QUALITY SYSTEM PROCESS DOC. No.
: QSP/QA/09
TITLE: PROCESS FOR STATISTICAL PROCESS REV. No. : 00
CONTROL (SPC) DATE : 05.07.2022
REVISION HISTORY
CHANGE
APPROVED
MADE BY AFFECTED REVISION
DATE CHANGES MADE BY
(QMS SECTION NO.
(Director)
HEAD)
05.07.20
Original Release. All 00
22
DOCUMENT OWNERSHIP AND TIME LINES
DOCUMENT "Internal
TITLE SPC CLASSIFICATION document"
DOCUMENT PREPARED
DATE OF ORIGIN 05.07.2022
BY
DOCUMENT REVIEWED 04.07.2023
REVIEWED
BY
DOCUMENT APPROVED
REVIEW DUE 03.07.2024
BY
1. TURTLE DIAGRAM:
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QUALITY SYSTEM PROCESS DOC. No. : QSP/QA/09
TITLE: PROCESS FOR STATISTICAL PROCESS REV. No. : 00
CONTROL (SPC) DATE : 05.07.2022
With What Resources? With Who? (Competence/ Skills
/Training)
Computer with SPC software.
SPC AIAG Manual Knowledge about SPC.
Process Owner
PROCESS INPUT PROCESS OUTPUT
HOD- QUALITY
Type of Measurement Selected Characteristic
Customer specific for Capability study.
requirements of process Preliminary Process
capability Capability plan
Previous/similar Process Measured data
Capability results Implemented Controls
Control plan\ PROCES charts
Risk Analysis & Event logs
Opportunity S Adjustment and
Corrective actions
STATISTICAL Attributes studies and
results
PROCESS Capability index results
CONTROL (Pp, Ppk, Cp,Cpk)
(SPC)
Team Members
Quality Executives
With what Methods? With what Key Criteria?
An SPC Plan is prepared covering Process Capability
special characteristics,
Responsibility for data collection,
analysis shall assigned
Capability reviewed, actions planned
and implemented.
Ensure that ongoing process capability
is meeting the customer requirement
2. PROCESS SCOPE:
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QUALITY SYSTEM PROCESS DOC. No. : QSP/QA/09
TITLE: PROCESS FOR STATISTICAL PROCESS REV. No. : 00
CONTROL (SPC) DATE : 05.07.2022
This process is applicable to establish and maintain a system for the application of Statistical
Technique for critical parameters in order to control the variation of critical product
characteristics and to assess & maintain the process capability.
3. PROCESS OWNER: HOD- QUALITY
4. DEFINITIONS/ABBREVIATION: SPC- STATISTICAL PROCESS CONTROL
Cp- PROCESS CAPABILITY
Cpk- PROCESS CAPABILITY INDEX
CSR- CUSTOMER SPECIFIC REQUIREMENT
5. PROCESS DESCRIPTION:
Sr. Responsibilit
Activity Ref. Doc.
No. y
5.1 Identify the need for statistical techniques
application for control of product, monitoring and
process improvements based on
----
a. Inspection & testing results QUALITY
b. Data analysis / Defect analysis
c. Process performance assessment
5.2 Analytical methods used to monitor processes
variation
Examples of methods
Check Sheet : - To count occurrences of
problems
Histogram : - To identify central tendencies and
any skewing to one side or the other
Pareto Chart : - To identify the 20% of the ----
modules which yield 80% of the issues QUALITY
Cause and Effect Diagram : - To identify
assignable causes
Scatter Diagram : - For identifying correlation
and suggesting causation
Control Chart : - For identifying processes that
re out of control
Graph : - For visually displaying data e.g in a pie
chart
5.3 Identify control characteristics of the process and
prepare S.P.C implementation plan.
The type of Statistical technique used to
----
measure process variation QUALITY
How characteristics are chosen for control
The method used to control the process
Operator responsibility
Sampling frequency
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QUALITY SYSTEM PROCESS DOC. No. : QSP/QA/09
TITLE: PROCESS FOR STATISTICAL PROCESS REV. No. : 00
CONTROL (SPC) DATE : 05.07.2022
5.4 Conduct an SPC study on specified critical characteristics
or dimensions based on customer requirements and past
SPC PLAN-
performance data. Implement an SPC plan to collect
QUALITY F/QA/21
readings at both ends of each roll every 100 meters
during ongoing production."
5.5 Collect the data for SPC. Then calculate Cp & Cpk
value
and Measure the process variation by Considering of SPC RECORD-
Cp, QUALITY F/QA/22
Cpk and Interpretation Of control Chart.
5.6 If doses not meet the target then take action SPC RECORD-
QUALITY F/QA/22
5.8 Decide the appropriate actions and implement on
the basis of process variation QUALITY CAR- F/QA/18
5.9 Training needs for the personnel for use of
statistical techniques are identified & provided. QUALITY ----
6. KEY PERFORMANCE INDICATORS:
Process Capability
7. REFERENCE DOCUMENTS & RECORDS:
SR. FORMAT/ DOC. NO.
DESCRIPTION RESPONSIBILITY
NO. (IF ANY)
01 SPC PLAN F/QA/21 QA
02 SPC RECORD F/QA/22 QA
03 CAR F/QA/18 QA
External origin documents:
04 SPC- AIAG Reference Manual ---- QA
---------
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