Table of Contents MODULE 1: QUALITY MANAGEMENT SYSTEM Introduction:... 3 What is a QMS (Quality Management System)?... 3

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2 Table of Contents MODULE 1: QUALITY MANAGEMENT SYSTEM... 3 Introduction:... 3 What is a QMS (Quality Management System)?... 3 The eight quality management principles:... 4 Principle 1: Customer Focus... 4 Principle 2: Leadership... 4 Principle 3: Involvement of people... 4 Principle 4: Process approach... 4 Principle 5: System approach to management... 4 Principle 6: Continual improvement... 5 Principle 7: Factual approach to decision making... 6 Principle 8: Mutually beneficial supplier relationships... 6 The concept of process:... 6 A process requires: (Figure 2 shows the diagram of a process)... 6 Processes in the company:... 7 What s an indicator?... 7 Characteristics of a good indicator:... 8 Different types of indicators:... 8 Process reviews:... 8 The management by processes is a management system with:... 8 The Company Constitution:... 9 How to locate the Quality Service... 9 On a vertical viewpoint... 9 On a transverse view point Quality Policy and the role of the management What s a Quality Policy? The Management: the breath of Quality Management The Management Review: Who is a Quality Manager? Quality Manager: His Qualities Quality Manager: His particular skills The Quality Manager has the responsibility and authority to: What is the role of the Quality Manager? Internal quality to the company The Production Quality The management of the Quality Team Quality Insurance: Metrology

3 Employees training: Information to the employees: Reports to Management: External Quality to the company Relations with customers Customer satisfaction Relations with suppliers The means of the Quality Manager: Service meetings These meetings also allow: Meetings inter services Communication in the company Company's Challenges The establishment of Company's Challenges The tools of progress of a Quality Manager: The "5S" Methodology: Riddance Arrangement Cleaning Order Rigor Basic Quality Tools The Quality Wall The Self-control Red bins Retouching management The Poka Yoke The start of production Conclusion:

4 MODULE 1: QUALITY MANAGEMENT SYSTEM Introduction: "The quality of a product or service is its ability to satisfy customer needs." This is the simplest definition of the concept of quality. Quality product or service will lead to customer satisfaction unlike poor quality which will cause a feeling of dissatisfaction. Therefore, only the customer can determine the quality of company s products. Engaging in a quality approach is essential to satisfying the needs of customers. Listening to customer concerns either through complaints or satisfaction surveys plays a key role in identifying and understanding customer needs. Quality approach measured through client satisfaction. What is a QMS (Quality Management System)? Quality is not only a major concern for industrial or service market leaders nor a management tool which improves the overall performance of the company. To understand the concept of quality approach in a company, it is important first to simplify and describe a very fundamental concept of quality management and understand its principles. The logic of Quality Management concept is understood after examining the eight quality management principles that are based on management standards of the ISO 9000 series. These principles can be used by management as a framework to improve the organization's performance. These principles were established on the basis of experience and collective knowledge of international experts. The eight quality management principles are defined in ISO 9000: 2005, Quality management systems -Fundamentals and vocabulary, and ISO 9004: 2009, lasting performance management of an organization-approach quality Management. 3

5 The eight quality management principles: The eight quality management principles have been identified and presented in ISO9004: 2000 and included in the December These principles enable organizations to improve their performance continuously while meeting the needs of all stakeholders (customers, employees, shareholders, suppliers, partners). Principle 1: Customer Focus Being customer focused means meeting explicit and implicit needs of customers. Wherever possible, it should strive to go beyond their expectations. This principle introduces the need for organizations to be attentive to customer concerns. Principle 2: Leadership The company's management establishes objectives and orientations to be achieved by fully involving all of its employees. Through proper internal communication, the objectives will be well understood, motivating and create common values and behavioral patterns based on fairness and ethics. Principle 3: Involvement of people The strength of an organization lies on the people who make it up. It is therefore necessary to ensure their involvement and motivation. This implication is vital. We must use all internal expertise for the benefit of the company, motivate employees, engage them and make them responsible and concerned with continual improvement. Principle 4: Process approach Process approach refers to managing the activities and resources as a process to achieve a desired result. By piloting a process, we can establish clear responsibilities, effective use of resources, analyze performance, impacts and propose actions for improvement. Principle 5: System approach to management Understanding and managing processes as a system contributes to achieving the company objectives. This allows structuring the system in the most efficient manner to ensure a better 4

6 understanding of the roles and responsibilities for achieving common objectives and reducing cross-functional barriers. Key processes for the functioning of the company must be identified and their interactions mastered to improve the organization's performance. This mastery requires the monitoring and measurement of inputs / outputs of each process. Principle 6: Continual improvement The main objective of a company should be improving its overall performance. Internal performance has a direct impact on customer satisfaction. This is a competitive advantage providing flexibility and responds quickly to opportunities that may arise. Training employees on the tools and methods of continuous improvement is essential. Setting targets, measuring results and recognition of improvements or corrections are even principle gasoline. Improve continuously through the logic of the PDCA (defined by William Edwards Deming), which is to plan what needs to be done, do it as planned, monitor and measure that has been done as expected and correct or prevent gaps between making and planning. We are talking of the wheel continual improvement (Figure 1 shows Deming wheel PDCA). Figure 1: The Deming wheel PDCA Plan: Determine the goals Do: Implement actions 5

7 Check: Check the implementation Act: Set priorities for improvement Principle 7: Factual approach to decision making A good decision is based on the analysis of elements of information and factual results. This principle calls for rationality. In fact it is because we have characterized objectively the magnitude of a situation that we are able to make the right decisions. Reply to this principle is to establish appropriate tools for monitoring and measuring process. Principle 8: Mutually beneficial supplier relationships A company and its suppliers are interdependent and must enlarge their capacity to create value. This allows flexibility and speed to market trends or customer needs. The company makes a clear communication with suppliers, sharing its achievements and resources, research ways to improve and encourage commodities made by its suppliers. The concept of process: A process is a set of interrelated or interacting activities that transform inputs into outputs. The processes of an input element are typically the other process outputs. The processes of an organization are generally planned and carried out under controlled conditions for value addition. In situations when the conformity of the product resulting may not be readily or economically verified, this is frequently referred to "special process". Do not confuse "process" and "method", the process is "what to do" (in a predefined order), the method is the "how to"(it's a task). This distinction is particularly important because it gives a clear indication of the level of detail that must be used to describe a process. Indeed, to describe a process it is rarely necessary to describe methods that make up the process. A process requires: (Figure 2 shows the diagram of a process) input data Output Data Means of control Activities Resources 6

8 Figure 2:Diagram of aprocess The identification of processes, their combinations and interactions is essential to their master (Figure 3 shows the Interactions between processes) Figure 3: Interactions between processes Processes in the company: There are three types of processes: Production Process: Set of processes ranging from customer to customer Support Process: A set of processes providing resources to other processes Management Process: Process control What s an indicator? An indicator is information or set of information that contribute to the assessment of a situation by the decision maker. 7

9 Characteristics of a good indicator: SMART: Specific Measurable Attainable Relevant Traceable Different types of indicators: Result indicators: It allows you to check the conformity of what is provided. It refers to objectives corresponding to specified requirements. Problem: The finding is sometimes late Process indicators: It provides information on the operation and effectiveness of the process at different stages. It allows quick response to malfunctions Input indicators: It measures compliance with the requirements for that which enters the process. It allows to examine the advisability or not to lead improvement. Process reviews: The pilot process periodically organizes process reviews. This allows: To guarantee full satisfaction of customer needs and expectations; To identify any drift of the process and define corrective actions if necessary; To identify opportunities to improve the effectiveness and efficiency of the process; To measure the maturity of the process and to compare the level measured with the previously fixed level. The management by processes is a management system with: A transverse operating mode Looking for added value orientated towards customers Continuous improvement based on performance analysis But the management by processes involves: 8

10 The commitment and involvement of management A specific organization The implementation of a structured and coherent approach The Company Constitution: The company is a profit center consisting of 3 major actors: Customers Stakeholders The external parts And they have 3 objectives: Objectives related to the security Objectives related to the product Objectives related to the environment Managing a business involves controlling risks and integrating all the ways to get the expected results. One objective is to limit the impacts of activities, especially to satisfy the customer. How to locate the Quality Service Quality Service is: A support service in the Production, Research and Development, Human Resource and during Purchase. A source of progress for the company's other services using different tools. Independent overlook other society services Directly connected to the Management On a vertical viewpoint(figure 4 shows the flowchart) 9

11 Figure 4: Flowchart On a transverse view point The service Quality is involved in each of the company's services: Production: Control of Product Quality, control of discharges, security rules Purchasing: control of purchased and delivered products and packaging Logistics: delivery time of products. HR: Employee Safety,Training The Service Quality in abusiness: Holds a central place in its operation Has functional links with all company departments Is the guarantor of respect for the company's Quality Policy But: The Quality management is insufflated by the Management which plays a major role. Quality Policy and the role of the management What s a Quality Policy? The quality policy can change the expectations and needs of customers and the strategy of the organization, taking into consideration the culture of the organization, its market and sector. 10

12 The Management: the breath of Quality Management The Management's role and mission: Provide strategic vision for the company Formulate quality policy for the company To provide viable objectives for the company Regularly schedule meetings in order to evaluate the company's progress The Management Review: Determines the company s objectives Checks the achievement of the objectives previously fixed Highlights the failures observed Implements various actions to eradicate deficiencies Checks the continuity of the company's efforts Each target derives the implementation of an action plan, responsible for the action. The management is the engine of the quality administration in the company. Quality service and the quality manager cannot integrate the quality management in the company without the implicit and explicit support of the Management. Quality management originates from the company's Management. Who is a Quality Manager? The quality manager or quality director assists the Manager in: Defining and writing the management policy Planning objectives Has crucial function of ensuring sustainable notoriety and effective management of the company Quality Manager: His Qualities Organized 11

13 Convincing to carry out all his missions Reactive Respects customers needs Have a sense of human relation Quality Manager: His particular skills Relationship aptitude to sensitize everyone in the company on the requirements of quality service Ability to coordinate all company departments Impeccable knowledge of incoming products, manufactured products and manufacturing processes The Quality Manager has the responsibility and authority to: Ensure that the required QMS processes are established, implemented and maintained Inform the management on the functioning of the QMS and any need for improvement Ensure that sensitization of customer requirements throughout the organization is encouraged What is the role of the Quality Manager? Internal quality to the company The Production Quality Ensure the quality of the produced items Final decision of acceptance or rejection of one or more items Creation and validation of the documents necessary for the production (control plan, control respecting clients requirements) Ensure correct application of procedures and instructions A key role in the production workshop The management of the Quality Team Depending on the size of the company, the quality team is more or less important. 12

14 Transmission of information during weekly meetings with technicians quality of the company: study of new control methods Search for solutions to the established problems Monthly report to the Managers of each department A source of progress for the company Quality Insurance: The management of Quality Insurance is even heavier than the company is (larger and more complicated process): Guarantor of the application of the standard Documentation of the general organization and determine company processes(management, implementation, support) Updating concerned documents of the QMS Measure of the efficiency of the management system (planning and conducting audits) Monitoring and analysis of indicators of each process operating indicators Implementation and monitoring of corrective and preventive actions Organization of groups to improve quality Guarantor of the implementation of the QMS and Quality Policy Metrology The Quality Manager is generally the guarantor of the metrology of produced parts: Ensure that the hardware resources are sufficient to satisfy the objectives Management and monitoring of the company's metrological Park Ensure the validity and capability at any time of each measuring instrument Guarantor of the metrological perking the company Employees training: The Quality Manager is also the guarantor of personnel training: 13

15 Check that the structure is sufficient to satisfy the objectives Establishment of a training plan for each type of job Validation of personnel training Guarantor of personnel training Information to the employees: The Quality Manager is the guarantor of the transmission of information quality to all employees: Implementation and monitoring dashboards showing the results of the company in various domains (Productivity, Production, 5S) Meetings allowing the remediation of any quality issues or deviations resulting to noncompliance Display of information Guarantor of the transmission of information to employees Reports to Management: The Quality Manager reports the level of the company quality to his superiors: Assessment of the company's Quality level Assessment of corrective or preventive actions Launching of corrective or preventive actions in case of incidents Guarantor to report on the quality level of his superiors External Quality to the company Relations with customers The Quality Manager is privileged interlocutor of the client: Keep good customer relations Stay in touch in the absence of quality problems 14 Respond to complaint clients Monitoring customers to ensure delivered Quality

16 Telephone contacts to minimize the impact of the complaint and react quickly to its eradication Write a quality failure sheet (8D...) o Immediate actions to be implemented to ensure future deliveries Response in 24 hours o Corrective and preventive actions to be implemented to eradicate the defect Response in 3 days Guarantor of customer responses and deadlines Customer satisfaction The Quality Manager always ensures customer satisfaction: Satisfaction Survey Listens Customers Representative of customer requirements in the company Relations with suppliers The Quality Manager has an essential role for the products entering in the company: Guarantor of the reception control act on products entering the business and writing control ranges Analysis of supplier quality in relation to the Purchasing Manager Emits suppliers quality complaints in case of refusal during the reception control Guarantor of the quality of products in the company In general, the external quality reflects the internal Quality 15

17 The means of the Quality Manager: Service meetings These meetings are weekly and allow: To review the quality assessment of the week based on the manufactured products for each team Validate the action plans established at the previous meetings To establish new control methods or lines of improvement on each product Essential point: Teamwork These meetings also allow: Reminder on different basics of quality (5S, 6 basic of quality) To remind and update on control instructions of different products To form quality team, for creating new rules, allowing the company to enhance the improvement To form quality team for them to engage in a team To form quality team on metrology Key point: Meetings should be useful to participants Meetings inter services The meetings held weekly and include: The company's Management The Production Manager The Quality Manager The individual Responsible for Maintenance The Logistics Manager The Purchasing Manage The HR Manager Key point: Working in teams for global improvement of the company Also, these meetings allow: 16

18 Make a weekly report per service (productivity, Customer complaints...) Analyze the indicators of each service (productivity, customer complaint...) To implement the necessary actions to improve each service To announce the work objectives for the coming week Communication in the company The communication in the company is: Inform employees about internal quality results Inform employees about external quality results Inform employees about implemented preventive or corrective actions Announce the objectives to be achieved Key point : the employees are the heart of the company and make direct impact on the performance of the company Company's Challenges The company's Challenges are: To motivate employees so as to ensure the highest level of quality To establish the company on various lines that have been identified as fragile To get the desired results by rewarding the employees Key point :a motivated and integrated into a challenge employee will hit a very high objective The establishment of Company's Challenges The company's Challenges are not only related to the quality service but also to all the company's services: Team Leaders: Increased productivity, reduced waste Quality /Operators: 0 customer complaints, respects basic quality... Logistics: 0 delivery delays, no delivery errors... Key point: a challenge is established for all employees; do not favor a service... 17

19 The tools of progress of a Quality Manager: The "5S" It s a simple and effective method for management to make rapid progress in the company It s a Management technique to introduce order and discipline in the Enterprise. Essential tool to initiate Total Quality Approach Methodology: The methodof"5s", which originated from the first letter of each of the five operations, is a management technique based on simple principles: Seiri riddance Seiton arrangement Seiso cleaning Seiketsu order Shitsuke rigor Progress Riddance The first operation aims to sort, remove unnecessary and prioritize work items. Fight against the accumulation Arrangement A place for everything and everything in place Develop the means to avoid loss of time and energy Cleaning Failure to respect cleanliness can have significant consequences causing anomalies or immobilization machines. The purpose of this operation is: Preventive: do not mess 18

20 Corrective: cleaned and inspected Order This consolidates previous. The order marks the respect of everyone in his immediate environment. There must be creative and specific arrangements Visual management becomes a very useful method Rigor This is the most important rule of"5s". It is the responsibility of the hierarchy. Made permanent effort to arrange the workstation Requires to acquire habits and also a state of mind Encourages employees to adhere to the rules The rigor develops around two major themes: Continuous check through reliable audits A dynamic communication The result of the 5S management method is measured: In Productivity In employee satisfaction with regard to the efforts to improve working conditions 6 Basic Quality Tools The Basic Quality Tools is the methods for the production progress to achieve the requirements set of Quality. The 6Basic Quality Tools are: The Quality Wall The Self-control Red bins Retouching management The Poka Yoke The start of production 19

21 Progress The Quality Wall The Quality wall can be defined as client protection relative to products manufactured and delivered. This is an additional control. The Quality wall can be used: As a preventive action: Start series production transfer Product / Process uncontrolled Lack of experience, high turnover As corrective action: The client requires an improvement in the quality Quickly Find customer confidence The Quality wall: Supervised by Quality Has rule reactions Delegate power to take decisions The Quality wall: A position occupied by trained operators and validated with scrap recordings A post dedicated to control: no added value A phone with a clear stream A phone with all the means of action needed The Self-control Performing a self-control operation is: 20 Check for defects Trained in advance

22 In a specific sequence With a predefined method to detect any type of defect Using visual tools to make decisions Within a predetermined time Control helps are: Control statements Control paths Final control Self-control Red bins Isolate the non-conforming product of the production line. This isolation should be made : For finished products For semi-finished products For EOP (External Original Parts) Terms of Use For no-conformity: Not for waste Must not be yellow or orange red Fixed Identification: no paper or adhesive tape Be careful to perform conditioning so as not to damage a piece that could adjustments Retouching management Retouching is an extraordinary transaction. It occurs outside the production line on a clear post, identified and provided for this purpose Training rework stations: The post-editing is handled as a reserved position: This involves: Clear identification of the workstation 21

23 Specific training o Specific instructions o The allowable alterations o References of means to use A validation training o validated by Quality Service employees The Poka Yoke The Poka Yoke is a simple and reliable device for preventing error leading to defect It makes transmission impossible Poka Yoke management: Each Poka Yoke should be defined in a different criteria: Detection Method Location of PokaYoke Job description before improvement Job description after improvement Effects of Poka Yoke Cost of Poka Yoke These criteria are generally recorded on a sheet definition of poka Yoke The start of production 1) Why? Ensure that the manufacturing process is able to produce compliant parts that meet the customer's quality requirements 2) When? Each team beginning (after ensuring the passage of instructions) At each change of reference manufactured Following a technical failure 22

24 Conclusion: We have seen what a Quality System and Quality Policy is; I wish you good luck as you apply what has been described and I m sure it will save your time and money. Azza NAFTI : Graduate in Computer Science and Quality. She works at CassiopaeMEA as Technical Consultant since2010. Contact:n_azza@hotmail.fr 23