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PQB D 19 S QSE IMS readiness

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D 19

QSE IMS readiness

Goal 1 Integrated system approach

1.1 Background 1.2 Common concepts 1.3 Principles, benefits and approach

2 Standards and definitions 2.1 Standards 2.2 Definitions

3 Process approach 3.1 Process

3.1.1 Management process 3.1.2 Realization process 3.1.3 Support process

3.2 Process mapping 3.3 Process approach

4 Requirements 4.1 General requirements 4.2 Legal and other requirements 4.3 Documentation

5 Management responsibility 5.1 Commitments 5.2 Management review

6 Resource management 7 Product realization and implementation

7.1 Planning 7.2 Stakeholders

7.2.1 Customers 7.2.2 Communication

7.3 Design and development 7.4 Purchasing 7.5 Production and operational control 7.6 Monitoring and measuring 7.7 Emergency

8 Measurement, analysis and improvement 8.1 General 8.2 Internal audit 8.3 Nonconforming product, incident, accident 8.4 Analysis of data 8.5 Improvement

8.5.1 Continual improvement 8.5.2 Corrective action 8.5.3 Preventive action

Annexes

Goal of the module: Readiness for implementation, certification, maintenance and improvement of your integrated Quality, Safety and environment management system so as

to be able to:

increase stakeholder satisfaction ensure workplace prevention and environmental protection

demonstrate compliance with customer, legal and regulatory requirements

QSE IMS readiness PQB D 19 S

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1 Integrated system approach 1.1 Background

In most cases an integrated management system has its origins in management systems related to:

quality health and safety environment

The targets are different (product, personnel, environment), but complementary, as no company can do without one of three elements.

Quality (Q)

Quality is anything that can be improved. Masaaki Imai

The evolution of the quality concept and the standards of quality management systems in the industrial countries in the 20th century can be summarised as:

quality control (till the 1980s) – quality practices, customers are (or seem) satisfied quality assurance (the 1990s) – the system is determined and implemented quality management (ISO 9000: 2000) – the system is controlled and its efficiency is

improved

The technical committee "Management and quality assurance" (ISO/TC 176) within the ISO (International Organization for Standardization) was created in 1980. ISO itself was created in 1947. ISO comes from the Greek "isos" (equal). The ISO 9000 standards (cf. figure 1-1) have appeared in:

1987: ISO 9000 first edition: ISO 9001; ISO 9002; ISO 9003; ISO 9004 1994: ISO 9000 first revision: ISO 9001; ISO 9002; ISO 9003; ISO 9004 – more

understandable, customer focus better determined, preventive actions added 2000: ISO 9000 second revision: ISO 9000; ISO 9001; ISO 9004 – simplified structure

(8 clauses), priority to process approach and customer satisfaction 2008: third revision (fourth edition of ISO 9001): clarification of the requirements (no

new requirement), better alignment with ISO 14 001

Figure 1-1. The first edition and revisions of ISO 9000



The new version of the ISO 9001 standard has been published in November 2008.

The ISO standards (more than 18 000) are used in countless fields and are recognized all over the world.

Health and safety (S)

The first laws relating to safety in France appeared in the late 19th century.

The integration of occupational risk assessment (related to health and safety of workers) in the management of each company since 2001 is an obligation of the Labour Code (R4121-1).

The standard BS OHSAS 18001: 2007 is neither French nor an ISO standard but is most commonly used for certifying health and safety worldwide.

Environment (E)

The first laws on environmental protection emerged in 70s of the last century.

The 2004 edition of ISO 14001 is different from the first version (1996) by:

improved compatibility with ISO 9001 greater clarity greater emphasis given to the continual improvement strengthening the evaluation of compliance (legal and regulatory) further simplification of documentation

1.2 Common concepts

The three quality, safety and environment (QSE) management systems (cf. figure 1-2) share the following concepts:

stakeholders: o needs o expectations o requirements o risks o satisfaction

PDCA approach process approach continual improvement commitments of management:

o policy o objectives o planning o implementation o communication o resources o management review

management responsibility corrective and preventive actions control of documents and records


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measurement and monitoring widespread prevention internal audits

Figure 1-2. Common concepts QSE

Some similarities are specific to two management systems (QS, QE and SE) and strengthen the integration of the QSE system.

1.3 Principles, benefits, approach

The eight quality management principles (cf. figure 1-3) will help us achieve sustained success (ISO 9000, sub-clause 0.2, ISO 9004, Annex B and the free ISO brochure “Quality management principles”).

http://www.iso.org/iso/qmp_2012.pdf

http://www.iso.org/iso/qmp_2012.pdf



Figure 1-3. The 8 quality management principles

The benefits of an integrated QSE management include:

the system is consistent the documentation is simplified costs are reduced prevention is widespread process performance is improved risks are better set and controlled improved image of the organization confidence in the company is increased the satisfaction of all stakeholders is best ensured commitment to sustainable development is real

A well-prepared approach is half successful

The approach to implementing an integrated QSE management system starts with the preparation. An example is shown in figure 1-4.


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Figure 1-4. IMS preparation

Step one involves identifying the needs and expectations (requirements) of stakeholders:

customers, consumers staff environment shareholders, investors suppliers, subcontractors, partners organizations and branch associations legal and regulatory authorities

The involvement of top management at its highest level is truly indispensable. The advice of a consultant is often solicited. A status of the management system (or what exists of it) would be welcome at this stage. An external certification body is chosen.

One of the key questions which comes up quickly (step 2) is the need for this decision. If this is really unnecessary or if the estimated costs of the certification approach exceed the available resources, it is better to give up the idea right now.

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 an integrated QSE management system are often:

improved image of the organization one step ahead of competition environmental protection reinforced increased safety of staff reduction of production costs reducing or eliminating incidents better preparation for emergencies anticipating sustainable development increased confidence and satisfaction of stakeholders



the prevention of pollution, hazards and risks becoming routine better economic results reduced energy consumption increased daily effectiveness staff is aware, consulted, motivated and proud high level of risk control reduced insurance costs commitment profitable for all good practices valorised standardization of know how control of processes legal obligations up to date

The benefits of the certification of an integrated management system 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!

The internalization of the spirit of the principles and requirements of standards 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 an integrated management system (IMS). 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 organization are set. The following step (4) includes the establishment of an outline of the QSE policy and quality objectives. If you do not have a copy of the ISO 9001, OHSAS 18 001 and ISO 14 001 standards, now is the time to get them (cf. sub-clause 2.1 of the present course).

Planning is the last step (5) of the project preparation for obtaining QSE certification. A reasonable period is between 6 to 12 months (each organization is unique and specific). A management representative is appointed project leader. Top management commitment is formalized in a document communicated to all staff.

The establishment and implementation of an integrated management system are shown in figure 1-5.


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Figure 1-5. IMS implementation

Step 1 aims to identify and determine the processes, the interactions, the owners, the responsibilities. Drafts of certain documents are prepared. Needs, expectations and requirements of all stakeholders are analysed. The first drafts of job descriptions, procedures, work instructions and forms for records are written with the participation of the maximum number of available persons. The outline of the QSE manual is written down.

In step 2 are set the resources to achieve the QSE objectives. Planning tasks, responsibilities and time frames are established. Internal staff and subcontractors are aware of potential hazards and environmental impacts. Training of internal auditors is taken into account.

Step 3 allows you to set and implement methods for measuring the effectiveness and efficiency of each process (indicators). Internal audits help to evaluate the degree of implementation of the system (customer requirements, hazard identification, risk assessment, identification of environmental aspects and impacts, legal and other requirements).

Nonconformities of all kinds are listed in step 4. A first draft for dealing with waste is established. A sort of corrective and preventive actions is introduced. Emergencies with potential impacts on health, safety and environment are listed. The responses (action and reaction) to emergencies are in place and documented.

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 (COQ) is filled by people with the information at hand. An approach to preventing nonconformities and eliminating causes is established. The activities associated with identified hazards and significant environmental



aspects, are planned and implemented. Legal watch is accomplished. The risk assessment document is developed. Communication internally and externally is established and formalized.

To conduct the pre-audit of the IMS (step 6) documents such the QSE manual, procedures and others are checked and approved by the appropriate people. A management review allows assessing compliance with applicable requirements. The QSE policy and objectives are finalized. A QSE manager from another company or a consultant can provide valuable feedback, suggestions and recommendations.

When the system is accurately implemented and followed, the certification of the IMS by an external body is a breeze, a formality (step 7).

An appropriate method for evaluating the performance of your integrated management system is the RADAR logic model of excellence EFQM (European Foundation for Quality Management) with its 9 criteria and overall score of 1000 points.

The Deming cycle (figure 1-6) is applied to control any process. The PDCA cycles (Plan, Do, Check, Act) are a universal base for continual improvement.

Figure 1-6. Deming cycle

Plan – prepare, develop and establish the strategy, the policy, the resources, the objectives, the documentation (cf. ISO 9001,clauses 4, 5 and 6; OHSAS 18 001 and ISO 14 001, sub-clauses 4.2 and 4.3)

Do – develop, implement processes, indicators, training, prevention, response to emergencies (cf. clause 7 of ISO 9001; OHSAS 18 001 and ISO 14 001, sub-clause 4.4)

Check – compare, adjust, adapt, inspect, analyse data, verify if objectives are achieved (effectiveness), conduct audits (cf. clause 8 of ISO 9001; OHSAS 18 001 and ISO 14 001, sub-clause 4.5)

http://www.efqm.org/


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Act – decide, improve, react with actions or find new improvements (new PDCA), (cf. sub-clauses 5.6, 8.3 and 8.5 of ISO 9001; OHSAS 18 001 and ISO 14 001, sub-clause 4.6)

For more information on the Deming cycle and his 14 points of management theory you can consult the classic book "Out of the crisis" W. Edwards Deming, MIT press, 2000.



2 Standards and definitions

2.1 Standards

Most commonly used standards for integrated management system are:

ISO 9001 (2008): Quality management systems - Requirements OHSAS 18 001 (2007): Occupational health and safety management systems -

Requirements ISO 14 001 (2004): Environmental management systems - Requirements with

guidance for use

The three standards are generic because they apply to any business, without any constraint on the size, activity or type. The scope of the integrated QSE management system is

determined and a record is maintained.

Similarities and differences in the purpose of the three standards are shown in figure 2-1:

Figure 2-1. Purpose of QSE standards

The structure of the OHSAS 18 001 standard is very similar to ISO 14 001. The common points are many and this is one reason for using OHSAS 18001 in QSE management systems.



As seen in annex B of ISO 14001 (Correspondence between ISO 14001: 2004 and ISO 9001: 2000) and annex A to ISO 9001 (Correspondence between ISO 9001: 2008 and ISO 14001: 2004) are many similarities in form and content. This shows that a company having implemented one of the two standards can easily implement the second.

Another demonstration of the close relationship between ISO 9001 and ISO 14001 is the common standard ISO 19011 (2011): "Guidelines for auditing management systems."

All these standards and many more can be ordered in electronic or paper format on the ISO site.

A British publicly available specification is dedicated to the integration of management systems:

PAS 99: 2012 Specification of common management system requirements as a framework for integration

2.2 Definitions

The beginning of wisdom is calling things by their proper names. Confucius

Some specific quality terms:

Customer: anyone who receives a product Customer satisfaction: top priority objective of every quality management system related to the satisfaction of customer requirements Nonconformity: non-fulfilment of a specified requirement Organization: a structure that satisfies a need Product (or service): every result of a process or activity Quality: aptitude to fulfil requirements Quality management: activities allowing the control of an organization with regard to quality Quality objective: quality related, measurable goal that must be achieved Stakeholder: person, group or organization that can affect or be affected by an organization Supplier: an entity that provides a product Examples of stakeholders: investors, customers, employees, suppliers, citizens, social or political organizations. Some specific health and safety terms: Acceptable risk: risk reduced to a tolerable level Accident: undesired event causing death or health and environmental damages Hazard: situation that could lead to an incident Incident: undesired event that could lead to health damages Occupational health and safety (OHS): everything that can influence the wellbeing of the personnel in a company OHSAS: Occupational Health and Safety Assessment Series Risk: probability of occurrence of a potential hazard Safety: aptitude to avoid an undesired event Some specific environmental terms: Environment: space in which any organization functions

http://www.iso.ch/



Environmental aspect: every element of an organization that interacts with the environment Environmental impact: every change in the environment caused by an organization Environmental objective: environment related, measurable goal that must be achieved Environmental target: value of a parameter, associated with an environmental objective, allowing the objective measure of its effectiveness Some common terms: Conformity: fulfilment of a specified requirement Effectiveness: capacity to realize planned activities with minimum efforts Efficiency: financial relationship between achieved results and used resources Indicator: value of a parameter, associated with an objective, allowing the measure of its effectiveness objectively Management system: set of processes allowing objectives to be achieved Process: activities which transform inputs into outputs Requirement: explicit or implicit need or expectation In the terminology of management systems do not confuse:

accident and incident o an accident is an unexpected serious event o an incident is an event which can lead to an accident

anomaly, defect, dysfunction, failure, nonconformity, reject and waste o anomaly is a deviation from what is expected o defect is the non-fulfilment of a requirement related to an intended use o dysfunction is a degraded function which can lead to a failure o failure is when a function has become unfit o nonconformity is the non-fulfilment of a requirement in production o reject is a nonconforming product which will be destroyed o waste is when there are added costs but no value

audit, inspection, auditee and auditor o an audit is the process of obtaining audit evidence o an inspection is the verification of the conformity of a process or product o an auditee is the one who is audited o an auditor is the one who conducts the audit

audit programme and plan o an audit programme is the annual planning of the audits o an audit plan is the description of the audit activities

calibration and gauging o calibration is the verification of a value found related to a standard (troy weight) o gauging is the positioning of reference marks

control and optimization o control is the achievement of an objective o optimization is the search for the best possible results

customer, subcontractor and supplier o a customer receives a product o a subcontractor provides a service or a product on which a specific work is

done o a supplier provides a product

effectiveness and efficiency o effectiveness is the level of achievement of planned results o efficiency is the ratio between results and resources

follow-up and review



o follow-up is the verification of the obtained results of an action o review is the analysis of the effectiveness in achieving objectives

inform and communicate o to inform is to give someone meaningful data o to communicate is to pass on a message, to listen to the reaction and discuss

objective, target and indicator o an objective is a sought after commitment o a target is specified objective o an indicator is the information on the difference between the pre-set objective

and the achieved result organization and enterprise, society, company

o organization is the term used by the ISO 9001 standard as the entity between the supplier and the customer

o enterprise, society, company are examples of organizations process, procedure, product, activity and task

o a process is how we satisfy the customer using people to achieve the objectives

o a procedure is the description of how to conform to the rules o a product is the result of a process o an activity is a set of tasks o a task is a sequence of simple operations

Remark 1: the use of ISO 9000, OHSAS 18 001 and ISO 14 001 definitions is recommended. The most important thing is to determine for everyone in the organization a common and unequivocal vocabulary.

Remark 2: the customer can be also the user, the beneficiary, the trigger, the ordering party, the consumer.

Annex 05 specifies the frequency of use of certain keywords contained in the ISO 9001 standard.

For other definitions, comments, explanations and interpretations which you don’t find in this module and in annex 06 you can consult:

ISO 9000: 2005 - Quality management systems. Fundamentals and vocabulary, (ISO, 2005)

Introduction and support package: Guidance on the Terminology used in ISO 9001 and ISO 9004 (Document ISO/TC 176/SC 2/N 526R2, 2008)

Quality management system – Indicators and synoptical tables (FD X50 - 171, ISO, 2000)

Books for further reading on QSE systems:

Philip B. Crosby, Quality is free, The Art of Making Quality Certain, McGraw Hill, 1979 Kaoru Ishikawa, What Is Total Quality Control?, The Japanese Way, Prentice Hall,

1981 W. Edwards Deming, Out of the crisis , MIT Press, 1982 Eliyahu Goldratt, Jeff Cox, The Goal, A Process of Ongoing Improvement, North River

Press, 1984 Masaaki Imai, Kaizen, the Key to Japan's Competitive Success, McGraw Hill, 1986 James H. Harrington, Poor Quality Cost, Dekker, 1987

http://www.pqbweb.eu/document-d-19-qse-ims-readiness.php


http://www.iso.ch/

http://www.iso.org/iso/iso_catalogue/management_standards/iso_9000_iso_14000/iso_9001_2008/terminology_used_in_iso_9001_and_iso_9004.htm

http://www.iso.ch/



Taiichi Ohno, Toyota Production System, Beyond Large-Scale Production, Productivity Press, 1988

Thomas Anton, Occupational Safety and Health Management, McGraw Hill, 1989 Willie Hammer, Occupational Safety Management and Engineering, Prentice hall,

1989 Joseph Cascio et al, ISO 14000 Guide: The New International Environmental

Management Standards, McGraw Hill, 1996 David Goetsch, Occupational Safety and Health, Prentice Hall, 1996 Gregory Johnson, The ISO 14000 EMS Audit Handbook, St Lucie, 1997 A. J. Edwards, ISO 14001 Environmental Certification Step by Step, Elsevier, 2004 Ken Whitelaw, ISO 14001 Environmental Systems Handbook, Elsevier, 2004 John Kinsella, Handbook for Implementing an ISO14001 Environmental Management

System, Shaw Environmental, 2005 Larry Webber, Michael Wallace, Quality Control for Dummies, Wiley, 2007 Joe Kauzek, OHSAS 18001: Designing and Implementing an Effective Health and

Safety Management System, Government Institutes, 2007 David Smith et al, Managing Safety the Systems Way: Implementing BS OHSAS

18001:2007, BSI Standards, 2008 Wayne Pardy et al,Integrated Management Systems: Leading Strategies and

Solutions, Government Institutes, 2009 David Hoyle, ISO 9000 Quality Systems Handbook, Elsevier, 2009 Joseph M. Juran, Juran’s Quality Handbook, McGraw Hill, 2010 Syed Imtiaz Haider, Environmental Management System ISO 14001: 2004: Handbook

of Transition with CD-ROM, CRC Press, 2010 Naeem Sadiq, OHSAS 18001 Step by Step: A Practical Guide, IT Governance

Publishing, 2012 EPA, Environmental Management Systems: Implementation Guide for Small And

Medium-Sized Organizations, BiblioGov, 2013



3 Process approach

3.1 Process

The word process comes from the Latin root procedere = go, development, progress (Pro = forward, cedere = go). Each process transforms inputs in outputs creating added value and potential nuisances. A process has three basic elements: inputs, activities, outputs. A process can be very complex (launch a rocket) and relatively simple (audit a documented procedure). A process is:

repeatable foreseeable measurable definable dependent on its context responsible for its suppliers

A process is determined among others by its:

title and type purpose (why?) beneficiary (for whom?) scope and activities initiators documents and records inputs outputs (intentional and not intentional) constraints resources:

o human o material

objectives and indicators person in charge (owner) and actors (participants) means of inspection (monitoring, measurement) mapping interaction with other processes risks and potential deviations opportunities for continual improvement

A process review is conducted periodically by the process owner.

The components of a process are shown in figure 3-1:



Figure 3-1. Components of a process

Figure 3-2 shows an example that helps answering some questions:

which materials, which documents, which tools? (inputs) which title, which activities, requirements, constraints? (process) which products, which documents? (outputs) how, which inspections? (methods) what is the level of performance? (indicators) who, with which competences? (human resources) with what, which machines, which equipment? (material resources)

Figure 3-2. Some elements of a process

Often the output of a process is the input of the next process.

You can find some examples of process sheets in the document pack D 02.

http://www.pqbweb.eu/document-d-02-processes.php



Any organization (company) can be considered as a macro process, with its purpose, its inputs (customer needs and expectations) and its outputs (products/services to meet customer requirements).

Our preference is to identify a process using a verb (buy, produce, sell) instead of a noun (purchases, production, sales) to differentiate the process of the company's department or procedure and recall the purpose of the process.

The processes are (as we shall see in the following paragraphs) of management, realization and support type. Do not attach too much importance to process categorizing (sometimes it's very relative) but ensure that all the company's activities fall at least into one process.

3.1.1 Management processes

Management processes are also known as piloting, decision, key or major processes. They are part of the overall organization, elaboration of the policy, deployment of the objectives and all required checks. They are the glue of all the realization and support processes.

The following processes can be part of this family:

develop strategy develop policy deploy objectives plan the QSE IMS acquire and manage human resources manage risks establish process ownership conduct an audit conduct management review communicate improve meet requirements measure customer satisfaction negotiate contract

3.1.2 Realization processes

The realization (operational) processes are related to the product, increase the added value and contribute directly to customer satisfaction. They are mainly:

design and develop purchase produce maintain equipment receive, store and deliver inspect control nonconformities prevent emergencies implement preventive and corrective actions apply traceability sell



investigate incident manage waste

3.1.3 Support processes

The support processes provide the resources necessary for the proper functioning of all other processes. They are not directly related to a contribution of the product's added value, but are still essential.

The support processes are often:

control documentation perform environmental analyses study hazards acquire and maintain infrastructure provide training manage inspection means provide information keep up to date the legal watch keep accountability manage staff

3.2 Process mapping

The process mapping is par excellence a multidisciplinary work. This is not a formal requirement of the ISO 9001 standard (or OHSAS 18 001 and ISO 14 001) but is always welcome.

The 3 types of processes and some interactions are shown in figure 3-3:



Figure 3-3. Process house

In the resulting output do not underestimate the unwanted products such as waste, nuisances, rejects.

The mapping among other things lets you:

obtain a global vision of the organization identify the beneficiaries (customers), flows and interactions define rules (simple) for communication between processes

To obtain a clearer picture you can simplify by using a total of about fifteen core processes. A core process can have several sub-processes, for example a process "develop the IMS" can contain:

develop strategy set policy manage risks plan the IMS deploy objectives



acquire resources establish process ownership improve

Two other process examples (design, figure 3-4 and produce figure 3-5):

Figure 3-4. Design process

Figure 3-5. Produce process

3.3 Process approach



Simple solutions for now, perfection for later

The process approach contributes enormously to the efficient management of the organization.

Process approach: management by the processes to better satisfy customers, improve the effectiveness of all processes and increase global efficiency

The process approach included during development, implementation and continual improvement of an integrated QSE management system allows one to achieve objectives that are related to customer satisfaction as is shown in figure 3-6.

Figure 3-6. Model of an IMS based on process approach and continual improvement

Process approach:

emphasizes the importance of: o understanding and complying with customer requirements o prevention so as to react to unwanted elements such as:

incidents accidents nuisances waste rejects customer returns

o measuring process performance, effectiveness and efficiency o permanently improving objectives based on pertinent measurements o process added value

relies on: o methodical identification o interactions



o the sequence and o process management which consist of:

determining objectives and their indicators directing related activities analysing obtained results permanently undertaking improvements

allows one to: o better view inputs and outputs and their relationship o clarify roles and responsibilities o judiciously assign necessary resources o break down barriers between departments o decrease costs, delays, wastes

and ensures in the long run: o control o monitoring and o continual improvement of processes

Process approach is not:

crisis management ("You will not solve the problems by addressing the effects") blaming people ("Poor quality is the result of poor management." Masaaki Imai) priority to investments ("Use your brain, not your money." Taiichi Ohno)



4 IMS requirements

4.1 General requirements (Requirements Q, S, E)

The requirements of the three standards ISO 9001, OHSAS 18 001 and ISO 14 001 are shown in figures 4-1, 4-2 and 4-3:

Figure 4-1. ISO 9001 requirements

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Figure 4-2. OHSAS 18 001 requirements



Figure 4-3. ISO 14 001 requirements

The requirements of the standards ISO 9001, OHSAS 18001 and ISO 14001 are complementary when they are not identical (cf. annex 04). To establish an integrated QSE management system you must include:

establish the scope establish the needs and expectations of all stakeholders determine the legal and other requirements perform an initial QSE diagnosis carry out an initial assessment of the risks and assess potential emergency situations identify the environmental aspects and determine the significant environmental

impacts set the QSE policy set objectives and targets implement a simple enough documentation system establish a programme(s) to implement the policy and achieve objectives and targets determine and provide the necessary resources establish a training programme identify processes and:

o their interactions o establish accountability o implement the methods of measurement and monitoring of each process




o establish criteria for process effectiveness apply communication internally and externally prevent nonconformities, eliminate the causes audit and evaluate the integrated QSE management system continuously improve the integrated management system

Pitfalls to avoid:

go overboard on quality have the QSE manager write all the procedures overlook the specifics of the company mores

Good practices

process mapping has enough arrows to show who is the customer (internal or

external)

for a process it is better to use a lot of arrows (several customers) rather than to

forget one

during the process review reveal the added value of the process

the analysis of processes performance is an example of continual improvement

evidence of the effectiveness of the IMS

top management regularly monitors the environmental and OHS objectives, targets

and programmes

commitments of top management regarding the prevention and continual improvement

are widely distributed

Bad practices

some process outputs are not set correctly (customers not considered) process effectiveness criteria not established process owner not formalized outsourced processes not identified control of outsourced services not described sequences and interactions of certain processes are not identified criteria and methods for ensuring effective processes not set monitoring the effectiveness of certain processes not established the scope of the IMS is not clearly set the IMS is not up to date (new processes not identified)

4.2 Legal and other requirements (Requirements S, E)

Ignorance of the law excuses no one. Latin proverb

In relation to the explicit and implicit requirements of all stakeholders a legal watch (cf. figure

4-4) is kept updated (documented procedure).

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Figure 4-4. Keep legal watch process

Thus, one can:

find and identify the applicable requirements:

o legal o others such as:

agreements with:

public authorities

customers

NGOs (nongovernmental organizations) orders of the Prefecture decrees guidelines principles of good behaviour commitments to environmental labelling

set the means for implementing these requirements maintain regular evaluation of compliance with applicable legal requirements and

other requirements to which the company subscribes

keep records of the evaluation of compliance

A procedure is documented to identify, plan, implement and maintain the evaluation of compliance with applicable legal requirements and other requirements to which the company subscribes regarding health, safety and environment. This is done periodically and records

are kept.



The Environmental Code (for France) contains the four principles of environmental regulations introduced by Law No. 2002-276 of 27 February 2002 relating to local democracy:

the precautionary principle the principle of preventive action and correction the polluter-pays principle and the principle of participation

Hazard risks in all business activities (from design to after-sales service) are taken into account.

Many of these requirements regarding occupational health and safety are present in the labour code (for France).

The main regulations in the EU are prioritized:

treaties, regulations, directives and decisions

For France it is:

laws, decrees, codes, orders and circulars

Good practices

the legal watch is regular and complete the application of legal and regulatory requirements is a preventive approach and not

a constraint the application of legal, regulatory, national, regional and local requirements on

environmental aspects and OH&S hazards is established and updated the procedure "Legal watch" is updated at least twice a year much of the OH&S requirements are present in the labour code

Bad practices

legal and regulatory requirements are not identified identification of legal requirements does not take into account other requirements to

which the company has subscribed (banned products by customers) the rules of procedure are not displayed in the workplace the requirements of a prefectural order are not taken into account the person in charge of the legal watch does not have sufficient legal knowledge to

interpret legislation the document for risk assessment is incomplete the document for risk assessment is not updated the implementation of some articles of the Labour Code is not followed some applicable regulations have not been identified the application of certain articles of the environment code is not followed the local rules on the condition of waste release to the network are not identified as a

regulatory requirement

4.3 Documentation (Requirements Q, S, E)






The right document, at the right place, at the right moment

The documentation of the integrated QSE management system may contain separate documents for each standard (cf. Figure 4-5).

Figure 4-5. The separated QSE documentation pyramid

The common documentation system (cf. figure 4-6) is preferable because it is clearer, simpler and sufficient.

Figure 4-6. The common QSE documentation pyramid

The manual (QSEM) describes as minimum the scope of the integrated QSE management system, the procedures or a reference to them and the interactions between processes (cf. annex 01). The QSE manual is like the Traffic Regulations, it is mainly a guide, a tool, but

does not teach you how to drive.




The technical report ISO/TR 10 013 (2006): "Guidelines for quality management system documentation" provides recommendations relative to the documentation of a QMS.

The documentation contains answers to requirements:

clauses 4 through 8 of ISO 9001 (305) clause 4 of OHSAS 18001 (230) and clause 4 of ISO 14001 (165)

Many of the requirements are common, hence the advantage of having an IMS for a simplified documentation.

The structure of the manual can follow clauses from a standard or follow the logic of the process approach.

The 6 mandatory procedures of ISO 9001 (cf. annex 02) are:

Control of documents (sub-clause 4.2.3). The procedure ensures: o verification o approval o updating o relevant version at points of use o availability o control of external documents o prevention of use of obsolete documents o sustainability of its know-how o integration of hired staff

Control of records (sub-clause 4.2.4). The procedure ensures: o identification o storing o protection o availability o distribution o retention time and o disposal of records

Internal audit (sub-clause 8.2.2)

Control of nonconforming product (sub-clause 8.3)

Corrective actions (sub-clause 8.5.2)

Preventive actions (sub-clause 8.5.3)

The OHSAS 18 001 standard requests in addition the procedures:

Identification of hazards (sub-clause 4.3.1)

Legal requirements (sub-clause 4.3.2)

Training (sub-clause 4.4.2)




Communication (sub-clause 4.4.3)

Operational control (sub-clause 4.4.6)

Emergencies (sub-clause 4.4.7)

Measurement and monitoring (sub-clause 4.5.1)

Evaluation of compliance (sub-clause 4.5.2)

Incidents and nonconformities (sub-clause 4.5.3)

The ISO 14 001 standard requests in addition the procedure:

Identification of aspects (sub-clause 4.3.1)

Procedure: set of actions to carry out a process

The requirement for procedures (total of 16) of the different standards are complementary, hence the advantage of getting the most common procedures. Some procedures can be grouped into one.

A procedure can be documented or not (cf. ISO 9000: 2005, sub-clause 3.4.5). Our preference is for the documented solution (written), short, simple and relevant, above all in cases where the lack of procedure may lead to deviations from the policy or the objectives. A review of the documentation is conducted periodically by the QSE manager.

True story

At a third party audit the auditor asked to see the history of the versions of three procedures and of some instructions.

The procedures all had more than 3 versions, and the instructions (in our case audit reports) had on average 2 or 3 versions (actions and one or two follow-ups).

The auditor was comforted because he was afraid to come across "inactive" documents.

Documentation can be in any form and any media.

The documentation is related to the size and type of the company, the complexity of processes and competence of staff. Only strictly necessary documents are required to obtain a simplified documentation. Examples of commonly used documents:

QSE manual organizational chart procedures process sheets specifications work or test instructions list of approved suppliers test and inspection plans prevention plan



security protocol emergency plan incident sheet

Each record is unique and cannot normally be changed. Any record demonstrates a task, operation, activity, process or requirement. The records are the database needed to analyse the effectiveness of processes and contribute to continual improvement of the integrated QSE management system.

Record: document providing objective evidence of achieved results

Spoken words fly away, written ones stay. Latin proverb Maintained records required by the IMS to prove conformity to the QSE requirements (sub-

clauses):

management review (ISO 9001, § 5.6.1), (OHSAS 18001, § 4.6), (ISO 14001, § 4.6) training, competence and experience (ISO 9001, § 6.2.2), (OHSAS 18001, § 4.4.2)

(ISO 14001, § 4.4.2) evidence that the realization processes and resulting product meet requirements (ISO

9001, § 7.1) results of the review of product requirements and resulting actions (ISO 9001, § 7.2.2) input elements of the design and development (ISO 9001, § 7.3.2) review results of the design and development, and necessary actions (ISO 9001, §

7.3.4) results of verification of the design and development, and necessary actions (ISO

9001, § 7.3.5) results of the validation of the design and development and measures (ISO 9001, §

7.3.6) results of the control of design and development changes and necessary actions (ISO

9001, § 7.3.7) supplier evaluation results and necessary actions (ISO 9001, § 7.4.1), (ISO 14001, §

4.4.6) process validation when the resulting output cannot be verified by subsequent

monitoring or measurement performed retrospectively (ISO 9001, § 7.5.2) where traceability is a requirement for unique identification of the product (ISO 9001, §

7.5.3) lost, damaged or otherwise found unsuitable for use customer property (ISO 9001, §

7.5.4) results of calibration, verification and validation of measuring equipment (ISO 9001, §

7.6), (OHSAS 18001, § 4.5.1), (ISO 14001, § 4.5.1) results of internal audits and follow-up actions (ISO 9001, § 8.2.2), (ISO 14001, §

4.5.5), (OHSAS 18001, § 4.5.5) evidence of compliance with the criteria for product acceptance including (the) person

(s) authorizing release of product (ISO 9001, § 8.2.4) nature of nonconformities and actions taken (ISO 9001, § 8.3), (OHSAS 18001, §

4.5.3), (ISO 14001, § 4.5.3) results of corrective action (ISO 9001, § 8.5.2), (OHSAS 18001, § 4.5.3) (ISO 14001,

§ 4.5.3) results of preventive actions (ISO 9001, § 8.5.3), (OHSAS 18001, § 4.5.3) (ISO 14001,

§ 4.5.3) policy (OHSAS 18001, § 4.2), (ISO 14001, § 4.2) hazard identification and risk assessment (OHSAS 18001, § 4.3.1)



environmental aspects and significant environmental impacts (ISO 14001, § 4.3.1) objectives and programmes (OHSAS 18001, § 4.3.3), (ISO 14001, § 4.3.3) resources and responsibility (OHSAS 18001, § 4.4.1), (ISO 14001, § 4.4.1) communication (OHSAS 18001, § 4.4.3), (ISO 14001, § 4.4.3) scope (ISO 14001, § 4.1), (OHSAS 18001, § 4.1) legal requirements (ISO 14001, § 4.3.2), (OHSAS 18001, § 4.3.2) testing preparedness for emergencies (ISO 14001, § 4.4.7), (OHSAS 18001, § 4.4.7) performance information (ISO 14001, § 4.5.1), (OHSAS 18001, § 4.5.1) evaluation of compliance with legal requirements (ISO 14001, § 4.5.2), (OHSAS

18001, § 4.5.2) incident investigations (OHSAS 18001, § 4.5.3)

Examples of often used other records:

process capability studies costs of obtaining quality change requests concession requests customer complaints

Good practices

the quality manual is short and simplified (easy to read by all staff) the control of documents can clearly show the author, the verification and approval of

the original document and the subsequent versions managing changes to a document (the middle line of the old text, red) can quickly

show the history methods of distribution of documents are described in the procedure "Control of

documents" the hierarchy of documents is logical and clear (manual, procedures, processes,

instructions, records) the master list of documents also includes the retention period for records procedures fulfil their role of controlling situations where their absence could lead to

deviations from legal requirements some work instructions contain a paragraph recalling its purpose (such as toxic effects

on human health and the environment) external documents (standards, regulations, documents of customers, suppliers and

machines) are coded as internal documents and the location of each external document is notified in a specific list

the link between aspects, objectives, targets, programmes, monitoring and measuring is shown in some documents

review of all the IMS documentation, conducted twice a year, is very well organized, the actions are completed on time

records show compliance with legal and regulatory requirements, the requirements of QSE standards and QSE policy of the company

the procedure "Control of records" determines conditions of storage and disposal of all types of records

a list of dates for implementation of changes is available in production workshop

Bad practices

the scope of the IMS is not mentioned in any document the QSE manual is not updated



in the QSE manual exclusions are neither detailed nor justified some process sheets are not fully filled out confusion between prevention plan and emergency plan instructions for use of hazardous materials are not available locally procedures are not updated OHS and environmental specificities are not identified in certain procedures the necessity of certain documents is not evaluated real activities are not identified in any process some documents are not codified documents are not approved prior to release documents are not at the place where they are needed instructions are not updated (version before last one) at the launch meeting of a project the list of participants is not recorded the protection of documents on the network is not set external documents (customer, supplier) are not controlled (codified) retention period and methods of disposal of records are not identified no document prohibits the use of dangerous equipment (not complying with legal

requirements) records not kept until the date of disposal QSE meetings without recorded report training needs are not kept

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