This document deals with the procedure for handling deviations during analysis so as to avoid occurrence of Out-of-specification result.
1. PURPOSE:
This document deals with the procedure for handling deviations during analysis so as to avoid occurrence of Out-of-specification result.
II. SCOPE:
Applicable to all analysis in the Quality Control department
III. RESPONSIBILITY:
It is the responsibility of all the personnel involved in the analysis.
IV. DOCUMENT REFERENCE:
SOPs : None
Forms : None
V. PROCEDURE:
1.0 Obvious errors may be as under but not restricted to,
1.1 Breakage of glassware during or after sample preparation
1.2 Wrong weighing (Spillages during transfers)
1.3 Wrong dilutions (Exceeding make up volumes, wrong pipetting etc)
1.4 Breakage of pellets during IR analysis (using KBr ) etc….
Responsibility: Analyst
2.0 Intimate the occurrence of any obvious error during analysis to the Section
Head/ other using deviation Form.
2.1 Forward the deviation report to the Section Head /senior analyst for verification.
2.2 A wait for further instructions.
2.3 In case any obvious error observed after completion of the analysis (breakdown of auto injector during sample sequence, GC flame out due to lack of gas etc), intimate the same using the same form and await instructions from Section Head. Do not calculate results from this data.
Responsibility: Section Head /senior analyst
3.0 Review the obvious error reported by analyst and verifies the authenticity of the same.
3.1 Based on verification, recommend corrective action (such as reweighing, re-diluting, re- injecting, re-measuring etc.)
3.2 Indicate the recommendations and forward it to the Department Head.
Responsibility: Department Head
4.0 Review the error and corrective action suggested and approve or reject the proposal based on review.
4.1 If the proposal is rejected, indicate what corrective action is to be initiated.
Responsibility: Section Head/Analyst
5.0 Execute the corrective action and attach the deviation form with all raw data (i.e. initial and the corrected one) with the analytical report.
Deviations, arising, arising, pipetting, breakdown
