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Quality Manual

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0% found this document useful (0 votes)
52 views

Quality Manual

Uploaded by

madhavansanjay
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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MOMAIZAH METAL FABRICATION

FACTORY LLC (MFF)

Quality Manual
Document No: MFF-QMS-001
Revision: C
Issued: 08/01/18

Conforms to ISO 9001:2015

(c) Copyright 2018 Momaizah Metal Fabrication Factory LLC; all rights reserved. This document may contain proprietary
information and may only be released to third parties with approval of management. Document is uncontrolled unless otherwise
marked; uncontrolled documents are not subject to update notification.
Momaizah Metal Fabrication Factory LLC (MFF)
Quality Manual
Revision C - 08/01/18

TABLE OF CONTENTS

0.0 Revision History and Approval ...................................................................................................................... 3


1.0 About Momaizah Metal Fabrication Factory LLC ......................................... Error! Bookmark not defined.
1.1 MFF Lab
Systems……………………………………………………………………………………………………4
1.2 MFF Playgrounds……………………………………………………………………………………………………4
1.3 MFF Metal
Fabrication………………………………………………………………………………………………5
2.0 About The MFF Quality Manual .................................................................................................................... 5
3.0 Terms and Definitions ................................................................................................................................... 5
4.0 Context of the Organization .......................................................................................................................... 6
4.1 Understanding the Organization and Its Context ...................................................................................... 6
4.2 Understanding the Needs and Expectations of Interested Parties ...........................................................6
4.3 Determining the Scope of the Quality Management System .................................................................... 6
4.4 Quality Management System and Its Processes ...................................................................................... 7
4.4.1 Process
Identification…………………………………………...………………………………………………..7
4.4.2 Process Control &
Objectives……………………………………………………………………………………7
5.0 Leadership..................................................................................................................................................... 8
5.1 Leadership & Commitment........................................................................................................................ 8
5.1.1 General ...................................................................................................................................................... 8
5.1.2 Customer focus ......................................................................................................................................... 8
5.2 Policy ......................................................................................................................................................... 8
5.3 Organizational Roles Responsibilities and Authorities ............................................................................. 9
5.3.1 Top Management…………………………………………………………………………………………………9
5.3.2 Manager/Supervisors…………………………………………………………………………………………….9
5.3.3 All Personnel………………………………………………………………………………………………………9
6.0 Planning ......................................................................................................................................................10
6.1 Actions to Address Risks and Opportunities ...........................................................................................10
6.2 Quality Objectives and Planning to Achieve Them .................................................................................10
6.3 Planning of Changes ...............................................................................................................................10
7.0 Support ........................................................................................................................................................11
7.1 Resources ...............................................................................................................................................11
7.1.1 General ....................................................................................................................................................11
7.1.2 People .....................................................................................................................................................11
7.1.3 Infrastructure ...........................................................................................................................................11
7.1.4 Environment for the Operation of Processes ..........................................................................................11
7.1.5 Monitoring and Measuring Resources ....................................................................................................11
7.1.6 Organizational Knowledge ......................................................................................................................12
7.2 Competence ............................................................................................................................................12
7.3 Awareness...............................................................................................................................................12
7.4 Communication .......................................................................................................................................12
7.5 Documented Information .........................................................................................................................13
8.0 Operation...................................................................................................... Error! Bookmark not defined.
8.1 Operational Planning and Control ...........................................................................................................13
8.2 Requirements for products and services ................................................................................................14
8.2.1 Customer communication .......................................................................................................................14
8.2.2 Determining the requirements related to products and services ............................................................14
8.2.3 Review of requirements related to products and services ......................................................................14
8.2.4 Changes to Requirements for Products and Services ............................................................................14
8.3 Design and Development of Products and Services...............................................................................14
8.4 Control of Externally Provided Processes, Products and Services ........................................................15

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8.5 Production and service provision ............................................................................................................15


8.5.1 Control of production and service provision ............................................................................................15
8.5.2 Identification and Traceability..................................................................................................................15
8.5.3 Property belonging to customers or external providers ..........................................................................16
8.5.4 Preservation ............................................................................................................................................16
8.5.5 Post-Delivery Activities ............................................................................................................................16
8.5.6 Control of Changes .................................................................................................................................16
8.6 Release of products and services ...........................................................................................................17
8.7 Control of nonconforming outputs ...........................................................................................................17
9.0 Performance Evaluation ............................................................................... Error! Bookmark not defined.
9.1 Monitoring, Measurement, Analysis and Evaluation ...............................................................................17
9.1.1 General ....................................................................................................................................................17
9.1.2 Customer Satisfaction .............................................................................................................................17
9.1.3 Analysis and Evaluation ..........................................................................................................................17
9.2 Internal Audit ...........................................................................................................................................18
9.3 Management Review ..............................................................................................................................18
10.0 Improvement ................................................................................................ Error! Bookmark not defined.
10.1 General ....................................................................................................................................................18
10.2 Nonconformity and corrective action .......................................................................................................19
10.3 Continual improvement ...........................................................................................................................19

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0.0 Revision History and Approval

Rev. Nature of changes Date


A Original release. 10/06/14

B Release of Section Updates to ISO 9001:2008 15/03/16

C Release of Section Updates per ISO 9001:2015 08/01/18

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1.0 About Momaizah Metal Fabrication Factory LLC (MFF)


Momaizah Metal Fabrication Factory (MFF) is a manufacturer of a wide range of equipment and
furnishings for industrial, governmental, commercial and private use. MFF provides turnkey services
starting from the consulting and design stage into custom manufacturing, installation and maintenance
services, offering highest standards of quality throughout the process.
The products and services offered are categorized into three main divisions as follows;

1.1 MFF Lab Systems


MFF Lab Systems is our lab furniture and equipment range. Technology, resources and
expertise are employed to manufacture standard as well as custom-built labs for a wide range
of projects. We manufacture laboratory furniture systems for industrial, educational, scientific
and medical and governmental sectors. Superior quality and adherence to internationally
accepted safety standards, has helped us in maintaining a strong and longstanding client base,
among them Saudi Aramco, SABIC, Saudi Arabian Mining Co.(MA’ADEN), Saudi Aramco Shell
Refinery (SASREF), Procter & Gamble, FZE in Jebel Ali, KFUPM, Bahrain University etc.

1.2 MFF Playgrounds


Since 1984, MFF Playgrounds has been a leading manufacturer of recreational equipment in
Saudi Arabia as well as other Gulf countries. We take on design, manufacture, installation, and
maintenance of high quality playground equipment, play structures, park furniture and gym
equipment. We also provide safety inspection services for recreation centers, schools, sport
facilities and residential compounds.

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1.3 MFF Metal Fabrication


With over 30 years of experience, MFF utilizes the latest technology in water jet and CNC laser
cutting machines, bending and turret presses and a fully equipped machine shop to custom
manufacture large as well as small projects. Our precision built products are finished to the
highest standard using our fully automated powder and PVC coating lines and electroplating
facility including electro galvanizing, chrome, zinc and cadmium. Experienced engineers and
staff are available to provide advice at the design as well as manufacturing stages.

2.0 About The MFF Quality Manual


This manual is prepared for the purpose of defining the company’s interpretations of the ISO
9001:2015 international standard, as well as to demonstrate how the company complies with that
standard. This manual presents “Notes” which are used to define how MFF has tailored its
management system to suit its purposes. These are intended to clarify implementation approaches
and interpretations for concepts which are not otherwise clearly defined in ISO 9001:2015. Notes
appear in italics, with gray background.
Where subordinate or supporting documentation is reference in this manual, these are indicated by
bold italics.

3.0 Terms and Definitions


MFF adopts the following terms and definitions within its Quality Management System. Where no
definition is provided, the company typically adopts the definitions provided in ISO 9000: Quality
Management – Fundamentals and Vocabulary. In some cases, specific procedures or
documentation may provide a different definition to be used in the context of that document; in such
cases, the definition will supercede those provided for in this Quality Manual or ISO 9000.
General Terminology
MFF – Momzaizah Metal Fabrication Factory LLC
Document – written information used to describe how an activity is done.
Record – captured evidence of an activity having been done.
Risk-Based Thinking Terminology
Risk – Negative effect of uncertainty
Opportunity – Positive effect of uncertainty

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Uncertainty - A deficiency of information related to understanding or knowledge of an event,


its consequence, or likelihood. (Not to be confused with measurement uncertainty.)
Products or Services Terminology
Throughout the text of this manual and accompanying procedures, the “products”
or “service” only apply to products and services intended for, or required by, a
customer.
Nonconforming Product Terminology
Rework: Efforts to bring nonconforming product into conformance through additional
operations that do not alter the original design of the product.
Repair: Efforts to bring nonconforming product into conformance through additional operations
that alter the original design of the product; this may be through the addition of material not
specified in the original design, or through altering pre-existing design features.
Scrap: The discard of nonconforming product in lieu of rework or repair.

4.0 Context of the Organization


4.1 Understanding the Organization and Its Context
The organization shall determine external and internal issues that are relevant to its
purpose and its strategic direction and that affect its ability to achieve the intended
result(s) of its quality management system.

MFF monitors and reviews information about external and internal issues during (but not limited
to) audits and management review meetings.

4.2 Understanding the Needs and Expectations of Interested Parties


The issues determined per 4.1 above are identified through an analysis of risks facing MFF and
its interested parties. “Interested parties” are those stakeholders who receive our products or
services, or who may be impacted by them, or those parties who may otherwise have a
significant interest in our company.
This information is then used by senior management to determine the company’s strategic
direction. This is defined in records of management review, and periodically updated as
conditions and situations change.

4.3 Determining the Scope of the Quality Management System


MFF located in Dammam Second Industrial City, Saudi Arabia defines its supply scope as
follows;
Design, fabrication and installation of Structural Steel, Play Ground Equipment,
Laboratory Furniture & similar products, electroplating, powder & PVC coating services.
The quality system applies to all processes, activities and employees within the company. The
facility is located at:
Street 77,
Second Industrial City,
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Dammam, KSA
Phone: +966-13-812 1125
Fax: +966-13-812 1043

4.4 Quality Management System and Its Processes

4.4.1 Process Identification


MFF has adopted a process approach for its management system. By identifying the top-level
processes within the company, and then managing each of these discretely, this reduces the potential
for nonconforming products or services discovered during final processes or after delivery. Instead,
nonconformities and risks are identified in real time, by actions taken within each of the top-level
processes.
Note: not all activities are considered “processes” – the term “process” in this context indicates the activity has been elevated
to a higher level of control and management oversight. The controls indicated herein are applicable only to the top-level
processes identified.

Each process may be supported by other activities, such as tasks or sub-processes. Monitoring and
control of top level processes ensures effective implementation and control of all subordinate tasks or
sub-processes.
Each top-level process has a Process Definition document which defines:
• applicable inputs and outputs
• process owner(s)
• applicable responsibilities and authorities
• applicable risks and opportunities
• critical and supporting resources
• criteria and methods employed to ensure the effectiveness of the process
• quality objectives related to that process

4.4.2 Process Controls & Objectives


Each process has at least one objective established for it; this is a statement of the intent of the
process. Each objective is then supported by at least one “metric” or key performance indicator (KPI)
which is then measured to determine the process’ ability to meet the quality objective.
Note: some processes have multiple objectives and multiple metrics. This is determined by the nature of the process, it’s
impact on Products or Services and associated risks.
Note: Whereas ISO 9001 discusses process measurements and “quality objectives” as separate concepts, MFF combines
them; i.e., quality objectives are used to control the processes. Additional objectives for Products or Services may be
assigned, but these will also be used to measure process effectiveness.

Throughout the year, metrics data is measured and gathered by process owners or other assigned
managers, in order to present the data to [Senior Management Team Name]. The data is then
analyzed by [Senior Management Team Name] in order that [Senior Management Team Name] may
set goals and make adjustments for the purposes of long-term continual improvement.
The specific quality objectives for each process are defined in the applicable Process Definition
document Metrics, along with current standings and goals for each objective, are recorded in records
of management review.
When a process does not meet a goal, or an unexpected problem is encountered with a process, the
corrective and preventive action process is implemented to research and resolve the issue. In addition,
opportunities for improvement are sought and implemented, for the identified processes.

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5.0 Leadership
5.1 Leadership & Commitment

5.1.1 General
Senior Management of MFF provides evidence of its leadership and commitment to the development
and implementation of the management system and continually improving its effectiveness by:
a) taking accountability of the effectiveness of the management system;
b) ensuring that the Quality Policy and quality objectives are established for the management
system and are compatible with the strategic direction and the context of the organization;
c) ensuring the integration of the management system requirements into the organization’s other
business processes, as deemed appropriate;
d) promoting awareness of the process approach;
e) ensuring that the resources needed for the management system are available;
f) communicating the importance of effective quality management and of conforming to the
management system requirements;
g) ensuring that the management system achieves its intended results;
h) engaging, directing and supporting persons to contribute to the effectiveness of the
management system;
i) promoting continual improvement;
j) supporting other relevant management roles to demonstrate their leadership as it applies to
their areas of responsibility.
Note: “business processes” such as accounting, employee benefits management and legal activities are out of scope of the
QMS.

5.1.2 Customer focus


Senior Management of MFF adopts a customer-first approach which ensures that customer needs and
expectations are determined, converted into requirements and are met with the aim of enhancing
customer satisfaction.
This is accomplished by assuring:
a) customer and applicable statutory and regulatory requirements are determined, understood
and consistently met;
b) the risks and opportunities that can affect conformity of products and services and the ability to
enhance customer satisfaction are determined and addressed;
c) the focus on enhancing customer satisfaction is maintained.

5.2 Policy
Senior Management has developed the Quality Policy, defined in section 3.0 above, that governs day-
to-day operations to ensure quality.
The Quality Policy is released as a standalone document as well, and is communicated and
implemented throughout the organization.

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The Quality Policy of MFF is as follows:

The quality and safety of our products are our first and foremost consideration. At each step of
the operation, namely the planning and design, material acquisition, lay-outs, production and
finally delivery and installation; these two key elements are considered for assurance of
customer satisfaction which is our main objective.

To accomplish our primary goal of maintaining high standards of quality and safety, MFF has
lain down and adhered to an "Internal Quality Control Procedures and standards" documented
code of practice. This manual embraces all steps and phases of the production starting from
the selection of suppliers for the procurement of materials to fabrication, treatment, coating,
electroplating, finishing, assembly, packaging, storing, shipping and recording in the accounts.

The Primary Purpose of this initiative is to ensure:


- Adherence to our Quality and Safety Standards
- Conformity with the Standard specifications required by our clients
- To ensure that our products are competitive in terms of quality and price.

5.3 Organizational Roles Responsibilities and Authorities


5.3.1 Top Management
- Define QMS policy and objectives.
- Ensure communication and understanding of the QMS policy throughout the organization.
- Take accountability for the effectiveness of the QMS.
- Ensure the integration of the QMS into the organizations business processes.
- Promote the use of process approach and risk based thinking.
- Ensure the resources needed for the QMS are available.
- Communicate the importance of conforming the QMS requirements.
- Engage, direct and support persons to contribute to the effectiveness of the QMS.
- Promote improvement.
- Support other relevant management roles to demonstrate their leadership as it applies to their
areas of responsibility.

5.3.2 Managers/Supervisors
- Implement the QMS as defined by this manual and related procedures.
- Obtains and communicate customer requirements to the appropriate personnel or functional
Organization.
- Ensure that qualified personnel and other resources are available to implement the QMS.
- Ensure that products/services satisfy customer requirements including quality, safety, cost,
schedule and performance.
- Ensure that personnel comply with applicable laws, regulations, specifications, standards and
documented procedures.

5.3.3 All Personnel


- Ensure quality of their work.
- Operate in conformance with the requirements of internal and customer requirements.
- Stop work in progress to make appropriate notifications when unsafe conditions exist or
requirements are not being met.

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6.0 Planning
6.1 Actions to Address Risks and Opportunities
Note: MFF deviates slightly from the approach towards risk and opportunity presented in ISO 9001. Instead MFF views
“uncertainty” as neutral, but defines “risk” as a negative effect of uncertainty, and “opportunity” as a positive effect of
uncertainty. MFF has elected to manage risks and opportunities separately, except where they may overlap. Formal risk
management may not be utilized in all instances; instead, the level of risk assessment, analysis, treatment and record
keeping will be performed to the level deemed appropriate for each circumstance or application.

MFF considers risks and opportunities when taking actions within the management system, as well as
when implementing or improving the management system; likewise, these are considered relative to
products and services. Risks and opportunities are identified as part of the “Context of the
Organization Exercise” defined in Context of the Org. document, as well as throughout all other
activities of the QMS.
Risks and opportunities are managed in accordance with the document Risk Management
document. This procedure defines how risks are managed in order to minimize their likelihood and
impact, and how opportunities are managed to improve their likelihood and benefit.

6.2 Quality Objectives and Planning to Achieve Them


As part of the adoption of the process approach, MFF utilizes its process objectives, as discussed in
4.4 above, as the main quality objectives for the QMS. These include overall product-related quality
objectives; additional product-related quality objectives may be defined in work instructions or
customer requirements.
The process objectives have been developed in consideration that they:
a) be consistent with the quality policy;
b) be measurable;
c) take into account applicable requirements;
d) be relevant to conformity of products and services and to enhancement of customer
satisfaction;
e) be monitored;
f) be communicated;
g) be updated as appropriate.
Process quality objectives are defined in the minutes of management review per section 9.3 below.
The planning of process quality objectives is defined in section 4.4. above.

6.3 Planning of Changes


Changes to the quality management system and its processes are carried out in a planned manner
per the procedure Change Management document.

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7.0 Support
7.1 Resources

7.1.1 General
MFF determines and provides the resources needed:
a) to implement and maintain the management system and continually improve its effectiveness
b) to enhance customer satisfaction by meeting customer requirements.

Resource allocation is done with consideration of the capability and constraints on existing internal
resources, as well as needs related to supplier expectations.
Resources and resource allocation are assessed during management reviews.

7.1.2 People
Senior management ensures that it provides sufficient staffing for the effective operation of the
management system, as well its identified processes.

7.1.3 Infrastructure
MFF determines, provides and maintains the infrastructure needed to achieve conformity to product
requirements. Infrastructure includes, as applicable:
a) buildings, workspace and associated facilities;
b) process equipment, hardware and software;
c) supporting services such as transport;
d) information and communication technology.
Equipment is validated per the procedure Equipment Validation document and maintained per the
procedure Preventive Maintenance document.

7.1.4 Environment for the Operation of Processes


MFF provides a clean, safe and well-lit working environment. The Senior Management of MFF
manages the work environment needed to achieve conformity to product requirements. Specific
environmental requirements for products are determined during quality planning and are documented
in subordinate procedures, work instructions, or job documentation. Where special work environments
have been implemented, these shall also be maintained per 6.3 above.
Human factors are considered to the extent that they directly impact on the quality of Products or
Services.
Note: Social, psychological and safety aspects of the work environment are managed through activities outside of the scope
of the management system. Only work environment aspects which can directly affect process efficiency or product and
service quality are managed through the management system.

7.1.5 Monitoring and Measuring Resources


Where equipment is used for critical measurement activities, such as inspection and testing, these
shall be subject to control and either calibration or verification; see the procedure Calibration
document.
Note: Calibration and measurement traceability is not employed for all measurement devices. Instead, MFF determines which
devices will be subject to calibration based on its processes, products and services, or in order to comply with specifications

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or requirements. These decisions are also based on the importance of a measurement, and considerations of risk.

7.1.6 Organizational Knowledge


MFF also determines the knowledge necessary for the operation of its processes and to achieve
conformity of products and services. This may include knowledge and information obtained from:
a) internal sources, such as lessons learned, feedback from subject matter experts, and/or
intellectual property;
b) external sources such as standards, academia, conferences, and/or information gathered from
customers or suppliers.
This knowledge shall be maintained, and made available to the extent necessary.
When addressing changing needs and trends MFF shall consider its current knowledge and determine
how to acquire or access the necessary additional knowledge.

7.2 Competence
Staff members performing work affecting product quality are competent on the basis of appropriate
education, training, skills and experience. The documented procedure Training document defines
these activities in detail.
Note: the management system does not include other aspects of Human Resources management, such as payroll, benefits,
insurance, labor relations or disciplinary actions.

7.3 Awareness
Training and subsequent communication ensure that staff are aware of:
a) the quality policy;
b) relevant quality objectives;
c) their contribution to the effectiveness of the management system, including the benefits of
improved performance;
d) the implications of not conforming with the management system requirements.

7.4 Communication
Senior Management of MFF ensures internal communication takes place regarding the effectiveness
of the management system. Internal communication methods include:
a) use of corrective and preventive action processes to report nonconformities or suggestions for
improvement
b) use of the results of analysis of data
c) meetings (periodic, scheduled and/or unscheduled) to discuss aspects of the QMS
d) use of the results of the internal audit process
e) regular company meetings with all employees
f) internal emails
g) memos to employees
h) MFF’s “open door” policy which allows any employee access to Senior Management for
discussions on improving the quality system

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7.5 Documented Information


The management system documentation includes both documents and records.
Note: the ISO 9001:2015 standard uses the term “documented information”; MFF does not use this term, but instead relies on
the terms “document” and “record” to avoid confusion. In this context the terms are defined by MFF as provided for in section
3.0 above. Documents and records undergo different controls as defined herein.

The extent of the management system documentation has been developed based on the following:
a) The size of MFF
b) Complexity and interaction of the processes
c) Risks and opportunities
d) Competence of personnel
Documents required for the management system are controlled in accordance with Document
Control Procedure QMS 0750. The purpose of document control is to ensure that staff have access
to the latest, approved information, and to restrict the use of obsolete information. All documented
procedures are established, documented, implemented and maintained.
A Record Master Registry QMS 0750.4 has been established to define the controls needed for the
identification, storage, retrieval, protection, retention time, and disposition of quality records. This
procedure also defines the methods for controlling records that are created by and/or retained by
suppliers.
These controls are applicable to those records which provide evidence of conformance to
requirements; this may be evidence of Product or Service requirements, contractual requirements,
procedural requirements, or statutory/regulatory compliance. In addition, quality records include any
records which provide evidence of the effective operation of the management system.

8.0 Operation
8.1 Operational Planning and Control
MFF plans and develops the processes needed for realization of its Products or Services. Planning of
Product or Service realization is consistent with the requirements of the other processes of the
management system. Such planning considers the information related to the context of the
organization (see section 2.0 above), current resources and capabilities, as well as Product or Service
requirements.
Such planning is accomplished through:
a) determining the requirements for the Products or Services;
b) establishing criteria for the processes and the acceptance of Products or Services;
c) determining the resources needed to achieve conformity to the Product or Service
requirements;
d) implementing control of the processes in accordance with the criteria;
e) determining, maintaining and retaining documented information to the extent necessary to
have confidence that the processes have been carried out as planned and to demonstrate the
conformity of Products or Services to their requirements.
Changes to operational processes are done in accordance with the document Change Management
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document.

8.2 Requirements for Products and Services

8.2.1 Customer Communication


MFF has implemented effective communication with customers in relation to:
a) providing information relating to Products or Services;
b) handling enquiries, contracts or orders, including changes;
c) obtaining customer feedback relating to products and services, including customer complaints;
d) handling or controlling customer property;
e) establishing specific requirements for contingency actions, when relevant.

8.2.2 Determining the Requirements Related to Products and Services


During the intake of new business MFF captures:
a) requirements specified by the customer, including the requirements for delivery and post-
delivery activities;
b) requirements not stated by the customer but necessary for specified or intended use, where
known
c) statutory and regulatory requirements related to Products or Services;
d) any additional requirements determined by MFF.
These activities are defined in greater detail in the procedure Quoting and Orders document.

8.2.3 Review of Requirements Related to Products and Services


Once requirements are captured, MFF reviews the requirements prior to its commitment to supply the
Product or Service. This review ensures that MFF has the capability and capacity to:
a) meet all requirements specified by the customer, including requirements for delivery and post-
delivery activities;
b) meet any requirements not stated by the customer, but which MFF knows as being necessary;
c) meet all requirements determined necessary by MFF itself;
d) meet all related statutory and regulatory requirements;
e) meet any contract or order requirements differing from those previously expressed (i.e., from a
previous MFF quote).
These activities are defined in greater detail in the procedure Quoting and Orders document.

8.2.4 Changes to Requirements for Products and Services


MFF updates all relevant requirements and documents when the requirements are changed, and
ensures that all appropriate staff are notified; see the documented procedure Change Management
document.

8.3 Design and Development of Products and Services


For new designs and for significant design changes, MFF ensures the translation of customer needs
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and requirements into detailed design outputs. These address performance, reliability, maintainability,
testability, and safety issues, as well as regulatory and statutory requirements.
This process ensures:
a) Design planning is conducted
b) Design inputs (requirements) are captured
c) Design outputs are created under controlled conditions
d) Design reviews, verification and validation are conducted
e) Design changes are made in a controlled manner.
These activities are further defined in the document Design Procedure document.

8.4 Control of Externally Provided Processes, Products and Services


MFF ensures that purchased Product or Service conform to specified purchase requirements. The
type and extent of control applied to the supplier and the purchased products or services are
dependent on the effect on subsequent Product or Service realization or the final product.
MFF evaluates and selects suppliers based on their ability to supply products and services in
accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation
are established.
Purchases are made via the release of formal purchase orders and/or contracts which clearly describe
what is being purchased. Received products or services are then verified against requirements to
ensure satisfaction of requirements. Suppliers who do not providing conforming products or services
may be requested to conduct formal corrective action.
These activities are further defined in the documents Purchasing document and Receiving
document.

8.5 Production and Service Provision

8.5.1 Control of Production and Service Provision


To control its provision of Product or Service, MFF considers, as applicable, the following:
a) the availability of documents or records that define the characteristics of the Product or Service
as well as the results to be achieved;
b) the availability and use of suitable monitoring and measuring resources;
c) the implementation of monitoring and measurement activities;
d) the use of suitable infrastructure and environment;
e) the appointment of competent persons, including any required qualifications;
f) the validation and revalidation of special processes if applicable (see below);
g) the implementation of actions to prevent human error;
h) the implementation of release, delivery and post-delivery activities.

8.5.2 Identification and Traceability


Where appropriate, MFF identifies its Product or Service or other critical process outputs by suitable
means. Such identification includes the status of the Product or Service with respect to monitoring and
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measurement requirements. Unless otherwise indicated as nonconforming, pending inspection or


disposition, or some other similar identifier, all Product or Service shall be considered conforming and
suitable for use.
If unique traceability is required by contract, regulatory, or other established requirement, MFF controls
and records the unique identification of the Product or Service.
The documented procedure Identification & Traceability document defines these methods in detail.

8.5.3 Property Belonging to Customers or External Providers


MFF exercises care with customer or supplier property while it is under the organization’s control or
being used by the organization. Upon receipt, such property is identified, verified, protected and
safeguarded. If any such property is lost, damaged or otherwise found to be unsuitable for use, this is
reported to the customer or supplier and records maintained.
For customer intellectual property, including customer furnished data used for design, production and /
or inspection, this is identified by customer and maintained and preserved to prevent accidental loss,
damage or inappropriate use.
This activity is defined in greater detail in the document Customer Property document.

8.5.4 Preservation
MFF preserves conformity of product or other process outputs during internal processing and delivery.
This preservation includes identification, handling, packaging, storage, and protection. Preservation
also applies to the constituent parts of a product.
The documented procedure Preservation document defines the methods for preservation of product.

8.5.5 Post-Delivery Activities


As applicable, MFF conducts the following activities which are considered “post-delivery activities”:
• Installation
• After sales service and maintenance
Post-delivery activities are conducted in compliance with the management system defined herein. In
determining the extent of post-delivery activities that are required, MFF considers:
a) statutory and regulatory requirements;
b) the potential undesired consequences associated with its of Product or Service;
c) the nature, use and intended lifetime of its of Product or Service;
d) customer requirements;
e) customer feedback.

8.5.6 Control of Changes


MFF reviews and controls both planned and unplanned changes to processes to the extent necessary
to ensure continuing conformity with all requirements.
Process change management is defined in the document Change Management document.
Documents are changed in accordance with procedure Control of Documents document.

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8.6 Release of Products and Services


Acceptance criteria for Product or Service are defined in appropriate subordinate documentation.
Reviews, inspections and tests are conducted at appropriate stages to verify that the requirements
have been met. This is done before Product or Service are released or services are delivered.
Each process utilizes different methods for measuring and releasing Product or Service. These
methods are defined in Process Definition document.

8.7 Control of Nonconforming Outputs


MFF ensures that Product or Service or other process outputs that do not conform to their
requirements are identified and controlled to prevent their unintended use or delivery.
The controls for such nonconformances are defined in Nonconformities and Corrective Action
Procedure QMS 1020.

9.0 Performance Evaluation


9.1 Monitoring, Measurement, Analysis and Evaluation

9.1.1 General
MFF has determined which aspects of its quality management system must be monitored and
measured, as well as the methods to utilize and records to maintain, within this Quality Manual and
subordinate documentation.
Monitoring and measurement of the processes, as defined in 4.4 above, ensure that the Senior
Management evaluates the performance and effectiveness of the quality management system itself.

9.1.2 Customer Satisfaction


As one of the measurements of the performance of the management system, MFF monitors
information relating to customer perception as to whether the organization has met customer
requirements. The methods for obtaining and using this information include:
• recording customer complaints
• product rejections or returns
• repeat orders for product
• changing volume of orders for product
• trends in on-time delivery
• obtain customer scorecards from certain customers
The corrective and preventive action system shall be used to develop and implement plans for
customer satisfaction improvement that address deficiencies identified by these evaluations, and
assess the effectiveness of the results.

9.1.3 Analysis and Evaluation


MFF analyzes and evaluates the data and information arising from monitoring and measurement in
order to evaluate:

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a) conformity of Product or Service;


b) the degree of customer satisfaction;
c) the performance and effectiveness of the quality management system;
d) if planning has been implemented effectively;
e) the effectiveness of actions taken to address risks and opportunities;
f) the performance of external providers;
g) the need for improvements to the quality management system.
Statistical techniques used may be defined in appropriate documented procedures; in all cases, the
methods are based on established standards or are otherwise determined to be statistically valid.

9.2 Internal Audit


MFF conducts internal audits at planned intervals to determine whether the management system
conforms to contractual and regulatory requirements, to the requirements of ISO 9001, and to
management system requirements. Audits also seek to ensure that the management system has been
effectively implemented and is maintained.
These activities are defined in the document Internal Auditing document.

9.3 Management Review


The [Senior Management Team Name] reviews the management system, at planned intervals, to
ensure its continuing suitability, adequacy and effectiveness. The review includes assessing
opportunities for improvement, and the need for changes to the management system, including the
Quality Policy and quality objectives.
Management review frequency, agenda (inputs), outputs, required members, actions taken and other
review requirements are defined in the documented procedure Management Review document.
Records from management reviews are maintained.

10.0 Improvement
10.1 General
MFF uses the management system to improve its processes, products and services. Such
improvements aim to address the needs and expectations of customers as well as other interested
parties, to the extent possible.
Improvement shall be driven by an analysis of data related to:
The results of analysis shall be used to evaluate:
h) conformity of products and services;
i) the degree of customer satisfaction;
j) the performance and effectiveness of the management system;
k) the effectiveness of planning;
l) the performance of external providers;

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m) other improvements to the management system.

10.2 Nonconformity and Corrective Action


MFF takes corrective action to eliminate the cause of nonconformity in order to prevent recurrence.
Likewise, the company takes preventive action to eliminate the causes of potential nonconformities in
order to prevent their occurrence.
These activities are done through the use of the formal Corrective Action system, and are defined in
the Nonconformities and Corrective Action Procedure QMS 1020.

10.3 Continual Improvement


Through the process effectiveness reviews, done as part of Management Review, MFF works to
continually improve the suitability, adequacy and effectiveness of the quality management system.
This includes seeking opportunities for improvement.

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