QMS PROCEDURE

DEPARTMENT: QUALITY
PROCEDURE FOR: PRODUCT SAFETY
Procedure No. P-1 Issue No.01 Rev. No. 00 Page: 1
Clause No.: 4.4.1.2 Issue Dt. 01.03.2021 Rev. Dt. - Of: 2
Approved by MR

 Purpose: Management of product-safety- related to products and manufacturing processes.

 Scope: Applicable to all products, for all customers, which are identified during incoming, in process, final
inspection as well as customer end fitment, To assure safety of the products.

 Responsibilities: All concerns including external provider.

 Procedures:

Reference
Sr. No. Activity Responsibility Record
Document

When an enquiry received from the

customer. Manufacturing feasibility
review is done to verify the given
parameters are. AS <SC> , <CC>,
<CAP> AND make a list of safety Marketing Customer Drawing Feasibility review report
a)
parameters From customer to Head/NPD Head
customer the symbols used for
critical parameter are different for
that ref Symbol conversion table or
Symbol is given in “Control Plan"

Identification of the statutory and

regulatory product safety Statutory and Regulatory
b) All concerns -
requirements and customer Records
notification

Identification of product safety- Identification of SC & CC

c) All concerns -
related characteristics. Characteristics

Identification and control of safety – FPA/In-process

d) related characteristics of product and QA In-charge Inspection Report/SPC
at the point of manufacture. Report/Control Plan

NPD
Approval of Control plan and
e) Head/Production - Control Plan & PFMEA
PFMEA
I/C

Reaction plan and escalation process

f) QA In-charge Control Plan
if any acceptance criteria not met
 QMS PROCEDURE
PROCEDURE FOR: TRAINING
PROCEDURE FOR: PRODUCT SAFETY
Procedure No. P-1 Issue No.01 Rev. No. 00 Page: 2
Clause No.:
Issue Dt. 01.03.2021 Rev. Dt. - Of: 2
Approved by MR 4.4.1.2
Conti.

Reference
Sr. No. Activity Responsibility Record
Document

Defined responsibility, definition of

escalation process and flow of
Control Plan / Organization
g) information, including top QA In-charge -
chart
management and customer
notification.

Training identification by the

organization or customer for
h) personnel involved in product-safety All concerns - Training record
related product and associated
manufacturing process.

Changes of product or process shall

be approved prior to implementation, Team Feasibility
Development
i) including evaluation of potential - Commitment For ECN/
Head
effect on product safety from process ECN Tracker
and product changes
Transfer of requirement with regards
to product safety throughout the
j) QA In-charge - -
supply chain, including designated
source.

Product traceability manufactured lot Store & Dispatch

k) - Identification label / FIFO
throughout the supply chain in-charge

Lesson learned for new product

l) NPD - -
introduction.