Handling of out of specification (OOS) results

PURPOSE

       To lay down the procedure for handling of Out of Specification (OOS) results.

SCOPE

This procedure is applicable for handling of OOS for XXXXXXXXXXX

RESPONSIBILITY

Head - Quality Control, Production, Ware House and Process development lab.

ACCOUNTABILITY

Head - Quality Assurance                                            

PROCEDURE

OOS Handling.

Definition of 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 Result.

Investigation for all OOS results shall be carried out to find out the cause of failure which help in making the decision of           

           a)Action to be taken to prevent the recurrence.

           b)To take proper decision for material disposition.

Investigation to find out the cause of OOS results shall be carried out in two phases that is

          a) Laboratory investigation

          b) Out side the laboratory investigation. Other relevant department  like production, warehouse and any other related department.

Investigation should be completed within 15 working days. Any deviation needs authorization from Head – QA in writing.

Laboratory Investigation.

When any OOS result is identified during analysis in QC laboratory, analyst should preserve the samples, standards, dilution and glassware.

Analyst shall inform immediately to Head – QC.

Head - QC shall initiate the laboratory investigation for the OOS result of the individual parameters within 24 hours.

Describe all the necessary information mentioned in the format ‘Laboratory investigation form’ (Format number: XXXXXX).

Serial number shall be generated from the log maintained by QC as per section 5.6 and for assigning the serial number refer section 5.5.

Laboratory investigation is not required for failure in the physical description.

If laboratory investigation is not required Head - QC shall transfer the OOS investigation form to QA. Otherwise Head - QC shall complete the investigation as per the following and thereafter send the executed form to QA.

If Laboratory investigation is required.

QC incharge shall conduct investigation as per the checklist for laboratory investigation in the section 2 of investigation form (Format number: XXXXXX).

In case of error found in laboratory investigation proceed for retest.

In case retest results also leads for OOS then proceed for production and Warehouse investigation as per the formats XXXXX and XXXXX.

In case error not found in laboratory investigation proceed for production and Warehouse.

In case error not found in production and Warehouse then proceed for resampling and retesting.

Quality Control investigation

Retesting

If any instrument or analyst error is identified, Head - QC shall take necessary corrective action to rectify the error and take the decision of retesting.

A sample used for the retesting should be taken from the originally collected, tested, and yielded the OOS results.

 Retesting shall be done by the different analyst with all fresh preparations. Retesting shall be performed only once.

In the case of an identified laboratory error, the retest results would substitute for the original test results. The original results should be retained, however, and complete OOS investigation shall be recorded in the OOS investigation format as per XXXXXX.

Head - QC shall propose the corrective action.

Head - QC shall arrange the training to train the analyst if the OOS is attributed to personal error and also document record of training.

Investigation forms shall be sent to QA.

The investigation form shall be filed with QA with all analytical raw data of initial test and retest or the reference of location of raw data.

Resampling

If sampling error is identified Head - QC shall plan for resampling and reanalysis.

Decision to invalidate the earlier OOS shall be done if all following criteria met.

Testing on resampled material meet the  Specification.

No assignable cause found in out of lab Investigation.

Resampling should be performed by the same sampling methods that were used for the initial sample.

If the investigation determines that the initial sampling method was in error, a revised sampling method must be developed, qualified, and documented.

Resampling shall be performed only once either by the previously approved method or revised method.

Inconclusive Investigation

Reanalysis using new sample preparations from the original sample, in triplicate by two different analysts (i.e. 3 weights or 3 aliquot of samples are needed for each analyst).

The original out of specification results shall be invalidated if the following conditions are met.

All the individual reanalysis results were found   to be within specification.

The RSD value of each set of triplicate determinations is less than 2.0%.

The difference between the average results obtained by the two analysis is less than 1.0%.

The original out of specification test result should not be averaged along with retest results.

OOS investigation flow chart is attached as Format no. XXXXXX.

Closing of OOS.

 All OOS investigation form shall be sent to Head/Designee-QA.

QA Head shall initiate the Closing form as per Format no. XXXXXX.

Closing form along with all executed investigation form shall be circulated to Head-QC, Head - Production or warehouse (as applicable) and Head- Process Development Lab or R&D to write their remarks on the format in the following way:

Head QC shall write the reason of Lab failure if applicable and action taken to prevent the recurrence of failure.

Head Production or warehouse shall write the reason of   failure as observed during Out of Lab Investigation and action taken to prevent the recurrence (if applicable).

Head Process Development shall write, whether the material rejected, can be reprocessed or reworked. If process is not available he shall arrange for developing the rework process (if applicable).

Head Quality Assurance shall assess all comments and finally decide whether the material is to be rejected or released.

If the material is rejected Head QA shall decide whether the material will be reprocessed or destroyed.

Head QA shall ask for the improvement in the system to prevent the reoccurrence of failure.

LOOK BACK AND LOOK FORWARD.

Head-QA shall analyze the OOS result, its investigation and find out the effect of reason of failure on the previous released material and take action on the case basis, based on the type of failure and its investigation results and assure the quality, safety and purity of the finished product.

Head - QA shall be responsible for reviewing the effect of the action (s) taken (to prevent the recurrence of failure) for its effect on the quality, safety and purity of the finished product of the proceeding batches.

After complete review of OOS investigation, further action taken and their effect on the preceding and proceeding batches, Incharge-QA shall close the OOS investigation format by final approval signature.

OOS closing document (Format no. XXXXXXX) shall be issued to QC for the closure of the document generated at QC.

OOS numbering

QC department shall assign OOS number on OOS investigation format.

Numbering of the OOS shall be as per following example.

Note: If any new labs are added the serial number shall be continued.

OOS Logging

QC department shall log the OOS investigation in a register    (as per Format No: XXXXXX) where details such as Serial number, Date of initiation, Product Name, Batch No/AR Number, OOS number, OOS test parameter, recorded by sign/date, Date of closing and status.

END OF DOCUMENT

Specification, quality control, development lab