PHASE I INVESTIGATION REPORT OF OSS

                                                                                                                        OOS No.         :

                                                                                                                        Date                :

Name of Finished Product/Raw material/Intermediate/ Stability Samples:

Lot / Batch No. / A.R. No.                             :

Specification No.                                            :

Test Procedure No.                                         :

Test OOS result is found                                :

Result                                                              :

Details of the finding                                      :

Analyst                                                            :

Date of Analysis                                             :

Date of Investigation Started on                    :

Description of Problem                                   :

Analyst  sign  :                                                                       

Date                :

                                                                       

Laboratory Investigation:

-                      Assignable Cause identified               :

      Explanation (Memo attached)                        :  Yes / No

-                     Assignable Cause Not identified        : 

      Explanation (Memo attached)                        :  Yes / No

-                     Action taken to prevent recurrence

(Memo attached)                                 :  Yes / No

            Prepared by     :  _________________                                   Date    :  ____________

                                          (Executive – QC)

            Approved by   :  _________________                                   Date    :  ____________

                                          (QC – Manager)

Category		Checklist item	Yes	No
Equipment	1	Did all equipment function properly?
	2	Is there evidence that the equipment is contaminated?
	3	Were instruments calibrated properly and within the calibration period?
	4	Was all the correct equipment used in analysis?
Methods / Procedures	5	Are the calculations correct?
	6	Were there instrument problem such as; noisy baseline poor peak resolution, poor injection reproducibility, not reproducible or unidentified peaks, or contamination that affected peak integration etc.?
	7	Was the correct method used?
	8	Was the method followed correctly?
Standards	9	Is there evidence of degradation of standards and / or samples (before or after preparation)?
	10	Were standards and samples properly weighed, prepared, and diluted?
	11	Were standards, samples, reagents, etc. properly labeled?
	12	Were standards, reagents, samples, and their solutions within their expiration date?
	13	Are the standard responses the same as previous value?
	14	Were the standards stored appropriately?
Sample preparation	15	Were reagents properly standardized?
	16	Is there evidence that reagents, solvents, standards, glassware (or any container) or other material used in the test were contaminated?
	17	Were the correct reagents, solvents, standards, glassware, or other auxiliary equipments used?
History	18	Is there a similar history with the product in the past?
	19	Have there been similar errors in the past?
Other

Additional information required:  Retest date and reason(s) for retest, all participant’s names, all retest results, evidence for the conclusion and names of individual (s) responsible for the corrective action.

If other additional is available concerning the nature of the problem, diagnostic test to the performed, more detailed results of the investigation or suggested corrective action, including procedure change, attach a memo to this form.