Honeywell QE Manual
Document Sample


Honeywell
Our Quality & Environmental
Commitment
The Sensing and Control (S&C)
Global Management System
Manual
Honeywell Page 1 of 35
HONEYWELL
Global Management System Manual
No. GMS 0001 Issue 3
Revision Date: March, 2006
The only valid copy is the master on the Global Quality web page, paper copies are uncontrolled.
A copy of this manual may be accessed by entering the Quality Intranet Website
http://acsnet.honeywell.com/C19/ACPquality/default.aspx
TABLE OF CONTENTS
Approvals and Revision History
1 Introduction
2 Purpose
3 Scope
4 Global Management System Requirements
4.1 General Requirements
4.2 Documentation Requirements
4.2.1 General
4.2.2 Quality & Environmental Manual
4.2.3 Control of Documents
4.2.4 Control of Records
5 Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality & Environmental Policy
5.4 Planning
5.4.1 Quality & Environmental Objectives
5.4.2. Quality & Environmental Planning
5.5 Responsibility, Authority, & Communication
5.5.1 Responsibility & Authority
5.5.2 Management Representative
5.5.3 Internal Communication
5.6 Management Review
5.6.1 General
5.6.2 Review Inputs
5.6.3 Review Outputs
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6 Resource Management
6.1 Provision of Resource
6.2 Human Resources
6.2.1 General
6.2.2. Competence, Awareness & Training
6.3 Infrastructure
6.4 Work Environment
7 Product and/or Service Realization
7.1 Planning of Realization Process
7.2 Customer Related Processes
7.2.1 and 7.2.2 Determination & Review of Requirements Relating to the Product
7.2.3 Customer Communication
7.3 Design & Development
7.3.1 Design & Development Planning
7.3.2 Design & Development Input
7.3.3 Design & Development Output
7.3.4 Design & Development Review
7.3.5 Design & Development Verification
7.3.6 Design & Development Approval
7.3.7 Control of Design & Development Changes
7.4 Supply Management
7.4.1 Supply Management Process
7.4.2 Supply Management Information
7.4.3 Verification of Purchased Product and/or Services
7.5 Production and Service Operations
7.5.1 Operations Control
7.5.2 Validation of Special Processes
7.5.3 Identification and Traceability
7.5.4 Customer Property
7.5.5 Preservation of Product
7.6 Control of Measuring and Monitoring Devices
8 Measurement, Analysis, & Improvement
8.1. General
8.2 Measurement & Monitoring
8.2.1 Customer Satisfaction
8.2.2 Internal Audit
8.2.3 Monitoring & Measurement of Processes
8.2.4 Monitoring and Measurement of Product
8.3 Control of Nonconformity
8.4 Analysis of Data for Improvement
8.5 Improvement
8.5.1 Continuous Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action
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Appendix A -- Definitions
Approvals and Revision History
This document is approved by the President and the VP of Integrated Supply Chain for S&C
Beth Wozniak Steve Spiller
President VP of ISC
Changes that do not affect the content will not require either review or approval but will be
recorded in the Revision History section by the technical owner.
Issue 1, revision date 13 February 2003 – New document covering the Global Management
System.
Issue 2, Updated for clarification on the purpose of the GMS, as well as the addition of
environmental requirements throughout the manual. Removed references to IM&C and ECC
and updated scope accordingly. Revision made to approval requirements based on this manual
only applying to S&C. Updated revision references on Standards. Added references from both
the AS and TS standards throughout the manual. Clarification regarding the three levels of
management reviews and management representatives.
Issue 3, Updated sections. 4.2.4, 5.1, 6.2.2, 7.1, 8.3 and 8.5.2 for references to the new revision
of ISO 14001. Update title from VP of Operations to VP of Integrated Supply Chain.
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1 Introduction
Honeywell is committed to quality leadership and continual improvement of its products and
processes, including the Global Management System (GMS) which supports them. This
document describes the elements of that framework.
Additional information about Honeywell International is available on the internet at
http://www.honeywell.com/
2 Purpose
Identify and document a common Quality and Environmental Management System. The
GMS is designed to incorporate the needs of our customers/regulatory agencies and uses ISO
9001:2000 and ISO14001:2004 as its foundation with AS9100:2004, and TS 16949:2002
requirements also being included and applicable in locations having the need to comply to
those requirements as well. AS9100:2004 requirements are printed in italics and TS
16949:2002 requirements are printed in bold.
The document is intended to provide an umbrella Quality & Environmental system.
Honeywell's vision is to use the GMS to provide a framework for sharing best practices and
ensuring consistent processes. Processes that are identified which can be effectively
deployed at a global level will be added to the GMS.
To meet the requirements of the relevant standards and the effective operation of individual
site operations, the GMS will be supported by local site supplement quality manuals,
procedures and processes where appropriate.
Sector specific quality standards or other relevant third party certifications not covered by
this manual will be referenced in the appropriate site quality manual supplement.
3 Scope
The scope of this manual covers the Sensing and Control (S&C) businesses within
Honeywell Automation and Control Solutions, hereafter referred to as “The Organisation.”
It incorporates the following:
Design development and manufacture of controls for Sensing and Control.
These controls cover applications for sensors, switches, controls systems, actuators and
instruments for measuring pressure, air flow, temperature and electrical current.
The integration of the quality and environmental systems supports the idea that quality and
caring for our environment should be part of our daily business.
Note: All references to Environmental Management Systems in this manual apply only to
sites that are ISO 14001 certified or in the process of becoming certified. References to AS
9100 and TS16949 requirements only apply to those sites which require certification or
compliance to these standards.
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4 Global Management System (4 ISO 14001)
4.1 General Requirements (4.1 ISO 14001)
A. Introduction: Description of Key Processes (Ref GMS section 4.1)
Figure 4.1 Market or
Customer Needs
1 2
Strategic Performance
Management Management
Process Process
4
3 Knowledge
Improvement Management
Process Process
5
Communication
Support Processes Process
Core Processes To all Core
Processes
6
Customer Needs
Identification
7 8 9
Product / Process Scheduling and Customer Support
Design & Analysis (Quotes, Contracts,
Verification Order Management)
10 11 12
Supplier Selection Production Shipping &
and Management Honeywell
Warehousing
Customer
To Support Satisfaction
Processes
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Each site must align their local management system with the Key Process map, Figure
4.1. Some sites may not have all of the processes identified on the map. Elements of
this may be sub-contracted or may be carried out by other sites within the scope of the
GMS. In those cases, any processes carried out by other locations should be stated in
the site quality manual supplement.
The organisation is responsible for conforming to customer requirements,
including those which may be controlled in outsourced processes.
4.2 Documentation Requirements
4.2.1 General (4.4.4 ISO 14001)
The documentation requirements of the GMS, including those requirements
imposed by the applicable regulatory authorities, and their relationships are
described in the Figure 4.2.3. The Business and Site levels are optional.
The organisation ensures that personnel are aware of and have access to the
quality management system documentation and relevant procedures. The
quality management system documentation is available on-site to customers
and/or regulatory authority representatives and this manual can be viewed on-
line at http://content.honeywell.com/sensing/about/quality.stm
4.2.2 Quality & Environmental Manual (4.4.4 ISO 14001)
This manual describes the requirements of the GMS. Each Site is required to
support the GMS and to provide direction and guidance to their relevant areas.
The Quality and HSE managers constitute the interface between the
requirements of the Quality and Environmental standards and the structure of
the company. The GMS is established and reviewed under the responsibility of
the System and Compliance group and approved by both the President and the
Operations Leader.
Cross references to Global Procedures are made in the appropriate sections of
this manual which they support. A hyperlink to each procedure is included for
internal usage only and is identified in a
Box
In addition to the GMS Manual, sites have a quality manual supplement. The
supplement defines:
a.) local processes and practices including their relationship to the
requirements of the AS 9100 standard,
b.) scope of system including identification of support locations and exclusions
(along with justification), and
c.) the applicability and sequence of the global key processes (Ref Figure 4.1) in
relation to the site.
ESGP 04.02.02 Application of the EMS to Projects, production
processes, contractors and tenants
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Control of Documents (4.4.5 ISO 14001)
4.2.3 Documents which maintain and improve the quality and environmental
performance of our products & processes are controlled by procedure, reference
QSGP 04.02.03, Global Document Control Procedure. Sites are responsible for
establishing and documenting procedures which cover the approval, legibility,
periodic review, revision control, distribution, availability and disposition of
obsolete documents, as might be appropriate for site specific documentation.
Document changes are coordinated with customers or regulatory authorities in
accordance with contract or regulatory requirements.
QSGP 04.02.03 Control of Documents Procedure
Figure 4.2.3
Who does what?
Quality and Environmental
Policies, Objectives, Site
Global Supplements and Global
Management Procedures
Manual
System
Site Processes How? Site
Guidelines and
and Procedures
Procedures
How? Dept/Function
Local Processes and Procedures Guidelines and Records
External documents, such as engineering specifications are distributed and
reviewed within 10 working days. Appropriate actions are taken and
records of implementation dates are maintained
.
4.2.4 Control of Records (4.5.4 ISO 14001)
Records which are required to show the effective operation of the GMS and its
processes are established and maintained at all appropriate levels. QSGP
04.02.04, Records Control Procedure is used at the S&C level.
Sites are responsible for establishing and documenting a Records Control
Procedure which controls the identification, storage, protection, retrieval,
retention and disposition of records, as appropriate for their business in
satisfying the needs of their customers and regulatory authorities. This
includes any records which are created by and/or retained by Honeywell
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suppliers. Where identified by customers and regulatory authorities, records
are available for their review.
All necessary precautions for the good conservation of the filed documents are
taken. Documents can be stored in computer file. Computer backup shall be
executed daily. All documents are analysed, evaluated, indexed, filed and
maintained by the responsible department at each site.
Corporate retention periods are defined in the following web link
http://my.honeywell.com/c2kbeans/docs/7279/RetentionGuidelinesVer2.pdf
(Production is on page 21 and Research/Development is on the page 27)
QSGP 04.02.04 Control of Records
4.3 Configuration Management
A configuration management process is established, documented and maintained as
appropriate to the product.
5 Management Responsibility (4.4.1 ISO 14001)
5.1 Management Commitment (4.2, 4.4.1, 4.4.7 ISO 14001)
Management at all levels are responsible for demonstrating their commitment to the
GMS. This is accomplished through:
conducting reviews of the QMS (otherwise known as the Management Review
Process);
establishing the Quality and Environmental Policies and Objectives;
assuring compliance and continuous improvement to the GMS;
ensuring resource availability;
communicating and ensuring customer and regulatory authority needs and
expectations, and
conducting reviews which assure the effectiveness and efficiency of the
product realization and supporting processes.
Each site shall establish and maintain procedures identifying the potential for and
responding to accidents and emergency situations, and for preventing and mitigating
the environmental impacts that may be associated with them. Procedures covering
emergency response are reviewed, revised as needed and tested periodically.
ESGP 05.01 Objectives, Targets and Programs
5.2 Customer Focus (4.3.1, 4.3.2 ISO 14001)
The primary goal is to focus relentlessly on satisfying customers.
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Management ensures that the customer and consumer needs and expectations are
determined, converted into requirements and achieved, e.g. contract review/customer
satisfaction surveys/field trials/quality function deployment.
Customer feedback including any field returned products are monitored/ analysed and
used to drive internal improvement.
Management ensures through management review, Customer Care Organisation, and
communication with employees that customer satisfaction is a continuous focus of our
efforts.
QSGP 05.02 Customer Satisfaction Measurement
5.3 Quality & Environmental Policies (4.2 ISO 14001)
Management establishes, approves and maintains a Quality & Environmental Policy
which is applicable throughout the organisation. Communication of the Policy to
employees, the public and other stakeholders is the responsibility of management.
Refer to:
http://content.honeywell.com/sensing/about/quality.stm
http://content.honeywell.com/sensing/about/ems/commitment_statement.pdf
These policies are reviewed for continuing suitability annually.
Quality Policy
Pursuit of Perfection in Everything We Do
the
Be first choice of our customers by delivering products and services of
uncompromising quality.
Utilize Six Sigma Plus and Digitization to become a Premier Lean Enterprise.
Achieve Operational Excellence through
Ensuring Ownership and accountability by all stakeholders.
Implementation of best practices and global processes.
A systematic review process which identifies and eliminates performance gaps
Focusing on Customer data to drive change
Environmental Policy
Commitment to Health, Safety and the Environment
We are committed to manage health, safety and environment as a core business value to
ensure compliance with all government standards and regulations. We integrate health,
safety and environment into all aspects of our business as a competitive advantage in
achieving profitable growth and accelerated productivity.
EMPLOYEE AND OPERATIONS – We seek to protect the safety and health of our
employees and minimize our environmental footprint through prevention of illness,
injury, and pollution. All employees should be personally involved in furthering this
objective.
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SOLUTIONS FOR CUSTOMERS AND SUPPLIERS – Health, safety and
environment concerns are integral to our processes, services and product designs,
including responsible management throughout the product lifecycle. We educate
customers, suppliers and the public about the safe use of our products and openly
communicate the protective measures we take for employees, our communities, and
other key stakeholders.
ACCOUNTABILITY – We utilize management systems to apply global standards,
including compliance with applicable laws and regulations. Our executives and
managers are measured and held accountable for the safety and environmental
performance of their businesses. We hold every employee accountable for his or her
role in meeting our commitment.
STAKEHOLDER INVOLVEMENT – We work with stakeholders in the development
of laws, regulations and standards that safeguard the community, workplace and
environment. As a responsible corporate citizen, we demonstrate this commitment by
working within our communities and actively pursuing independent certifications and
recognition, as appropriate.
CONTINUOUS IMPROVEMENT – We address occupational injuries and illnesses,
emissions, wastes and inefficient use of resources and energy as preventable process
defects. We continuously improve our compliance processes and business practices
using quantifiable goals and measure and taking actions to drive sustained safety and
environmental performance.
The Environmental Policy is described in the “Commitment to Health Safety and the
Environment” and in the environmental procedure envr-1.
These documents can be found on the HSER web
http://dmweb.allied.com/hserdm:/document_control/HSER/Procedures/HON_Procedures.htm
5.4 Planning (4.3 ISO 14001)
5.4.1 Quality & Environmental Objectives (4.3.3 ISO 14001)
Management is responsible for establishing top level quality and environmental
objectives and measurements. These objectives and measurements are
established during the annual strategic planning process and are cascaded
throughout the organisation to the relevant functions and levels. The objectives
are to be measurable and consistent with the Quality and Environmental
policies. Quality objectives and measures are defined in support of the
Quality Policy and recorded in the Business Plan.
ESGP 05.01 Objectives, Targets and Programs
5.4.2 Quality & Environmental Planning
Management is responsible for the planning of resources and activities in order
to achieve the Quality & Environmental objectives at all levels. The objectives
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in 5.4.1 are reviewed during the annual evaluation of the performance
appraisal/HPD and management review processes.
In general, our Quality and Environmental management systems are designed to
ensure business objectives are not compromised when organisational changes
occur.
ESGP 05.01 Objectives, Targets and Programs
5.5 Responsibility, Authority & Communication (4.1 ISO 14001)
5.5.1 Responsibility & Authority (4.4.1 ISO 14001)
Management ensures that functions and their interrelations are identified in the
key process Figure 4.1 and ensure that responsibilities and authorities are
defined and communicated within the organisation through items such as lower
level organisational charts, job descriptions, and Site procedures, as well as
team and department meetings.
President and VP of Integrated Supply Chain:
Ensure Global Management System and Quality & Environmental policies are
communicated and deployed, as applicable, throughout the entire organisation.
Operations, Technology and Business Leaders:
Ensure Quality and Environmental Policies and GMS are communicated,
deployed and implemented, as applicable, throughout their reporting
organisations.
Global Quality & Environmental Leaders:
The Global Quality and Environmental Leaders are assigned the responsibility
and authority for development and maintenance of the GMS and ensuring its
implementation and responsible to act on the behalf of the top management to
ensure:
the GMS and Quality & Environmental Policies are communicated,
effectively deployed and implemented; and
the GMS and its core processes are measured, monitored, and continually
improved.
Product or process nonconformities are promptly reported to the manager
who is responsible for assuring the corrective action. When action is needed
to correct product quality problems, the person responsible for the quality
of the product may stop production. In multiple shift operations, each shift
has a shift leader who is responsible for product quality.
5.5.2 Management Representative
Global Quality Management Representative:
The responsibilities of the Global Quality Management Representative include
but are not limited to:
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ensuring the GMS is established, implemented, and maintained at relevant
levels;
reporting to top management on the performance of the GMS as a basis for
continual improvement of the GMS;
ensuring the promotion of awareness of customer requirements throughout
the organisation; and
resolving quality matters freely throughout the organisation globally.
Business level Quality Management Representatives: (Assignment of a
Management Representative at this level is optional.)
The responsibilities of the Business level Quality Management Representative
are the same as that of the Global Management Representative but limited only
to their own line of business. Additional responsibilities includes role up of
information from the Business level Management Reviews to the Global
Management Review.
Site Quality and HSE Management Representatives:
The responsibilities of the Site Quality and HSE Management Representatives
are the same as that of the Global Management Representative but limited to
either the Quality or Environmental scope of certification for the site as
applicable. They are responsible for ensuring consistency between site specific
documentation and the GMS Manual and to ensure all local documentation is
compliant with ISO9001:2000, as well as AS 9100:2004, TS 16949:2002 and
ISO 14001:2004 requirements when applicable. Additional responsibilities
include the communication of information from the Site Management Reviews
to Global Quality Management Representative or the Business level
Management Representative when appropriate.
The Management Representative is responsible for ensuring that customer
requirements are reviewed and addressed.
5.5.3 Internal & External Communication (4.4.3 ISO 14001)
Internal
It is the responsibility of management to gather and communicate information
regarding the effectiveness of the Global Management System to their
organisations.
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External
The Site Leader is responsible for the external communication in case of
incidents. The HSE manager is responsible for the communication with local
environmental authorities.
The Site Leader will ensure that customers and/or regulatory authority
representatives can obtain access to relevant documentation, when requested.
The Site Leader will ensure that quality and HSE matters are included in regular
communications within their sites.
ESGP 05.01 Objectives, Targets and Programs and ESGP 07.02.03
Environmental Related Communications
5.6 Management Review (4.6 ISO 14001)
5.6.1 General
The Management Representatives (as described in Section 5.5.2.) are
responsible for conducting management reviews of the GMS at least once a
year. These reviews ensure the continuing suitability, adequacy, and
effectiveness of the GMS, including assessing opportunities for improvement
and the need for changes. Data from these reviews is utilized in the optional
Business level reviews and global reviews.
The HSE & Global Quality leadership are responsible for continuous
improvement of the Environmental and Quality System. The complete
Management Review process is described in the Figure 5.6.
These quality reviews include all of the quality management system
requirements and performance trends, including quality objectives, cost of
poor quality measure, and customer satisfaction.
QSGP 05.06 Global Management Review
5.6.2 Review Inputs
There are standard inputs for the management review. Besides the standard
inputs, the team can add other (system related) inputs if required. The inputs
are:
review Quality and Environmental objectives, targets and Policies;
results of assessments/audits;
supplier selection and Quality performance;
customer satisfaction feedback;
process performance (reference Global Scorecard);
product conformity;
status of preventive and corrective actions;
follow-up actions from earlier management reviews;
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planned changes that could affect the Quality & Environmental management
system;
recommendations for continual improvement;
analysis of actual and potential field-failures and the impact of these
failures on quality, safety and the environment;
summary of results related to design and development phase
measurements;
incidents and accidents*; and
development in techniques and legal requirements.
*Only applicable in those sites with ISO 14001 systems.
5.6.3 Review Outputs
The output from the management review includes decisions and actions related
to:
improvement of the effectiveness of the Quality & Environmental
framework and its processes;
improvement of product and processes related to customer requirements;
and
resource needs.
Results of management reviews are to be recorded and maintained.
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Figure 5.6 - Management Review Process
A
Mgmt Site Site Next
level
Input Review Mgmt Output Review?
Package Review (Quality
Only)
Audit Results QSM Improvements
Customer Feedback Product/Process Improvements B
Process Conformity Resource Needs
Corrective/Preventive Action Status
Mgmt Rev Follow-up Actions
QSM Changes
Improvement Recommendations
Business Business Business
A Level Mgmt Output B
Roll-Up Review
Global Global Global
B Roll-Up Mgmt Output
Review
QSM Improvements
Product/Process Improvements
Resource Needs
6 Resource Management (4.4.1 ISO 14001)
6.1 Provision of Resources
Management is responsible for planning and deploying resources to achieve the goals
of the GMS. Resource requirements are defined during the business planning process
and reviewed during the Management Review process. Resources include human
resources and specialized skills, technological and financial resources. New employees
are always instructed on Quality & Environmental related items.
6.2 Human Resources
6.2.1 General
Management is responsible for identifying and assigning personnel based on
appropriate education, training, skills, and experience. Ref performance
development web page http://my.honeywell.com/perfdev/index.jsp
6.2.2 Competence, Awareness & Training (4.4.2. ISO 14001)
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Management uses the HPD (Honeywell Performance and Development) system
or annual performance review system to assess and manage the training
requirements and competency of employees.
Management cascades goals throughout the organisation annually using the
Annual Operating Planning process which then cascades objectives down to
individuals.
Each site develops procedures regarding identification of training needs,
implementation of training, and assessment of competence. Training includes
assuring that individuals are aware of how they contribute to quality and
environmental policies, objectives and targets.
Product design personnel are skilled in the usage of the appropriate tools
for achieving the design requirements.
In addition to the identification of training needs, the documentation
includes responsibility for conducting training, recording of the completion
of training and evaluating the training provided.
Both full and part time personnel, who affect the quality of products and
services, are given on the job training when given new or changed work
assignments. Also they are told of the consequences to customers when
there is a non-conformance in quality requirements.
Processes are in place to motivate achievement of quality objective,
continual improvements, and an environment for innovation, with a
measurement process for determining the level of employee awareness.
6.3 Infrastructure (4.4.1 ISO 14001)
The organisation provides and maintains the infrastructure necessary to achieve
conformity of products and services (including subcontracted).
Including but not limited to:
buildings, workspace and associated facilities;
process equipment, both hardware and software; and
supporting services (e.g. transport, communications, facilities, maintenance).
The organisation utilizes a cross-functional team approach in developing the plans
for facilities, equipment, and processes. The objective is to optimize process and
material flow, floor plans, and the use of floor space. As indicated in the
appropriate procedures, evaluations are made of the factors that affect our
manufacturing capability, such as plant layout, work flow, automation and human
factors issues, and inventory management.
Plans are developed to assure that emergencies which cause work stoppage are
planned for. This includes plans for utilities and equipment failures, labour
shortages, and field returns.
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6.4 Work Environment
Functions and sites provide the appropriate work environment needed to achieve
conformity of product, and to minimise any risk to the environment.
In the design and development of products and manufacturing processes,
consideration is given to the safety risks of employees. This includes
considerations made during FMEA risk analysis, error proofing during design
and process control, and consideration for compliance to regulations.
The sites maintain a clean and orderly work environment appropriate to the
products being produced.
7 Product and/or Service Delivery (Realization) (4.4, 4.4.6 ISO 14001
7.1 Planning & Product Delivery (Realization) (4.3.1, 4.4.6, 4.5.2, ISO 14001)
Management provides the infrastructure (including needed resources) for deployment,
maintenance and implementation of processes, including local and customized
processes.
The organisation establishes and maintains controlled processes for performing and
verifying all key processes shown in Figure 4.1. These processes are described in
procedures (text or process map) and work instructions.
Each process has its own clearly defined targets. It is the site leader’s responsibility to
ensure and evaluate compliance with Honeywell requirements, and environmental
legislation, as well as other applicable requirements (4.5.2 ISO 41001).
ESGP 07.01 Legal, Regulatory and other Requirements
Environmental aspects (4.3.1 ISO 14001) are considered for each key process shown in
Figure 4.1. The identification and impact assessment of the environmental aspects is
documented in a global procedure (ESGQ 04.02.02) These are reviewed annually at a
minimum and consideration is given to new developments, activities and products, as
well as those currently existing.
ESGP 04.02.02 Application of the EMS to Project and Production
Processes
During the development of the quality plan, consideration is given to customer
specific requirements, as well as those of the current revision of the TS 16949
standard.
Acceptance criteria for product is defined in test plans and approved by the
customer if required. Acceptance criteria for attribute data sampling is zero
defects.
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Confidential documents and data are controlled to ensure against possible misuse.
This includes customer data and documentation.
A process is in place for control and reaction to changes to both products and
processes, and which looks at the effects of the changes. The need for verification
and validation of changes is determined and carried out as appropriate.
Consideration is given to the requirements of the customer during verification and
validation.
7.2 Customer Related processes
7.2.1 and 7.2.2 Determination and Review of Requirements Relating to the Product
(4.3.1, 4.3.2, 4.4.6 ISO 14001)
The method of determining and reviewing product requirements is controlled at
the Business and/or Site levels as appropriate for each business and customer
set. The organisation determines customer requirements both stated and not
stated, as well as other additional requirements including statutory and
regulatory requirements. Reviews are conducted prior to acceptance of a
contract or order.
These reviews include requirements of the product, order or contract. Needs
related to special characteristics, traceability, safety, environmental
requirements, produceability, and after sales support will be defined.
Manufacturing feasibility, including risk analysis, are conducted and
documented as part of these reviews. In addition, risks are evaluated to
determine those which may adversely affect the ability to meet the commitment
to supply product to the customer.
7.2.3 Customer Communication (4.4.3 ISO 14001)
Customer focus and two way communication is a key element of everyone’s
responsibility. When designated, the customer’s specified language and
format for communications is followed.
Feedback of the customer and regulatory agencies, related to both positive and
negative experiences is used as feedback for the organisation and is used for
continuous improvement of the quality & environmental system.
ESGP 07.02.03 Environmental Related Communications
7.3 Design & Development (4.4.6 ISO 14001)
The product development processes define the inputs, outputs and review process
required.
The organisation uses the “New Product Introduction Process” to manage product
development. It may be customized, to meet unique operating environments. Owners of
customized processes are responsible for ensuring deployment, maintenance,
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implementation, and monitoring of these customized processes. Input data is reviewed
to verify that there is consistency with the requirements identified.
7.3.1 Design and Development Planning
The development process is defined by documented procedures. Every project
encounters different circumstance, conditions and constraints and has different
needs and requirements which must be met. Each project development team
has responsibility to determine and document the elements (both mandatory and
optional deliverables/tasks) that are necessary to accomplish the project and the
order in which they will be accomplished in a project plan, as well as
identification of configuration management needs. In planning, consideration is
given to identification of project owner and team members, design requirements
including the input and output needs as it relates to each element, and for
achieving the objectives for the safety and functionality of the product including
those requirements identified by customers and regulatory authorities.
Environmental considerations are part of the design process from early concept
through to delivery. Each element’s input data is reviewed to assure that they
are consistent with the requirements.
ESGP 04.02.02 Application of the EMS to Project and Production
Processes
A cross-functional approach is used in the product realization process, including
the development and review of FMEA’s and control plans, as well as the
development and monitoring of special characteristics.
7.3.2 Design & Development Input
During the requirements stage, a detailed methodology is available to assure
that customer and environmental requirements are accomplished. Documents
are used to identify and register the different requirements.
The technology organisation is responsible for completing all necessary steps
needed for customer, agency and environmental requirements.
The design and manufacturing process design inputs are identified,
documented and reviewed, and include the identification of special
characteristics.
7.3.3 Design & Development Output
Quality records required by the project plan are kept in a project file (electronic
or hardcopy). These are the outputs in the stage summary matrices of all
elements that are mandatory as well as all other project specific elements the
team has selected. The project outputs:
meet the inputs requirements,
provide valuable information to assure appropriate purchasing, production,
and servicing,
identify the acceptance criteria for the product,
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identify any characteristics important to the safe and proper use of the
product, and
specify key characteristics related to the design and contract requirements.
The product design output is verified and validated, and includes:
design FMEA, reliability results,
product special characteristics and specifications,
product error-proofing, as appropriate,
product definition including drawings and mathematically based data,
product design review results, and
diagnostic guidelines, where applicable.
The manufacturing process design outputs are verified and validated
against manufacturing process design input requirements, and includes:
specifications and drawings,
manufacturing process flow chart/layout,
manufacturing process FMEAs,
control plan,
work instructions,
process approval acceptance criteria,
data for quality reliability, maintainability and measurability,
results of error-proofing activities, as appropriate and methods of rapid
detection and feedback of product/manufacturing process
nonconformities.
A project file accessible to all team members are established and maintained by
the project team. Data is provided which supports the configuration, design,
manufacture, and sale of conforming product. This includes, but is not limited
to, drawings, part lists, routings, product specifications, inspection and test
documents, work instructions, and quality plans.
7.3.4 Design & Development Review
During the stages of the Design and Development process, reviews are built in
to assure the full potential of the new design/development to meet the
customer/market and environmental requirements. During review, problems are
identified and solutions proposed, and if warranted authorization is give to
move on to the next design and development phase. Checklists are completed to
keep track of the process.
Measurements for specific phases of design and development are defined,
and analysed. These may focus on areas such as quality risks, costs, lead-
times, and critical paths, to name a few. Results from the analysis are
summarized and provided as input into the site’s Management Review.
7.3.5 Design & Development Verification
The verification of the Design and Development Process is planned to assure
that output of this process is consistent with inputs of the process. Records are
completed as a part of the verification process.
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7.3.6 Design & Development Approval
The Design and Development approval process is a team based process. A
project approval form is completed by the team.
Upon completion of the design and development activity, records showing that
the product meets the defined specifications are maintained.
The planning, conducting, reviewing and documenting of tests for verification
and validation are performed when required. This provides evidence that:
the plans address the product and test objectives, acceptance criteria, the
conditions that the test is run under, and the resources to be utilized;
the test procedures address the test methods, performance and results;
the proper product configuration was provided for testing;
the test plan and procedures were followed; and
the criteria for acceptance were met.
Design and development validation is performed in accordance with
customer requirements (e.g. program timing).
The prototype process utilizes the same suppliers, tooling, equipment and
processes that are planned for use in the production of the product.
Performance testing to requirements is conducted according to plans.
Outsourced processes are controlled in the same manner that would be
applied if they were being performed in-house, including the providing of
technical support.
The product and manufacturing process approval procedure applies both
internally and to suppliers.
7.3.7 Control of Design & Development Changes
When changes in the design or development occur, the team reviews the impact
for the customers. When the changes have a significant impact for the
customers, or there are contractual requirements to do so, the changes are
discussed with the customer. Customers and regulatory authorities are given
change control approval when required by contract or regulatory requirement.
7.4 Supply Management (4.4.6 ISO 14001)
7.4.1 Supply Management Process
The organisation ensures that requirements for purchased products and services
are clearly defined, communicated to and understood by the supplier. This
includes the need for purchased products and materials to conform to any
applicable regulatory requirements.
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Suppliers are evaluated and selected on their ability to meet the defined
requirements, the nature and criticality of the product or service being
purchased and the supplier’s environmental impact. Suppliers are certified to
ISO 9001:2000 and have a goal of achieving conformance to the TS
16949:2002 standard, exceptions require customer approval. The use of
customer-designated approved suppliers may be specified by the customer
through contract; purchase orders, drawings, or specifications. Careful
consideration is given prior to the usage of a customer-designated supplier to
assure that the supplier is capable of providing the same quality of product
and service, we require from all our suppliers. The organisation maintains
records of qualified suppliers.
To ensure the quality of the supplied material meets the requirements, a supplier
selection and assessment process has been established. New suppliers are
selected according to criteria, including but not limited to, the following:
quality;
delivery time;
price;
service and readiness to join in a continuous quality improvement program
(zero defects goal); and
environmental aspects.
Goods and services are purchased from suppliers that are included on our
current approved suppliers list/database which identifies the supplier and scope
of their approval. Supplier performance is reviewed and the level of controls to
be placed on individual suppliers is identified. The extent of control exercised is
dependent on the type of product being purchased, and when applicable, the
supplier’s previously demonstrated capability and performance. This control
includes the actions which are taken on suppliers who do not meet
requirements, the use of customer-approved special process suppliers, and a
process for disapproving the use of suppliers.
7.4.2 Supply Management Information
The organisation’s purchasing documents clearly describe the products or
services being purchased. Including where appropriate:
the requirements for approval of the product or service,
qualified personnel,
management system,
identification (including revision) of drawings, procedures (processes,
inspection) and other technical information,
acceptance methods (test, inspection, etc.),
management of test samples (production, identification and storage),
handling of nonconforming product, including notification and approval;
product and process changes;
access of supplier facilities and records by the organisation, also by our
customers or their representative, and any applicable regulatory agencies
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when specified by contract and with prior coordination with the
organisation; and
flow down of requirements from the supplier to its sub-tier suppliers,
including any Key Characteristics.
These documents are reviewed and approved for the adequacy of the specified
requirements prior to release to the suppliers.
7.4.3 Verification of Purchased Product and/or Services
The organisation plans for verification of purchased products and services to
determine that they meet the specifications of purchase. This verification may
include one or more of the following:
receipt of and review of objective evidence of quality of the product
supplied, including documentation such as inspection and test reports, C of
C’s, statistical data and process control records;
inspection or audit at suppliers facilities, including those by 2nd or 3rd
parties when supported by delivery of acceptable product quality;
documentation review;
incoming inspection;
evaluation of material at an approved laboratory, and
delegation of inspection to supplier or certification by supplier.
When specifically agreed to by the customer, other verification methods
may be utilized.
Incoming material released without verification is recorded to allow for recall
and replacement.
The organisation may delegate the verification activities to the supplier.
Records of delegation are maintained. Methods, acceptance and reporting
criteria for these verification activities are documented in appropriate
procedures, quality plans or other instructions. Test reports for raw materials
are periodically validated by the organisation.
Where specified on the purchasing documents, verification at the supplier’s
premises may be carried out by the organisation and by customer’s
representative or regulatory agencies when the contract specifies. Verification
by the customer is not evidence of quality control and does not relieve the
organisation of its responsibility to provide product with meets requirements,
nor does it prevent rejection by the customer later.
Supplier performance is monitored based on the following:
product quality;
customer interruption including those involving field returns;
delivery performance (including incidents of premium freight); and
quality or delivery issues identify by customer.
Suppliers are encouraged to monitor the performance of their own
production processes.
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7.5 Production & Service Operations (4.4.6 ISO 14001)
7.5.1 Operations Planning and Control
Operations Planning includes establishing of process controls and the
development of control plans, when key characteristics are identified;
establishing in-process verification method, when conformance can not be
verified at later phases of production; provision of tooling to take variable
measurements, include those for key characteristics; and consideration of
special processes (see 7.5.2).
The organisation establishes and maintains controlled conditions for performing
and verifying production and service processes. These controlled conditions
include:
information describing the product characteristics;
monitoring and controlling suitable process and product characteristics
during production, with emphasis on those characteristics designated as key
by the organisation, or the customer;
documented procedures and/or work instructions for production;
generation and retention of quality records as evidence of the completion of
planned manufacturing and inspection operations.
identification of activities related to process monitoring and measurement;
to release, delivery and post-delivery; and to Foreign Object Detection;
use of suitable equipment and working environment (including documented
compliance with government safety, environmental, and hazardous material
related regulation as appropriate)
planning and performing of regular scheduled maintenance of production
equipment as necessary, to ensure process capability and reduce downtime,
criteria for workmanship are either written or expressed by means of
representative samples;
identifying and accounting for all product during production; and
monitoring and controlling utilities (such electricity, gas and water) and
supplies (such chemicals) as it relates to their effect on product quality.
These processes are described in detail at the Business or Site level and include
quality and environmental controls.
Control plans are developed for the pre-launch and production phases and
are updated when changes affect the product realization. Processes that
affect the quality of the products are documented in procedures or work
instructions and support the quality plan, control plan and product
realization process. This documentation is available to the employees
responsible for these processes. Verification of job set-ups is preformed
when setting up the initial run, and after change over. Set up personnel
have access to the work instructions as well. Statistical techniques are
utilized where appropriate. Preventive and predictive maintenance
methods are applied to key equipment, tooling and gauging. In
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conjunction with outside resources, tooling and gauging is designed,
produced, and verified. Production scheduling is driven by customer
requirements. Field claims are managed through the corrective action
process and involve manufacturing, engineering and quality. When a
service agreement is in place by customer contract, action will be taken to
assess the effectiveness of the service centre equipment, tools including
software and training of personnel.
Production operations are completed in accordance with approved
documentation which may include, but is not limited to, drawings, part and
tooling lists, routings, product and process specifications, inspection and test
documents, work instructions, and machine programs.
Changes to production processes are reviewed to assure that they do not result
in any adverse effects to the quality of the product. Documented processes are
in place to control changes affecting production processes, equipment, tooling
and programs. Approval of changes is limited to those identified as authorized
to do so. When required by contract or regulatory requirements, approval of
changes is obtained from customers or regulatory authorities.
Prior to usage, production equipment, tooling and programs are checked to
assure that they have been maintained and inspected in accordance with
documented procedures. First piece inspection to design specifications prior to
production may be used as validation. Periodic checks of tooling and equipment
in storage are conducted.
If work must be temporarily transferred outside of the organisation’s facilities,
it is controlled and monitored in the same manner applied internally in order to
assure the quality of the work is maintained.
When identified as part of an agreement with a customer, the service process
will include:
collection and analysis of service data;
investigation, resolution and reporting of problems related to service;
control and maintenance of related service documentation;
control, implementation and approval of repair instructions; and
controls for performing work off-site.
7.5.2 Validation of Special Processes
The organisation validates processes where resulting output cannot be verified
by subsequent measurement or monitoring. The organisation ensures that these
processes are carried out under control conditions which are documented at a
Business or Site level. This includes any processes where deficiencies may
become apparent only after the product, service, or solution has been delivered.
Validation includes review, qualification and approval of the process before use,
approval of equipment and qualified personnel, control and usage of
documented operating procedures, maintenance of records and re-validation.
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Requirements stated in this section apply to all production processes which
must be compliant to TS 16949:2002, not just those identified as Special
Processes.
7.5.3 Identification & Traceability
The organisation maintains identification of products throughout manufacturing,
stocking, delivery and services in accordance with procedures. A record of the
product configuration as it is built is maintained to allow for identification of
any discrepancies between the “built to” and “agreed to” configurations.
Stamps, electronic signatures and passwords utilized for acceptance authority
are controlled by the organisation.
A unique identification is used and recorded when traceability is a requirement.
Dependent on the level of traceability required by customers’ contract or
regulatory requirements, the system is capable of maintaining:
identification of the product throughout its life;
traceability of all products manufactured from the same batch of raw
material or in the same manufacturing batch (including the tracking of all
product from the batch);
identification of components in the next higher assembly; and
retrievable records of the products production.
7.5.4 Customer Property
The organisation identifies, verifies and protects customer supplied materials,
equipment, intellectual property and data. Customer property, including
returnable packaging, which is lost, damaged or otherwise found to be
unsuitable for use is recorded and reported to the customer.
Customer-owned tooling and equipment are visibly and permanently
marked to allow identification of ownership.
7.5.5. Preservation of Product
The organisation maintains processes on the handling, storage, packing and
delivery for the preservation, protection of products (including its individual
parts), and the environment. The organisation maintains processes to ensure
that documents required by the contract/order are sent with the product and are
protected against being lost or destroyed during shipment.
Where applicable, preservation includes provisions for:
cleaning;
Foreign Object Detection;
handling of sensitive products( such as ESD sensitive);
marking and labelling (including warnings related to safety);
controlling shelf life and rotation of stock; and
handling of materials which may be hazardous.
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At a minimum, annual stock condition checks are conducted. Finished
product stock is managed on a First-In-First-Out (FIFO) basis. Obsolete
product is handled in a manner similar to that of nonconforming product.
7.6 Control of Measuring & Monitoring Devices (4.5.1 ISO 14001)
Functions and sites using measuring and monitoring devices are responsible to provide
a process for identifying measurements and the monitoring devices required to assure
conformity of product to requirements, as well as those devices required for the
environmental management system. This includes employee-owned and customer
supplied devices which may be used to provide evidence of conformity. A listing of
active devices is maintained along with its location and identification information, a
detail description of the item, the calibration frequency, method for checking and
acceptance criteria, and certification showing traceability on primary standards.
Calibration records also include revisions following engineering changes,
assessment of the impact of out-of-specification conditions, evidence of conformity
after calibration or verification, and data regarding the notification of the
customer if suspect product has shipped as a result of an item in out-of
specification condition.
Measuring and monitoring devices are used and controlled to ensure that measurement
capability is consistent with the measurement requirements. The environments of the
calibration areas are controlled to maintain suitable conditions for the types of
calibrations being performed.
Where applicable, measuring and monitoring devices are:
calibrated or verified at specific intervals or prior to use, against measurement
standards traceable to international or national measurement standards; where no
such standards exist, the basis used for calibration and verification is recorded;
adjusted or re-adjusted as necessary; safeguarded from adjustments that would
invalidate the calibration;
identified to enable calibration status to be determined;
safeguarded from adjustments that would invalidate the measurement results;
protected from damage and deterioration during handling, maintenance and storage;
and
recalled through a system which provides a listing of items due for recertification.
Statistical studies are utilized to analyze the variation of each type of measuring
and test equipment system.
Internal and external laboratories which perform calibration, testing and
inspection, have a documented scope which defines their capabilities to perform
these services. Before utilizing an external laboratory, evidence is in place to
demonstrate that either the customer accepted the lab or the lab is accredited to
ISO/IEC 17025 or an equivalent national standard.
8 Measurement, Analysis, & Improvement (4.5 ISO 14001)
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8.1 General
Management plans and implements monitoring, measurement, analysis, and
improvement processes which ensure conformity and continuous improvement of the
GMS, as well as conformity of products and services to requirements. Six Sigma Plus
tools and the review and monitoring of targets are used to drive improvement of
processes, products and the environment. During APQP, determination is made on
the appropriate usage of statistical tools and is included in the control plan. Basic
statistical tools are understood and use throughout the organisation.
8.2 Measurement & Monitoring
8.2.1 Customer Satisfaction
Management monitors the level of customer satisfaction and other information
relating to customers’ perception as to whether customer requirements are met
and appropriate actions are taken. Customer Satisfaction is also monitored
by evaluating PPM, customer disruptions, delivery performance including
premium freight costs, and notifications to customers regarding product
quality and delivery. Product quality and the efficiency of the
manufacturing processes are monitored for compliance to customer
requirements.
8.2.2 Internal Audit (4.5.4 ISO 14001)
The organisation plans and documents internal audits which are used to assess
the effectiveness of the GMS, compliance to its requirements and identify
related opportunities for Continuous Improvement activities. Qualified
auditors conduct assessments to a wide variety of standards, such as ISO
9001, ISO 14001, AS9100 and TS 16949. When identified by customer
contract or regulatory requirements, internal audits are conducted in
accordance with those requirements. In addition to the effectiveness of the
GMS, audits are conducted at defined frequencies to verify compliance to
TS 16949 and customer specific quality requirements, effectiveness of the
manufacturing processes, and conformity of products, including product
dimensions, functionally, packaging and labelling, at appropriate phases of
production and delivery.
Ref. QSGP 08.02.02.a S&C Global Internal Auditing Process. This procedure
includes:
the responsibilities and requirements for conducting assessments;
ensuring the personnel conducting the quality & environmental system
assessments are independent of the functions being assessed;
recording results; and
reporting to appropriate management.
When planning the audit program, consideration is given to the status and
importance of the activities and areas to be assessed, as well as the results of
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previous assessments, internal and external nonconformities, and
complaints. Internal audits cover all quality management processes and
activities on all shifts. The assessment scope, frequency and methods are
defined. Management takes timely corrective action on deficiencies found
during the assessment. Follow-up actions include the verification of the
implementation of corrective action, and the reporting of verification results.
Checklists, process flowcharts and other similar tools are used to support the
audit process in assessing the organisations performance and in assuring the
completion of an effective internal audit.
Nonconformities that affect the GMS globally are reported up to the Global
Management Representative or their designee.
QSGP 08.02.02.a S&C Global Internal Auditing
8.2.3 Monitoring & Measurement of Processes (4.5.1 ISO 14001)
The organisation defines, plans and implements appropriate monitoring and
measurement activities to achieve planned performance. The performance is
affected by the deployment, implementation, effectiveness, maintenance
activities, and improvement of its processes. Local environmental legislation
requirements will be monitored as required. Corrective action is taken when
planned results are not achieved. In addition to taking corrective action on a
process non-conformance, determination is made as to the possible effects on
product conformity. Product nonconformity is addressed in accordance with
QSGP 08.03, Nonconforming Material Procedure.
QSGP 08.03 Nonconforming Material Procedure
Process studies are conducted and documented on new manufacturing
processes. When characteristics are not statistically capable or are
unstable, a reaction plan from the control plans is initiated. Records are
maintained of the effective dates of process changes.
Where environmental significant aspects are identified, processes are in place to
monitor and measure these as a basis for continuous improvement. Each site
will establish and maintain a procedure for periodically evaluating compliance
with relevant environmental legislation and regulations.
8.2.4 Monitoring & Measurement of Product
The organisation establishes practices for monitoring, measuring and verifying
that specified product requirements are met throughout the product realization
process. Key Characteristics are monitored and controlled. Product control
plans specify the need for completion of layout inspections and functional
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verifications to customer requirements and product performance
standards.
Inspection procedures are developed which control sampling levels applied, in
order to minimize risk and maximize benefits to our customers. Unless
otherwise required by customer specifications, C=0 sampling is used for
inspecting incoming material as well for final inspection on product. When
required by customers, these plans are presented for their approval.
No product is released until specified operations in the appropriate quality plan
or other instructions are satisfactorily completed and verified.
Inspection and testing requirements are contained in a variety of process and/or
product documentation. Contained with the documentation is information
regarding:
acceptance/rejection criteria;
identification of the point in the process which the inspection and testing
operations are completed;
records of the inspection and test results; and
information regarding the equipment/instruments used to perform the
inspection and testing operation.
When required by the plan, inspection and test data is recorded and the record
is maintained to demonstrate product compliance to requirements.
The First Article Inspection process typically consists of verifying dimensions,
characteristics, and weight of a sample or representative item for a product run
for the first time or following significant changes which may affect the results
from the prior First Article conducted. Additional First Article requirements
may be included through agreement with customers.
8.3 Control of Nonconformity (4.5.3 ISO 14001)
The organisation ensures that materials which do not conform to requirements are
identified and controlled to prevent unintended use or delivery. Suspect material or
that whose status is unknown is treated as nonconforming material.
The responsibilities for control of nonconforming materials are documented in QSGP
08.03, Global Nonconforming Material Procedure. Site procedures define the process
for approving personnel who review and approve the disposition of nonconforming
material.
QSGP 08.03 Nonconforming Material Procedure
One or more of the following actions are taken when addressing nonconforming
materials:
eliminate the nonconformity;
authorisation to either use, release or accept under specified conditions, which may
require approval by the customer as well; and
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prohibit the use of the material for its original intent.
Records of the nonconformity and the actions taken are generated and maintained.
Approved documentation is available for the repair, rework, reclassification, or
sort of material. Also included are instructions for re-inspection.
“Use-as-is” or “repair” dispositions are not utilized without prior approval of the
customer, except when the design is not under the control of the customer and the
material continues to meet the customer specified requirements.
Until scrap material is made physically unusable, it is controlled to prevent its
unintended use. Control may be the obvious and permanent marking of the material as
scrap or maintaining the scrap material under secure conditions.
Upon detection of delivery of nonconforming material, interested parties are
promptly notified.
A customer waiver is required prior to the deviation from any approved process
or product. Records related to terms of the waiver are maintained, and any
material shipped under this waiver is appropriately identified.
8.4 Analysis of data for improvement (4.5.1 ISO 14001)
Relevant data is gathered and analysed to determine the suitability and effectiveness of
the GMS and to evaluate where continuous improvements are needed. Data reviewed
includes but is not limited to:
customer satisfaction;
conformance to product, service, or solution requirements;
characteristics and trends of processes, products and environment including
opportunities for preventive action;
suppliers; and
quality and environmental objectives/targets.
Actions are taken when results show that progress is not being made toward
achievement of objectives.
8.5 Improvement (4.2 ISO 14001)
8.5.1 Continuous Quality & Environmental Improvement (4.3.4 ISO 14001)
The organisation utilizes process improvement methodologies including those
defined by Six Sigma Plus to continuously improve the effectiveness of the
GMS.
Continuous improvement is supported through the following elements:
quality & environmental policies;
quality & environmental objectives;
audit results;
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analysis of data;
corrective and preventive action;
management review; and
Define Measure Analyse Improve Control (DMAIC) cycle used by Six Sigma
projects.
The improvement of manufacturing processes focuses on the reduction of
variation and it subsequent control.
8.5.2 Corrective Action (4.5.3 ISO 14001)
The organisation establishes and maintains problem solving procedures for
eliminating the cause of nonconformities identified against their products,
processes and environment to prevent reoccurrence. Reference QSGP 08.05.02,
Global Corrective Action Procedures unless there is agreement with the
customer to utilize another defined process. Procedures for the corrective
action process will cover:
reviewing nonconformities (including customer complaints);
determining the causes of nonconformity (if root cause is identified as the
responsibility of a supplier, requirements for corrective action are flowed
down to the supplier);
evaluating the need for actions to ensure that nonconformities do not recur;
determining and implementing the action needed includes error-proofing;
recording results of action taken including those on similar products and
processes; and
reviewing corrective actions taken (if actions are not timely or effective,
additional actions are specified).
QSGP 08.05.02 Corrective Action Procedure
Customer’s rejected parts are analysed in a timely manner and corrective
action taken to prevent reoccurrence.
8.5.3 Preventive Action
The organisation establishes and maintains procedures (Reference QSGP
08.05.03, Global Preventive Action Procedures) for eliminating the cause of
potential nonconformities identified against their products, processes and
environment in order to prevent occurrence. Procedures for the Preventive
Action process will cover:
determining potential nonconformities and their causes;
evaluating the need for action to prevent occurrence of non conformities;
determining and implementing action needed;
recording results of action taken; and
reviewing preventive action taken.
QSGP 8.5.3 Preventative Action Procedure
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Appendix A - Definitions
Assessment:
For the purposes of this document the word assessment is used to describe the audits (Internal
Audits - 8.2.2.a) conducted by Internal Assessors.
Audit:
Systematic, independent process for obtaining evidence and evaluating it objectively to
determine the extent to which certain criteria are fulfilled.
Continual improvement:
Includes improvement of the GMS framework and business and product, service, or solution
performance. NOTE: The process of continual improvement need not take place in all areas of
activities, products and services simultaneously; business units and sites may prioritise continual
improvement efforts based on their specific quality and business objectives.
Corrective Action:
Action taken to eliminate the cause of an existing detected nonconformity or other undesirable
situation; action taken to prevent recurrence. These actions may include but are not limited to:
(1) root cause analysis; (2) changes to processes; 3) changes to procedures; (4) changes to
requirements; and (5) changes to monitoring and measurement programs.
Customer
The term customer is used in this document to describe both external customers and regulatory
agencies.
Document:
Information and its support medium; may include but is not limited to electronic, photographic,
drawn, written or printed material
Functional organisations:
Organisation performing specific tasks or functions, for example: legal or procurement.
Global Management System:
The Honeywell Quality & Environmental Management System put in place to provide direction
and support to the business processes which includes organisational structure, planning activities,
responsibilities, practices, procedures, processes and resources for developing, implementing,
achieving, reviewing and maintaining the Quality & Environmental Policy.
Key Characteristics: The features of a material, process, or part whose variation has a
significant influence on product fit, performance, service life, or manufacturability.
Procedure:
Specified way to carry out an activity or a process; a series of activities that define a particular
task, which may include, but is not limited to, instructions, checklists, and flowcharts.
Procurement:
Purchasing function.
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Product:
Result of a process, services and items developed, manufactured, assembled, provided or sold by
the organisation. Products: components, assemblies, parts, software, support, education,
management; includes products, services, intellectual property and solutions.
Quality & Environmental Policies:
Statement by the organisation, which provides a framework for setting quality & environmental
objectives and targets at the SBE level.
Record:
Document stating results achieved or providing evidence of activities performed; evidence that
an event or activity occurred including, but not limited to, written evidence in the form of hard
copy or soft copy memoranda, checklists, meeting minutes or notes, presentations, budgets, and
capital and/or expense plans.
SBE:
Strategic business enterprise
Services:
see product
Shall:
"must" or "is required."
Should:
"suggested" or "recommended"
Site:
Any Honeywell site, including but not limited to, manufacturing, development, research,
distribution, marketing sites, and field and service centres.
Top Management:
Highest level of management with direct responsibility for an enterprise, site, function, or
product. Where the term top management is applicable it should be defined.
End of Document
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