Ab

Dhaka, Bangladesh

FAILURE MODE EFFECT– RISK REDUCTION

Title of Risk Assessment: Cleaning validation protocol of Manufacturing Equipment (Worst case protocol: Don-A 10 Tablet)
Source: Change Control Source Ref. No.: CCR/SDU-VAL/22/003 Ref. No. of QRM Report: QRM/SDU-CCR/22/028

RPN
Sl. RPN Risk Accepted?
(Ref.: Appendix- Recommended action Responsibility S P D
No. (SxPxD) Class Y or N
E)
.
1. Cleaning procedure SOP of Hose pipe and dies
Production Y, based on
punch will be change
01 16 and 4 1 1 4 Low implementation of
2. Cleaning validation will be done according to new Validation proposed risk
method and sampling technique.
reduction action.

Here, RPN is Risk Priority Number.

Summary of Risk Assessment: The proposed risk reduction action may eliminate the risk associated this changes.

Report Submitted By (QRM Team) Report Checked By Report Approved By

Md. Mohaiminul Sumon Shorab Hosen

Miton Chowdhury Tanzina Afrin Md. Naim Hasan Mahmudul Hasan
Islam Asst. Chandra Pal Chowdhury Shah Sharfin
Executive, Asst. Manager, Manager, Deputy Manager,
Manager . Asst. Manager Sr. Manager, QA
Validation R&D Validation QA
Production Manager, QA Production

Form No.: SOP/ACME-QA/007/F06 Page 1 of 1