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Quality management - Formalization of QM

41 important questions on Quality management - Formalization of QM

What is the difference between a QMS vs MSSs?

A QMS allows for the development, design, production and delivery of a quality product or service, while managing quality in an efficient and effective manner to achieve the quality objectives.

Set of policies, procedures and tools that make it possible to manage quality effectively and efficiently to achieve the objectives set in terms of quality.

In this system, managing quality will mean to plan, control and improve the activities carried out within the organization related to quality

What involves the planning of quality management?

- who are the clients

- what are their needs

- what should the characteristics of the product or service be in order to
meet these needs?

What involves the control of quality management?

- Evaluating the real quality behavior

- Compare real behavior with quality objectives and act on the differences

What does the improvement part of quality management involve?

- Identification system of improvement needs

- Personnel and material resources to motivate and train teams to:

- detect

- control

- solve

What is the Management system standard about?

A document established by consensus and approved by a recognized institution that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose.
MS standards studied in the subject: ISO 9000 family, ISO 10000 family, ISO 14000 family (unit 4)

What are the main qms standards from ISO?

Iso 9000 (2005); fundamentals and vocabulary, principles of continual improvement, documentation, pyramid (under review)

Iso 9001 (2008); QMS requirements, top management responsibility, resource management, product realization, measure, analysis and improvement

Iso 9004 (2009) Managing for the sustained success of an organization; a quality management approach

Iso 19011 (2011) Guidelines for auditing management systems

Quality management principles of the ISO 9000 (2005)

- Eight quality management principles have been identified that can be used
by top management in order to lead an organization towards improved
performance;

* Customer focus

* Leadership
* Involvement of people

* Process approach
* System approach to management
* Continual improvement
* Fact- based approach to decision- making

* Mutually beneficial supplier relationships

These provide the foundation for QMS standards in the ISO 9000 family

What is the involvement of people

To achieve that all the people and working teams belonging to the company develop their tasks according to their real and potential capacity

What is systems approach to management

Identifying, understanding and managing interrelated processes as a system with one objective: organizations efficiency and efficacy improvement

What is the factual approach to desicion making?

Analyzing the data and relevant information before making any decision

What are mutually beneficial supplier relationships?

Involving the external suppliers into the organization's activity to improve the common capacity and working

What is the structure of the norm (iso 9000, 2005)

0 introduction

1 scope

2 fundamentals of quality management systems

3 terms and definitions

Why is the ISO 9001 useful?

- It has the requirements to follow if an organization wants to certify its MS and quality assurance

- Establishes the patterns to create a business culture focused on customers

- Defines a management model to satsify customers' needs and expectations

What aspects does the ISO 9001 influences?

- Process approach

- Customer satisfaction
- Continual improvement

- Personnel training

What is the process approach?

The process approach is a systematic identification and management of different processes applied within an organization (interaction)

What is the process map?

The graphical representation, tidy and sequential, of all the activities realized within the organization

Allows for quickly visualizing and understanding the impact of processes on the organization's objectives

It should be defined to have a clear vision of all the tasks done in the organization and facilitate continual improvement

What are the different measurement methods for customer satisfaction?

Different measurement methods;

- surveys or questionnaires

- opinion studies

- follow- up visits by the commercial team

- Customer complaints analysis

- Orders repetition index

- etc.

Important to maintain a close collaboration with customers in order to define their expected requirements

The analysis of data collected from customer satisfaction measurement should enable further progress in continual improvement

What is continual improvement?

A structured process in which the whole organization participates with the objective of increasing quality, competitiveness and productivity in a changing environment, increasing the value for customers and reducing the cost of resources used.
Based on PDCA or Deming cycle

What are the benefits of continual improvement?

- Higher response level to customers' requirements

- Sensitivity to detecting opportunities, increased resource performance

- Increased personnel capactiy and motivation, greater satisfaction from the activities done

What factors influence the implementation of continuous improvement?

- Organization of any sector and size

- Top management commitment

- Existence of a coordinator and favorable working environment

- Possibility of using experienced external consultant

What competences do employees defined with responsibilities in the QMS need to have?

- Received training

- Training

- Practical abilities

- Experience

Top management has to identify the need for competences and provide adequate training if they are insufficient

What are the external motivation for implementing ISO?

Clients; market demands a service or product of higher quality

Competitors: increasing competition (globalization)

Society: Access to new markets, laws and standards, improve the organization''s impact on society

What are the internal motivations for implementing ISO?

- Culture and organizational structure; commitment to improvement, the need for tools to improve internally and increase competitiveness

What stages of ISO exist?

Analysis; quality evaluation (consultant)

Development: data gathering and activities planning, declare the organizations quality, elaborating specific procedures, elaborating manual elaborating technical instructions

Implementation: qms implementation

Evaluation: Quality audit

Certification: certification by an accredited certification body

0. Introduction
The QMS adoption is a strategic decision of the organization
What are the factors affecting the QMS design and implementation?

a) organization's environment, changes in the environment and its related risks

b) changing needs

c) particular objectives

d) products provided

e) processes applied
f ) size and structure of the organization

The purpose is not providing uniformity in the QMSs structure or documentation

The working procedures should reflect the spirit of the standard and fit its requirements and are useful for (3)

- Keeping the organization's knowledge

- Systematizing tasks and ensuring homogeneous results through the repeatability of the realized taks at different times or by different people.

- activities in which operations are related and different people or departments act on them.

Each part of the organization is reflected in one or more working procedures, which should be interrelated to define how the organization operates.

What are quality records?

Completed formats with the appropriate information to provide evidence of the correct performance of the activity defined in the procedure or working instructions

What are the characteristics of Quality records?

They are the objective proof of working performance, they have to be established and maintained to provide evidence of conformance to requirements. They are a key element of QMS audit.

5. Management responsibility
What is the responsibility of the management?

Top management shall provide evidence of its commitment to the development and implementation of the QMS and continually improve its effectiveness by :

- Management commitment

- Customer focus

- Quality policy

- Planning

- Responsibility, authority and communication

- Management review

6. Resource management
What is the role of resource management?

- Top management shall ensure the availability of the resources needed for the implementation of the organizanization's strategies and objectives:

- provision of resources

- Human resources

- Infrastructure

- Working environment

7. Product realization
What are the organizations responsibilities concerned with product realization?

The organization shall ensure that is realizing its processes to satisfy stakeholders efficiently and with efficacy:
- Planning of product realization
- Customer- related processes
- Design and development
- Purchasing
- Production and service provision
- Control of monitoring and measuring devices
It is the most specific requirement of the norm

8. Measurement, analysis and improvement
What are the organizations responsibilities concerned with measurement, analysis and improvement?

The organization shall establish the procedures of measurement, monitoring, analysis and improvement to:
a) Demonstrate the conformance with the product requirements

b) Ensure QMS conformity

c) Continual improvement of the system

activities

- Monitoring and measurement

- Control of nonconforming product

- Analysis of data

- Improvement

What is the Evaluation: audit"?

Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled (set of policies, procedures and requirements)

Methodological and independent exam carried out to :

1) determine whether the activities and results relating to quality satisfy the established provisions

2) Check that these provisions are actually performed and appropriate to achieve the objectives

What is the AIM of evaluation; audit?

Check:

- system adequacy to a specific normative reference

- conformance of the activities and effectiveness of the system

Objective observation

Useful to:

- detect and identify weak points in the system (nonconformities)

- help in determining corrective actions

- verify efficacy of corrective actions

Who is participating?

- Client: person or organization requesting an audit (potential client, client, auditee)

- Auditee: organization being audited

- Auditor: person with the demonstrated personal attributes and competence to conduct an audit

What are the stages in the audit?

1) Preparing the audit (objectives, scope, check lists, audit plan etc)

2) Audit execution (meeting, evaluation, post-audit meeting, report draft)

3) Audit report writing (write the final report, deliver the report to client and auditee, decisions on corrective actions, follow-up audit planning, closing)

4) Final report (complete and precise) - > QMS acceptability -> levels:

- unconditionally approved

- conditionally approved

- unconditionally disapproved

continual information is very important

What does the audit consist of?

Objective; process, product, system

Field; internal (1st party), external; clients (2nd party), certification body (3rd party)

What are the involved bodies with the certificate of the ISO 9001 (2008)

Accreditation body -> certification body - > certified organizations

What is a certified organization?

AN organization that has a QMS that has been inspected, audited and verified by a certification body, which awards the organization with the relevant certificate.

What steps are involved in the certification process?

Information

Formal application

Designation of auditors

Documentation exam

Audit planning

Audit

Result ; linked to corrective actions linked to formal application

certificate

follow up audit

renewal audit

What are the benefits of ISO 9001 implementation?

Improvement of internal organization

Greater knowledge of organization's activities

Higher customer satisfaction

Reduction in customer complaints

More motivated employees

Reduction in complaints

What is the customer satsifaction?

A customer's perception of the degree to which the customer's requirements have been fulfilled

QMS standards regarding customer satisfaction; ISO 10000 family;

10001 code of conducts for organizations

10002 complaints handling in organizations

10003 dispute resolution external to organizations

10004 measurement and monitoring of customer satisfaction

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Quality management course topics

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