Quality System Procedure For Change Point Control
Quality System Procedure For Change Point Control
Quality System Procedure For Change Point Control
1 DEFINITION : - The lot control of parts with all changes including planned / unexpected changes
to part specifications and manufacturing plan shall be considered as change
point control.
4 DETAILS: -
S.NO. ACTIVITY RESPONSIBILITY
4.1 The MAL shall record the point of first application of a change to parts HOD QA
specifications or manufacturing method as a change point. The change point
can be defined as unexpected change and planned change.
4.2 Mal shall record The unexpected change is the sudden changed include the All HOD
following :-
a) Unexpected suspension of work or change of operator.
b) Line stop and restart.
c) Process change due to abnormality of equipment.
d) Follow-up of delay in operation.
The change point record shall contain following,
e) Nature of the change.
f) Time and date of the change occurred or found.
g) Date of manufacture or release.
4.3 The communication for change point control shall be carried out to customer All HOD
with IPP Tag
(Initial Part Production Tag.)
4.10 The MAL shall Comply with FIFO in order and release IPP accordingly. All HOD
4.11 Manufacturing department will carry on the communication with IPP Tag Concern
received from design department with utmost care and & will run concerned lot Department HOD
separately along with MMC Card/Route Card and IPP-Tag will must attached
with Bin/Crate.
For Multiple Bin/Tag number of True Copies can use.
4.12 A Material Movement Card / Route Card must be attached along with IPP for Concern
change point traceability purpose & user should comply FIFO. Department HOD
4.13 In IPP Tag the originator will maintain following points record at minimum, I/C Design
a) Nature of Change.
b) Time and date of change occurred or found.
c) Date of manufacture/release.
d) Inspection result.
4.14 A special inspection carried out for IPP lot with Layout/sample inspection as I/C F.I QA
per MAL/STD-1 & 100% visual inspection done at Final Inspection stage.
The Final QA will document his signature over IPP-Tag in specified column &
approved by HOD-QA.
4.15 The Manufacturing Head will responsible for signature over responsible person Head-
column for verification of implemented change points as per customer voice. Manufacturing
4.16 IPP Tag will carry with every bin / crates till customer end from dispatch Concern
department. Department HOD
4.17 If there are more than one delivery locations, IPP tag shall be attached to each I/C-Dispatch
initial lot released for each of the location.
In case where an IPP lot is divided and delivered in multiple containers, the
supplier shall attach a supplemental IPP tag to each container.
4.18 Before transit IPP Tag should be enrolled to IPP tag control register with IPP I/C Dispatch.
Tag no, Date of Issue, Item Name, and Change description.
4.19 One copy of the IPP Tag will be kept in supplier end & document retention MR
period is 15 years.
4.20 Process Control :-
The MAL shall monitor the process of IPP after transition to mass production
for a period of one month.
4.21 The MAL shall control the same IPP Procedures for sub supplier supplied HOD PROJECT
parts.
4.22 Retention Period :-
5. REFERENCE RECORD