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Implementing a Quality Management System

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1 Implementing a Quality Management System
Presented by USDA GRAIN INSPECTION, PACKERS AND STOCKYARDS ADMINISTRATION This training is presented as a project of the USDA, Grain Inspection, Packers and Stockyards Administration. It is intended for managers and supervisors in the grain, oilseeds, livestock or seed industry, or an associated industry, that are being called upon to implement a quality management system. This training, entitled “Implementing a Quality Management System”, is provided from an auditor’s point of view and is intended for individuals who have attended the earlier training “Creating and Documenting a Quality Management System” or have taken the training online from the GIPSA or AMS website. Link to the Course Outline

2 What is a QMS? The short answer: Say what you do (documentation)
Do what you say (implementation) Prove what you do (records) Review and improve (continuous improvement) We’re going to start with a review of fundamentals, such as – What is a Quality Management System.

3 QMS Definitions A Quality Management System is:
System for managing the quality of an organization Includes everything in the organization that relates to quality: Products and services Processes Operations Customer Satisfaction Here is another definition It is the system for managing the quality of an organization (not a product). Most importantly, it includes all aspects of the organization that relate to quality. This means that everyone, from top management to the janitors who clean the plant after everyone else has gone home, are part of the Quality System of the plant. Janitors add quality because sanitation relates to the environment of the workers as well as the quality of the product being produced. ISO 9000 places a very strong emphasis on customer satisfaction, so the quality of the product as well as the delivery of the product are considerations of the QMS.

4 QMS Description As required by ISO 9000:
The Quality System is well documented, implemented, understood, maintained and continually improved Emphasis is placed on problem prevention rather than inspection Quality planning is required The PROCESS APPROACH to management is encouraged The ISO 9000 description of the QMS is on this slide.

5 QMS Description Quality Standard or Regulation Product or Service
ISO 9001:2000 Process Verified ISO Guide 65 Quality System Assessment Program National Organic Program Product or Service Consistent quality feed Identity Preserved livestock or grain Consulting Service Organic Certification and Organic Production Beef Export Verification (BEV) Here is another way to describe a QMS. It has two very definite components that require equal attention. Each component has requirements for procedures, work instructions and records that will be part of the QMS documentation. First, there is the Quality Standard or Regulation, which relates to the quality of the business, that must be met. These would include the ISO requirements, ISO 9000, for example, or Guides 65 and 61. The Quality System Assessment Program is an AMS Livestock and Seed Programs standard. The National Organic Program regulates three different QMS systems: production and handling of organic food, certification of producers and handlers and accreditation of certifying agents. Second, there is the actual production or service that requires its own set of procedures. Documentation must explain all aspects that ensure the quality of the product or service being delivered.

6 What makes it so special?
Process Approach to management Integration of processes into a System/ Interrelation of all activities Continual Improvement at all levels Communication among all employees and management that leads to full utilization of everyone’s talents Process approach looks at the systems which create a high quality product or service, and it allows systems to be integrated. Evaluation and re-evaluation from internal audits and management reviews allows for continual improvement at all levels. Communication from top management to employees and from employees to top management builds trust that everyone has a role in quality. It allows full utilization of everyone’s talents.

7 DEFINITION “A desired result is achieved more efficiently when activities and related resources are managed as a process.” PROCESS – collection of interrelated activities that transform inputs into outputs Following are some definitions that will help you understand the QMS. They will also be valuable when discussing implementation.

8 DEFINITION “Identifying, understanding, and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objective.” SYSTEM – a collection of interrelated processes with a common set of objectives and outputs.

9 Yes, more DEFINITIONS PROCESS CHAMPION – member of top management who has interest in promoting the control and improvement of a specific process. PROCESS OWNER – the head of one of the key functions involved in the actual operation of the process and is responsible for ensuring that the process is understood, documented, implemented, controlled, and improved.

10 Last of the DEFINITIONS
VERIFICATION – the confirmation that specified requirements have been met VALIDATION – confirmation through the provision of objective evidence that the requirements for a specific intended use or application have been fulfilled

11 Process – making coffee
INPUTS Sub-process MEASURE MANUFACTURE Every process has inputs and an output or outputs. There are steps included in every process. In some cases, there are sub-processes necessary to complete the entire process. Remember from the earlier definition that “verification” confirms that the requirements are met. In this case, it’s the recipe. VERIFY OUTPUT

12 VALIDATION Process – making coffee
Validation is confirmation through the provision of objective evidence that the requirements for a specific intended use or application have been fulfilled.

COFFEE BACON & EGGS ORANGE JUICE A system is a collection of interrelated processes with a common set of objectives and outputs. In this example, you can easily imagine the processes needed to create the end product, which is breakfast. TOAST

This concludes the first portion of the training session. At this time, you should work alone or with your group to identify processes and systems within your organization. Try to think of some processes or systems that are not directly related to manufacturing the product, for example the payroll system.

Now that we have a vocabulary to work from, let’s begin to look at how different companies operate.

16 Vertical Management Inputs Administration/Management Marketing
Research and Development Companies in the past have been vertically managed with very little inter-action between the different departments. A classic example – especially from the standpoint of communication and training -- would be the automobile assembly line. Employees are trained for one job, that is the only job they perform. There is little cross training and no one cares what talent an employee has other than what is necessary to perform the designated job. In this diagram, each component operates in a bubble with little or no communication. Only the essential information is passed on so that the product or service can be produced. Information flows in straight lines from one unit to another. Purchasing Production Outputs

17 Vertical Management Style
Focus on end product Customer satisfaction only relevant to complaints Communication on a “need to know” basis Improvement on an “as needed” basis Responsibility not established until something goes wrong! Above are characteristics of a vertical management style.

18 ISO 9000 QM System Continuous Improvement of the QMS Satisfaction
Management Responsibility Customers Customers Measurement, Analysis and Improvement Resource Management As you can see, the QMS style is considerably different. Customer requirements are the input, and the product is the output. Customer satisfaction is critically important. There has to be direct involvement of the 4 major processes: Management Responsibility; Resource Management; Product Realization; and Measurement, Analysis and Improvement. TO SUCCESSFULLY IMPLEMENT A QUALITY MANAGEMENT SYSTEM, YOU HAVE TO CHANGE YOUR MIND. “QUALITY” NO LONGER RELATES TO THE PRODUCT OR SERVICE PRODUCED. “QUALITY” NOW RELATES TO THE HEALTH AND INTERACTION OF THE FOUR PROCESSES MENTIONED ABOVE. Satisfaction Requirements Product Realization Product Input Output

19 Quality Management Style
Focus on the entire system Customer is main concern Communication at all levels Continuous Improvement Responsibility assigned Above are some characteristics of the QMS style.

20 Why Implement a QMS? (ISO 9000)
Ensure Customer Satisfaction Improve Quality System Enhance Control of Resources Improve Suppliers Performance You are probably asking yourself why it is so important to implement a QMS. It seems like a lot of trouble with all the documentation and record keeping that has to be done. But over the years that quality management systems have been in effect, businesses find that a QMS provides a better product and a better company. This concludes the training that compares vertical management with a QMS. Please review the handouts “Employee Motivation, the Organizational Environment and Productivity”, ”Industrial Management and Technology”, and “Leadership Styles and Problem Solving”. Work alone or with your group to identify more characteristics of Vertical Management Style and a Quality Management System. Link to “Employee Motivation, the Organizational Environment and Productivity” Link to ”Industrial Management and Technology” Link to “Leadership Styles and Problem Solving”

21 ISO 9000 REQUIREMENTS In the following slides, we will examine the eight areas of the ISO 9000 requirements.

22 ISO 9000 Requirements SCOPE covers why the standard is used
APPLICATION states that the standard is generic and there can be exclusions from section 7 3. TERMS AND DEFINITIONS reference ISO 9000 and 9001 vocabulary The first 3 requirements are important to the standard itself, but do not effect the implementation of the QMS.

23 ISO 9000 Elements General Requirements (Documentation requirements covered in earlier training) 5. Management Responsibility 6. Resource Management 7. Product Realization 8. Measurement, Analysis and Improvement The section 4 requirements were covered in the earlier training course entitled, Creating and Documenting a Quality Management System. Sections 5 – 8 were shown earlier in the QMS diagram (slide 18). We will talk about each one of them separately in the next series of slides.

24 Just a Refresher Documentation – The information used to provide a description of your operation and to record its activities Quality Manual, Work Instructions, Sales Invoices Documents – work papers used for activities. They will change over time (living) Procedures, Forms, Policies Records – historical material that will not change, but will be retained for reference (dead) Meeting minutes, Completed forms, Reports Before we begin, it’s time to review a few more terms. Documentation can include paper, electronic, video, signage or any other means your company uses to compile, distribute, or retain information. Documentation includes both documents and records. Documents include any documentation that can be changed to meet the needs of your company. Records are the evidence used to verify and validate conformance to the QMS that you’ve created.

25 General ( Documentation)
ISO 9000 Element 4 General ( Documentation) Covered in “Creating and Documenting a Quality Management System” Managers and supervisors most likely would write or participate in writing documents: procedures forms work instructions Managers and supervisors provide oversight of record creation, preservation, and retention Managers most likely are brought into the process of writing the documents that explain product realization, such as work instructions or procedures. This is best done as a collaboration with the people actually doing the work. A manager’s role is to project a positive, enthusiastic attitude about the writing project and to provide time for the project to be completed. Managers also oversee records, and need to convey to the people they supervise that records are an essential piece of the QMS. Managers can set a good example by their own orderly record retention.

26 ISO 9000 Element 5 Management Responsibility
Management Commitment Customer Focus Planning (Objectives & QMS) Responsibility, Authority and Communication (Management Representative) Management Review The first of the four major processes in a QMS is Management Responsibility. This element addresses the 5 responsibilities of top management. Without the commitment of Top Management, the QMS will fail. Their commitment is the energy that drives the QMS forward. As we review each of the 5 elements, try to determine how they contribute to ensuring a quality product.

27 Management Responsibility
ISO 9000 Element 5 Management Responsibility Top Management is responsible for Meeting Customer Requirements, Policy, Objectives, Planning, Management Review, and Management Representative Mid-level Managers and Supervisors are responsible for supporting Top Management’s Objectives, Fostering Communication at ALL Levels, and Building Enthusiasm for the QMS Throughout the Company Managers and supervisors need to support their top management by positively conveying information to the people they supervise about customer related issues, planning, and the quality policy and objectives of top management. Managers and supervisors also provide input to the Management Review.

28 ISO 9000 Element 6 Resource Management
(Human, Infrastructure and Environment) Provision of Resources Human Resources General Competence, Awareness, and Training Infrastructure Work Environment The second major process in ISO 9000 is Resource Management. Each of the 4 areas is essential to creating a quality product. Top Management is responsible for ensuring, through the planning process, that there is enough capital to provide the resources needed to produce a high quality product. Without an adequate number of well trained and appropriately education personnel, a high quality product cannot be produced. The human resources process contributes highly to a quality product. Safe, durable equipment and buildings must be available to ensure the best possible product. Work environment means not only safety and physical comfort, it also means that anyone can make a suggestion for improvement without fear of criticism or loss of their job. It means that employees have an opportunity to training that will improve their circumstances. Only through a process that allows each person to develop his or her full talents, can a company be assured of the best product it can produce.

29 ISO 9000 Element 6 Resource Management
(Human, Infrastructure and Environment) Mid-level Managers and Supervisors must: Ensure that all employees are competent to do their jobs; strive for performance improvement Be observant of buildings, machinery and property; make recommendations as appropriate Follow all safety rules and make certain employees follow your example; make working conditions as comfortable as possible – including both physical and emotional comfort Resource management is everyone’s responsibility. While top management must provide the resources necessary to meet customer demands and continually improve the QMS, managers and supervisors are responsible for keeping top management informed about the status of the resources. All employees should be encouraged to maintain equipment, continually improve their knowledge and skills, and to establish a safe and productive work environment. Mangers and supervisors should know the people they supervise, encourage their growth, and provide an open “safe” environment for new ideas and suggested improvements.

30 ISO 9000 Element 7 Product Realization
7.1 Planning 7.2 Customer-Related Processes 7.3 Design and Development 7.4 Purchasing 7.5 Production and Service Provision 7.6 Control of Monitoring and Measuring Devices The third major process in ISO 9000 is Product Realization. There are 6 areas for the product realization process. This is where the product is actually made or the service provided. As you can see, there is a logical progression of ideas that, when combined, ensure a quality product. Most companies are very good at performing the activities of product realization. Most companies fail to see Product Realization as just one of several processes that combine to make a Quality Management System.

31 ISO 9000 Element 7.1 Product Realization Planning of Product Realization
Plan and Develop Process Planning Consistent with other processes must determine: Quality Objectives and Requirements New processes, documents and resources Verification, validation, monitoring, inspection and testing Records Suitability This element helps managers make certain that all steps in the realization processes (Production, Installation, and servicing) are executed under controlled conditions to ensure that quality objectives are met.

32 ISO 9000 Element 7.2 Product Realization Customer-Related Processes
Determination of requirements related to the product Review requirements related to the product Customer communication Customer-related processes ensure that customers’ needs can be met before accepting an order and that there is communication between the company and the customer.

33 ISO 9000 Element 7.3 Product Realization Design and Development
Planning Inputs Outputs Review Verification Validation Control of changes This section sets out a procedure to make certain that the new product produced by your company meets all specified design requirements set by the customer, regulatory agencies, and statutory law. In some instances, a company can request an exclusion of this element under ISO 9000 and the USDA Process Verified Program.

34 ISO 9000 Element 7.4 Product Realization Purchasing
Purchasing Process Purchasing Information Verification of Purchased Product By following this element, managers can make certain the products received from suppliers meet your requirements. You, in turn, incorporate this product into your production process to make the product that meets your customer’s requirements. “Product” includes hardware, software, service, and processed materials.

35 ISO 9000 Element 7.5 Product Realization Production and Service Provision
Control of Production and Service Provision Validation of Processes Identification and Traceability Customer Property Preservation of Product Control of Production and Service Provision makes certain that processes are carried out under controlled conditions. Validation of Processes ensures that processes are validated after delivery in situations where it may not be possible to verify quality immediately after production. Identification and Traceability ensure that product is properly identified at all stages of production and avoids errors that can cause scrap and rework. Customer Property protects the property received from your customers that will be incorporated into your product and ultimately meet all of your customers’ requirements. Preservation of Product makes certain that procedures for identification, handling, storage, packaging, preservation, protection, and delivery of product are adequate, and that product integrity is protected at all stages.

36 ISO 9000 Element 7.6 Product Realization Control of Monitoring and Measuring Devices
Determine the monitoring and measurement needed and the devices to be used Establish processes to ensure that monitoring and measurement can be carried out Ensure that equipment is calibrated correctly, identified, safeguarded, protected and keep records Asses validity of previous measuring results when equipment is faulty/take appropriate action/record Confirm intended use of computer software Under this element, monitoring and measuring devices are identified. Processes are established to make certain that inspection, measuring, and test equipment is capable of consistently providing specified measurement requirements, so that proper decisions can be made for control and acceptance of product.

37 ISO 9000 Element 8 Measurement, Analysis and Improvement General
Monitoring and Measurement Control of Nonconforming Product Analysis of Data Improvement The fourth, and last, major element in ISO 9000 is Measurement, Analysis and Improvement. This process asks businesses to reflect upon the product that has been produced by measuring customer satisfaction and performing internal audits. It establishes a means of measuring product and process and sets the requirements for dealing with non-conforming product. It sets the framework for analysis of data about the customer, product and processes. Finally, it provides a means for improvement through corrective and preventive actions.

38 ISO 9000 Element 8.1 & 8.2 Measurement, Analysis and Improvement
8.1 General 8.2 Measurement Customer Satisfaction Internal Audit Monitoring and Measurement of Process Monitoring and Measurement of Product In the broad sense, this element helps you make certain that the monitoring and measurement activities needed to ensure conformity and accomplish improvement are defined, planned, and implemented. There are several measurement activities: Customer Satisfaction: To make certain that the total of all efforts to meet customer requirements actually results in satisfied customers. Internal Audit: To make certain that your quality activities meet requirements and demonstrate the effectiveness of your quality management system. This strives to ensure the continued capability of all elements of quality practice. Monitoring and Measurement of Process: To make certain that processes conform to all requirements at each production stage, and to facilitate corrective action and continual improvement. Monitoring and Measurement of Product: To make certain that product conforms to requirements at each production stage, to identify nonconforming product at the earliest possible stage, and to facilitate corrective action and continual improvement.

39 ISO 9000 Element 8.3 & 8.4 Measurement, Analysis and Improvement
8.3 Control of Nonconforming Product 8.4 Analysis of Data Control of nonconforming product is critical to ensure that you do not use or unintentionally install nonconforming product. Analysis of data helps managers determine that the quality management system is effective, and that places in your process where the collection and analysis of data is necessary to ensure quality, to detect potential problems, and to target improvement opportunities have been identified.

40 ISO 9000 Element 8.5 Measurement, Analysis and Improvement Improvement
Continual Improvement Corrective Action Preventive Action Improvement is critical to a Quality Management System. Improvement come from 3 specific activities: 1. Continual Improvement from the internal auditing process. Internal audits include all of the ISO 9000 elements, not just the product of service being produced. Corrective Action that results from the internal audit or from non-conforming product. Not only should action be taken to correct non-conformances to ISO 9000, but follow up activities must be undertaken to ensure that the corrective action was effective. Preventive Actions must be established to detect and eliminate potential causes of nonconformances before they occur. These actions contribute to continual quality improvement.

41 ISO 9000 QM System Continuous Improvement of the QMS Satisfaction
Management Responsibility Customers Customers Measurement, Analysis and Improvement Resource Management Given the information just provided, this diagram should make more sense. Please take a few minutes to review the ISO 9000 elements and see how they integrate into this diagram. Link to PVP Checklist Link to Standard Illustrations The PVP Checklist has a different numbering system than ISO 9000 in the Standard Illustrations; however, all of the critical elements are included. Use the PVP Checklist, the Standard Illustrations and the information gathered today to begin a gap analysis of your company. The gap analysis will help you determine which of your company’s activities already conform to ISO 9000 requirements. Gaps indicate areas where work needs to be done. Homework: Analyze your organization by comparing it with a vertical management style and with a QMS. Identify processes that you are familiar with and relate them to the ISO 9000 Elements. Determine whether you are the Champion or the Owner of the Processes. Satisfaction Product Realization Requirements Product Input Output


43 What are ISO 9000 Principles?
Fundamental beliefs that form the foundation of the ISO requirements Lead to quality excellence by following them Are based on practical application Can be applied at any level of the quality pyramid Quality Control (QC) Quality Management (QM) Total Quality Management (TQM) As you’ve probably guessed, Quality Management is more than a sterile list of business management practices. It is an attitude, a philosophy, and a way of life for some. Underlying ISO 9000 are a set of 8 principles. Application of the principles builds a quality pyramid that any organization can climb. The base of the pyramid is Quality Control. Most viable companies do this very well. The mid-level of the pyramid is Quality Management. This is a step closer to the top. Total Quality Management is the level to which all companies should aspire.

44 ISO 9000 Principles Customer Focus Leadership Involvement of People
Process Approach Systems Approach to Management Continual Improvement Factual Approach to Decision Making Mutually beneficial supplier relationship Here is a list of the eight ISO 9000 Principles. On the following pages we will examine the principles from the Quality Control (QC), Quality Management (QM), and Total Quality Management (TQM) perspectives. As you go though the principles on the following slides, try to determine ways in which your company can immediately move up the pyramid. What can you do to implement those activities?

45 ISO 9000 Principles Customer Focus
QC -- understand and meet basic requirements; little or no knowledge of customer perceptions QM – better understanding of overall requirements; customer satisfaction tracked TQM – customer information collected systematically throughout the company; knowledge of customer perception; ability to offer preferred products Quality Control – The focus is upon meeting customer requirements that are clearly spelled out or in satisfying customer needs that are understood by the organization. There may be little effort to clearly understand the customer beyond basic requirements, but the control system focuses on achieving sufficient conformity to ensure that the product or services is merchantable. Organizations that focus only on Quality Control typically do not have sufficient customer knowledge to accurately target customer perceptions. In reality, it is perceptions that are addressed when an organization attempts to exceed the expectations of its customers. Quality Management – Much the same as Quality Control except the organization’s focus has shifted from controlling defined characteristics to better understanding the customers’ overall needs. QM systems typically include customer complaint or returns management systems that are linked to data analysis. These systems provide a means to understand customer feedback and lead to one means for redefining customer needs to prevent future problems. Total Quality Management – An organization has complete knowledge of its customers, their current and future needs, and their perceptions. This knowledge is not just the purview of sales and marketing departments; rather, it is information collected systematically throughout the organization.

46 ISO 9000 Principles Leadership
QC – management provides resources sufficient for quality control QM – management establishes policy, objectives and environment to control processes that ensure quality TQM – managers provide personal examples that create customer satisfaction; quality is a strategic issue Quality Control -- Leadership creates an environment where quality is sufficiently important to provide resources for its control. Quality Management -- Management establishes policy, objectives, and an environment in which processes can be controlled to ensure quality. Total Quality Management – Leadership tends to become a more personal thing, with managers providing personal examples of the behaviors that facilitate creation of high levels of customer satisfaction. Quality is treated as a strategic issue by the organization’s leaders. Target setting and management review are ongoing activities, and leaders integrate the quality and human resources plans of the organization fully with the strategic business plans.

47 ISO 9000 Principles Involvement of people
QC – people must create and operate basic process; does not draw on full talents QM – processes defined and personnel qualified; employees contribute to improvement TQM – employees fully engaged & entirely involved; high level of communication between leaders and employees Quality Control -- People must create and operate the basic processes of the business. People are key because processes may be less well defined. Little is done to draw on the full talents of all employees. Processes may not be fully understood, and this makes full participation in improvement activities difficult. Managers, supervisors or technical experts conduct virtually all improvement activities. Quality Management -- Individuals involved in work are fully qualified and capable of carrying out the processes to which they are assigned. Training and process qualification have been mastered. Employees are beginning to be able to contribute to the improvement of the organization. There is a corrective action process into which most employees can make inputs. Employees may be asked to serve on teams to introduce new products or processes, improve safety, and conduct other activities. Total Quality management -- All employees are fully engaged in their jobs and actively involved in making improvements. There is a consistently high level of communication between the leadership and all employees. Leaders focus on achieving full alignment between the goals of the organization and the personal goals of individual employees. Organizations at this level tend to share lots of important business data and information with all employees. They do this to make certain that everyone’s daily work is aligned with the overall objectives of the organization.

48 ISO 9000 Principles Process Approach
QC – inspection and testing are common; controlled processes provide feedback QM – movement from control of only process outputs to control of the process itself ; additional processes such as management review, corrective actions, etc. TQM – optimizes resources, continually improves, uses process measures Quality Control –Quality control must be defined and executed in a manner that provides assurance that the final product or services meets requirement. Simple controlled processes for inspection and testing are common. Where statistical quality control techniques are used, the key characteristics of the product must be defined, along with the points in the production cycle where measurements should be made. The organization may implement some ISO 9001 basic elements, such as controls for nonconforming product. Quality Management -- The organization has clearly defined the processes for designing, producing, and delivering the product or service. Processes for ensuring that customer requirements are met will have been defined and implemented. Control of product and service quality will have moved “upstream” from control of only process outputs to control of the process itself. The organization had implemented ISO 9001 activities such as management reviews, corrective and preventive action, and audits. Total Quality Management -- The organization is focused on the optimization of resources in each process. There is an attitude that the processes can always be improved and activity is present in the organization to make planned improvements. The organization will be using process measures extensively, and there is a clear understand of process performance.

49 ISO 9000 Principles 5. System Approach to Management
QC – inspection and control systems work together but not integrated with the rest of the organization QM – moved to integrate the process for creating the product with verification of the final product; focus on customer satisfaction TQM – fully understands the interaction among the processes; continually improves Quality Control – Organizations at this level can begin to better understand how to improve quality and its control by recognizing the need for key processes to function together. Some may have inspection or quality control systems that are a collection of control processes that work together to make certain the product or service delivered meets requirements. These systems, however, tend to be disconnected from the processes that actually produce the product. The system is characterized by the “re’s” – rework, redo, rewrite, remake, and so on. The focus of the system is to get the final product “right”, not on efficient production or delivery of a product. Quality Management –The organization has integrated the processes for creating the product with those for verifying that the product meets customer needs. The emphasis is on developing a quality management system that is suitable for the organization’s situation and effective in assuring that customer requirements are met. The focus has shifted from controlling only verification and validation processes to the design, development, production and delivery processes as well. The purpose is to achieve customer satisfaction. Uses customer satisfaction along with other data to perform day-to-day management and decision making. Management review process has matured and uses these data along with audit results to assess system effectiveness. Total Quality Management – The fully functioning organization understands and manages the interaction among the various processes which are aligned with each other and with the goals of the organization. Focus is on achieving results by continually improving the management system. The organization uses data on its processes along with customer feedback for strategic decision making and overall business planning.

50 ISO 9000 Principles Continual Improvement
QC – focus on improvements to ensure that the customer does not receive defective products QM – focus on improving the effectiveness and efficiency of the QMS; mature corrective/preventive loop TQM – focus on efficiently meeting customer needs through the QMS; leaders involved in improvement process QC – There is a focus on improvement of the processes used to make certain that the customer does not receive defective products or services. QM – There is a mature corrective and preventive action loop. The focus is on improving the effectiveness and efficiency of the quality management system. TQM -- Leaders establish targets and goals against key measures of customer satisfaction and internal performance. There is a drive to achieve and stretch improvement goals. Leaders themselves are involved in the improvement process and provide resources to ensure that targets are met. Focus is on efficiently meeting future customer needs and on achieving business results through the quality management system.

51 ISO 9000 Principles Factual Approach to Decision Making
QC – uses data to distinguish nonconformities; statistical data ensure requirements are met; little use of data to measure trends QM – facts and data used to make decisions regarding the QMS; focus on improvement TQM – analysis used to improve market position; information gathered from all members of the organization QC – This method makes use of data and facts to distinguish good products from those that contain nonconformities. It also uses facts in the decision-making process to determine the disposition of nonconformities. Statistical data are used to ensure that products and services meet customer requirements. Analysis tends to be a day-to-day activity with little use of trends or indicators of performance. QM – Facts and data are used in the QMS to make decisions related to the system’s operation. The information used is gained for analysis of audit results, corrective action, customer complaints and other sources. Analysis tends to be focused on data that can be used to improve customer satisfaction and the effectiveness of the QMS. TQM – Decisions and actions are based on the analysis of a broad range of data. Customer data are derived by using all available “listening posts” to understand what is important and make decisions that will improve the organization’s market position. Information is derived from analysis of data and from the innovative ideas of all members of the organization. The focus is on improving productivity while eliminating waste and rework and enhancing market value.

52 ISO 9000 Principles Mutually Beneficial Supplier Relationship
QC – some validation of the suppliers product QM – processes to define and document, review and evaluate; well developed and defined validation process TQM – focus changes with established strategic alliances or partnerships; mutual commitment to customer satisfaction; focus on continual improvement becomes common CQ – There is typically some validation of the supplier’s product or service. QM – An organization has processes to define and document requirements to be met by suppliers. There are processes in place to review and evaluate suppliers’ ability to meet those requirements. Product validation processes should be well developed and defined at this level in the hierarchy. TQM – The processes established for the QMS remain important. The focus tends to change as organizations establish strategic alliances or partnerships with suppliers. In many cases, organizations involve suppliers very early in defining requirements for joint development. Organizations work with suppliers to develop mutual trust, respect and commitment to customer satisfaction. Mutual efforts focusing on continual improvement become common. Integration of the supplier quality process with other efforts related to supplier systems becomes common.

53 THANK YOU for Your Participation
Beth Hayden, Process Verified Program Manager Grain Inspection, Packers and Stockyards Administration This concludes the QMS training, “Implementing a Quality Management System”. There are several good publications and websites I would like to share with you. Link to Helpful URLs and Books Thank you for sharing your time with us. If you have any questions or wish to provide feedback, please feel free to contact me at the number listed above. To learn more about the AMS Process Verified Program for Livestock and Seed, check their website: To learn more about the FGIS Process Verified Program for Grains and Oilseeds, check our website:

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