1 Quality approach T 15

 

1.1 Background

Quality standards' evolution

Other proverbs and quotes

1.1

The evolution of the qualityaptitude to fulfill requirements (see also ISO 9000, 3.6.2) concept and the standards of quality management systemsset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4) (Quality Management System = QMS) in industrial countries in the 20th century can be summarized as:

The technical committee "Management and quality assurance" (ISO/TC 176) within the ISO (International Organization for Standardization) was created in 1980. ISOInternational Organization for Standardization   itself was created in 1947. ISO comes from the Greek "isos" (equal).

The ISO 9000 standards (see figure 1-1) have appeared in:

backgrond
Figure 1-1. Revisions of ISO 9000 family

The new version of the ISO 9001 standard (fouth revision) was published in September 2015.

The ISOInternational Organization for Standardization   standards (more than 18,000) are used in countless fields and are recognized all over the world.

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1.2 Scope

Scope of the QMS, when certain requirements cannot be applied 

1.2

The ISO 9001 standard (Quality management systems - Requirements) is generic as it can be applied to the management systemset of processes allowing objectives to be achieved (see also ISO 9000, 3.5.3) of any company, without limitations on size, activity or type. It is a voluntary international standard which allows certification by accredited bodies.

Nevertheless, certain requirementsexplicit or implicit need or expectation (see also ISO 9000, 3.6.4) cannot be applied in particular cases. This is possible when:

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1.3 Principles and steps

Quality management principles, preparation and implementation, Deming cycle

1.3 

Quality is anything that can be improved. Masaaki Imai

The qualityaptitude to fulfill requirements (see also ISO 9000, 3.6.2) approach is a state of mind which starts with top managementgroup or persons in charge of the organizational control at the highest level (see also ISO 9000, 3.1.1) as a priority strategic decision and extends to all employees. Top managementgroup or persons in charge of the organizational control at the highest level (see also ISO 9000, 3.1.1) develops a quality policystatement by top management allowing the establishment of quality objectives (see also ISO 9000, 3.5.9)   which determines the quality objectivesquality-related, measurable goal that must be achieved (see also ISO 9000, 3.7.2), themselves applicable to all activities. The tool used to achieve the objectives is the qualityaptitude to fulfill requirements (see also ISO 9000, 3.6.2) systemset of interacting processes (see also ISO 9000, 3.5.1). Prevention is a key concept of quality management systemsset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4).

Quality management systemsset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4) include three distinct and interrelated steps:

The purpose of a quality management systemset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4) is to increase the satisfaction of customersanyone who receives a product (see also ISO 9000, 3.2.4)   (both external and internal) by meeting their needs and expectations through continual improvement of the effectivenesscapacity to perform planned activities with minimum effort (see also ISO 9000, 3.7.11)   of the processesactivities that transform inputs into outputs (see also ISO 9000, 3.4.1).

Qualityaptitude to fulfill requirements (see also ISO 9000, 3.6.2) is almost free when customersanyone who receives a product (see also ISO 9000, 3.2.4)   are satisfied: they remain loyal to us. It’s only when the customeranyone who receives a product (see also ISO 9000, 3.2.4)   is not fully satisfied that qualityaptitude to fulfill requirements (see also ISO 9000, 3.6.2) becomes very expensive to us: sooner or later the customeranyone who receives a product (see also ISO 9000, 3.2.4)   will go to a competitor.

Quality remains long after the price has been forgotten

The seven quality managementactivities allowing the control of an organization with regard to quality (see also ISO 9000, 3.3.4) principles (cf. figure 1-2) will help us achieve sustained success (cf. ISO 9000: 2015, sub-clause 2.3). Previously there were eight but now the system approachmanagement of a set of interacting processes to be able to achieve organizational objectives (see also ISO 9004, Annex B.6) is integrated into the process approachmanagement by the processes to better satisfy customers, improve the effectiveness of all processes and increase global efficiency (see also ISO 9001, 03).

principles
Figure 1-2. The 7 quality management principles

A well-prepared approach is half successful

The approach to implementing a quality management systemset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4) starts with the preparation. An example is shown in figure 1-3.

prep
Figure 1-3. QMS preparation

Step 1 involves identifying the needs and expectations (requirements) of interested partiesperson, group or organization affected by the impacts from a company (see also ISO 14001, 3.2.3):

The involvement of top managementgroup or persons in charge of the organizational control at the highest level (see also ISO 9000, 3.1.1) at its highest level is truly indispensable. The advice of a consultant is often solicited. Determining the current status of the management systemset of processes allowing objectives to be achieved (see also ISO 9000, 3.5.3) (whole or partial) would be welcome at this stage. An external certification body is chosen.

One of the key questions that comes up quickly (step 2) is the need for this decision. If this is not really necessary or if the estimated costs of the certification approach exceed the available resources, it is better to reject this idea immediately.

The ISO 9000 family of standards will stop you making promises you can't fulfil and help you keep those you can. David Hoyle

The benefits of implementing a quality management systemset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4) are often:

  • improved image of the organization
  • one step ahead of the competition
  • enhanced customer satisfaction
  • better economic results
  • increased daily efficiency
  • staff is aware, consulted, motivated and proud
  • high level of risk control
  • reduced insurance costs
  • profitable engagement for all
  • best practices valorized
  • formalization of knowledge
  • process control
  • updated legal obligations

The benefits of the certification of a quality management systemset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4) are often:

  • new customers
  • increased market share
  • increase in sales
  • better financial performance

More than one and a half million businesses worldwide can not be wrong!

True story 

Motorola used ISO 9001 to reduce production costs and improve process efficiency. Streamlined operations eliminated waste and reduced cycle times.

Motorola recorded substantial savings, demonstrating the positive impact of ISO 9001 on financial performance. This certification has enabled the company to stand out from the competition and access new markets.

The internalization of the spirit of the principles and requirementsexplicit or implicit need or expectation (see also ISO 9000, 3.6.4) of an ISO standard significantly improves the overall performance of your business, especially when it is not considered as a constraint.

The third step shall determine whether this approach receives the approval of the staff. A communication campaign is launched in-house on the objectives of a quality management systemset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4) (QMSQuality Management System). The staff is aware and understands that, without their participation, the project cannot succeed.

Have confidence: success will come with the involvement and effort of all!

The vision (what we want to be), the mission (why we exist) and the business plan of the company are determined. The following step (4) includes the establishment of an outline of the quality policy and quality objectives. If you do not have a copy of the ISO 9001 standard, now is the time to get it (see sub-clause 2.1 of the present course).

Planning is the last step (5) of the project preparation for obtaining ISO 9001 certification. A reasonable period is between 5 to 8 months (each company is unique and specific). The financial resources and staff are confirmed by top managementgroup or persons in charge of the organizational control at the highest level (see also ISO 9000, 3.1.1). A managementrepresentative is appointed as project leader. Top management commitment is formalized in a documentany support allowing the treatment of information (see also ISO 9000, 3.8.5) communicated to all staff. A person is appointed project leader for obtaining ISO 9001 certification.

The establishment and implementation of an ISO 9001 quality management systemset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4) are shown in figure 1-4.

implementation
Figure 1-4. QMS implementation

Step 1 aims to identify and determine the processes, interactions, owners, responsibilitiescapacity to make a decision alone and drafts of certain documented informationany support allowing the treatment of information. The first versions of process sheets, job descriptions and work instructions are written with the participation of the maximum number of available persons.

The necessary resources to achieve the quality objectivesquality-related, measurable goal that must be achieved (see also ISO 9000, 3.7.2) are determined in step 2. Planning tasks, responsibilitiescapacity to make a decision alone and time frames are established. Training of internal auditorseveryone who is trained to carry out audits (see also ISO 19011, 3.8)   is taken into account.

Step 3 allows you to set and implement methods for measuring the effectivenesscapacity to perform planned activities with minimum effort (see also ISO 9000, 3.7.11)   and efficiencyfinancial relationship between achieved results and resources used (see also ISO 9000, 3.7.10) of each processactivities that transform inputs into outputs (see also ISO 9000, 3.4.1) (indicators). Internal auditssystematic and independent survey to determine whether activities and results comply with pre-established measures and are capable of achieving the objectives (see also ISO 19011, 3.1) help to evaluate the degree of implementation of the system.

Nonconformities of all kinds are listed in step 4. A first draft for dealing with wasteanything that adds cost but no value is established. Corrective actionsaction to eliminate the causes of nonconformity or any other undesirable event and to prevent their recurrence (see also ISO 9000, 3.12.2) are implemented and documented. A sorting out of correctve actions is introduced.

A first encounter with the tools and application areas of continual improvement is made in step 5. A table with the main costs of obtaining quality (COQcosts of obtaining quality) is filled by people with the information at hand. Riskslikelihood of occurrence of a threat or an opportunity (see also ISO Guide 73, 1.1) are determined, actions are planned and improvement opportunities are found. An approach to preventing nonconformitiesnon-fulfillment of a specified requirement (see also ISO 9000, 3.6.9)   and eliminating causes is established. The internal and external communicationexchange of information   is established and formalized.

To conduct the pre-audit of the QMS (step 6), documented informationany support allowing the treatment of information is checked and approved by the appropriate people. A management reviewperiodic survey carried out by top management of the management system for its continual improvement allows the evaluation of compliance with applicable requirementsexplicit or implicit need or expectation (see also ISO 9000, 3.6.4). The quality policystatement by top management allowing the establishment of quality objectives (see also ISO 9000, 3.5.9)   and objectives are finalized. A qualityaptitude to fulfill requirements (see also ISO 9000, 3.6.2) manager from another company or a consultant can provide valuable feedback, suggestions and recommendations.

When the systemset of interacting processes (see also ISO 9000, 3.5.1) is accurately implemented and followed, the certification of the QMS is a breeze, a formality (step 7).

An example of a certification project plan with 26 steps is shown in annex 01. record

An appropriate method for evaluating the performance of your quality management systemset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4) is the RADAR logic model of excellence EFQM (European Foundation for Quality Management) with its nine criteria and overall score of 1000 points.

The Deming cycle (figure 1-5) is applied to control any processactivities that transform inputs into outputs (see also ISO 9000, 3.4.1). The PDCA cycles (Plan, Do, Check, Act) are a universal base for continual improvementprocess allowing the improvement of the global performance of the organization (see also ISO 9000, 3.3.2).


pdca
Figure 1-5. Deming cycle

  • Plan – define context, issues, and processes, demonstrate leadership, establish quality policy and objectives (clauses 4, 5 and 6)
  • Do – realize the product, develop, implement and control processes, demonstrate leadership, bring support (clauses 5, 7 and 8)
  • Check – compare, evaluate, inspect, analyze data, conduct audits and management reviews, demonstrate leadership (clauses 5 and 9)
  • Act – adapt, demonstrate leadership, treat nonconformities, react with corrective actions and find new improvements (new PDCA cycle), (clauses 5 and 10)

For more information on the Deming cycle and his 14 points of management theory (cf. table 1-1) you can consult the classic book "Out of the crisis",  W. Edwards Deming, MIT press, 1982.

Table 1. The 14 Deming points

The 14 Deming points
Points
Description
1 Create constancy of purpose for permanent improvement of products and services, in order to become competitive, stay in business and provide jobs
2 Adopt the new philosophy in the new economic age. Western management must accept its responsibilities and lead for change
3 Don't be dependent on inspection to achieve quality. Eliminate mass inspection by including quality in the product in the first place
4 Stop buying just on the basis of a low price. Minimize further total costs by cutting down the number of suppliers and build long-term relationships of loyalty and trust with them
5 Improve the production system permanently, improve quality and productivity to obtain costs decrease
6 Establish training for all
7 Establish leadership. The purpose of supervision is to help people, equipment and tooling to do a better job
8 Keep fear out of sight: everybody's work will be more efficient
9 Break down barriers between departments. Teamwork is needed throughout the whole organization to foresee potential problems
10 Eliminate slogans and targets asking for zero defects from the work force. Most of the causes of low quality and productivity belong to the system
11 a. Eliminate work quotas on the shop floor. Substitute leadership b. Eliminate management by objectives. Eliminate management by numerical goals. Substitute leadership
12 a. Remove barriers that rob the worker of the pride of their workmanship b. Remove barriers that rob the people in management of the pride of their workmanship
13 Establish a vigorous training and self-improvement program
14 Put everybody to work to accomplish the transformation. It's everybody's job

See the online training T 15v15 ISO 9001 readiness version 2015.

 

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