Clause 7.1 of ISO 9001:2015 states, “The organization shall determine and provide

the resources needed for the establishment, implementation, maintenance and

continual improvement of the quality management system.”

Knowledge is important for successful projects and business development. The new

standard considers knowledge like any other resource to be managed:

• Identify the knowledge necessary to carry out the activity in compliance with the

QMS and to achieve the defined objectives.

• Knowledge must be maintained, protected and made available where necessary.

• Anticipate changes in knowledge needs and manage the risk of failing to acquire

knowledge in due time.

List of resources that might be useful for QMS evolution is given in [1]. There are

two procedures in TRIZ crossover QMS to solve problems and to help with evolution

of QMS where these resources can be employed as internal or free resources.

1. Boris Zlotin and Alla Zusman, Directed Evolution Philosophy, theory and practice,

Appendix 5. Analysis of evolutionary resources p.p. 61 to 63, 2001-2005 Ideation

International Inc.

1

From source [1]

Technical resourcesFunctional resources:•Additional useful functions which the system and/or its environment can perform•Harmful actions taking place in the system and/or its environment which can be used toward some benefit

Informational resources:•Properties of the system and or/its elements (such data, information, reports … generated by QMS)

Time resources:•Time before process starts•Time during the process, such as:

•Pauses•Idling motions

•The possibility to perform several operations simultaneously•Post process time

Spatial resources:•Unoccupied space•Space between elements•Space inside elements•Unoccupied surfaces of elements space occupied by unnecessary objects/elements•Space occupied in dimension(s) other than those already in use

Human resourcesPeople supporting transition:•At the top level•At middle level•At lower level•Those on whom implementation will depend•Other individuals and/or groups inside the organization•People outside the organization

Financial resources and other assets•Investment•Cash reserve•Loans•Barter•Other

Other assets:•Equipment•Facilities•Inventory•Information•Other

Specific resources for evolution useful for the next system generation:•New needs that the system could satisfy•New requirements to the system•Useful functions provided by other systems that could be transferred to the given system•New functions that could be invented and added to the given system•New principles (not used previously)

2

The purpose of the standard is to take account of technological and societal

changes. Information is no longer created, organized, managed, maintained,

disseminated and accessed as it was 20 years ago when paper was the primary

medium.

Electronic data base can be more appropriate than paper records, because data in

electronic form can be used with modern data analysis tools. Documents like work

instructions can show the procedures that workers should follow using videos they

can observe on their smart phones. The RFID technology can be used instead of

paper records like “travelers” enabling automatic reading and writing product status

from producer through all supply chain operations.

3

4

5

Management should pay particular attention to cost control. QMS procedures should be developed with cost control in mind. It is important to present data about quality issues to the management in a way that they can understand. Additional, unforeseen costs arising from nonconformities that occur in processes. This means that the quality management system should discover nonconformities in time so that they can be corrected before cost rise excessively and corrective actions preformed to prevent recurrence of nonconformities due to the same cause.

The QMS should give us information about:Where does nonconformities (NC) originate?

Where are nonconformities detected?What is the cost of nonconformities?

Figure shows sequence of processes in the QMS. Diagram shows number of nonconformities as they appear in the processes. Note that some undetected nonconformities and their effects can cause another nonconformities in later processes.

Slika prikazuje zaporedje glavnih procesov v podjetju. V vsakem procesu lahko nastanejo določene napake. Diagram prikazuje kako so napake porazdeljene. Bolj ko gremo proti koncu, bolj se napake akumulirajo, saj tiste, ki so bile storjene na začetku, povzročajo dodatne napake v naslednjih procesih.

6

Some errors we made in the sales and marketing process might be discovered in

design process , but there are many that will become evident in later processes or

even by customer.

Procedures which define how processes operate, should be designed to prevent

errors to happen. In case if they happen, they must be detected before causing

further damage (unnecessary costs, delays, rework …).

7

Purchasing process is responsible that externally provided processes, products and

services conform to requirements. The type and extent of control should ensure

that externally provided processes, products and services do not adversely affect

the organization's ability to consistently deliver conforming products and services to

its customers.

Costs of purchased products and services represents essential part of cost in price

structure and thus greatly influence the competition of the organization.

8

Majority of previously undiscovered nonconformities will produce some harmful

effects in production and service provision. Some new nonconformities can also be

generated. Appropriate actions based on the nature of the nonconformity and its

effect on the conformity of products and services should be performed in order to

correct outputs. All corrections should be verified before releasing product or

services to the next process or customer.

9

Checkpoints are placed at points in the process where the possibility of error detection is

the highest. Usually checkpoints are positioned prior to submission to the next process or

to the customer.

Manual inspection can never discover all nonconformities. Sometimes inspectors make

errors too. They overlooked nonconforming product and pass it to the next process step or

they reject good product. For that reason inspection is meaningful only with automated

test equipment (ATE), if QA can assure that ATE operates properly.

10

After product release, we can’t make any more nonconformities.

11

Failure to fulfill the requirement is a nonconformity. They can be detected only after the

failure has occurred. That is why the diagram showing detected nonconformities is delayed

and skewed according to diagram of failures causing nonconformities although the areas of

both diagrams are equal.

12

Some of design errors might be discovered by suppliers:

• errors in identification of products and services

• obsolete materials/products no longer in production

• others

13

Some nonconformities originated in previous processes become evident in

production and service provision process::

• design errors,

• inappropriate work instructions,

• inappropriate materials,

• late or early delivered materials,

• inappropriate documentation,

• late documentation,

• inappropriate maintenance of equipment,

• inappropriate tools,

• incapable processes,

• other

14

Product testing is a process of measuring the properties of products. Any deviation in

excess of the agreed value is considered as nonconformity. According to ISO 9001:2015

clause 8.7.1, the organization shall deal with nonconforming outputs in one or more

of the following ways:

a) correction;

b) segregation, containment, return or suspension of provision of products and

services;

c) informing the customer;

d) obtaining authorization for acceptance under concession.

Each of activities prescribed above will cause additional cost.

15

If nonconformity is not detected by the organization, then customer might discover it

during product use. If this will cause customer’s dissatisfaction, he/she will try to find

another supplier.

16

Any failure causes costs. The sooner you discover a nonconformity, the less the is the cost

to correct it. If an error is detected after the products have been sold , it must be rectified

so that the customer returns the product for repair, or a team of experts in the field

eliminates the error. Costs for debugging grow exponentially.

17

The effect of QMS should be to steadily reduce the number of nonconformities by

eliminating causes for nonconformities and to reduce risk of nonconformities.

18

When designing processes we should inbuilt methods for detecting nonconformities

early in a process. The sooner they will be discovered the less it will cost us to

perform corrections.

19

Monitoring, measurements, analysis and evaluation can be automated using state of the

art sensory equipment, information equipment and software to relieve personnel of

repeating tasks and enable them to take decisions on the basis of factual data converted to

information suitable for decision making.

As Lord Kelvin pointed out, “When you can measure what you are speaking about, and

express it in numbers, you know something about it; but when you cannot measure it,

when you cannot express it in numbers, your knowledge is of meager and unsatisfactory

kind; it may be the beginning of knowledge, but you have scarcely, in your thoughts,

advanced to the stage of science.”

20

In management information systems, a dashboard is "an easy to read, often single

page, real-time user interface, showing a graphical presentation of the current

status (snapshot) and historical trends of an organization’s or computer

appliances key performance indicators to enable instantaneous and informed

decisions to be made at a glance.

Reference:

Vikipedia,

https://en.wikipedia.org/wiki/Dashboard_(management_information_systems)

21

22

The scope of the management review is extended by the addition of the strategic direction

of the organization, consideration of the “relevant interested parties“ and “assessment of

risks and opportunities“ at a strategic level.

23

The organization shall determine and select opportunities for improvement and

implement any necessary actions to meet customer

requirements and enhance customer satisfaction.

These shall include:

a) improving products and services to meet requirements as well as to address

future needs and expectations;

b) correcting, preventing or reducing undesired effects;

c) improving the performance and effectiveness of the quality management system.

NOTE Examples of improvement can include correction, corrective action, continual

improvement, breakthrough change, innovation and re-organization.

24

10.2.1 When a nonconformity occurs, including any arising from complaints, the

organization shall:

a) react to the nonconformity and, as applicable:

1) take action to control and correct it;

2) deal with the consequences;

b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in

order that it does not recur or occur elsewhere, by:

1) reviewing and analyzing the nonconformity;

2) determining the causes of the nonconformity;

3) determining if similar nonconformities exist, or could potentially occur;

c) implement any action needed;

d) review the effectiveness of any corrective action taken;

e) update risks and opportunities determined during planning, if necessary;

f) make changes to the quality management system, if necessary.

Corrective actions shall be appropriate to the effects of the nonconformities

encountered.

10.2.2 The organization shall retain documented information as evidence of:

a) the nature of the nonconformities and any subsequent actions taken;

b) the results of any corrective action.

25

The organization shall continually improve the suitability, adequacy and

effectiveness of the quality management system.

The organization shall consider the results of analysis and evaluation, and the

outputs from management review, to determine if there are needs or opportunities

that shall be addressed as part of continual improvement.

26

27

Incremental improvement is an improvement within the existing paradigm. These

are minor improvements that do not require large-scale technological change of the

processes. This results in slight cost reductions of the process, product or service,

time optimization, improved capacity utilization and the like.

Quantum leap improvement represents a shift to a new paradigm. Revision of the

concept of a product or technology is required. This produces a completely new

solution (i.e. replacement of electronic tubes with transistors or replacement of

transistors with integrated circuits ... or replacement of CD with MP3 and the like).

Indeed, it is the evolution of the product in the direction of the Ideal Final Result

(IFR).

28

This example is showing how to use problem solving tool which is a function of TRIZ

crossover QMS application.

29

30

31

Crowdsourcing, a modern business term coined in 2005, is defined by Merriam-

Webster as the process of obtaining needed services, ideas, or content by soliciting

contributions from a large group of people, and especially from an online

community, rather than from traditional employees or suppliers.

Outsourcing might be too expensive, crowdsourcing can be much cheaper.

Reference: Wikipedia https://en.wikipedia.org/wiki/Crowdsourcing

32

33