Quality Assurance / Quality Management

Quality Assurance / Quality Management
The implementation of an effective Quality Management System is critical to the success of every organization. Quality improvement is a continuous process, driven by ongoing change in customer demands. In order to drive improvement in your quality assurance process you need to ensure you have a full understanding of the various requirements associated with implementing a quality system. Quality Management is about driving product and process improvement, designing to achieve quality expectations, ensuring a comprehensive documentation system is in place, ensuring all change is effected via a comprehensive change management process, capturing and acting upon customer complaints, implementing an effective quality audit process, …… etc.

 

640 page information and training presentation on Quality Assurance & Quality Management, contents:

 

Introduction to Quality Assurance.

The meaning of Quality. How quality issues can affect business. The developers of the modern Quality Management System. The application of Quality Management as a driving force for business performance improvement. The Quality Policy. The Quality Management System (QMS). The Principles of Quality Management. The objective and elements of the Quality Manual. Quality Control versus Quality Assurance. Quality specifications, testing for conformance to specifications.

 

The Quality Management System (QMS).

What is a Quality Management System (QMS)? Requirements of key International Quality Standards: e.g. Process Control, Corrective Action, Records identification, Training processes, Management Review, etc..

 

Changes implemented to the ISO 9001 QMS Standard under the 2015 update.

Details of the changes and new requirements introduced resulting from the publication of the 2015 revision to the ISO 9001 standard.

 

Continuous Improvement in Product and Process Quality.

Approach to continuous improvement. Relationship between continuous improvement and organizational strategy & direction. Model for continuous product and process improvement.

 

Quality in product and process design.

The rational for design control. The process of design control. Design & development planning. Design input and design output expectations. The design review process. Validation & verification in product and process design. Design transfer expectations. Building and maintaining the design history file.

 

Approach to good manufacturing practices.

What are Good Manufacturing Practices (GMP’s). Review the principles of the GMP’s. Quality, Safety & Efficacy as defined by good manufacturing practice. Explanation of the quality system requirements for effective GMP implementation.

 

Implementing an effective quality documentation processes.

The necessity for controlled documentation as part of an effective Quality Management System (QMS). Review of the various types of documentation normally controlled within a Quality Management System (QMS). Implementing and maintaining compliant Standard Operating Procedures. The fundamental rules within a documentation system. The process of controlling official procedures, specifications and standards.

 

Calibration certification.

The reasons for implementing a calibration system. Types of calibration certificate. Extent of testing to be requested when requesting a calibration. Value and limitation of accredited calibration. The key elements to be detailed in a calibration certificate.

 

Ensuring an effective change control process.

The importance of change control to a compliant quality system. The different categories of change control. Developing an effective change control process.

 

Training for quality management system effectiveness.

The importance of training in building and improving quality performance. Training requirements for product and process performance. Training versus education. The driving forces for training. Training needs identification, assessment, the training schedule. Types of training & types of training delivery. The maintenance of training records.

 

Product and process validation as part of a quality management system.

The benefits of validation in providing a continually reliable product and process. The different types of validation. How validation is executed. The Validation Master Plan. The objective of the VMP, the benefits to an organization and the key required elements within the VMP.

 

Supplier quality assurance processes.

Implementing a supplier quality approval process. Supplier assessment and rating. Ship to Stock and Ship to Line processes. Implementing supplier corrective and preventative action.

 

Determination of quality costs.

The purpose and benefits of analyzing quality costs. Review of the various types of quality costs. The effect of quality costs awareness on business performance improvement.

 

Management of Product & Process Deviations to SOP’s & Specifications.

Determining what are “Deviations”, how they occur and how they are processed. Planning for product and process “Deviation”. Investigating and addressing “Deviations” when they arise.

 

Ensuring quality in projects.

Elements of Project Management. The Project Lifecycle. Building Quality into the various stages of a project: e.g. initiation, planning, execution, controlling, closure.

 

Customer Complaint management system.

Management of customer complaints and using complaints as a means to improve systems & processes. The potential sources of complaints must be identified and processes established to gather relevant information. Impartial investigation needs to be performed. Root causes must be identified and actions taken to permanently address to the satisfaction of customers.

 

The impact of quality on competitiveness.

Review of the elements which enable and inhibit competitiveness.

 

Implementing an effective audit process to drive quality performance improvement.

Approach to implementing an effective audit process. Developing the audit terms of reference. Scope and approach to the audit. Auditing techniques. Conducting a risk assessment of audit observations. Audit reports and corrective actions.

 
Further details.