4.2.3 Document control 6.2 Human resources 7.5.2 Confirmation of production and service provision process
4.2.4 Record Control 6.2. 1 General 7.5.3 Identification and traceability
5 Management Responsibilities 6.2.2 Ability, Awareness and Training 7.5.4 Customer Property
5. 1 Management Commitment 6.3 Basic Equipment 7.5.5 Product Protection
5.2 Pay attention to customers 6.4 Work environment 7.6 Control of monitoring and measuring devices
5.3 Quality Policy 7 Product Realization 8 Measurement, Analysis and Improvement
5.4 Planning 7. 1 Product Realization Planning 8. 1 General Rules
5.4. 1 quality objective 7.2 customer-related process 8.2 monitoring and measurement
5.4.2 Quality management system planning 7.2. 1 Determination of product-related requirements 8.2. 1 Customer satisfaction
5.5 Responsibility, authority and communication 7.2.2 Review of product-related requirements 8.2.2 Internal audit
5.5. 1 responsibilities and authority 7.2.3 customer communication 8.2.3 process monitoring and measurement
5.5.2 Management Representative 7.3 Design and Development 8.2.4 Monitoring and Measurement of Products
5.5.3 Internal Communication 7.4 Procurement 8.3 Nonconforming Product Control
5.6 Management Review 7.4. 1 Procurement Process 8.4 Data Analysis
5.6. 1 General 7.4.2 Improvement of purchasing information 8.5
5.6.2 review input 7.4.3 verification of purchased products 8.5. 1 continuous improvement
5.6.3 Review Output 7.5 Production and Service Provision 8.5.2 Corrective Measures
6 Resource Management 8.5.3 Preventive Measures
Edit the psychological quality of quality engineers in this paragraph.
According to labor psychology, different industries and positions require employees to have different psychological qualities, which in turn affects work efficiency and quality. Quality engineers are mainly engaged in quality management, and of course they have their own special requirements for psychological quality. A quality engineer is a person who specializes in quality management. In addition to the corresponding quality management knowledge and professional knowledge, he must also have the corresponding ideological quality, intellectual quality and physical quality. In my opinion, he should also have the necessary psychological knowledge and corresponding psychological quality.
Cheerful and enthusiastic temperament
First of all, a quality engineer should have a cheerful and enthusiastic temperament. In all kinds of management systems of enterprises, quality management may be the most open system, and quality managers have to deal with each other from top managers to front-line workers and logistics workers. Financial, environmental, production, technology and other management systems are difficult to compare with. The so-called "three aspects" of total quality management ("the whole process", "the whole enterprise" and "the whole staff") precisely reflect the nature of this completely open quality management system. The nature of this fully open system requires quality engineers to be outgoing, cheerful, lively, active, enthusiastic and good at communication. Because of the particularity of the original work, engineers and technicians who are selected from professional technical posts (such as design and technology) to quality management posts are often introverted, withdrawn, indifferent to people, paying too much attention to details and lacking organizational ability. This state of mind should be changed. For young people, if your ambition is to be a quality engineer, you must first grasp your own psychological characteristics. If you are a depressed person who can't change, you might as well give up your plan to be a quality engineer. Generally speaking, people with depressed temperament are not lively, slow-witted, slow-moving, gloomy and obviously introverted. If you are engaged in quality management, it must be difficult to deal with people, so don't work in the quality management department, especially the leader of the quality management department.
Good communication skills.
Secondly, quality engineers should have good communication skills. In fact, in enterprises, the main work of quality management is not technical work, but non-technical work of communicating with people. Carry out education and training, establish a quality management system, plan and review, implement monitoring and measurement, and organize quality improvement. It is inseparable from dealing with people (from enterprise managers to ordinary employees), investigating, analyzing, discussing and persuading ... If you don't have the ability to communicate with others, it is difficult to understand others' views and you can't effectively convey your own views to others. How do you manage? For example, when dealing with nonconforming products, psychological factors (whether intentional or unintentional, whether nervous or careless, whether fatigue or negligence, etc. ) the investigation and analysis of the operators are not detailed, the emotions of the production managers are not grasped in place, and there is too little communication research on the opinions in the specific treatment, which may not be handled.
A firm but not stubborn character
Third, quality engineers should have a firm but not stubborn personality. In real life, even if a small quality problem is solved, there will inevitably be disputes or even quarrels. In an enterprise, quality conflicts with quantity, schedule, cost and so on. From their own point of view, all relevant personnel will always have opinions on the solutions put forward by quality management personnel, and even express strong opposition. For example, if you want to monitor and measure the work of a department, the department is likely to express dissatisfaction and take some measures to obstruct it, or argue with you or cover it up with illusions. As a quality engineer, it is difficult to do a good job in quality work if he is not determined, goes with the flow and obeys blindly without principles. Quality engineers should be rational and independent people, calm and thoughtful, good at independent thinking, willing to express different opinions and strong self-control ability. But we should also be good at listening to different opinions, but we should draw conclusions early. If the personality is extreme and stubborn, it will not only be conducive to solving quality problems, but also affect interpersonal relationships and bring trouble to future work.
Psychological knowledge and methods
Finally, quality engineers should know some psychological knowledge and methods. Quality management is not the management of things in essence, but the management of people. People are not vegetation, who can be ruthless? Enterprise managers and employees have their own psychological characteristics such as cognition, emotion and will. In the communication with them, if we can better grasp these psychological characteristics, it will certainly help to communicate the opinions of both sides and make the relevant management work go smoothly. However, if you don't know some psychological knowledge, you obviously can't grasp the psychological characteristics of people. When dealing with people, we should also pay attention to methods. Communication itself is the research object of psychology, and it also needs psychological methods and skills. For example, we should be good at grasping each other's psychological characteristics and emotional dynamics, learn certain psychological analysis methods, and master techniques to help others discharge psychological pressure. ...
Edit this paragraph Quality Engineer: Expecting "Profession" to Become "Practice"
"Quality engineer is not a traditional concept of quality in a narrow sense, but a comprehensive and systematic social examination, covering comprehensive knowledge and focusing on professional technology. In the future, its market demand will be bigger and bigger, and its market maturity will be higher and higher. For example, this year's exam will begin to implement online exams with a wide range of topics. In addition, its teaching materials are not static, but constantly updated with the changes in the actual situation, so the gold content is also increasing day by day. " Han Furong, a quality expert, knows the quality engineer exam very well. Although the prospect is gratifying, Han Furong regrets that the current quality engineer examination system is subject to many restrictions and needs to be improved urgently. "Quality engineers should not be a profession, but a practice. Occupation is optional like ears, and practice is necessary like hands. Quality engineers should go from profession to practice and from ear to hand. "
Edit the list of knowledge related to the quality engineer examination in this paragraph.
Keywords: 1: qualified rate
Although the quality engineer exam has been conducted five times, this year's exam may be the happiest one for the candidates-it is the highest pass rate in five years, with an overall pass rate of 37.68%, including 30.76% for the primary pass rate and 40.90% for the intermediate pass rate. There are 9,295 people in China who have obtained the quality professional qualification certificates issued by the Ministry of Personnel and the General Administration of Quality Supervision, Inspection and Quarantine. This year, the provinces and cities with higher pass rates than the national average are Shanghai, Jiangsu, Fujian, Guangxi, Beijing, Jiangxi, Hunan, Anhui, Guangdong, Zhejiang and Liaoning, with pass rates of 53.45%, 45.79%, 45.6 1%, 39.70%, 39.37% and 39.27% respectively. The reporter found that compared with the passing rate of 50% in American quality engineer examination, the passing rate of quality engineer examination in China is still low. Relevant persons in the Quality Department of the General Administration of Quality Supervision, Inspection and Quarantine believe that on the one hand, quality personnel in China are unfamiliar with this form of examination questions, on the other hand, most candidates have not participated in systematic learning and their knowledge is aging. I believe that after several years of examination and training, the overall quality of high-quality talents in China will be greatly improved, and the passing rate of examinations will also be improved.
Keywords: 2. Hard indicators
11June, the Yunnan Provincial Bureau of Quality and Technical Supervision and the Yunnan Provincial Department of Personnel jointly issued the Opinions on Further Improving the Implementation of the Professional Qualification System for Quality Professionals. The document sets a hard target for the number of quality engineers in enterprises: for enterprises with annual sales of more than 65.438+0 billion yuan or enterprises producing famous brand products in China, there shall be no less than 5 senior qualified personnel and no less than 654.38+00 intermediate qualified personnel; Enterprises with annual sales below 1 100 million yuan or enterprises producing famous brand products in Yunnan should have at least 4 senior qualified personnel and 8 intermediate qualified personnel. The document also puts forward the 11th Five-Year Plan for quality engineers in Yunnan Province-strive to have all enterprises and related quality management personnel in the province take up their posts with certificates within five to 10 years. A person from the Quality Department of the General Administration of Quality Supervision, Inspection and Quarantine pointed out that the issuance of such a document in Yunnan Province is the first case in China, which will play a very good role in promoting the examination of quality engineers.
Keyword 3: Reward
11June, the Quality Control Department of Shanghai Bureau of Quality and Technical Supervision and the Registration Management Center jointly held the "2005 Shanghai Symposium for Quality Professionals and Technicians", which commended and rewarded the comrades who won the top three in this year's junior high school entrance examination and exchanged learning experiences. The reporter learned that the passing rate of quality engineers in Shanghai has always ranked first in the country, which is inseparable from its active promotion of quality engineers.
Keyword 4: Advanced
In 2006, the registration of quality engineers has begun, but the registration of advanced examinations, which had received much attention before, has not yet begun. The reporter learned that the report of the quality engineer examination has been submitted to the Ministry of Personnel, but it has not been finally passed. According to a person from the Quality Department of the General Administration of Quality Supervision, Inspection and Quarantine, even if the advanced examination can be held next year, it will not be held until the second half of the year. Another possibility is the 2007 exam, which will be held at the same time as the primary and intermediate exams. In addition, the advanced examination form for quality engineers has been set to take only one exam and open the book.
Keyword 5: Sampling survey
On June 19, the National Quality Professional Vocational Qualification Examination Office conducted a sample survey of candidates from six regions including Beijing, Fujian, Guangdong, Jiangsu, Shandong and Shanghai after the quality engineer examination. The survey results show that 35% of the candidates are from state-owned enterprises, 33% from foreign-funded and joint ventures, and 24% from private and private enterprises, accounting for 92% of the sample. Among the candidates, 73% are taking this exam for the first time; 73% of the candidates did not participate in the pre-test training; 43% of the candidates think that the difficulty of the test paper is appropriate; There are 4 1% candidates who think the examination paper is difficult; 12% of the candidates think the test paper is difficult. According to the analysis, the candidates' motivation is to improve their ability, evaluate their professional titles, help find jobs and meet the requirements of the company, and the corresponding proportions are about 57%, 265, 438+0%, 65, 438+05% and 7% respectively. After passing the qualification examination, the most desirable rewards for candidates are to apply for a better job, get the corresponding professional title, raise salary and promotion, and the corresponding proportions are about 38%, 32%, 22% and 7% respectively.
ISO quality management system standard format
I. List of Quality Records
Second, non-conformance report
Three, the internal quality management system audit report (attached paper)
Four. Customer property problem notice
Verb (abbreviation of verb) product quality information feedback form
Six, internal quality loss statistics account
Seven, receipt registration form.
Eight, check the original records
Nine, oral order registration account
Ten, facilities (tools, molds, fixtures) management account
Eleven, quality information feedback statistical account
Twelve, raw materials, purchased parts warehousing acceptance statistics account
Thirteen, product quality statistics account
Fourteen, product after-sales service registration form
Fifteen, file recovery registration form
Sixteen, measurement cycle calibration plan
Seventeen, measuring instruments scrapped application form
Eighteen, zero (Taiwan) pieces of quality inspection records
Nineteen, economic contract performance accounting, statistics and analysis list
20. Daily equipment check card of Limited Company.
Twenty-one, technical documents issued registration form
Twenty-two, monthly production material plan
Twenty-three, procurement plan
Twenty-four, outsourcing, outsourcing parts inspection notice
Twenty-five, production plan
Twenty-six, monthly sales output value, sales product output value index list
27. Product quality consultation of Limited Company.
Twenty-eight, the purchase and sale of raw materials monthly report.
Twenty-nine, document distribution registration form
Thirty, product quotation
Thirty-one, equipment maintenance plan
Thirty-two, facilities scrap list
Thirty-three, mold fixture technical status record
34. Training Approval Form
Thirty-five, training record form
Thirty-six, management review notice
Thirty-seven, management review report
38. Order Confirmation Form
Thirty-nine, the contract change notice
Forty, facilities acceptance form
Forty-one, facilities management account
Forty-two, design and development input list
Forty-three, process design and development appraisal report
Forty-four, waste notice
Forty-five, return product notice
46. Annual training plan
Report on improvement, prevention and corrective measures
Forty-eight, employee training file card
Forty-nine, production facilities configuration application form
50. List of qualified suppliers
5 1. Supplier rating standard method
52. The first (last) meeting sign-in form of internal audit
53. Distribution table of unqualified items
54. Internal audit list
Fifty-five, special type of work (process) training account
Fifty-six, technical data (blue, base map) filing registration.
Fifty-seven, training personnel sign-in form
Fifty-eight, product warehousing daily report
Fifty-nine, procurement statistics account
Sixty, design and development plan
6 1. List of production facilities
Sixty-two, the factory requisition
Sixty-three, product quality inspection report
Sixty-four, send and receive list
Sixty-five, three inspection cards
Sixty-six, file destruction application
Sixty-seven, management review plan
Sixty-eight, equipment accident report
Sixty-nine, product requirements review form
Seventy, deviation parts reuse application form
Seventy-one, file change notice
Seventy-two, the audit schedule
Seventy-three, supplier evaluation record form
Seventy-four, annual internal audit plan
Seventy-five, review the implementation plan
Seventy-six, internal calibration record form
Seventy-seven, product outbound order
Seventy-eight, improvement plan
Seventy-nine, product inspection warehousing notice
Eighty, design and development output list
Eighty-one, mold adjustment records
Eighty-two, improvement, corrective and preventive measures implementation list
Eighty-three, nonconforming product report
Eighty-four, customer satisfaction questionnaire
Eighty-five, corrective/preventive measures list
Eighty-six, equipment inspection committee
1 preface
Over the years of reform and opening up, the market economy system has become increasingly mature, consumers are more rational, and competition among enterprises is fierce. If small and medium-sized enterprises want to develop and succeed in the market, the only way out is to improve product quality and establish good customer reputation. It is a very good means to reduce production cost and improve product quality by establishing quality management system and improving quality management level. ISO9000 standard provides a management model for enterprises, the core of which is to help enterprises establish a set of standardized and effective quality management system.
1. 1 ISO quality management system
The ISO O9000 standard is a concept put forward by the International Organization for Standardization (ISO) in 1994, which means "an international standard formulated by ISO/TC 176(ISO Technical Committee for Quality Management and Quality Assurance). This third-party certification is not dominated by the economic interests of both producers and sellers, and it is notarized and scientific, and it is a passport for countries to evaluate and supervise the quality of products and enterprises. As the basis for customers to audit supplier quality system; Enterprises have the ability to meet the technical requirements of the products they order.
1.2 management status of small and medium-sized food enterprises
Small and medium-sized enterprises are relatively large enterprises in the same industry, accounting for more than 99% of Chinese enterprises, and are an important force to promote China's economic development. During the period of 1999, the definition of small and medium-sized enterprises in China was based on sales revenue and total assets: it was divided into four categories: super-large, large, medium and small. Among them, medium-sized enterprises with annual sales revenue and total assets below 500 million yuan and above 50 million yuan, and small enterprises with annual sales revenue and total assets below 50 million yuan.
Take a biscuit and pastry manufacturer as an example. This enterprise is a private enterprise. It was established in early 2006. Because it specializes in producing biscuits, its workshop area is less than 300 square meters and the number of employees is 65,438+000. At present, it has grown to more than 20 varieties of biscuits and cakes, with an annual output value of more than 5 million, workshop area 1000m2 and employees 100 people. Although the scale of the enterprise has expanded, the management level has never changed, and the factory director is responsible for procurement, sales and production. At present, most small and medium-sized food processing enterprises, such as the above-mentioned biscuit and cake production enterprises, still have a low education level of production personnel; The establishment of enterprise functional departments is incomplete; Production, sales and procurement are almost all the responsibility of the factory director; There is no quality management department, and the factory inspection requirements are not strictly implemented.
2 Analysis of management status of small and medium-sized food enterprises
(1) Enterprise management is not perfect.
The basic management of some small and medium-sized enterprises has not been done well. Generally speaking, there is a lack of management talents and management system, and people often do things according to their personal preferences. Especially in small and medium-sized family enterprises, people are more dominant, and business owners and some managers often handle things according to their own feelings.
(2) weak production management
Production management lacks management means, production operation and production process can not be effectively controlled, and the phenomenon of "dirty, chaotic and poor" can be seen everywhere. Production based on the experience of managers and workers even leads to the failure to meet the production delivery date.
(3) The quality management method is backward, and the quality management system has not been established or operated effectively. Afterwards, the control is carried out blindly, and no one is responsible for the quality management system.
(4) financial management is not perfect
Financial management methods are relatively backward. The management mechanism of small and medium-sized enterprises is flexible, so the methods of financial management are flexible and diverse, but it is difficult for small and medium-sized enterprises to attract and retain the talents they need, so financial management talents are scarce. Lack of funds and poor fund-raising ability. Low cost management level.
(5) Poor research ability
Small and medium-sized enterprises in China generally despise the concept of R&D management without considering creating an environment suitable for enterprise R&D; Some developed technologies and patents have rich achievements, but they have not been well protected and developed.
3 the main problems of quality management in small and medium-sized food enterprises
Through the analysis of the research object, we believe that the quality management of small and medium-sized food enterprises mainly has the following problems:
3. 1 The quality target is unclear.
The quality goal of the above-mentioned enterprises is this: to produce satisfactory products for consumers. The quality goal is not quantified, which leads employees to be confused about how to achieve the quality goal.
3.2 The factory inspection of products is not in place.
The factory inspection indexes of biscuits and cakes produced by this enterprise include moisture, total number of colonies, coliform bacteria and so on. Because there is no special quality inspection department, the factory inspection report provided to customers only includes appearance, net content and moisture. The indicators required to be inspected before leaving the factory have not been inspected, and they have not been inspected batch by batch according to the standard.
3.3 Poor process and chaotic workshop management
Production planning and implementation have always been arranged directly by the factory director. In the early stage of enterprise development, small output embodies the advantages of fast and flexible production. However, with the expansion of the enterprise scale, the factory director should give consideration to procurement and sales. He has no energy to manage the production arrangement, and he has not identified the processes of various producers, which is very arbitrary and will inevitably lead to confusion in workshop management.
3.4 The organization is not perfect and lacks necessary rules and regulations.
Because the enterprise has always followed the management principle in the early days of its establishment, it has not set up corresponding functional departments. Therefore, even if some rules and regulations are established, they are ineffective because there is no executive department, and they cannot be implemented because there is no corresponding responsibility and authority.
4 the establishment of management system for small and medium-sized food enterprises
4. 1 planning
4. 1. 1 Planning of quality policy and quality objectives
The definition of quality policy is the overall quality purpose and direction of the organization officially issued by the top management of the organization. Quality objective is the specific quantitative objective of quality policy. According to the discussion and practice, the quality policy of this pastry factory is determined as: quality first, customer first, scientific management and continuous innovation. The quality objectives are: the first pass rate of products is 95%, the customer complaint handling rate is 100%, the qualified rate of purchased raw materials is 100%, the ex-factory inspection rate of products is 100%, and the customer satisfaction is ≥95%.
4. 1.2 responsibility, authority and communication
Referring to the process method of quality management, the organizational structure of the enterprise is planned, and the responsibilities, authorities and communication methods of each department are stipulated: the factory director has a management representative (deputy factory director), an office and a finance department, and the quality director has a production department, a quality control department and a supply and marketing department, and communicates through regular meetings and telephone calls.
4. 1.3 management review
Plan the time interval, input and output of management review to ensure its continuous suitability, adequacy and effectiveness. The review shall include evaluating the opportunities for improvement of the quality management system and the requirements for changes, including the requirements for changes in quality policies and quality objectives.
4. 1.4 Planning of product realization process
In order to make the process meet the requirements, the organization should plan and develop the process required for product realization. The planning of product realization should be consistent with the requirements of other processes of quality management system.
① Determine the quality objectives and requirements of products;
According to the national and industry standards, determine the quality requirements of the products produced, formulate the quality requirements of semi-finished products and other related processes, and determine the quality objectives of the factory.
(2) Determine the requirements of product determination process, documents and resources;
(3) determine the verification, confirmation, monitoring, measurement, inspection and test activities required by the product, as well as the product acceptance criteria;
(4) Determine the records needed to provide evidence for the realization process and its products to meet the requirements.
4. 1.5 planning of support process
It also plans the supporting processes such as procurement, sales and service, determines the quality objectives and requirements, and determines the acceptance criteria.
4. 1.6 planning results
The results of the whole planning finally form a document, which properly describes the quality management system established by the enterprise and provides guidance for the operation of the system.
The contents of quality management system documents mainly include:
① Quality Manual
② Program files
③ Working document
④ record
4.2 Implementation and operation of quality management system
4.2. 1 quality management system training
Training exports qualified talents for enterprises, and small and medium-sized enterprises gradually realize the importance of outstanding talents. The implementation and operation of the quality management system can not be separated from qualified personnel, so it is necessary to train the employees of the enterprise on the knowledge of the quality management system so that everyone can master the necessary theoretical and practical knowledge. 4.2.2 Implementation and operation of procurement process
For food production enterprises, the quality of raw materials is related to whether qualified finished products can be produced. Therefore, enterprises should strictly control and do a good job in purchasing according to the requirements of the quality management planning support process.
4.2.3 Implementation and operation of production process
The production process is the value-added process of enterprises. In order to obtain good benefits, we must pay attention to the control of production process.
① Control all factors affecting product quality.
② Clarify the responsibilities of all parties in the implementation and operation of the production process.
③ Pay attention to supplier management and regularly evaluate supply performance.
(4) Strengthen workshop management, carry out production in strict accordance with work instructions, and it is forbidden to violate process requirements.
(5) Pay attention to equipment management, maintain it regularly, and clean and disinfect it on time.
⑥ In particular, strengthen health management, pay attention to the hygiene of personnel and instruments, carry out daily health management and cleaning and disinfection operations in strict accordance with requirements, and conduct regular physical examinations for personnel.
4.2.4 Implementation and operation of inspection process
The inspection process of this enterprise includes: ex-factory inspection, incoming inspection of raw and auxiliary materials, process inspection and outsourcing inspection.
(1) Set up a full-time department to be responsible for the inspection work, and have full-time personnel to start the work, clarify relevant responsibilities and formulate the inspection process.
② Formulate various inspection methods and acceptance criteria, and ensure operability.
(3) according to the relevant requirements to produce a batch, a batch of inspection.
(4) Raw and auxiliary materials shall be inspected according to the Incoming Inspection Operating Procedures, semi-finished products and semi-finished products shall be inspected according to the Process Inspection Operating Procedures, and finished products shall be inspected according to the Finished Product Inspection Operating Procedures.
4.3 Measurement, Analysis and Improvement
In order to confirm the conformity of product requirements, ensure the conformity of quality management system and continuously improve the effectiveness of quality management system, enterprises should plan and implement the process of measurement, analysis and improvement.
Measurement, analysis and improvement include: monitoring and measurement, nonconforming product control, data analysis and improvement.
4.3. 1 Monitoring and measurement
The means of monitoring and measurement include: customer satisfaction, internal audit, process monitoring and measurement, product monitoring and measurement;
① Customer satisfaction
Through customer satisfaction survey, user comments and so on.
② Internal audit
Through the arrangement of the audit plan, the internal audit is carried out according to the internal audit procedures and the specified time.
A) Develop an audit outline.
B) Determine the audit scope.
C) Prepare the audit plan.
D) conducting audit activities.
E) Take follow-up measures.
③ Process monitoring and measurement
Monitor and measure according to the quality objectives and requirements of different processes and each process or the requirements of acceptance criteria.
④ Monitoring and measurement of products
Monitor and measure according to the determined product inspection process.
4.4 Control of nonconforming products
For the control of nonconforming products, enterprises should formulate nonconforming product control procedures, specify the responsibilities and authorities for the control and disposal of nonconforming products, and dispose of nonconforming products according to the requirements of the procedures.
4.5 Data analysis
Analyze the results of various monitoring and measurement, such as customer satisfaction and product qualification, to confirm the effectiveness and suitability of the quality management system.
4.6 improvement
Enterprises can use quality policy, quality objectives, audit results, data analysis, corrective and preventive measures and management review to continuously improve the effectiveness of the quality management system, so as to find weak links, correct and prevent them, and formulate corrective and preventive measures to maintain the effective operation of the quality management system.