1. Introduction

Welcome to FAAS Engineering & Consultancy Sdn Bhd (FAAS). FAAS was incorporated on 17th July 2014. It was formerly known as FAAS Engineering Sdn Bhd & DETRAC Sdn Bhd (Destini Technology Research and Advance Customization Sdn Bhd). We are actively involved in Research and Development comprising many fields of technology. Nonetheless, our technical support team comprises of motivated individuals with extensive knowledge and experience in various areas of engineering field. Our entire employees share a common goal, which is to ensure that every project is successfully be implemented within contract period. Our company brings together a team of highly qualified and experienced professionals, with specialization in various technical and engineering disciplines.

2. Purpose

This Quality Manual portal defines the organization structure, policy, objective and procedure in accordance with the current ISO 9001:2015 standards. It is approved by the top management and must be complied accordingly to achieve the intended standard that full fill the customer, regulator and company quality required.

3. Term and Definitions

FAAS  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 9001:2015 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 supersede those provided for in this Quality Manual. General Terminology 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 Uncertainty - A deficiency of information related to understanding or knowledge of an event, its consequence, or likelihood. (Not to be confused with measurement uncertainty.) Nonconforming Product Terminology Rework: Efforts to bring the nonconforming product into conformance through additional operations that do not alter the original design of the product. Repair: Efforts to bring the nonconforming product into conformance through additional operations that alter the original design of the product; this may be through the addition of material no 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. Context of Organization

4.1. Understanding the Organization and Its Context

FAAS has reviewed and analyzed key aspects of itself and its stakeholders to determine the strategic direction of the company. This requires understanding internal and external issues that are of concern to FAAS and its interested parties (per 4.2 below); the interested parties are identified in the context of the organization. Such issues are monitored and updated as appropriate and discussed as part of management reviews.

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 FAAS 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. These parties are identified n the context of the organization. This information is then used by top 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

FAAS's core business is delivering  technical services of electrical and electronic's and mechanical engineering related to defense equipment such as:

• Weapon support equipment
• Electro-optical systems
• Electronic control systems

The quality management system applies to all processes, activities, and employees of the following location within the company:

4.4. Quality management system and its process

 

4.4.1. Process Identification

FAAS 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. The following top-level processes have been identified for FAAS:

1. Core Process
2. Quality Management Process
3. Shared Process

The sequence of interaction of these processes is illustrated below.

 

4.4.2. Process Controls and 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’s ability to meet the quality objective. Throughout the year, metrics data is measured and gathered by process owners or other assigned managers, in order to present the data to top management. The data is then analyzed by top management in order that they 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 quality objective. 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.

4.4.3. Outsourced Processes

Any process performed by a third party is considered an outsourced process and must be controlled, as well. The company’s outsourced processes and the control methods implemented for each are defined in External Provider. The type and extent of control to be applied to the outsourced process take into consideration:

1. The potential impact of the outsourced process on the company’s capability to provide a product that conforms to requirements,
2. The degree to which the control for the process is shared,
3. The capability of achieving the necessary control through the purchasing contract requirements.

 

5. Leadership

5.1. Leadership and commitment

5.1.1. General

Top management of FAAS provides evidence of its leadership and commitment to the development and implementation of the management system and continually improving its effectiveness by:

1. Taking account of the effectiveness of the management system;
2. 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;
3. Ensuring the integration of the management system    requirements into the organization’s other business processes, as deemed appropriate
4. Promoting awareness of the process approach;
5. Ensuring that the resources needed for the management system are available;
6. Communicating the importance of effective quality management and of conforming to the management system requirements;
7. Ensuring that the management system achieves its intended results;
8. Engaging, directing and supporting persons to contribute to the effectiveness of the management system;
9. Promoting continual improvement;
10. Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.!!!# Customer Focus

Top management of FAAS 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:

1. Customer and applicable statutory and regulatory requirements are determined, understood and consistently met;
2. The risks and opportunities that can affect the conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;
3. The focus on enhancing customer satisfaction is maintained.

 

5.2. Quality Policy

The top management has developed the quality policy, 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.!!# Organization Roles Responsibilities and Authorities The top management has assigned responsibilities and authorities for all relevant roles in the company. These are communicated through the combination of the organization charts and job descriptions. In addition, the following overall QMS responsibilities and authorities are assigned as follows:

 

6. Planning

6.1. Actions to Address Risks and Opportunities

FAAS 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, as well as throughout all other activities of the QMS. Risks and opportunities are managed in accordance with the risk management procedure. 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, FAAS 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:

1. Be consistent with the quality policy;
2. Be measurable;
3. Take into account applicable requirements;
4. Be relevant to the conformity of products and services and to the enhancement of customer satisfaction;
5. Be monitored;
6. Be communicated;
7. Be updated as appropriate.

 

6.3. Plan for Changes

Changes to the quality management system and its processes are carried out in a planned manner per the procedure Plan for Changes!# Support

6.4. Resources

6.4.1. General

FAAS determines and provides the resources needed:

1. To implement and maintain the management system and continually improve its effectiveness
2. 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.!!!# People Top management ensures that it provides sufficient staffing for the effective operation of the management system, as well its identified processes.!!!# Infrastructure FAAS determines, provides and maintains the infrastructure needed to achieve conformity to product requirements.  Infrastructure includes, as applicable:

1. Buildings, workspace, and associated facilities;
2. Process equipment, hardware, and software;
3. Supporting services such as transport;
4. Information and communication technology.

Equipment is maintained and validated per the support procedure for tools and equipments.!!!# Environment for the Operation of Processes FAAS provides a clean, safe and well-lit working environment.  The management 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 and services. !!!# 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 calibration process under tools and equipment procedure.!!!# Organizational Knowledge FAAS 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:

1. Internal sources, such as lessons learned, feedback from subject matter experts, and/or intellectual property;
2. 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, FAAS shall consider its current knowledge and determine how to acquire or access the necessary additional knowledge.

6.5. Competence

Staff members performing work affecting product quality are competent on the basis of appropriate education, training, skills, and experience defined as per human resource related procedures.!!# Awareness Training and subsequent communication ensure that staff are aware of:

1. The quality policy;
2. Relevant quality objectives;
3. Their contribution to the effectiveness of the management system, including the benefits of improved performance;
4. The implications of not conforming with the management system requirements.!!# Communication

The top management ensures internal communication takes place regarding the effectiveness of the management system. Internal communication methods include:

1. Use of corrective and preventive action  processes to report nonconformities or suggestions for improvement
2. Use of the results of the analysis of data
3. Meetings (periodic, scheduled and/or unscheduled) to discuss aspects of the QMS
4. Use of the results of the internal audit process
5. Regular company meetings with all employees
6. Internal emails
7. Memos to employees
8. FAAS’s “open door” policy which allows any employee access to top management for discussions on improving the quality system!!# Documented Information

The management system documentation includes both documents and records. The extent of the management system documentation has been developed based on the following:

1. The size of FAAS
2. Complexity and interaction of the processes
3. Risks and opportunities
4. Competence of personnel

Documents required for the management system are controlled in accordance with control of documents procedure. The purpose of document control is to ensure that staff has access to the latest, approved information, and to restrict the use of obsolete information. All documented procedures are established, documented, implemented and maintained.   A procedure 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  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.

7. Operation

7.1. Operational Planning and Control

FAAS plans and develops the processes needed for the 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, current resources, and capabilities, as well as product or service requirements. Such planning is accomplished through:

1. Determining the requirements for the products or services
2. Establishing criteria for the processes and the acceptance of products or services
3. Determining the resources needed to achieve conformity to the product or service requirements;
4. Implementing control of the processes in accordance with the criteria;
5. 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 plan for changes document. Outsourced processes and the means by which FAAS controls them are defined in the documented procedures.

7.2. Requirements for Products and Services

7.2.1. Customer Communication

FAAS has implemented effective communication with customers in relation to:

1. Providing information relating to Products or Services
2. Handling inquiries, contracts or orders, including changes;
3. Obtaining customer feedback relating to products and services, including customer complaints;
4. Handling or controlling customer property;
5. Establishing specific requirements for contingency actions, when relevant.!!!#Determining the Requirements Related to Products and Services

During the intake of new business FAAS captures:

1. Requirements specified by the customer, including the requirements for delivery and post-delivery activities;
2. Requirements not stated by the customer but necessary for specified or intended use, where known
3. Statutory and regulatory requirements related to products or services;
4. Any additional requirements determined by FAAS.

These activities are executed during management review meeting and monthly meeting.!!!#Review of Requirements Related to Products and Services Once requirements are captured, FAAS reviews the requirements prior to its commitment to supply the product or service. This review ensures that FAAS has the capability and capacity to:

1. Meet all requirements specified by the customer, including requirements for delivery and post-delivery activities;
2. Meet any requirements not stated by the customer, but which FAAS knows as being necessary;
3. Meet all requirements determined necessary by FAAS itself;
4. Meet all related statutory and regulatory requirements;
5. Meet any contract or order requirements differing from those previously expressed (i.e., from a previous FAAS quote).

These activities are defined in greater detail in the customer relation procedure.!!!# Changes to the Requirements of Products and Services FAAS updates all relevant requirements and documents when the requirements are changed, and ensures that all appropriate staff is notified; see the documented change of management procedure. !!#Design and Development of product services For new designs and for significant design changes, FAAS ensures the translation of customer needs 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:

1. Design planning is conducted
2. Design inputs (requirements) are captured
3. Design outputs are created under controlled conditions
4. Design reviews, verification, and validation are conducted
5. Design changes are made in a controlled manner.

These activities are further defined in research and development.

7.3. Control of Externally Provided Processes, Products, and Services

FAAS ensures that purchased products or service conforms 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. FAAS 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 that clearly describe what is being purchased. Received products or services are then verified against requirements to ensure the satisfaction of requirements. External providers who do not provide conforming products or services may be requested to conduct formal corrective action.

7.4. Production and Service Provision

7.4.1. Control of Production and Service Provision

To control its provision of products or services, FAAS considers, as applicable, the following:

1. The availability of documents or records that define the characteristics of the products or services as well as the results to be achieved;
2. The availability and use of suitable monitoring and measuring resources;
3. The implementation of monitoring and measurement activities;
4. The use of suitable infrastructure and environment;
5. The appointment of competent persons, including any required qualifications;
6. The validation and revalidation of special processes if applicable (see below);
7. The implementation of actions to prevent human error;
8. The implementation of release, delivery, and post-delivery activities.!!!# Identification and Traceability

Where appropriate, FAAS 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 measurement requirements. Unless otherwise indicated as nonconforming, pending inspection or disposition, or some other similar identifier, all products or services shall be considered conforming and suitable for use. If unique traceability is required by contract, regulatory, or other established requirements, FAAS controls and records the unique identification of the product or service.

7.4.2. Property Belonging to Customers or External Providers

FAAS exercises care with the 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.

7.4.3. Preservation

FAAS preserves the conformity of the 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.!!!# Post-Delivery Activities As applicable, FAAS conducts Product Warranty as “post-delivery activities”. Post-delivery activities are conducted in compliance with the management system defined herein. In determining the extent of post-delivery activities that are required, FAAS considers:

1. Statutory and regulatory requirements;
2. The potential undesired consequences associated with it's of products or services ;
3. The nature, use and intended lifetime of it's of products or services;
4. Customer requirements;
5. Customer feedback.

 

7.4.4. Control of Changes

FAAS reviews and controls both planned and unplanned changes to processes to the extent necessary to ensure continuing conformity with all requirements. Documents are changed in accordance with the procedure Control of Documents.

7.5. Release of Products and Services

Acceptance criteria for products or services 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 products or services are released or services are delivered. Each process utilizes different methods for measuring and releasing products. These methods are defined in Technical Services procedures.!!# Control of Nonconforming Outputs FAAS ensures that products or services 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 control of NC products/services.

8. Performance Evaluation

8.1. Monitoring, Measurement, Analysis, and Evaluation

8.1.1. General

FAAS 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 top management evaluates the performance and effectiveness of the quality management system itself.

8.1.2. Customer Satisfaction

As one of the measurements of the performance of the management system, FAAS monitors information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information include:

1. Recording customer complaints
2. Product rejections or returns
3. Repeat orders for product
4. Changing volume of orders for product
5. Trends in on-time delivery
6. Submittal of customer satisfaction surveys

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.!!!# Analysis and Evaluation FAAS analyzes and evaluates the data and information arising from monitoring and measurement in order to evaluate the conformity of products or services;

1. The degree of customer satisfaction;
2. The performance and effectiveness of the quality management system;
3. If planning has been implemented effectively;
4. The effectiveness of actions taken to address risks and opportunities;
5. The performance of external providers;
6. 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.!!# Internal Audit FAAS conducts internal audits at planned intervals to determine whether the management system conforms to contractual and regulatory requirements,  to the requirements of ISO 9001:2015, and to management system requirements. Audits also seek to ensure that the management system has been effectively implemented and maintained.!!# Management Review The top management 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 Management Review procedure. Records from management reviews are maintained.

9. Improvement

9.1. General

FAAS 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 the conformity of products and services;

1. The degree of customer satisfaction;
2. The performance and effectiveness of the management system;
3. The effectiveness of planning;
4. The effectiveness of actions taken to address risks and opportunities;
5. The performance of external providers;
6. Other improvements to the management system.!!# Nonconformity and Corrective Action

FAAS 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 non-conformities in order to prevent their occurrence.!!# Continual Improvement Through the process effectiveness reviews, done as part of Management Review, FAAS works to continually improve the suitability, adequacy, and effectiveness of the quality management system. This includes seeking opportunities for improvement.