Quality Engineering

What is workplace safety and health/ occupational health and safety

It is an interdisciplinary area concerned with protecting the health, safety and welfare of people engaged in work or in employment.

What is the goal of occupational health and safety systems

It is to ensure an environment of safe working

What are the objective of WSH framework 2018

It aims to coordinate resources and efforts to achieve: A safe and healthy workplace for everyone.

What are the three principles of WSH framework

1. Reducing risks at source by requiring all stakeholders to eliminate or minimise the risks they create

2. Instilling greater ownership of safety and health outcomes by industry

3. Preventing accidents through higher penalties for poor safety management

Coverage of the WSH act 2006

1. Factory

2. Laboratory

3. Airport

4. Shipyard

5. Construction

The importance of safety culture in the workplace

1. Create attitude, practices and policies that incorporate safety for awareness, prevention and education

2. Results in everyone’s commitment to safety as an important part of doing business

3. Reducing or eliminating accidents saves money for individuals, families and businesses.

The impact of WSH on individual, fellow workers and workplaces

1. They feel safe and comfortable in their working environment

2. Understand the rules and regulations of workplace safety

3. Able to complete their jobs while remaining safe at all times

4. Gives them the confidence they need to work without fear of safety

The vision of the national plan WSH 2018

To achieve sustained and continuous improvement in WSH standard

The 4 strategic outcomes of the national plan WSH 2018

1. The reduction in WSH incident rates

2. Workplace safety and health as an integral part of business

3. Singapore as a renowned Centre of Excellence for WSH

4. A progressive and pervasive WSH Culture

What are the types of Hazards commonly found in the industry

1. Electrical

2. Mechanical & Machinery

3. Chemical

4. Biological

5. Ergonomics

6. Environment

7. Construction

What are the common occupational diseases

1. Noise-induced deafness

2. Occupational skin diseases

3. Chemical Poisoning

4. Occupational Lung diseases

What is occupational skin disease

An occupational skin disease is any skin disorder which is caused by a person’s work

What are the 2 causes of occupational skin disease

1. Irritation

2. Allergy

What are the effects of occupational skin diseases

1. Allergic contact dermatitis

2. Irritant contact dermatitis

3. Protein contact dermatitis

4. Skin infections

5. Pigment changes

What are the types of hazardous chemical

1. Physical hazards

2. Health hazards

3. Environmental hazards

What are the symptoms of chemical poisoning

1. Skin rashes

2. Boils

3. Major organ damage

What are the ways hazardous chemicals can enter the body

1. Inhalation

2. Skin contact

3. Eating or smoking with contaminated hands

4. Accidental injection through the skin

What is occupational lung disease

They are lung problems that are made worse in certain work environments

What are common types of occupational lung diseases

1. Asthma

2. Lung Cancer

3. Pneumoconiosis

4. COPD ( Chronic obstructive pulmonary disease)

What are some measures taken to prevent occupational lung diseases

1. Limitation of exposure to harmful agents

2. Prevent hazardous emissions through substitution

3. Prevent airborne exposure using engineering controls such as process enclosure and ventilation

4. Proper use of PPE (personal protective equipment)

5. Stop cigarette smoking

When does a company need to do risk assessment again

1. Once every 3 years

2. When there is significant changes to workplace processes or design

3. Whenever there is an injury or incident

What is risk assessment

It is a systematic method of looking at work activities, considering what could go wrong, and deciding on suitable control measures to prevent loss, damage or injury in the workplace

The importance of risk assessment

1. It is required by the law

2. It helps stakeholders to eliminate, reduce or mitigate hazards

3. It keeps employees safe in their workplace

Name all the control based on the hierarchy of control from most effective

1. Elimination

2. Substitution

3. Engineering controls

4. Administrative controls

5. Personal protective equipment

What are the main components of risk management

1. Preparation

2. Risk assessment

3. Risk Control Implementation

4. Record Keeping

5. Review

What are the steps of risk assessment

1. Hazard identification

2. Risk evaluation

3. Risk control

How to calculate the risk prioritization number (RPN)

RPN= Severity . Likelihood

What are the seven primary quality tools

1. Check sheet

2. Control charts

3. Histogram

4. Flow chart

5. Cause-and-Effect diagram

6. Pareto chart

7. Scatter diagram

What is Statistical process control (SPC)

It is defined as statistical methods for analyzing and controlling the variation of a process.

What are the objectives of SPC

1. Control

2. Minimise process variation

3. detect if a process is in or out of control

What are the basic concept of SPC

1. Quality is conformance to specifications

2. Processes and product vary

3. Variation can be measured

What are the benefits of SPC

1. Improve relative ability to compete

2. Lower cost of quality & improve pricing flexibility

3. Improve quality of incoming devices& materials

4. Improve the productivity of the resources

5. Trained shopfloor personnel

What is 2 types of variation

1. Non-assignable / chance causes

2. Assignable / special variation

What are the type of Variation

1. Within-piece

2. Piece-to-piece

3. Time-to-time

What are the key element of lean 6 sigma

1. Delivering higher quality service in less time

2. Improve processes by eliminating defects and focuses on how work flows through the processes

3. Use teamwork and share ideas to solve problems

4. All decisions made are based on data and facts

What are the benefits of lean 6 sigma

1. Improve productivity

2. Improve quality and customer satisfaction

3. Reduce waste

4. Reduce inventory

5. Eliminate defects and errors

What are the principles of lean 6 sigma

1. Specify what creates value from the customers perspective

2. Identify all the steps along the process chain

3. Make those processes flow

4. Make only what is pulled by the customer

5. Strive for perfection by continually removing waste

What are the 7 waste of Lean 6 sigma

1. Waiting

2. Overproduction

3. Excess inventory

4. Excess motion

5. Inappropriate processing

6. Transport

7. Defects

What is value add in lean 6 sigma

Any activity in the process that is essential to deliver the service or product to the customer

What is Non Value add or waste in lean 6 sigma

Activities that add no value from the customer’s perspective and are not required for financial, legal or other business reasons

What are the key concepts of 6 sigma

1. Critical to Quality

2. Defect

3. Process capability

4. Variation

5. Stable Operations

6. Design for Six Sigma

What is DMAIC in 6 sigma

• Define - Define problem and explains the project goal

• Measure - Measure the problem and process from which it was produced

• Analyse - Analyze data and process to identifyies all the root causes and opportunities

• Improve - Improve the process by finding solutions to prevent future problem

• Control - Implement, Control and Sustain the improvements to keep the process on the new course

What is ISO 9001:2015

It is a international quality management standard. It applies to all types of organizations. It can help both product and service oriented organizations achieve standards of quality that are recognized and respected throughout the word

What are the 7 quality management principles

1. Customer focus

2. Leadership

3. Engagement of people

4. Process approach

5. Improvement

6. Evidence-based decision making

7. Relationship management

What does customer focus mean in Quality management principles

Organizations depend on their customers and therefor should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.

What does Leadership mean in Quality management principles

Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.

What does Engagement of people mean in Quality management principles

People at all levels are the essence of an organization and their full involvement enables their ability to be used for the organization’s benefit

What does Process approach mean in Quality management principles

A desired result in achieved more efficiently when activities and related resources are managed as a process

What does Improvement mean in Quality management principles

Improvement is essential for a n organization to maintain current levels of performance, to react to changes in its internal and external conditions and to create new opportunities

What does Evidence-based decision making mean in Quality management principles

Decision making can be a complex process, and it always involves some uncertainty. It often involves multiple types and sources of inputs, as well as their interpretation, which can be subjective.

It is important to understand cause-and-effect relationships and potential unintended consequences. Facts, evidence and data analysis lead to greater objectivity and confidence in decision making

What does Relationship Management mean in Quality management principles

Interested parties influence the performance of an organization. Sustained success is more likely to be achieved when the organization manages relationships with all of its interested parties to optimize their impact on its performance. Relationship management with its supplier and partner networks is of particular importance

What are ISO 9001 : 2015 Clauses

1. Context of the organization

2. Leadership

3. Planning

4. Support

5. Operation

6. Performance Evaluation

7. Improvement

What is ISO 14001

It is an international standard that specifies a process for controlling and improving a company’s environmental performance

What is the benefits of ISO 14001

1. Better environmental management reduce waste and energy use

2. Improve efficiency to cut the cost of running your business

3. Demonstrate compliance to expand your business opportunities

4. Meet legal obligations to win greater stakeholder and customer trust

5. Prepare for the changing business landscape confidently

What is the application of ISO 14001

1. Healthcare Sector

2. Manufacturing Sector

3. Process Industries

4. Service Industries

What is ISO 14001 Clauses

1. General Requirements

2. Environmental Policy

3. Planning

4. Implementation and Operation

5. Checking

What is ISO/TS 16949

It is an internationally recognized Quality Management System specification for the Automotive Industry

Why do Companies want to Implement ISO/TS 16949

Registration to the ISO is a requirement for any company wanting to supply its products to the Automotive Industry

What ISO/TS 16949 purpose

1. Continual Improvement

2. Emphasizing defect prevention

3. Reduction of Variation

4. Reduction of waste in the supply chain

What does ISO/TS 16949 apply to

• Design and Development, Production and, when relevant, Installation and Service of automotive-related products

• It is applicable to sites of the organization where customer-specified parts for production and/ or service are manufactured

• Automotive related parts means parts that actually installed on the vehicle

What are the benefits of ISO/TS 16949

1. Gain your license to trade internationally and expand your business

2. Improve processes to reduce waste and prevent defects

3. Remove the need for multiples certificates for vehicle manufacturing

4. Demonstrate compliance to win new business and investment prospects

5. Integrate ITAF 16949:2016 with other management system

What is OHSAS/ OHSMS

• OHSAS: Occupational Health and Safety Assurance System

• OHSMS: Occupational Health and Safety Management System

• Both terms are used interchangeably and it is all about identifying “OHS hazards”, estimating “risks” and taking appropriate measures to mitigate “consequences”

What is the definition of OHSAS/ ISO 18001:2016 Newly revised ISO 45001:2016

It is a new international standard for Occupational Health and Safety Management Systems to help organizations to improve employee safety, reduce workplace risks and create better, safer working conditions, all over the owrd

Who is suitable for ISO 45001

1. Large Organizations and enterprises

2. Small and medium-sized enterprises

3. Public and not-for-profit organizations

4. Non-government organizations (NGOs) and charities

What are the benefits of ISO 45001

1. Reduced incident and accident rates

2. Improved performance monitoring and accident reporting

3. Better control of OH&S risks

4. Decrease in overall costs of accidents

5. Decrease in insurance premiums

What is ISO 13485

It is a management systems standard specifically developed for the manufacture of medical devices

Benefits of ISO 13485

1. Increase access to more markets worldwide with its certification

2. Outline how to review and improve processes across your organization

3. Increase efficiency, reduce costs and monitor supply chain performance

4. Demonstrate that you produce safer and more effective medical devices

5. Meet regulatory requirements and customer expectation

What is a medical device

Medical Equipment designed to aid in diagnosis, monitoring or treatment of medical conditions

What are the examples of medical devices

1. Surgical instrument

2. MRI machine

3. Ultrasound

4. Pace Maker

5. Blood pressure monitors

Consequences of failing to comply with ISO standard

1. Poor consistency of service and product performance

2. Low customer satisfaction levels

3. Low productivity and efficiency

4. Increased costs

5. Poor communications, morale and job satisfaction

6. Reduced marketing and sales opportunities

What is the Objectives of Quality Audits

1. To determine the conformity or non-conformity of the quality system elements to specified requirements

2. To determine the effectiveness of the implemented quality system in meeting specified quality objective

3. To provide opportunity for improving the quality system

4. To permit listing of audited organization’s quality system in a register

5. To meet regulatory requirement

What is the purpose of Quality Audit

1. Determine that actual performance conforms to the documented QMS

2. Initiate corrective action activities in response to deficiencies

3. Follow up on noncompliance items from previous audits

4. Provide continued improvement in the system through feedback to management

5. Cause the auditee to think about the process, thereby encouraging possible improvements

Auditor should possess what skills and characteristics

1. Be qualified individual

2. Possess good written skills

3. Possess good oral communication skills

4. Be a good listener

5. Be good at taking notes

Techniques of quality audit

1. Examination of documents

2. Observation of activities

3. Interviews

Auditing Procedure

1. The pre-audit meeting

2. The audit

3. And a closing meeting

What is the pre-audit meeting

During the pre-audit meeting, the audit process and the timetable are discussed and prior audits are reviewed.

Minutes of the meeting should be recorded and included with the audit documentation. A list of those attending the meeting is recorded in the minutes

What is the audit

The purpose is to determine how well the quality system has been implemented and maintained.

What is the closing meeting

The lead auditor presents a summary of the audit findings along with the evidence that supports them. An estimate is made of when the final report will be issued.

The distribution of the report is agreed upon. Again, minutes of the meeting are recorded, along side with a record of attendance.

What are the two types of Optical measurement

1. Magnified Scales

2. Magnified Objects

What draw and list components in a general optical system of projection

1. Light Source

2. Collimator Lens

3. Object

4. Projection Lens

5. Image on screen

What are the 4 essential elements of a optical profile projector

1. Source Light - must be a point source placed at principle focus of collimating lens

2. Collimating Lens - condense and rendered parallel beams of light

3. Projection Lens - combination of lens and forms image on screen

4. Screen - to allow the image to be displayed. It either opaque or translucent

What are the 2 Error in projections

1. Poor Definition - Chromatic Aberration & Spherical Aberration

2. Distortion - Barrel & Pin-cushion

What is chromatic aberration

Lights refracts through the lens and disperses into different wavelengths or colors. Each wavelength or color focus at a different plane which results in numerous images & observed as fringes with colors

What is Spherical Aberration

Rays through lens center and periphery are focused at different planes which results in a “Diffusion” of the image

What is 3 basic applications of optical projector

1. Components that cannot be measured by contact method such as small radius and angles.

2. Components that are fragile and would deform if pressure is applied

3. Components that have irregular shape, and cannot be inspected by other methods

What are the advantages in using optical projector

1. Measurements are direct, which is more reliable than transfer methods

2. Convenience, 2 or more people to participate simultaneously

What is the limitation in using optical projector

Must ensure that part lies in the plane of sharpness

What is the objection of Quality Inspection Operation

1. Explain the need for inspection in a manufacturing process

2. Describe different stages of inspection by using a flowchart

3. Explain the three methods of inspection

What is the objective of conducting an inspection process

To ensure that the products being produced meet the standards of quality and quality levels which have been previously established

What are the types of inspections operation

1. Outgoing inspection

2. Receiving/Incoming Inspection

3. Rectifying Inspection

What is Outgoing inspection

It is performed immediately following production and done before product or part is shipped to the customer

What is Receiving/Incoming inspection

Lots or batches of product are inspected as they are received from the supplier

What is Rectifying inspection

It is accepting or rejecting sampled lots by various lot disposition. Items in rejected lots are typically scrapped, recycled, reworked or replaced with good units

What are the methods of inspection

1. Spot checking

2. 100% inspection

3. Sampling inspection

What is spot checking

Inspecting small sample ‘here and there’ hope to achieve a result that reflects the quality of the batch. However it is cheap and risky method of inspection

What is 100% inpsection

It mean every single item that is produced is inspected. It is the best method of inspection however it is not 100% reliable, fatigue, boredom and distraction to operator and it is a very expensive method

When to use 100% Inspection

• Job is just going into production

• Production is extremely limited

• Requirement to check every piece of product

• Product is to be sorted

• Zero Defect quality control

What is sampling inspection

• It is also called acceptance sampling.

• Sample size is carefully calculated and selected at random from a batch

• Acceptance and rejection depends on Acceptance Number of sampling plan

What are the advantages of Sampling inspection

1. When test is destructive

2. Less expensive as compared to 100% inspection

3. Less handling damage due to inspections

4. Places responsibility for quality

5. Fewer personnel involved

6. When many similar units are to be inspected

7. Gives strong motivation for improvement

What are the disadvantages of Sampling inspection

1. Risk of rejecting Good lots

2. Risk of accepting Bad lots

3. More time and effort for planning and documentation

4. No assurance given that the entire lot conforms to specification