What is a Quality Management System? A Tactical Viewpoint ISO/TS 16949:2002

Why have a Quality Management System? TS or Not TS Legislation states that we must have the following systems: Safety Management System, Environmental Management System These do not have to be certified systems unless required by company or customer? There is no legislation that states we must have a Quality Management System. This is a certified system. Safety and Environmental Systems must be initiated because of legislation but they need not be certified to International Standards. Yet most companies have a Quality System that is certified to an International Standards but a QMS is not required by legislation.

Group Activity 1 What does a QMS do for us? Break into groups: Flipchart & Markers Answer the following questions: Why do we have a SMS ? Why do we have an EMS ? Why do we have a QMS ? Facilitators Notes: Have the class break into groups and discuss these questions. They are to put their answers on a flipchart and then discuss their findings to the rest of the class. In short: Safety Systems are put in place to protect people. Environment Systems are put in place to protect the planet. Quality Systems are put in place to protect the product and therefore the company. Expand on these answers and question the floor. Why do we want to protect people? Why do we want to protect the Planet? These should be self explanatory. Why do we want to protect the Product? Because ultimately it protects our business which in turn protects us both financially and securely. What would we be doing if we did not have a job today? What if we lost a major customer? What would happen to our business and our job security? Ensure that the class understands the links between a quality product and business viability. Explain Certification and the reasons companies do it voluntarily. They choose to have the QMS in place. There are often outside forces, usually, customer pressure. The Certificate is a sales tool and a business tool. Certification is having a system accredited to an International Standard by a Registrar What does a QMS do for us?

What does a Quality System aid us in? People, Planet, Product Protection The government wants us to PROTECT both PEOPLE and the PLANET from harm. A Safety System will aid in reducing injury to PEOPLE……….HOW? An Environmental System will aid in reducing damage to the PLANET……….HOW? Facilitators Notes: Open discussion: Address these questions to the class. Write the responses in dot point form on a Flipchart or Board for the class to compare the reasons. Highlight the commonality between the systems and that they are ALL PROTECTION systems in their own right. They each protect a resource. What does a Quality System aid us in?

Who makes us implement a QMS? Group Activity 2 Break into groups: Flipchart & Markers What does a Quality System aid us in? A Quality System will aid in reducing damage to the PROCESS and PRODUCT. How does a Quality System aid in doing this? A Quality System will aid us by ensuring repeatability by implementing process controls. Facilitators Notes: Link the Safety and Environmental System ‘Protection’ thinking to the responses to these questions. In this way everyone should understand that each system should be viewed in the same light. None more important than the other. They each have the same thought process: To PREVENT INJURY or DAMAGE to PEOPLE, PLANET and PRODUCT What does a Quality System aid us in? A Quality system aids us in reducing damage to the Process and Product by implementing Policies, Procedures and Work Instructions that dictate How, When and why we perform tasks. How does the Quality System aid in doing this? By having Policies, Procedures and Work Instructions a QMS gives us repeatability. We will all have the same goals and rules to ensure that processes are maintained, Work instructions followed, Systems improved and Product guaranteed. Who makes us implement a QMS?

What are the similarities in the Systems? Why Quality? Who makes us Implement a QMS? Our Customers require us implement a QMS, however, Good business practices and common sense dictate that we must endeavor to produce the best product. Our customers expect it and we in turn expect it when we purchase goods. Therefore we should implement a QMS for our continued improvement. This says to our customer ‘We are QUALITY and we ASSURE you of the product integrity’ Facilitators Notes: Who makes us Implement a Quality Management System? Good business practices dictate that we must endeavor to produce the best product. Our customers expect it and we in turn expect it when we purchase goods. A good QMS is a must a business aims to reduce risk to the product. What are the similarities in the Systems?

People, Planet, Product Overarching Systems PEOPLE PLANET PRODUCT What are the Similarities in the Systems? PEOPLE & PLANT PEOPLE SAFETY PEOPLE & PLANET PLANET ENVIRONMENT PEOPLE & PROCESS PRODUCT PROCESS QUALITY Facilitators Notes: Review the previous responses. Highlight the common factors. All have written procedures (Doc Control and Records) All offer Protection (Process Control) All have Incident Reporting and Investigation (CAPA) All have Reviews and Audits (Internal Audits) Overarching Systems

Prevention is Better than Cure! Safety Question What is an Overarching system? These systems are ALL protection measures so we must make use of our knowledge of more prominent systems such as Safety to aid us in understanding Quality. Examples are useful: What would you do if you saw a loose object above a walkway? You would remove it and report it! Why? To Prevent Injury Now and into the future! Facilitators Notes: Highlight recent Examples: Additional Photos of a hazard or a live example would benefit the students understanding of a Risk. Explain reporting methods etc Prevention is Better than Cure!

Prevention is Better than Cure! Quality Question Hazard What would you do if you saw a foreign object in a stockpile of material? You would remove it and report it! Why? To Prevent Contamination or Non Conformance Now and into the future. Facilitators Notes: Highlight Recent Examples Additional Photos of a hazard or a live example would benefit the students understanding of a Risk. Explain reporting methods etc Do you see the link? The Link is the common aim of PREVENTION! Prevention is Better than Cure!

Riddle me this Protect! How do these protection systems work? They work because they have standards and legislation that we must comply with. How do we Comply? We implement Policies, Procedures and Work Instructions etc that state What & How we do things. Facilitators Notes: Expand on ‘How we Comply’ and Why we need to comply. Explain the benefits to US! Show the Standard and Work Instructions etc Explain the Work Instructions (What and who they are designed for, Continual review and improvement) Protect!

(Specifications, Packaging, Transportation and Delivery) Riddle me this 2 How? How does this help our business? It gives us Repeatability. How does Repeatability help us? We can assure our customers that their order will be delivered the same, every time. Facilitators Notes: Get the class to discuss REPEATABILITY. What are the facets that we want to look for in a completed task or product? The order is more than a number on a chart to be completed. Conformity to In house Specifications Conformity to the Customer Specifications Conformity to the Order (Tonnage, Amount, Price, Time etc) Packaging requirements and Standards Transport Arrangements, Deadlines, Costs (Specifications, Packaging, Transportation and Delivery) We are Quality!

Let’s Wrap it up!! YOU! What is the common link in all systems? How? What is the common link in all systems? PEOPLE! Systems are only as effective as the PEOPLE that implement, use and control them Who is responsible for QUALITY? Facilitators Notes: The ONUS is on everyone to ensure that the systems work. All the paperwork and procedures in the world are not going to produce a quality product unless PEOPLE ensure that they are followed. They must adhere, monitor, report, improve etc YOU!

Your Journey has just begun!! What Next? Where to from here? We have discussed the ‘Quality Management System’ from the view of ‘Product and Process Control’. A QMS is in fact an Overarching Management Strategy that includes all of these systems plus: Customers and Suppliers, Leadership and Management, People, Product and Processes, Continual Improvement and Decision making. Your Journey has just begun!! Facilitators Notes: This is a good place to show them the standard and the management principles. Explain that the system should be more than Quality Assurance and Control but a total Business System Package. What are we doing, How are we going to get there and how are we going to keep improving?