OUT OF SPECIFICATION INVESTIGATION REPORT Page 1 of 2

OOS Report No.:

(i) Material Name :

(ii) Sample Code :

(iii) Test result(s) :

(iv) Specification limit :

(v) Specification reference :
(vi) STP reference :
Analyst Name Signature Date

Review of analysis: (Use OOS review checklist)

□ Determinate Error □ Indeterminate Error □ Clerical Error

Details of corrective / Preventive action:

Investigation done by Name Signature Date

Analyst

Lab -In charge

xxxxxxxxxx
 OUT OF SPECIFICATION INVESTIGATION REPORT Page 2 of 2

Results of Investigation (attach copies of repeat results if applicable)

Repeat analysis Result(s) Analyst / reference Date

Analyst “A”

Analyst “B”

Analyst “C”

Reported results:_______________________________________
Sample status: □ Meets specification □ Failure confirmed
Impact analysis (Related batches):

Lab In-charge Name Signature Date

QA Assessment
(i) Lab investigation has been reviewed and is
□ Complete □ Incomplete □ Further investigation required:
(ii) Corrective action adequate
□ Yes □ No □ Further corrective action required
(iii) Is this a recurring problem for this product
□ Yes □ No □ Further corrective action to eliminate the problem
(iv) Comments, if any:

OOS Report Name Signature Date

Approved by (QA)
Authorised by (Director)
IQAD/038-02/01