Manual Procedures
Manual Procedures
Manual Procedures
TABLE OF CONTENTS
Quality/Environmental Manual.........4
Documentation Requirements..........93
Control of Documents......................96
Control of Records.........................100
Management Review.......................103
Work Instructions..........................124
Work Instructions..........................127
Page: 3
QUALITY/ENVIRONMENTAL MANUAL
SOP 4.2.2
1. Scope
General
Page: 4
International Automotive Task Force (IATF)
Guidance to ISO 9001 and all related documents
Company Background
XXXX,
XXXX
Page: 5
Application
Exclusion Table
Clause Exclusion Justification
2. Reference Documents
Page: 6
Customer Specific Requirements:
Page: 7
3. Addresses additional control chart
methods and tools
MSA-3, Measurement Systems Analysis
(MSA)
TS-QSA2, Quality System Assessment
Checklist, Checklist to ISO/TS 16949:2002
TS-GS, IATF Guidance to ISO/TS
16949:2002
General Requirements
Page: 8
Management review meetings, include the Quality
and Environmental policies and objectives for
continuing suitability.
Page: 9
General requirements – Supplemental
General
Page: 10
processes is made available and actions necessary to
achieve planned results and support continuous
improvement.
Page: 11
Quality manual
Control of documents
Page: 12
Quality/Environmental records are legible, readily
available and retained for a specified period in
Quality Record Matrix. Record retention must
satisfy both regulatory and customer requirements,
as well as ISO/TS requirements. Once retention
time is met, records should be disposed of
accordingly.
Page: 13
g) Prevent the unintended the use of obsolete
documents, and to apply suitable identification
to them if they are retained for any purpose.
Engineering specifications
Master Lists
Control of records
Page: 14
Quality/Environmental Systems requirements and
effective operation of The Company’s’ Quality and
Environmental system. Pertinent Records from our
sub-contractors are an element of this. Records may
be in the form of hard copy or electronic media.
SOP 4.2.4 details procedures necessary to control
Quality/Environmental Systems records that, as a
minimum, are prepared to document:
Records Retention
Page: 15
Records controlled include customer-specified
records.
Disposition of records also includes their
disposal.
Management Responsibility
Management commitment
Page: 16
reviewed during employee performance reviews
(Section 5 and 6).
Process efficiency
Customer focus
Page: 17
These customer focused communications and
interactions ultimately yield clear, explicit
customer requirements and expectations in the
form of a contractual agreement or customer
order; the Managing Director has overall
responsibility for ensuring that specified and
unspecified requirements are determined,
understood, and converted into requirements
(Section 7).
Page: 18
policies contained in this manual, is reviewed for
continuing suitability during management review
meetings (Section 5).
Quality/Environmental Policy
Quality Policy
1. Make statement
2. Make another statement
Planning
Quality objectives
Page: 19
The Company’s Management Team annually reviews
business plan and revises, as appropriate, to encourage
customer satisfaction and overall growth of the
organization. The business plan includes short and
long-term goals relating to quality and environmental
policy objectives, and defines timeframes to achieve
each goal. We also have methods to track update and
revise fall under the Continuous Improvement Process.
Page: 20
Overall Operational Efficiency and Manufacturing
Process Efficiency (Section 5 and 6)
Page: 21
c) Develop and implement Advanced Product
Quality Planning (APQP) practices and
procedures in accordance with ISO/TS
16949:2002, including the AIAG “Advanced
Product Quality Planning and Control Plan”
reference manual, APQP-2, and associated
customer specific requirements documents.
(Section 7)
Page: 22
regulations of the jurisdictions in which we do
business (Section 6).
Page: 23
Responsibility, authority, and communication
Top Management
Page: 24
the provision of resources needed to implement and
improve Quality/Environmental Systems and
management reviews (Sections 5 and 6).
Management
Employees
Page: 25
Detailed responsibilities and authorities for Quality/
Environmental Systems implementation and
improvement are contained in lower level documents
referenced throughout this manual and other
Quality/Environmental Systems documents including
procedures, flow charts, job descriptions, work
instructions, etc.
Management representative
Page: 26
Customer representative
Internal communication
Page: 27
The Company uses internal audits (Section 8) to
reinforce or communicate appropriate information
to employees.
Management review
Page: 28
procedures detailed in SOP 5.6. The Managing Director
or designee chairs the corporate reviews and top
management from all relevant functions attends.
(Section 8)
Page: 29
processes (i.e. plant, facility and equipment, Section 6)
as an essential part of our continual improvement
process (Section 8).
Review input
Page: 30
Review output
5. Resource Management
Provision of resources
Page: 31
Subject
Quality/Environmental Planning
Business Planning
Human Resource Planning
Plant, Facility, Equipment and other
Infrastructure Planning
Contingency Planning
Work Environment, and Safety Planning
Product Quality Planning (including
Advance Product Quality Planning)
Planning of Customer-related Processes
Product and Manufacturing Process Design
and Development Planning
Planning of Purchased Product (Materials,
Services and Vendors)
Production, and Service Provision Planning
Measurement Systems Planning (including
the conduct of MSA)
Measurement, Analysis, and Improvement
Planning (including the use of SPC)
Organizational Continual Improvement
Planning
Manufacturing Process Continual
Improvement Planning
Page: 32
The MD, with input from other responsible managers,
monitors and measures overall operational efficiency
(including the cost of poor quality) and provides related
input and recommendations that may affect Quality/
Environmental Systems effectiveness to Top
Management for review and action (Section 5).
Human resources
General
Page: 33
quadrants have been achieved. This Competency
Matrix is available to persons assigning work. All
personnel understand the importance of their activities
and their contribution to the achievement of the quality
and environmental objectives. (SOP 6)
Need Determination
Page: 34
requirements and are skilled in design methods (Section
7) needed to achieve desired results.
Training
On-the-job-training
Page: 35
The Company carries out periodic audits with
employees to determine their awareness of the
relevance and importance of their activities and
contribute to the achievement of the quality and
environmental objectives.
Provision.
Effectiveness
Page: 36
The responsible manager collects the documents for
each training event. Responsible managers monitor and
measure the overall training effectiveness and to meet
competency needs and provides related
recommendations to Top Management for review and
action (Section 5).
Employee Awareness
Records
Infrastructure
Page: 37
requirements, including buildings, workspace and
associated utilities; process equipment (hardware and
software as necessary); and any supporting services that
are needed, such as transportation or communication.
Page: 38
Plant, facility, and equipment planning
Work environment
Page: 39
employees in an empowered environment of continual
improvement (Section 6). We engender total
participation by involving employees in internal audit
(Section 8) and improvement (Section 8) activities. The
Human Resources Department has overall
responsibility for identifying, implementing, and
maintaining effective employee benefit and workforce
involvement programs.
Cleanliness of premises
Page: 40
6. Product Realization
b. Environmental aspects/impacts
Page: 41
and environmental objectives and targets,
including the prevention of pollution
Page: 42
approval for any changes affecting customer
requirements, we notify the customer and validate
changes before implementation.
Page: 43
Production Part Approval Process (PPAP) (Section 7).
The APQP Team Leader implements the PPAP
recognized by our customers, PPAP-4; see SOP 7.1) in
the absence of any specific instructions, we will default
to a level 3 PPAP submission. PPAP approval is
obtained prior to the first production shipment of
product (unless specifically waived by the customer).
Acceptance criteria
Page: 44
Confidentiality
Change control
Customer-related processes
Page: 45
Determination of requirements related to the
product
Page: 46
product requirements are defined, contract or order
requirements differing from those previously expressed
are resolved, and The Company can meet the defined
requirements.
This review is conducted before the purchase contract is
accepted, unless customer waives review requirement.
During Quoting, feasibility reviews and risk analysis
are carried out and documented to determine the
manufacturing feasibility of the product. Records of
feasibility reviews are maintained as in noted in the
Quality and Environmental Records.
Organization manufacturing feasibility
Customer communication
Page: 47
stage and the responsibilities and authorities for design
and development.
Page: 48
requirements into specifications, products, processes, or
systems. The Program Manager maintains a list of
products for which The Company has design
responsibility, i.e. the authority to establish a new, or
change an existing, tooling specification; this
responsibility includes testing and verification of design
performance within customer specified applications.
The Program Manager has overall responsibility for
managing tooling design and development activities in
accordance with SOP 7.3.
Design planning
Page: 49
stages, fixed design reviews, scheduled verification and
validation activities.
Multidisciplinary approach
Design inputs
Page: 50
identified, documented and reviewed. These inputs
include functional performance requirements,
applicable legal and regulatory requirements and other
requirements essential for design and development.
Page: 51
b. Targets for productivity, process capability and
cost
c. Customer requirements
Design outputs
Product error-proofing
Page: 52
Product definition including drawings or
mathematically based data
Tool designs
Page: 53
Design review
Monitoring
Design verification
Page: 54
Final validation testing is conducted to validate the final
product, design, and process. Validation is performed in
accordance with customer requirements, including
program timing, Production Part Approval Process
(PPAP) for customers requiring this program or other
sample submission programs as required.
Design validation
Page: 55
As applicable, the Design (or APQP) Team Leader
plans and carries out or oversees design validation to
ensure it is performed in accordance with customer
requirements, including program timing.
Page: 56
will validate all production-engineering changes to
PPAP requirements.
Purchasing
Purchasing process
Regulatory conformity
Page: 57
Purchasing, Quality Control, and Engineering work
together to ensure purchased products and /or services
conform to all specified requirements, including those
from the customer. Purchasing procedures are
documented.
Customer-approved sources
Page: 58
disruptions including field returns; delivery schedule
performance (including incidents of premium freight);
and special status customer notifications related to
quality or delivery issues.
Purchasing information
Page: 59
The Quality Manager plans and implements appropriate
sampling plans and other statistical techniques to verify
purchased product per Section 8. As applicable, the
Quality Manager documents and communicates the
intended verification arrangements and method of
product release related to verification activities
performed at our suppliers’ premises.
Page: 60
Control plan
Page: 61
Work instructions
The Production Manager prepares appropriate work
instructions for all employees having responsibility for
processes that impact product quality and employee
safety (Section 6). The instructions are derived from
sources such as the control plan and the product
realization process and are accessible to the work areas
where they are needed.
Page: 62
Documenting, evaluating, and improving
maintenance objectives.
Management of production tooling
As part of manufacturing process design, (Section 7),
the Program Manager provides resources and oversees
efforts related to tool and gauge design, fabrication, and
verification activities. The Production Manager
establishes and implements a system for production
tooling management (or monitors these activities if any
work is outsourced), including:
Setup
Page: 63
Feedback on information from services
Information
Page: 64
Such information is provided through job schedules,
plans, team meetings, work instructions posted in areas
where they are needed, and through job specific
information included in individual job packs.
Work Instructions
Equipment
Monitoring Activities
Page: 65
the quality of the work and that employees understand
the procedures for reporting related problems and
suspected nonconforming conditions.( SOP 7.5.1) The
Quality Manager is responsible for planning and
implementing in-process inspections needed to ensure
process control and product quality. (Section 8)
Page: 66
Defining criteria for review and approval of the
processes
Page: 67
Identification and traceability – Supplemental
Customer property
Page: 68
Customer-owned production tooling
Preservation of product
Page: 69
‘first-in-first-out’ (FIFO) basis. Further, obsolete
product (including expired age dated material, e.g.) is
controlled as nonconforming product. (Section 8)
Page: 70
All monitoring and measuring devices that can affect
product quality are identified and calibrated at
prescribed intervals against certified equipment having
a known valid relationship to internationally or
nationally known standards.
Calibration/verification records
Page: 71
requirements, including employee and customer owned
equipment, include:
External Laboratory
General
Page: 72
process monitoring and measurement, and product
monitoring and measurement.
Customer Satisfaction
Page: 73
measuring customer satisfaction per procedures
contained in SOP 8.2.1:
Internal audit
Page: 74
promoting awareness of customer requirements and
effectiveness of the Quality/ Environmental Systems.
Product audit
Page: 75
is achieving the desired results or established
objectives. Responsible managers may also request that
the audit be used to gather “value added” data serving
as input to aid in monitoring, measurement, and
improvement of Quality/Environmental Systems
processes and systems. (Section 8)
Auditor qualification
Page: 76
The ISO Management Representative maintains all
internal audit records, including internal auditor
training records, results of internal audits and related
follow-ups; periodically reviews internal audit results as
well as progress towards achievement of corporate level
objectives aimed at improving overall
Quality/Environmental Systems effectiveness and
provides related recommendations for review by Top
Management. (Section 5)
Page: 77
process capability and suitable performance as specified
by the customer part approval process (PPAP)
requirements (Section 7).
Process Monitoring
Page: 78
Production personnel follow documented reaction plans
when processes become unstable or no longer capable.
The Quality Manager then initiates a corrective action
plan indicating the timing and assigned responsibilities
to assure the process becomes stable and capable. The
corrective action plan is reviewed with and approved by
the customer, and requires application of a customer
recognized or approved problem-solving approach
(Section 8).
Page: 79
Receiving Inspection
In-process Inspection
Page: 80
Release
Evidence of Conformity
Page: 81
Appearance Items
Identification
Page: 82
Documentation
Segregation
Evaluation
Disposition
Page: 83
(from relevant authority) a waiver of or deviation from
requirements; return to supplier; scrap or other disposal.
Product Recall
Nonconformance Reporting
Page: 84
to the appropriate specifications will be reworked or
segregated, and disposed of as is detailed in the
Nonconforming Product Procedure. Because
rework/repair is only performed for minor defect
problems, the operations are a repetition of one or more
original production processes. Therefore, original
process instructions are used and reworked material is
verified by the verification activities specified on the
control plan.
Customer Information
Customer Waiver
Page: 85
specifications) are processed per customer requirements
and the procedures defined in SOP 8.3.
Analysis of data
Page: 86
Computerized information systems are implemented for
timely reporting of data related to product usage.
(Section 5).
Analysis and Use of Data: Trends in quality and
operational performance are compared with progress
toward objectives and related recommendations for
improvement are developed and are presented to Top
Management for review and action during management
reviews. (Section 5)
Continual improvement
Page: 87
Essentially, such actions are effective if the problems
corrected do not reoccur, potential problems identified
do not occur, and other improvement actions
accomplish the desired results or objectives. Inputs to
the management review process are used to establish
new or changed improvement objectives and to
initiate/prioritize additional improvement actions.
(Section 5)
Page: 88
The Quality Manager has overall responsibility for
establishing and implementing an effective continual
improvement system (SOP 8.5) which includes
improvement actions and corrective and preventive
actions as outlined in Section 8.
Corrective action
Page: 89
Evaluating the need for action to prevent
occurrence or recurrence
Page: 90
encountered. Results of this analysis and related
recommendations are presented to Top Management for
review and action during management reviews.
(Section 5)
Preventive action
Environmental Aspects
The Company has identified the environmental aspects
of its activities, products and services that it can control
and influence and has determined those that have, or
could have, a significant environmental impact. These
significant environmental aspects and their associated
impacts were identified during the Initial
Environmental Aspects Review.
Page: 91
Ongoing determination of environmental aspects and
impacts is conducted during Advanced Quality/
Environmental Planning
The Company considers these significant
environmental impacts and aspects when establishing
environmental objectives as described in Environmental
Objectives, Targets, and Action Plans.
Legal and Other Requirements
Page: 92
The Company considers it’s legal and other voluntary
requirements, its significant environmental aspects, its
technological options and its financial, operational, and
business requirements, as well as the views of
interested parties, when establishing its environmental
objectives and targets.
Environmental objectives and targets are consistent
with The Company environmental policy, including its
commitment to the prevention of pollution.
Environmental Operational Control
Page: 93
environmental accident or incident and references
appropriate emergency response instructions, where
they exist.
Emergency response drills are conducted, as a
minimum, annually. Procedures and instructions are
reviewed and revised after drills and after the
occurrence of accidents or emergencies.
Monitoring and Measurement
Page: 94
Procedures
This booklet contains sample procedures. They are very
generic in nature and would need to be added to or
changed for a real company.
Page: 95
DOCUMENTATION REQUIREMENTS
SOP 4.2
1.0 Purpose
2.0 Application
3.0 Definitions
Not applicable
4.0 Responsibility
Page: 96
The Program Manager and/or designee are
responsible for controlling issuance and
maintenance of drawings.
Page: 97
6.0 Procedure
Revision History
Page: 98
Page: 99
CONTROL OF DOCUMENTS
SOP 4.2.3
1. Purpose
2. Application
3. Definitions
Page: 100
4.0 Responsibility
Page: 101
Drawing Control Procedure and Engineering
Change Process.
Page: 102
in-process and operator instructions) are in
agreement.
Revision History
Page: 103
CONTROL OF RECORDS
SOP 4.2.4
1.0 Purpose
2.0 Application
3.0 Definitions
None
4.0 Responsibility
Page: 104
The Program Manager and/or designee is
responsible for ensuring the proper retention of
appropriate tooling records. This is inclusive of all
prints.
Page: 105
SOP 5.6 Management Review
Procedure
6.0 Procedure
Page: 106
Obsolete documents, other than production part
approvals, tooling records, purchase orders and
amendments, shall be maintained for the length
of time established by the corresponding
Department Manager and in accordance with
minimum customer requirements.
Revision History
Page: 107
MANAGEMENT REVIEW
SOP 5.6
1.0 Purpose
2.0 Application
3.0 Definitions
None
4.0 Procedure
Page: 108
In response to changing or special conditions and
events, the Operations Manager may call for
unscheduled extraordinary reviews.
Attendance
Agenda
Page: 109
completed may be extended with a new due date,
reassigned to another person/function, changed, or
abandoned. Reasons for the failure to implement
the action and any decisions regarding
continuation of the action are recorded in the
Management Review Report.
Process performance and product conformity
Page: 110
cycle, the frequency of audit findings against
particular elements of the quality system and
discussion of significant findings.
Changes and quality system planning
Page: 111
toward achieving the objectives and fulfilling the
quality policy. Quality objectives are established
to improve performance and/or the quality system
and thus fulfill the quality policy and other
organizational goals and aspirations.
Page: 112
6.0 Management review output
Page: 113
Quality objectives
Page: 114
SOP 4.2.4 Operational Procedure, Control of
Records
Page: 115
COMPETENCE AWARENESS & TRAINING
SOP 6.2.2
1.0 Purpose
2.0 Application
3.0 Definitions
Not applicable
4.0 Responsibility
Job Description
Page: 116
Training Records
Page: 117
activities and how they contribute to the
achievement of our overall quality objectives. The
employee’s manager/supervisor in the
performance review process determines individual
training needs.
Safety Training
Page: 118
to which our personnel are aware of the relevance
and importance of their activities and how they
contribute to the achievement of the quality
objectives.
Orientation Manual
Job Descriptions
6.0 Procedure
Identify training needs.
Provide Training
Page: 119
On-The-Job training is provided for all
personnel, including contract or service
personnel, in any new or modified job.
Determine Effectiveness of Training
Revision History
Page: 120
CONTROL OF NONCONFORMING PRODUCT
SOP 8.3
1.0 Purpose
2.0 Application
3.0 Definitions
4.0 Responsibility
Page: 121
documented procedures and work instructions
for product which does not conform to specified
requirements. It is clearly (visually) identified
and quarantined or segregated to prevent
inadvertent use or installation. Material is
reviewed and disposition is determined by
management and quality. The Quality
Department is responsible for maintaining and
analyzing data from NC material activities.
Page: 122
SOP 8.5.2 Corrective/Preventive Action
Procedure
FO 8.3 Quarantine Area Record
FO 8.3 Scrap Log
6.0 Procedure
Page: 123
Acceptable Product - some rework
necessary with written instructions &
records.
Unacceptable Product (placed in red
“SCRAP” container / on rack)
Questionable Product (QA disposition
required)
Revision History
Page: 124
CORRECTIVE AND PREVENTIVE ACTION
SOP 8.5.2/8.5.3
1.0 Purpose
2.0 Application
3.0 Definitions
Not applicable
4.0 Responsibility
Page: 125
SOP 8.3 Control of Nonconforming
Product Procedure
FOPARLOG Preventative Action Log
6.0 Procedure
Page: 126
problems and commensurate with the risks
encountered.
Page: 127
Preventive actions will be reviewed during regular
management review meetings.
Revision History
Page: 128
Work Instructions
This booklet contains sample Work Instructions. They
are very generic in nature and would need to be added
to or changed for a real company.
Page: 129
WORK INSTRUCTIONS
WI-SB-5.2.2
Important General Safety Notes
PPE:
Safety glasses
Gloves
Important General Notes
Setup includes:
Press
Carpet Cutter
Over Bend fixture
Check Fixture
Final Pack Container
Stage Material for production:
Page: 130
Process:
Page: 131
11. When the container is full, the operator calls the
material handler to remove the container and bring
an empty one
Revision History
Page: 132
WORK INSTRUCTIONS
WI-DL-6.2.2
General Safety Notes
PPE:
Safety Glasses
Kevlar Gloves
Kevlar Sleeves
Knife
General Notes
Setup includes:
Check Fixture
Burnishing Table
Page: 133
The material handler:
Page: 134
8. The operator burnishes the part edges of extra fuzz
(if necessary).
Correct Color
No Forming Flaws (I.E., Excess Carpet,
Carpet Wrinkles)
Clean Trim Edge – No Fuzz Or Debris
Hole Clean – No Slugs
Slots and additional cutouts are cut or punched
clean.
Overall Appearance Good
Page: 135
14. The quality inspector records the findings (If
needed follow SOP 8.3 – Nonconforming product)
Rework Instructions:
Page: 136
MANAGEMENT REVIEW FC-MR-5.6
Significant Impact on
System
Plan & Schedule
Managament Review
Meeting
Page: 137
Status reports on actions from previous
Management Reveiws
Identification of any stratigic or operations changes
that could affect the System
Identification of any policy issues requiring review
Status reports on progress towards meeting specific
improvement objectives:
Customer Satisfaction
Supplier Performance
Overall System effectiveness including evidence
of repeat audit findings or other repeat problems
Overall operational effedciency including an
evaluation of the cost of poor quality
Manufacturing process effectivness and
efficiency including performance against
customer specified (or other targets for
productivity, process capability and cost
Overall product performance including an
analysis of actual and potential field failures and
their impacton on quality, safety, or the
environment
Oerall product qualtiy including performance
against customer spcified (or other) targets
related to product quality
Overall effectiveness of training completed including
skills training, on-the-job training, and employee
awareness and effectiveness of employee motivation
Recommendations for improvement and plans
Page: 138
Page: 139
Page: 140