Director.

5.3 When a test result is found, which fails to meet specification defined in Procedure / Standard test procedure the analyst performing the test must record it immediately and request for format titled ‘Investigation of Out of Specification Result Record’ (Format No.:- F/SOP/QAD/012/01-00) from QA personnel / Head-QA.

5.4 QA personnel / Head-QA shall issue the format ‘Investigation of Out of Specification Result Record’ and shall assign an OOS No. as per Format No. F……………….. titled “OOS Issue Control Register”.

5.5 The analyst shall fill the OOS details with the appropriate information in the issued format.

5.6 The analyst must report the OOS results to Report Head / Study Director as soon as possible (within 24 hours), so that the laboratory investigation is performed timely.

5.7 Numbering of Out Of Specification(OOS)

5.7.1 All Out Of Specification shall be numbered as per unique numbering system of 14 characters as below: OOS/XXX/YY/ZZZ

Where, 1st, 2nd and 3rd characters are ‘OOS’ signify Out Of Specification; 5th, 6th and 7th Characters are ‘XXX’ which signify ‘Department Code’ to which Out Of Specification belongs i.e. QAD for Quality Assurance Department; 9th and 10th Characters are ‘YY’ signify the last digit of the year; 12th, 13th and 14th Characters are ‘ZZZ’ which signify the serial number of Out Of Specification. eg. 001, 002, etc.; Character no. 4th, 8th, and 11th are oblique Mark (/).

5.7.2 For example First Out Of Specification generated in QAD in the year 2015 shall be numbered as OOS/QAD/15/001.

5.8 Investigation of OOS

5.8.1 QA personnel and Respective department Head shall carry out an investigation and fill the OOS form.

5.8.2 An investigation must be conducted for all OOS results to determine whether the out-of-specification result is a laboratory error or a true representation of a product/process failure.

5.8.3 The initial investigation must be performed within the laboratory as per the checklist given in Format No.:- F………………., where the OOS result was obtained. It must be performed by the original analyst and an appropriate senior analyst.

5.8.4 If evidence of laboratory error is found a retest may be conducted on the same sample or on a re-sampled sample (in case of sample error) after the approval by Head – QA. In this case, the initial OOS result may not be considered.

5.8.5 If no evidence of laboratory error is found, an OOS report shall be given to sponsor/manufacturer at the earliest in Format No.:- F…………………….. to allow for conducting batch, process or product investigation as per their standard procedure.

5.8.6 If the investigation of the product/process shows no evidence of error in the process, the OOS result must be confirmed by a retest of the original sample by the original analyst (A) and another analyst (B) in duplicate.

5.8.7 If the retest results from both analysts are within specification, perform a statistical analysis of all results generated to determine whether the original result is an outline.

5.8.8 The results and investigation reports must be reviewed by the respective department Head and Head-QA for a decision to approve the product.

5.8.9 If the retest results from both analysts are out of specification results, the OOS shall be confirmed and the same shall be reported to the sponsor/manufacturer of a product to reject/handle the batch as per their procedure.

5.8.10 If the retest result of the analyst (A) shows as OOS and that of the analyst (B) shows within specification, then another retest in duplicate should be performed by the third analyst (C), preferably senior.

5.8.11 If the retest result of the analyst (C) is OOS, the sample must be rejected. If the retest result of the analyst (C) is within the specification the sample may be accepted.

5.8.12 The decision on the status of the sample shall be made only after the review of the investigation and OOS test reports by Head- QA.

5.8.13 Document the “OOS repeat/retest analytical test record, review and final conclusion record” (Format No.:- F………………………).

5.8.14 The sequence of operations and decisions involved at each stage of the OOS investigation represented in Annexure No.:- A/SOP/QAD/012/01-00.

5.8.15All the OOS documentation shall be archived in Quality Assurance.

5.9 The objective of the investigation is to determine whether OOS results are due to an analytical error.

5.10 OOS investigation is filed along with the new and old results.

5.11 Do not discard any raw datasheet or calculation sheet or chromatogram. All raw datasheet or calculation sheet or a chromatogram shall be retained and archived.

5.12 The out-of-specification test results are not averaged along with repeat analysis results.

5.13 The material giving OOS results shall be declared as “Rejected”/ “Does not comply with the specification” in case no flaw is observed due to testing.

6.0 ENCLOSURES

6.1 Formats

Sr. No.	Format Title	Format No.	No. of pages
1.	Investigation OOS result record	F………………………..	01
2.	OOS issue control register	F………………………..	01
3.	Laboratory investigation report	F………………………..	04
4.	Report card for sponsor	F………………………..	01
5.	Repeat/retest analytical test record	F………………………..	03

6.2 Annexures

Sr. No.	Annexure Title	Annexure No.	No. of pages
1.	Decision path for assessment of out of specification results	A..................................	01

7.0 ABBREVIATIONS

7.1 SOP- Standard Operating Procedure

7.2 QAD- Department of Quality Assurance

8.0 REFERENCES

8.1 In-house

9.0 REVISION HISTORY

9.1 Nil


                                                              

END OF THE DOCUMENT

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