2 Definitions and books
2.1 Definitions
Quality manager, definitions, terms, acronyms
The beginning of wisdom is the definition of terms. Socrates
The word responsible comes from the Latin respondere "to answer for one's actions".
Some authors replace the term quality manager (QM), with more or less success. Some synonyms, of which for the moment none manages to impose itself include:
- quality specialist
- animator
- facilitator
- responsible for non-quality
- administrator
- manager
- decision maker
- coordinator
- agent
- stirrer
- correspondent
- quality director
- management representative (term used in the ISO 9001: 2008 standard)
- quality engineer
- quality delegate
- responsible for continual improvement
- adviser
- consultant
- in charge of mission
- assistant
Of course, neither the quality manager nor the department are solely responsible for quality in a company. Deming says that 94% of the troubles belong to the system for which top management is responsible.
In a company, everyone assumes their responsibilities, but the responsibility for quality begins with top management because, as the Romanian proverb says:
When you sweep the stairs, you start at the top. Romanian proverb
Some definitions and acronyms:
5 M: Mothe nature, Material,Method, Manpower, Machine (Fishbone or Ishikawa diagram)
5 W: five times Why?
5 S: from Japanese Seiri = sort, Seiton = set in order, Seiso = shine, Seiketsu = standardize and Shitsuke = sustain
Anomaly: variation compared to what is expected
AV: added value
CC: compliance cost
Conformity: fulfillment of a specified requirement
Control plan: document describing the specific measures to carry out the control of a product or process
Control: ensure compliance with the specified criteria
COQ: cost of obyaining quality
Corrective action: action to elimiate the causes of nonconfority or any other indesirable event and to prevent their recurrence
Criticality: level of a potential risk
Curative action: action to eliminate a detected nonconformity
Customer satisfaction: tthe top priority objective of every management system
Customer: the one who receives a product
Defect: nonconformity related to a specified use
Direction: group or persons responsible for management at the highest level of the company
Dysfunction: deviation in the ability of a functional unit to perform a specified function
Effectiveness: capacity to perform planned activities with minimum effort
Efficiency: financial relationship between achieved results and resources used
Fail safe device: system allowing the prevention of errors by eliminating the human factor
Failure: variation of an aptitude of a functional unit to satisfy a specified function
FMEA: Failure Mode and Effects Analysis
Gemba: from Japanese, real place, in the field
Indicator: value of a parameter, associated with an objective, allowing the objective measure of its effectiveness
Interested party: person, group or organization affected by the impacts from a company
ISO: International Organization for Standardization
Kaizen: from Japanese, kai = change and zen = good (for the better, better), Kaizen = continual improvement
Management system: set of processes allowing objectives to be achieved
Manager: someone who gets results through other people
Muda: from Japanese, waste
Mura: from Japanese, irregularity
Muri: from Japanese, difficulty
NCC: non-compliance cost
Nonconformity (NC): non-fulfillment of a specified requirement
Non-quality: non-fulfillment of a specified requirement
Organization: a structure that satisfies a need
Poka-Yoké: system allowing the prevention of errors by eliminating the human factor (fail safe device)
Preventive action: action to eliminate the potential causes of nonconformity or any other undesirable event and to prevent their appearance
Problem: gap that must be reduced to obtain a result
Process: activities that transform input into output
Product (or service): any result of a process or activity
QCDSE: Quality, Cost, Deadline, Safety, Environment
QM: quality manager
QMS: quality management system
Quality management system (QMS): everything necessary for the quality management of a company
Quality management: activities allowing the control of an organization with regard to quality
Quality objective: quality related, measurable goal that must be achieved
Quality policy: statement by top management allowing the establishment of quality objectives
Requirement: implicit or explicit need or expectation
Risk: likelihood of occurrence of a threat or an opportunity
Safety: absence of unacceptable risk
Scrap: treatment of an unrecoverable product
SMED: Single Minute Exchange of Die
SPC: Statistical Process Control
Stakeholder: person, group or company that can affect or be affected by an organization
System: set of interacting processes
Supplier: the one who procures a product
Top management: group or persons in charge of the organizational control at the highest level
TQC: Total Quality Control
Waste: anything that adds cost but no value
WWWWHHW: Who, What, Where, When, How, How much, Why
In the terminology used, do not confuse:
- accident and incident
- an accident is an unexpected serious event
- an incident is an event that can lead to an accident
- anomaly, defect, dysfunction, failure, nonconformity, reject and waste:
- an anomaly is a deviation from what is expected
- a defect is the non-fulfillment of a requirement related to an intended use
- a dysfunction is a degraded function that can lead to a failure
- a failure is when a function has become unfit
- a nonconformity is the non-fulfillment of a requirement in production
- a reject is a nonconforming product that will be destroyed
- waste is when there are added costs but no value
- audit program and plan
- an audit program is the annual planning of the audits
- an audit plan is the description of the audit activities
- audit, inspection, auditee and auditor
- an audit is the process of obtaining audit evidence
- an inspection is the conformity verification of a process or product
- an auditee is the one who is audited
- an auditor is the one who conducts the audit
- control and optimize
- to control is to meet the objectives
- to optimize is to search for the best possible results
- customer, external provider and subcontractor
- a customer receives a product
- an external provider provides a service or a product
- a subcontractor provides a product or service on which specific work is done
- effectiveness and efficiency
- effectiveness is the level of achievement of planned results
- efficiency is the ratio between results and resources
- follow-up and review
- follow-up is the verification of the obtained results of an action
- review is the analysis of the effectiveness in achieving objectives
- inform and communicate
- to inform is to give someone meaningful data
- to communicate is to pass on a message, to listen to the reaction and discuss
- objective and indicator
- an objective is a sought after commitment
- an indicator is the information on the difference between the pre-set objective and the achieved result
- organization and enterprise, society, company
- organization is the term used by the ISO 9001 standard as the entity between the supplier and the customer
- an enterprise, society and company are examples of organizations
- process, procedure, product, activity and task
- a process is how we satisfy the customer using people to achieve the objectives
- a procedure is the description of how we should conform to the rules
- a product is the result of a process
- an activity is a set of tasks
- a task is a sequence of simple operations
Remark 1: the use of ISO 9000 definitions is recommended. The most important thing is to determine a common and unequivocal vocabulary for everyone in the company.
Remark 2: the customer can also be the user, the beneficiary, the trigger, the ordering party or the consumer.
Remark 3: documented information is any information that we must maintain (procedure ) or retain (record ).
Remark 4: each time you use the expression "opportunity for improvement" instead of nonconformity, malfunction or failure, you will gain a little more trust from your interlocutor (external or internal customer).
For other definitions, comments, explanations and interpretations that you don’t find in this module and in annex 06, you can consult:
- ISO Online Browsing platform (OBP)
- IEC Electropedia
Minute of relaxation. Cf. game: Effectiveness
2.2 Books
Books related to quality manager, standards
When I think of all the books still left for me to read, I am certain of further happiness. Jules Renard
Books for further reading on quality:
- Armand V. Feigenbaum, Total Quality Control, McGraw-Hill, 1951
- Kaoru Ishikawa, Guide to Quality Control, APO, 1971
- Philip B. Crosby, Quality is Free, Mentor, 1979
- Kaoru Ishikawa, What Is Total Quality Control?, The Japanese Way, Prentice Hall, 1981
- Charles Kepner, Benjamin Tregoe, The New Rational Manager, Princeton Research Press, 1981
- Edwards Deming, Out of the Crisis, MIT Press, 1982
- Kenneth Blanchard, Spencer Johnson, The One Minute Manager; The Quickest Way to Increase Your Own Prosperity, Berkley Books, 1982
- Masaaki Imai, KAIZEN, The key to Japan’s competitive success, McGraw-Hill, 1986
- James H. Harrington, Poor-Quality Cost, Dekker, 1987
- Taiichi Ohno, Toyota Production System: Beyond Large-Scale Production, Productivity Press, 1988
- Stephen Covey, The Seven Habits of Effective People, Franklin Covey Co, 1989
- Peter Senge, The Fifth Discipline, The Art & Practice of The Learning Organization, Doubleday 1990
- Edwards Deming, The New Economics, MIT Press 1993
- Masaaki Imai, GEMBA KAIZEN, A Commonsense Low-Cost Approach to management, McGraw-Hill, 1997
- Peter Scholtes, The Leader’s Handbook, McGraw-Hill, 1997
- Jeffrey Liker, The Toyota Way, McGraw Hill, 2004
- Nancy Tague, The Quality Toolbox, ASQ Quality Press, 2005
- Larry Webber, Michael Wallace, Quality Control for Dummies, Wiley, 2007
- Denise Robitaille, The (Almost) Painless ISO 9001:2015 Transition, Paton Professional, 2015
- Jan Gillet, Implementing Iso 9001:2015: Thrill your customers and transform your cost base with the new gold standard for business management, Infinite Ideas, 2015
- Charles Cianfrani, John West, ISO 9001:2015 Explained, ASQ Quality Press, 2015
- Craig Cochran, ISO 9001:2015 in Plain English, Paton Professional, 2015
- Denise Robitaille, ISO 9001:2015 Handbook for Small and Medium-Sized Businesses, Quality Press, 2016
- Jeremy Hazel, José Dominguez, Jim Collins, Memory Jogger ISO 9001:2015: What Is It? How Do I Do It? Tools and Techniques to Achieve It, Goal/QPC, 2016
- Alka Jarvis, Paul Palmes, ISO 9001: 2015: Understand, Implement, Succeed!, Prentice hall, 2016
- Ray Tricker, ISO 9001:2015 for Small Businesses, Routledge, 2016
- Christopher Paris, Surviving ISO 9001: 2015, Oxebridge Quality Press, 2016
- Team, Quality Manager A Complete Guide - 2021 Edition, The Art of Service - Quality Manager Publishing, 2020
- Massimiliano Mazzei, Being a Quality Manager: Quality Manager's Notebook, Independently published, 2023
The ISO 9000 family of standards includes three essential booklets:
- ISO 9000 (2015): Quality management systems – Fundamentals and vocabulary
- ISO 9001 (2015): Quality management systems – Requirements
- ISO 9004 (2018): Guidelines for achieving sustained success
A standard added in 2002 and revised in 2018 is:
- ISO 19011: Guidelines for auditing management systems
The standards in the ISO 10001 to ISO 10019 series are guidelines for quality management systemsset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.2.3) and will help you find many answers (see ISO 9004: 2018, Bibliography).
Standards related to risks:
- ISO 31000: 2018, Risk management – Guidelines
- ISO 31010: 2009, Risk management – Risk assessment techniques
- ISO Guide 73: 2009, Risk management - Vocabulary
FMEA document:
- AIAG & VDA FMEA Handbook, AIAG, 2019
For automobiles:
- IATF 16949 - Quality management system requirements for automotive production and relevant service parts organizations, IATF, 2016
Other standards related to the quality approach:
- CEI 60812: Failure modes and effects analysis (FMEA and FMECA), IEC, 2018
- PAS 99: Specification of common management system requirements as a framework for integration, BSI, 2012
- The EFQM model, EFQM 2019
None of these standards are mandatory, but as Deming said:
It is not necessary to change. Survival is not mandatory
Minute of relaxation. Paganini's violin concert performed with facial expressions.