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Deviation management

Introduction

The quality management system is the management of services offered, and which includes planning, controlling, and improving those elements of an organization that, in some way, affect or influence customer satisfaction and the achievement of the results desired by the organization.[1].

The concept of 'Quality Management System' or 'Quality Management Method' was born in the manufacturing industry, it can be applied in a wide variety of sectors, such as the automotive sector, services and the government sector. In particular, Zeithmal, Parasuraman and Berry (1993) designed the "deficiencies model" in quality management in companies.

Principles of quality management.

Here are the principles of quality management according to ISO 9001:2015:.

1.-Customer focus: Organizations must understand and meet the present and future needs of customers, seeking to exceed their expectations whenever possible.

2.-Leadership: The organization's leaders must establish clear direction and create an internal environment in which staff can contribute to the achievement of the organization's objectives.

3.-Commitment of people: Staff at all levels are essential for the success of the organization and their involvement is necessary to achieve the desired results.

4.-Process-based approach: The organization's activities and resources must be managed as interconnected processes that deliver value to customers.

5.-Improvement: Continuous improvement must be a permanent objective of the organization. This involves constantly improving processes, products and services.

6.-Approach based on evidence-based decision making: Decisions must be based on data analysis and relevant information.

7.-Relationship management: An organization and its suppliers are interdependent, so it is important to establish mutually beneficial relationships.

8.-Approach to systems management: Identify, understand and manage interconnected processes as a system contributes to the effectiveness and efficiency of the organization.

9.-Social responsibility: Organizations must operate ethically and take into account the social and environmental impact of their decisions and activities.

These principles are the basis for the development, implementation and continuous improvement of a quality management system in accordance with the ISO 9001:2015 standard.

Deviation management

Introduction

The quality management system is the management of services offered, and which includes planning, controlling, and improving those elements of an organization that, in some way, affect or influence customer satisfaction and the achievement of the results desired by the organization.[1].

The concept of 'Quality Management System' or 'Quality Management Method' was born in the manufacturing industry, it can be applied in a wide variety of sectors, such as the automotive sector, services and the government sector. In particular, Zeithmal, Parasuraman and Berry (1993) designed the "deficiencies model" in quality management in companies.

Principles of quality management.

Here are the principles of quality management according to ISO 9001:2015:.

1.-Customer focus: Organizations must understand and meet the present and future needs of customers, seeking to exceed their expectations whenever possible.

2.-Leadership: The organization's leaders must establish clear direction and create an internal environment in which staff can contribute to the achievement of the organization's objectives.

3.-Commitment of people: Staff at all levels are essential for the success of the organization and their involvement is necessary to achieve the desired results.

4.-Process-based approach: The organization's activities and resources must be managed as interconnected processes that deliver value to customers.

5.-Improvement: Continuous improvement must be a permanent objective of the organization. This involves constantly improving processes, products and services.

6.-Approach based on evidence-based decision making: Decisions must be based on data analysis and relevant information.

7.-Relationship management: An organization and its suppliers are interdependent, so it is important to establish mutually beneficial relationships.

8.-Approach to systems management: Identify, understand and manage interconnected processes as a system contributes to the effectiveness and efficiency of the organization.

Implementation of quality systems

Understanding what a quality system is and its different methodologies, you may be wondering how to efficiently implement this system in your business, where the following phases must be taken into account:

Other common quality management tools are the cause and effect diagram, control sheet, control chart, Pareto diagram, stratification analysis, histogram and scatter diagram. [1]

The programs and tools that support this type of systems allow you to automate, manage and facilitate quality processes. Some of the features they offer include:.

Document Management: The programs allow you to organize and control critical documentation, such as quality manuals, procedures and records, ensuring that they are up-to-date and easily accessible to the appropriate personnel.

Control of Non-Conformities: Identifying, recording and managing non-conformities or deviations in production processes is essential. These tools allow detailed tracking of each incident, from identification to resolution.

Internal Audits: The software helps plan and carry out internal audits to verify compliance with quality management standards. These audits can be automated to improve efficiency and reduce human errors.

Risk Management: They allow potential risks to quality to be identified and evaluated, helping to prevent problems before they occur, which is essential to maintain a high quality standard.

Indicator Tracking: The systems also allow the creation of key performance indicators (KPIs) that measure the effectiveness of the quality system in real time, allowing for quick adjustments when necessary.

Some of the most used programs include:.

ISO 9001 software: These solutions help implement and maintain a system compliant with the ISO 9001 standard, with functionalities such as documentation management, quality control, audits and data analysis.

Minitab: Specialized in statistical analysis, it is widely used for quality control and continuous improvement through data analysis.

Qualsys: Offers a comprehensive approach to managing your QMS, from quality to compliance, risk management and audit.

MasterControl: A robust software that integrates all quality functions, such as document control, training, audits and change management, especially in regulated industries.

Sparta Systems (TrackWise): Offers solutions for quality management, including tracking non-conformities, complaints, audits, CAPAs (corrective and preventive actions), among other functionalities.

Examples

An organization must take into account the following structure:[4][1].

Currently we are facing a competitive world, where we find new technologies that surprise us every day, customers are increasingly demanding, they require products or services with characteristics that satisfy their needs and expectations.

That is why organizations must work towards the total satisfaction of their customers, through a process of continuous improvement and implement standardized standards to achieve the maximum quality of the products or services they offer. The full collaboration of all the staff of the organization or company is important so that the service provided is effective, and in this way excellent results are obtained for the company.

Policy:

Comprehensive Policy.

The ITE establishes the commitment to implement and guide all its strategic processes and activities of the educational process, towards the Quality of the Educational Service and respect for the environment, the prevention of work injuries and illnesses, complying with the requirements of the student and interested parties, environmental legislation, applicable health and safety legislation.

Organization Chart: It has an organizational chart which shows us the institutional hierarchy, that is, from the director to the deputy directors who make it up.

Responsibility matrix: As its name indicates, this shows us the activities and those responsible for each of them, which includes the different departments that make up the institution. In addition to placing the symbols that allow identification to be more efficient and understandable.

Quality master plan: The quality master plan shows us the indicators that must be taken into account, an example of which is the institutional average of the evaluation of teaching performance, qualification by area in service audits, complaints and suggestions addressed and at the end, through a formula, the indicator number of compliance with the quality master plan is obtained for each teacher.

Quality plan of the educational service: This shows us the fulfillment of the quality characteristics of the educational service, where it shows us a comparative table of the procedure, product, quality characteristics, the acceptance criteria, the evaluation method, the record, the person responsible and the action when the acceptance criterion is not met. It focuses on procedures such as registration, re-registration, course management, residencies, support of the professional reception act, title registration and issuance of a professional cell.

Strategic linking process: This section shows us the procedure that must be followed to be able to acquire a visit to the companies, where certain quality characteristics, acceptance criteria, evaluation methods, records, responsible parties, and the action when the acceptance criterion is not met are met. In addition, it tells us about the social service that students must perform at a certain time, as well as the cultural and sports activities that help the student meet their accreditation points.

Map and Interaction of Processes: This shows us the interaction of each department that contemplates the strategic processes of linkage, resource management, quality.

Master List of Controlled Internal Documents: It is a compilation that contains all the documents requested for the quality management manual within the school.

Master List of Controlled External Documents: It is a compilation that contains all the documents requested that break down the quality processes.

Master List for Record Control: It is the collection of data on record name, code, handling, storage and protection, retention time, disposition and person responsible for preserving it.

Responsibility and Authority of the QMS: This table shows us the responsibilities of each assigned area and the authority assigned to them.

QMS External Processes: These are all external processes where the procedure, service providers, evidence, and types and degree of control are seen. Authorizations, registration, appointments and certificates.

Implementation of quality systems

Understanding what a quality system is and its different methodologies, you may be wondering how to efficiently implement this system in your business, where the following phases must be taken into account:

Other common quality management tools are the cause and effect diagram, control sheet, control chart, Pareto diagram, stratification analysis, histogram and scatter diagram. [1]

The programs and tools that support this type of systems allow you to automate, manage and facilitate quality processes. Some of the features they offer include:.

Document Management: The programs allow you to organize and control critical documentation, such as quality manuals, procedures and records, ensuring that they are up-to-date and easily accessible to the appropriate personnel.

Control of Non-Conformities: Identifying, recording and managing non-conformities or deviations in production processes is essential. These tools allow detailed tracking of each incident, from identification to resolution.

Internal Audits: The software helps plan and carry out internal audits to verify compliance with quality management standards. These audits can be automated to improve efficiency and reduce human errors.

Risk Management: They allow potential risks to quality to be identified and evaluated, helping to prevent problems before they occur, which is essential to maintain a high quality standard.

Indicator Tracking: The systems also allow the creation of key performance indicators (KPIs) that measure the effectiveness of the quality system in real time, allowing for quick adjustments when necessary.

Some of the most used programs include:.

ISO 9001 software: These solutions help implement and maintain a system compliant with the ISO 9001 standard, with functionalities such as documentation management, quality control, audits and data analysis.

Minitab: Specialized in statistical analysis, it is widely used for quality control and continuous improvement through data analysis.

Qualsys: Offers a comprehensive approach to managing your QMS, from quality to compliance, risk management and audit.

MasterControl: A robust software that integrates all quality functions, such as document control, training, audits and change management, especially in regulated industries.

Sparta Systems (TrackWise): Offers solutions for quality management, including tracking non-conformities, complaints, audits, CAPAs (corrective and preventive actions), among other functionalities.

Examples

An organization must take into account the following structure:[4][1].

Currently we are facing a competitive world, where we find new technologies that surprise us every day, customers are increasingly demanding, they require products or services with characteristics that satisfy their needs and expectations.

That is why organizations must work towards the total satisfaction of their customers, through a process of continuous improvement and implement standardized standards to achieve the maximum quality of the products or services they offer. The full collaboration of all the staff of the organization or company is important so that the service provided is effective, and in this way excellent results are obtained for the company.

Policy:

Comprehensive Policy.

The ITE establishes the commitment to implement and guide all its strategic processes and activities of the educational process, towards the Quality of the Educational Service and respect for the environment, the prevention of work injuries and illnesses, complying with the requirements of the student and interested parties, environmental legislation, applicable health and safety legislation.

Organization Chart: It has an organizational chart which shows us the institutional hierarchy, that is, from the director to the deputy directors who make it up.

Responsibility matrix: As its name indicates, this shows us the activities and those responsible for each of them, which includes the different departments that make up the institution. In addition to placing the symbols that allow identification to be more efficient and understandable.

Quality master plan: The quality master plan shows us the indicators that must be taken into account, an example of which is the institutional average of the evaluation of teaching performance, qualification by area in service audits, complaints and suggestions addressed and at the end, through a formula, the indicator number of compliance with the quality master plan is obtained for each teacher.

Quality plan of the educational service: This shows us the fulfillment of the quality characteristics of the educational service, where it shows us a comparative table of the procedure, product, quality characteristics, the acceptance criteria, the evaluation method, the record, the person responsible and the action when the acceptance criterion is not met. It focuses on procedures such as registration, re-registration, course management, residencies, support of the professional reception act, title registration and issuance of a professional cell.

Strategic linking process: This section shows us the procedure that must be followed to be able to acquire a visit to the companies, where certain quality characteristics, acceptance criteria, evaluation methods, records, responsible parties, and the action when the acceptance criterion is not met are met. In addition, it tells us about the social service that students must perform at a certain time, as well as the cultural and sports activities that help the student meet their accreditation points.

Map and Interaction of Processes: This shows us the interaction of each department that contemplates the strategic processes of linkage, resource management, quality.

Master List of Controlled Internal Documents: It is a compilation that contains all the documents requested for the quality management manual within the school.

Master List of Controlled External Documents: It is a compilation that contains all the documents requested that break down the quality processes.

Master List for Record Control: It is the collection of data on record name, code, handling, storage and protection, retention time, disposition and person responsible for preserving it.

Responsibility and Authority of the QMS: This table shows us the responsibilities of each assigned area and the authority assigned to them.

QMS External Processes: These are all external processes where the procedure, service providers, evidence, and types and degree of control are seen. Authorizations, registration, appointments and certificates.