htna supplier quality manual - hayashi telempu … ii-9 - process control.pdf · htna supplier...
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Revision No.”D” Date: 12/2/16 HTNA
Page 1 of 2 Section ll.9
HTNA SUPPLIER QUALITY MANUAL
SECTION II.9 – PROCESS CONTROL
PURPOSE: To define the expectations of the supplier’s method for controlling process.
SCOPE: This applies to all suppliers of purchased production intent parts to HTNA.
EXPLANATION:
The supplier is responsible for developing a quality system that provides for the identification and planning of the
production, installation, and servicing processes that directly affect quality. These processes are to be carried out
under appropriately controlled conditions.
SUPPLIER RESPONSIBILITIES:
1. Process Control:
HTNA Supplier Quality System Requirements reflect TS 16949 Section 6.4 Work Environment
HTNA Clarification
As a general rule, the supplier at a minimum should have systems in place that monitor, control, and
evaluate the following:
A. Written procedures that define the requirements for the production, installation, and servicing
processes.
B. Use of suitable production, installation, and servicing equipment and a clean environment to produce.
A contingency plan should exist explaining the course of action during emergency situations or
machine failures.
C. Compliance to standards, procedures, and quality systems.
D. Supplier and HTNA required process parameters and product characteristics.
E. A plan exists to identify, evaluate, and approve processes and equipment prior to production use.
F. Quality standards shall be clearly understood and visible to the operator while performing the
operation (i.e. – written standards, boundary samples, pictures, drawings, etc.).
G. Equipment/Tooling maintenance and repair should be properly planned, performed, documented, and
reviewed to ensure continuous process capability. Key components of machinery should be made
readily available to prevent excessive downtime and/or missed deliveries to HTNA.
2. Process Monitoring and Operator Instructions:
HTNA Supplier Quality System Requirements reflect TS 16949 Section 7.5.1.2 Work Instructions
HTNA Clarification
The supplier shall have documented process monitoring and operator instructions for all personnel who
have responsibility for monitoring, controlling, and evaluating the process. These quality standards shall be
clearly understood and visible to the operator while performing the operation (i.e. – written standards,
boundary samples, pictures, drawings, etc.). The supplier can use any form of documentation they believe
conveys the appropriate control information to the operator; however, HTNA strongly believes that the
addition of Operator Work Instruction Sheets (see SQM Section II.9.8, Operator Work Instruction Sheets)
can help dramatically improve quality and standardized work.
3. Maintaining Process Control:
HTNA (HTNA) Supplier Quality System Requirements reflect TS 16949 Section 8.2.3.1 Monitoring and
Measurement of Manufacturing Processes
Revision No.”D” Date: 12/2/16 HTNA
Page 2 of 2 Section ll.9
HTNA SUPPLIER QUALITY MANUAL
HTNA Clarification
The supplier shall have systems in place to maintain (or exceed) the process capability or performance
which was initially established during the Production Part Approval Process (PPAP). Some of the
documents that are required to help maintain the process include but are not limited to the following:
Process Control Plan
Process Failure Mode Effects Analysis (PFMEA)
Process Flow Diagram
Process Layout (Standardized Work Analysis Sheet)
Line Balancing
Operator Task Sheet (Standardized Work Combination Table)
4. Modified Process Control Requirements:
HTNA Supplier Quality System Requirements reflect TS 16949 Section 8.2.3.1 Monitoring and
Measurement of Manufacturing Processes
HTNA Clarification
In some cases HTNA may wish to call out a specific capability or performance requirement. In these cases,
the supplier’s process control plan should reflect the appropriate changes.
5. Verification of Job Setups:
HTNA Supplier Quality System Requirements reflect TS 16949 Section 7.5.1.3 Verification of Job Setups.
HTNA Clarification
At a minimum, verification is required whenever a setup is performed at:
Initial run setup
Tooling/Material change
Job change
Significant time between production runs
HTNA request
6. Process Changes:
HTNA Supplier Quality System Requirements reflect TS 16949 Section 7.1.4 Change Control
HTNA Clarification
The supplier is encouraged to generate continuous improvement activities of which these activities may
ultimately lead to a process change. All processes that require change must first have the approval of
HTNA prior to implementation (See SQM Section II.2.4, Production Part Approval Process (PPAP)).
Records of changes and their effective dates must be maintained for the life of the program and accessible
to HTNA upon request (15 year retention.)