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Sample
Pages
of
ISO
/ TS 16949:2009 Quality System Model
table of contents
quality manual -
procedures - flowcharts
requirements checklist |
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Content of the Quality Management System Model ISO/TS 16949:2009
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Introduction
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Quality System Model (manual,
procedures, flowcharts, work instructions, master lists, forms)
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Checklist of ISO/TS 16949:2009
Requirements
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Documentation/Procedures Development
Guide
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Implementation Plan and Schedule
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Documentation Development Files
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Documents
and Procedures
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Quality Manual (1) incl. flowchart
of the interaction of processes of the quality system
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Operating Procedures (57), incl.
78 control forms and 8 procedures with optional flowchart version
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Work Instructions (6)
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Document master lists (16)
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Operating Procedures
and Work Instructions by Department
The standard ISO/TS 16949
requires 7 mandatory documented procedures. It is up to the discretion
of the organization to document additional procedures included in this
quality system model, or just to implement them in order to meet the requirements
of the standard. |
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Engineering
EG 01 Quality Planning of
Product/Processes
EG 02 Document and Data
Control (Eng.), + flowchart version
EG 03 Request for Design
Initiation and Change
EG 04 Out-Contracting of
Tooling Construction/Design
EGW 01 Process of Quality
Planning, Product/Process
Manufacturing
MF 01 Health and Safety
Training
MF 02 Cycle Counts
MF 03 Traceability of Manufactured
Product
MF 04 Production Scheduling
MF 05 Material Resource
Planning
MF 06 Manufacturing Process
Control
MF 07 Set-Up Procedure
MF 08 Preventive Maintenance
of Equipment
MF 09 Regulatory Requirements,
compliance
MF 10 Housekeeping
Purchasing
PU 01 Purchase Orders, processing
and follow-up
PU 02 Supplier Database,
set-up and maintenance
PU 03 Purchasing Product-Database
PU 04 Assessment, Eval., Appr., Rating of Suppliers
PU W 01 Suppliers Performance
Rating System
Quality Assurance
QA 01 Control of Nonconforming
Product, + flowchart version
QA 02 Receiving Inspection
QA 03 In-Process Inspection
QA 04 Inspection and Testing
of Finished Product
QA 05 Control of Monitoring
and Measuring Equipment
QA 06 Out Of Calibration
Report
QA 07 Measurement Equipment Analysis
QA 08 Customer Return Analysis
QA 09 Positive Recall Control
QA 10 Customer Approval
of Production Parts
QA 11 DMRs to Suppliers
QA 12 Layout Inspection
and Functional Testing |
Quality
System Administration
QS 01 Document Review
QS 02 Training, + flowchart version
QS 03 Control of Documents, + flowchart version
QS 04 Operational Performance
QS 05 Evaluation of Customer
Satisfaction
QS 06 Customer Complaints
QS 07 Customer Satisfaction
Survey
QS 08 Internal Quality Audits,
+ flowchart version
QS 09 Preventive Action,
+ flowchart version
QS 10 Corrective Action,
+ flowchart version
QS 11 Continual Improvement
QS 12 Control of Records,
+ flowchart version
QS W 01 Corrective Action
Request
QS W 02 Problem Analysis
QS W 03 Quality Improvement
Proposal
QS W 04 Document Identification
Sales
SA 01 Warranty Control
SA 02 Review of Quotations
and Contracts
SA 03 Product/Price File
and Customer File
SA 04 Order Taking and Processing
SA 05 Delivery Performance,
order entry
SA 06 Customer Returns
SA 07 Service Requirements
Toolroom
TR 01 Tooling Construction
TR 02 Approval of Customer-Supplied
Tooling
TR 03 Prev. Maintenance,
Repair, Admin. of Tooling
TR 04 Tooling Repair Request
Warehouse
WH 01 Shipping of Product
WH 02 Receiving of Product
WH 03 Handling and Storage
of Product
WH 04 Temperature Control |
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Forms
Forms or control forms are
part of operating procedures or work instructions. These forms facilitate
the performance of activities, document results, and provide evidence of
compliance with requirements. In most cases, these forms can be used without
documenting the applicable procedure, and it is up to the organization
to document the procedure or only to implement the procedure and using
the control form to ensure compliance and create records. |
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Engineering
- Quality Planning – Project
Summary Form
- Engineering Document and
Data Control Form
- Document Distribution
Log
- Document Receiving Log
- Design/Development Project
Request Sheet
- Quality Planning Project
- Plan and Schedule
- Project Review Checklist
- Process FMEA Form
- Control Plan
Manufacturing
- Training Attendance Record
Form
- Cycle Count Records Form
- Material Requirement for
Production Form
- Process Sheet
- Manufacturing Order Form
- Material Supply Order
Form
- Product Identification
Tag
- Tools and Fixture Requisition
Sheet
- Request for QC-Approval
(first-off/last-off) Form
- Preventive Maintenance
- Master List of Equipment
- Preventive Maintenance
Checklist
- Equipment Replacement
Parts - MIN / MAX inventory
- Weekly Maintenance Schedule
of Equipment Sheet
- Maintenance Record
Purchasing
- Supplier Database - Setup
and Maintenance Form
- Product Database - Setup
and Maintenance Form
- Supplier Self Assessment
Questionnaire
- Supplier Evaluation and
Approval Sheet
- Approved Supplier List
Quality Assurance
- Quarantined Product Tag
- Quarantine Order Sheet
- Receiving Inspection Report
- Rejected Product Tag
- In-Process Inspection
Report
- In-Process Inspection
Report - Master List
- First – Off Tag
- Approved for Shipping
Tag
- Last–Off Tag
- Master List of Measuring,
Monitoring, Testing Equipment
- Calibration Status Tag
- Calibration and Maintenance
Record Sheet
- Out Of Calibration Report
- Authorization for Positive
Recall Form
- Under Positive Recall
Control Tag
- Discrepant Material Report |
Quality
System Administration
- Training Record
- Templates: manual, procedures,
work instructions
- Performance Statistics
Form
- Customer Complaints Log
- Customer Satisfaction
Survey Form
- Internal Quality Audit
Plan / Schedule
- Audit Report Form
- Corrective Action Request
Sheet
- Problem Analysis Form
- Quality Improvement Proposal
Sheet
Sales
- Quotation Sheet
- Project Order Form
- Customer File Setup and
Maintenance Form
- Product/Price Record Form
- Customer Order Sheet
- Material Return Authorization
Form
- Service Report Form
Toolroom
- Tooling Work Plan
- Try-Out Record
- Tooling Inspection Report
- Preventive Maintenance
Tag
- Tooling Inventory Log
- Preventive Maintenance
Report
- Tooling Repair Request
Form
Warehouse
- Temperature Record Sheet
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Checklist of ISO/TS 16949:2009 requirements
This detailed checklist of 57 pages assists with
the identification of - and compliance with - the
requirements of ISO/TS 16949:2009. A handy tool
for the development of documentation, procedures
and auditing processes, as well as the
identification of documents that address specific
related requirements of ISO/TS 16949:2009.
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Sample
page
of an ISO/TS 16949:2009 Quality Manual, page 41
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RC
Auto-Parts
Manufacturing |
Quality
Manual |
Page No. : 41 of
42
Revision : 00
Issued
: 2009/09/01
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The
objectives of the corporate quality policy are taken into
consideration for planning of improvement. During Management
Reviews, the effectiveness of continual improvement is
reviewed and opportunities for improvement are identified.
8.5.1.2
Manufacturing process improvement
It
is the responsibility of personnel in Manufacturing to
continually monitor the performance of manufacturing processes
regarding conformity with product characteristics and process
parameters. In monthly meetings with the production staff,
process performance of production areas are analyzed, and
opportunities for improvement are identified and implemented
(QS11).
8.5.2
Corrective action
It
is the responsibility of the Management Representative to
implement and maintain the documented procedure QS10
Corrective Action which defines a corporate approach for
corrective action.
Following
the established procedure for corrective action (QS10),
nonconformities are identified, root causes are determined,
corrective action is evaluated and defined, recurrence of the
nonconformity is prevented, corrective actions and their
results are recorded, and the effectiveness of corrective
action taken is reviewed. Corrective actions are appropriate
to the importance and impact of the addressed nonconformity.
It is the responsibility of the department heads to inform the
Sales/Service department of all customer complaints (QS06) and
related corrective actions.
It is the responsibility of the department heads to establish
and maintain records of corrective actions and their results.
8.5.2.1
Problem solving
To
determine the root cause of a problem or deficiency, and to
establish required corrective action, a disciplined problem
solving method as outlined in the work instruction QSW02, or
any other suitable method, is used as appropriate.
8.5.2.2
Error-proofing
As
appropriate, the Quality Team applies error-proofing methods
in the corrective action process to prevent recurrence of the
problem.
8.5.2.3 Corrective
action impact
As
applicable, the Quality Team applies implemented corrective
action to other similar processes or products in order to
correct nonconformity.
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Sample
page
of an ISO/TS 16949:2009 operating procedure Corrective Action
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RC
Auto-Parts
Manufacturing
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Operating
Procedure
QS 10
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Page
No. : 01 of 01
Revision : 00
Issued
: 2009/09/01
Effective
:
2009/09/01
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Prepared
by:
Herb S. |
Date
Sept.
01/2009 |
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Reviewed/approved
by Dept. Head
John K. |
Date
Sept.
01/2009 |
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Reviewed/approved
by Mgmt. Rep.
Herb S.. |
Date
Sept.
01/2009 |
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| Changes made: |
new
issue |
| Purpose: |
Document
the process for corrective action activities,
including analysis, root causes, action taken
and monitoring the effectiveness of corrective
action.
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| Scope: |
Nonconformities
and deficiencies of products, manufacturing
processes, services, technical service,
customer returns, customer complaints,
products and services provided from internal
and external suppliers, including carriers.
Preventive action. |
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Procedure
General
If
there is a need of establishing a documented record of
an internal nonconformity or deficiency which requires
a formal approach of corrective action, a Corrective Action Request (CAR)
is issued (see Work Instruction Corrective
Action Request).
No CAR should be issued without prior communication with functions
concerned. There should be no CAR
issued for a minor problem that can be taken care
of with a simple phone call or a five-minute
conversation.
The benefits of using a CAR
are
·
that
the problem, nonconformity or deficiency is described
in detail and documented
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that
responsibilities are defined and assigned
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that
temporary corrective action is taken if required, in
order to satisfy the immediate needs
of the (external or internal) customer
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that
root causes are determined
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that
corrective action is taken to permanently correct the
problem, nonconformity or deficiency
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that
the suitability and effectiveness of results is
monitored, reviewed and recorded
For the processing of a CAR,
the work instruction Corrective
Action Request (CAR) is followed.
If corrective action requires changes to documents of
established procedures, the responsible department
head ensures that documents and procedures are updated
and that changes are implemented. New procedures are
established, documented and implemented as required.
Similar processes are analyzed and corrective action
shall be applied to these processes as
appropriate.
Where appropriate and applicable, a structured problem
solving method is used, such as the method outlined in
the work instruction Problem
Analysis, a customer-prescribed method, or
any other suitable problem solving method.
Error-proofing shall be part of the corrective action.
Customer complaints are handled according to the
operating procedure Customer Complaints.
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Sample
page
of an ISO/TS 16949:2009 operating procedure Corrective Action
flowchart format (page 1 of 2) |
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RC
Auto-Parts
Manufacturing
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Operating
Procedure
QS 10
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Page
No. : 01 of 02
Revision : 00
Issued
: 2009/09/01
Effective
:
2009/09/01
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Prepared
by:
Herb S. |
Date
Sept.
01/2009 |
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Reviewed/approved
by Dept. Head
John K. |
Date
Sept.
01/2009 |
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Reviewed/approved
by Mgmt. Rep.
Herb S.. |
Date
Sept.
01/2009 |
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| Changes made: |
new
issue |
| Purpose: |
Document
the process for corrective action activities,
including analysis, root causes, action taken
and monitoring the effectiveness of corrective
action.
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| Scope: |
Nonconformities
and deficiencies of products, manufacturing
processes, services, technical service,
customer returns, customer complaints,
products and services provided from internal
and external suppliers, including carriers.
Preventive action. |
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Procedure
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Sample
page
of an ISO/TS 16949:2009
control form Corrective Action Request
(page 1 of 2) |
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Sample Page
of the Checklist of ISO/TS 16949:2009 Requirements (page 55
of 57)
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Requirements
Checklist for ISO/TS 16949:2009
For internal use only
Page 55 of 57
Important: This checklist shall assist with the
assessment of compliance with requirements
of ISO/TS 16949:2009. The standard ISO/TS
16949:2009 shall be used for the interpretation of the
standard.
Review performed by:
_______________________________________________
Date:_________________________________
Y = yes, I = improvement needed, N
= no, X
= not applicable
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ISO
9001 System Clauses / Requirements
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M
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Procedures
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Y
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I
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N
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X
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8.5.1.1
Continual improvement of the
organization
A
process for continual improvement
shall
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be defined
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8.5.1.2
Manufacturing process improvement
Manufacturing
process improvement shall continually
focus on
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control of variation in product
characteristics |
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control of variation in manufacturing
process parameters
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reduction of variation in product
characteristics |
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reduction of variation in
manufacturing process parameters |
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8.5.2 Corrective action
To
eliminate the cause of nonconformities
in order to prevent their recurrence,
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corrective action shall be taken |
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Corrective
action shall be
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appropriate to the impact of the
nonconformity encountered |
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A
documented procedure for corrective
action
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shall be established and maintained |
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The
documented procedure for corrective
action shall define the requirements
for
a)
- reviewing nonconformities (including
customer complaints) |
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- determining the causes of
nonconformity |
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c)
- evaluating the need for action to
ensure that nonconformities do not
recur |
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| d)
- determining corrective action needed |
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- implementing corrective
action needed |
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| e)
- records of results of action taken |
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| f)
- reviewing corrective action taken |
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