OBJECTIVES

In this module the student will acquire specific skill and knowledge which will enable the student to develop, manage and maintain quality systems in manufacturing.

TARGET GROUP

This unit is of particular interest to Quality Assurance (QA) managers and personnel, production managers and supervisors.

TRAINING METHODOLOGY

For each of the topic covered, the students are first taught the basic concepts. The principle of operation and its practical implementation are then covered. Series of hands-on activities will be conducted to facilitate the learning. Demonstrations will be conducted and explanations will be given to lead the participants into various applications of the total quality management in the industries. Participants will then perform hands on activities to develop, manage and maintain quality systems.

TRAINING PROGRAM OUTLINE

Day 1:

Module 1: Establish requirements of the quality system

1.1.    Develop policies expressing the organization’s commitment to the quality system and processes

1.1.1.Develop quality policies for the enterprise in consultation with senior management and other stakeholders.

1.1.2.Develop workforce commitment, capability and responsibility for the quality system. This involves identifying, negotiating and scheduling training, inclusion of responsibilities and duties relating to quality system implementation and integration in all job descriptions and work instructions, clear communication of responsibilities and requirements, delegation of tasks and responsibilities and inclusion of the workforce in consultative and continuous improvement processes.

1.1.3.Identify and describe process capability.

1.2.    Legislative requirements for enterprise quality systems

1.2.1.Ensure the quality system meets legislative and regulatory requirements.

1.3.    Scope and objectives of the quality system

1.3.1.Describe the key concepts, philosophies and tools of quality management.

1.3.2.Links with enterprise operations, customers, suppliers and contractors.

1.4.    Quality performance standards

1.4.1.Customer and supplier service standards

1.4.2.Identify the applicable quality standards, regulations, codes, legislation and customer requirements for the quality system and explain the implications for the enterprise.

1.4.3.Identify research and update sources of quality information and advice including technical and regulatory information to support enterprise quality system.

 

 

1.5.    Resource requirements

1.5.1.Financial, human resource and operational plans.

1.5.2.Control of documents, data, quality records

1.5.2.1.              Explain documentation requirements of the quality system (including levels) and their roles in the functioning of the system, including the requirement for effective and secure quality record-keeping systems.

1.5.3.Coverage of contracts, purchasing, supply, processing, handling, storage, packaging, preservation, storage and delivery of products

1.5.4.Definition of management responsibilities

1.5.5.Design and process controls

1.5.6.Inspecting and testing, control of non-conforming product, preventative and corrective action, auditing

1.5.6.1.              Describe the role audits play in a quality system.

1.5.7.Management of links and impacts on all systems within the enterprise

1.5.7.1.              Describe the management and organisational structure of the enterprise and its impact on enterprise systems.

1.5.8.Production identification and traceability

1.5.9.Training.

Day 2 & 3: 

Module 2: Design and prepare for the quality system

2.1 Select and design quality systems.

2.1.1 Apply substantial product and process knowledge to the development of the quality system and the interpretation of quality data.

2.2 Quality principles to achieve business goals and performance standards.

2.2.1 Outline the principles and functions of hazard analysis and control, validation (including auditing) and verification in quality systems.

2.3 System components, procedures and supporting documentation

2.3.1 Correction

2.3.1.1 Disposition

2.3.1.2 Corrective action

2.3.1.3 Liability management

2.3.1.4 Customer complaint resolution

2.3.2 Prevention

2.3.2.1 Training

2.3.2.2 Develop consultative and feedback procedures and opportunities for identification and resolution of quality issues and problems.

2.3.2.2.1 Operator feedback

2.3.2.3 Manuals

2.3.2.4 Technology and equipment reliability and maintenance

2.3.2.5 Analyze complex statistical data and prepare corrective responses to non-conformances and variations identified in the data, relevant to enterprise quality systems and operations.

2.3.2.5.1 Statistical collection and information.

2.3.2.6 Supplier QA

2.3.2.7 Standard Operating Procedures (SOPs) and work instructions.

2.4 Consultative and communication strategies are developed to link the quality system with all aspects of enterprise operations.

2.4.1 Apply relevant communication and mathematical skills.

2.5 Supplier or contractor service standards and audit requirements are determined and negotiated.

2.5.1 Oversee audit processes (internal and external), act on audit findings and provide feedback to personnel for improvement of the system.

2.5.2 Oversee the preparation for third party certification.

2.6 Performance measures and indicators are developed to measure performance against policies, goals and performance standards.

Day 4 & 5:

Module 3: Implement and monitor the quality system

3.1 Implementation plan is prepared and resourced.

3.1.1 Prepare quality implementation plans, identifying goals, key personnel and areas, resources, strategies, timelines and milestones.

3.2 Training plans to provide personnel at all levels with quality concepts and skills are prepared and resourced.

3.2.1 Plan and resource the enterprise training strategy, consistent with regulatory requirements, to assist personnel at all levels in the implementation of the quality system.

3.3 Quality system requirements and customer focus are addressed in the establishment, operation and evaluation of all enterprise systems.

 

3.3.1 Apply quality concepts and tools to problem-solving and the development of quality data collection, data management systems and analysis strategies.

3.3.2 Use appropriate questioning, observation, listening and recording skills in the collection and monitoring of quality data.

3.4 Control and preventative action measures are identified and validated.

3.4.1 Prepare and sign off quality policies, manuals and documentation for the enterprise, including the preparation and updating of preventative, corrective and responsive procedures and strategies, supplier criteria and specifications, supplier and contractor audit requirements.

3.5 Corrective action procedures are developed and monitored.

3.5.1 Identify appropriate monitoring systems and strategies to support the enterprise quality system.

3.6 Procedures for reporting, recording and responding to non-conformances and non-compliances are established.

3.6.1 Present reports according to legal and enterprise requirements.

3.7 Customer and supplier service standards are monitored and documented.

3.7.1 Monitor and certify processes and product to meet third party requirements (eg importing country, public health requirements, customers).

3.8 Quality data is collected and analysed, and implications reported.

3.8.1 Explain enterprise goals and directions and their implications for the quality system.

3.9 Quality costs and performance are monitored.

3.10 Quality system is prepared for external review and approval by relevant authorities.

Day 5 & 6:

Module 4: Continuously improve the quality system

4.1 Impacts of the quality system on enterprise operations are monitored and reviewed.

4.2 Responses to customer complaints and requests are resolved and used to improve the system.

4.2.1 Lead personnel in the implementation and improvement of the quality system.

4.2.2 Resolve customer complaints promptly and provide corrective action responses.

4.3 Procedures for the ongoing identification and resolution of issues are established.

4.3.1 Exercise judgement, pragmatism and quality knowledge in the management and resolution of quality issues and problems.

4.4 Quality system is updated for changes in process, technical information, customer and regulatory requirements.

4.5 Stakeholders are included in decision making and continuous improvement processes and strategies.

4.5.1 Develop continuous improvement processes and team building using the ‘plan, do, check, and act cycle’.

4.6 Quality results, findings and conclusions are fed into improvement processes.

4.7 Costs and benefits of the quality system are analysed.

4.7.1 Monitor and analyze the costs of the quality system, including prevention costs, appraisal costs, total quality costs and failure costs.

4.8 Quality goals and targets are continuously reviewed.

4.8.1 Communicate quality goals, requirements and findings to stakeholders in formats and styles appropriate to the context and purpose.

Module 5: Communicate quality outcomes

5.1 Certification of product and processes consistent with quality outcomes is completed according to customer and regulatory requirements.

5.2 Regulatory authorities and agencies are promptly notified of breaches and non-compliance incidents.

5.2.1 Consult, negotiate with and report to regulatory authorities openly and promptly, consistent with enterprise ethical standards. This includes the notification of breaches and the preparation of non-compliance reports.

5.2.2 Outline the legal requirements for the establishment and maintenance of the enterprise QA system including responsibilities for reporting breaches to authorities and implementing audit findings. Quality outcomes are used to promote public confidence in enterprise products and services.