Month: June 2020

Manufacturers of consumer products should incorporate human factors into their Quality Management Systems (QMS).  Because human factors are directly connected to product safety, it is important that it be considered in all phases of product development and life cycle.  The Division of Human Factors, U.S. Consumer Product Safety and Health Canada’s Consumer and Hazardous Products Safety Directorate jointly released Guidance on the Application of Human Factors to Consumer Products in February 2020.  This was released to help consumer product manufacturers integrate human factors into their product development process.

What is Human Factors?

Human Factors is a discipline that studies of relationships between humans and elements of a system or product.  The discipline is comprised of engineering and test and evaluation practices.  User Experience and Usability are associated fields that evaluate human/product interfaces.  Design methods that consider human characteristics, capabilities and limitations create safe and effective products.  The benefits of including human factors into product design include:

• Improved usability and acceptance.
• Increased safety.
• Reduced lifecycle cost and risk.
• Reduced support and help desk costs.

Quality Management and Human Factors

Human Factors engagement is not limited to product design.  It also applies to testing, validation, and evaluation during the production and post-production phases of a product lifecycle.  Because these activities are identifiable and create viable metrics for assessing product effectiveness and safety, they can be implemented into a QMS’s policies and procedures.  Risk identification and mitigation for product safety should:

• Identify potential cost, schedule, design, safety, and performance risks that result from design aspects of human-system integration;
• Quantify these risks and their impacts on cost, schedule, and performance;
• Define and evaluate sensitivity of potential risks as related to the human interface;
• Identify alternative solutions to human factors problems and define the associated risks of each alternative;
• Document the identified risks, their impact on the product, and the mitigation action(s) taken;
• Take actions to avoid, minimize, control, or accept each human factors risk; and
• Ensure that human performance risks are included in the overall product’s risk-management process.

CVG Strategy QMS Solutions

CVG Strategy Quality Experts have experience with ISO 9001:2015 , AS9100D, ISO 27001:2013, ISO 13485:2016 and Association of American Railroads (AAR) M-100.  We can help in designing a QMS that is tailored to your business needs with relevant procedures and work instructions.  Understanding quality systems is a fundamental aspect of our work as consultants.  We help our customers make their businesses run more efficiently and improve customer satisfaction. 

Creating Effective Quality Management Documentation

Effective Quality Management Documentation is the backbone of a ISO 9001:2015 quality program.  The documentation created therefore should be clear, concise, and targeted for its intended audience.   Documents serve to explain and instruct all stakeholders on policies, procedures, and work instructions.  They also provide the basis for evaluation for continuous improvement and organizational development.

Documentation Requirements

Documentation requirements will vary in complexity and from organization to organization.  Factors that will determine this complexity include:

• The size of the organization
• Activities of the organization
• Types of processes and products
• Complexity of those processes
• Level of competence of intended audience

Document requirements serve several purposes in the quality program.  High level documents are required for defining the scope, processes, policies, and objectives of the program.  Lower level documentation is required to define organizational responsibilities, procedures, work instructions, quality plans and other information.  Additional documentation is required for providing the results of quality processes.  These documents are required for demonstrating conformity.

Knowledge as a Basis for Documentation

Because we are all products of an educational system that rewards the perception of competency, it is easy to create obtuse documents.  Real knowledge of a given subject provides a basis for simple and clear documentation.  This will effectively convey expectations of performance and establish goal posts for review. 

Required knowledge includes an understanding of the upper level objectives of the quality program, the Context of the Organization, who the stake holders are, and what audience the document is intended for.

CVG Strategy Quality Experts Can Help

CVG Strategy provides Quality Management System (QMS) consulting services for ISO 9001:2015, AS9100, ISO 27001, and other standards.  We can help your organization establish and modify a QMS that can improve your business performance and save money.  We can provide training and auditing services.  CVG can also provide a complete documentation set, customized for your program requirements.

Contact Us today to see what our certified quality management experts can do for you.