One of the most commonly cited reasons for implementing an ISO 14001 environmental management system is that it helps an organization comply with environmental laws and regulations.
ISO 14001 registration will provide additional assurance to City Council, senior management, regulators and key stakeholders that appropriate procedures have been implemented to identify, track, and communicate environmental laws and regulations. ISO 14001 registration will also provide assurance that our Administration is controlling, monitoring, and improving performance, relative to these laws/regulations.
A strong environmental management system, aimed at legal/regulatory compliance, will serve the City of Edmonton by increasing the likelihood of avoiding convictions, fines and judgments; avoiding internal legal costs; and promoting positive relations with regulators.
Wednesday, October 21, 2009
Saturday, October 3, 2009
Emergency Preparedness and Response In ISO 14001
Emergency Preparedness and Response In ISO 14001
Under the Emergency Preparedness and Response requirement of ISO 14001:2004 (§4.4.7), the organization is required to establish procedures for identifying the potential for and responding to emergency situations and accidents that can have an impact on the environment.
Identification of Potential Emergency and Accident Situations – Experience indicates that organizations infrequently have a preexisting procedure for identifying potential emergency and accident situations.The norm is to establish emergency and accident responses for a variety of emergency and accident situations irrespective of the potential for their occurrence. But ISO 14001 is specific about requiring a procedure to identify the potential for emergency situations and accidents. Adhering to the requirement of the procedure is a valuable exercise that helps organizations identify weaknesses in their own emergency planning and to plan for that which is most likely to occur.Because many environmental impacts of an emergency or accident situation are secondary in nature, it appears that all potential emergency or accident situations need to be identified before a determination of environmental impacts can be made. An organization that attempts to identify potential emergency or accident situations based on a review of its environmental aspects would likely miss the environmental impact potential of, say, an automobile accident.
There are five steps implied by the emergency preparedness and response requirement:
1) Identify the potential for emergency situations and accidents of all kinds;2) Paying particular attention to the potential environmental impacts of accidents and emergency situations, identify how the organization can prevent and mitigate associated adverse environmental impacts;3) Determine how the organization and its employees should respond to emergency situations and accidents;4) Periodically simulate emergency situations to test response capabilities; and,5) Review and revise procedures based on experience derived from actual and simulated emergency situations and accidents.
Accident and Emergency Situation Identification – In order to identify potential for and responding to emergency situations and accidents, the organization should develop a procedure for systematically identifying accident and emergency situations, evaluating their probability of occurrence, their likely consequences, and their severity.Organizations often engage risk management specialists to assist in the identification of potential emergency or accident situations that could lead to human injury, environmental damage, or economic loss. While many checklists are available to facilitate this kind of evaluation, there is virtually no substitute for physical evaluation of facilities by knowledgeable personnel, whether employees or outside professionals.
Emergency Response Procedures – The organization is required to develop procedures for responding to emergency situations and accidents when they occur. Typically, response procedures include identifying public emergency response agencies and their capabilities, identifying individuals within the organization who are trained and able to provide assistance in emergencies, establishing an emergency communications network, and providing emergency lighting, signage, and equipment. Because Emergency Response Procedures are based on identified potential emergency situations and accidents specific to the organization, the emergency response plan will be unique for each organization.
Periodic Testing – The value of conducting emergency response exercises lies not only with simulating situations that could occur but also in identifying flaws in the response plan. Practice drills can be the most effective test of the system to give employees, emergency response personnel, and management the opportunity to walk through the plan and gain familiarity with its procedures. While a full-dress response exercise is valuable, testing of procedures can be effectively done on much smaller scales and still provide the benefits of testing. Above all, the organization should not let the impracticality of a full-dress exercise keep it from testing sub elements of the emergency response plan.
Review and Revise – ISO 14001 calls for continual improvement of the EMS. Periodically reviewing and revising emergency response plans based on the experience gained from the occurrence of emergency situations or accidents or in testing response plans is an example of continual improvement.
Written Response Plans – Many written emergency response plans are too cumbersome to be of value in an emergency situation – their value depends entirely upon previous training of persons who will be called upon to execute them. Yet, many organizations fail to provide the emergency response training necessary to make the plans functional.Keeping in mind that even the simplest, most direct emergency response plan requires training for effective implementation, an alternative for organizations to consider is establishment of abbreviated, readily available Immediate Response Directions established for each kind of potential emergency situation or accident. Such an emergency response plan might consist of a laminated card prepared for each potential emergency situation or accident and providing specific responsibilities and associated actions for employees and visitors, supervisors, emergency coordinators, and emergency directors.
Under the Emergency Preparedness and Response requirement of ISO 14001:2004 (§4.4.7), the organization is required to establish procedures for identifying the potential for and responding to emergency situations and accidents that can have an impact on the environment.
Identification of Potential Emergency and Accident Situations – Experience indicates that organizations infrequently have a preexisting procedure for identifying potential emergency and accident situations.The norm is to establish emergency and accident responses for a variety of emergency and accident situations irrespective of the potential for their occurrence. But ISO 14001 is specific about requiring a procedure to identify the potential for emergency situations and accidents. Adhering to the requirement of the procedure is a valuable exercise that helps organizations identify weaknesses in their own emergency planning and to plan for that which is most likely to occur.Because many environmental impacts of an emergency or accident situation are secondary in nature, it appears that all potential emergency or accident situations need to be identified before a determination of environmental impacts can be made. An organization that attempts to identify potential emergency or accident situations based on a review of its environmental aspects would likely miss the environmental impact potential of, say, an automobile accident.
There are five steps implied by the emergency preparedness and response requirement:
1) Identify the potential for emergency situations and accidents of all kinds;2) Paying particular attention to the potential environmental impacts of accidents and emergency situations, identify how the organization can prevent and mitigate associated adverse environmental impacts;3) Determine how the organization and its employees should respond to emergency situations and accidents;4) Periodically simulate emergency situations to test response capabilities; and,5) Review and revise procedures based on experience derived from actual and simulated emergency situations and accidents.
Accident and Emergency Situation Identification – In order to identify potential for and responding to emergency situations and accidents, the organization should develop a procedure for systematically identifying accident and emergency situations, evaluating their probability of occurrence, their likely consequences, and their severity.Organizations often engage risk management specialists to assist in the identification of potential emergency or accident situations that could lead to human injury, environmental damage, or economic loss. While many checklists are available to facilitate this kind of evaluation, there is virtually no substitute for physical evaluation of facilities by knowledgeable personnel, whether employees or outside professionals.
Emergency Response Procedures – The organization is required to develop procedures for responding to emergency situations and accidents when they occur. Typically, response procedures include identifying public emergency response agencies and their capabilities, identifying individuals within the organization who are trained and able to provide assistance in emergencies, establishing an emergency communications network, and providing emergency lighting, signage, and equipment. Because Emergency Response Procedures are based on identified potential emergency situations and accidents specific to the organization, the emergency response plan will be unique for each organization.
Periodic Testing – The value of conducting emergency response exercises lies not only with simulating situations that could occur but also in identifying flaws in the response plan. Practice drills can be the most effective test of the system to give employees, emergency response personnel, and management the opportunity to walk through the plan and gain familiarity with its procedures. While a full-dress response exercise is valuable, testing of procedures can be effectively done on much smaller scales and still provide the benefits of testing. Above all, the organization should not let the impracticality of a full-dress exercise keep it from testing sub elements of the emergency response plan.
Review and Revise – ISO 14001 calls for continual improvement of the EMS. Periodically reviewing and revising emergency response plans based on the experience gained from the occurrence of emergency situations or accidents or in testing response plans is an example of continual improvement.
Written Response Plans – Many written emergency response plans are too cumbersome to be of value in an emergency situation – their value depends entirely upon previous training of persons who will be called upon to execute them. Yet, many organizations fail to provide the emergency response training necessary to make the plans functional.Keeping in mind that even the simplest, most direct emergency response plan requires training for effective implementation, an alternative for organizations to consider is establishment of abbreviated, readily available Immediate Response Directions established for each kind of potential emergency situation or accident. Such an emergency response plan might consist of a laminated card prepared for each potential emergency situation or accident and providing specific responsibilities and associated actions for employees and visitors, supervisors, emergency coordinators, and emergency directors.
Migration to ISO 9001:2008
Migration To ISO 9001:2008
The International Accreditation Forum (IAF) and the International Organization forStandardization (ISO) have agreed on an implementation plan to ensure a smooth transition ofaccredited certification to ISO 9001:2008, the latest version of the world’s most widely usedstandard for quality management systems (QMS). The details of the plan are given in the jointcommuniqué by the two organizations which appears below.Like all of ISO’s more than 17 000 standards, ISO 9001 is periodically reviewed to ensure that itis maintained at the state of the art and a decision taken to confirm, withdraw or revise thedocument.ISO 9001:2008, which is due to be published before the end of the year, will replace the year2000 version of the standard which is implemented by both business and public sectororganizations in 170 countries. Although certification is not a requirement of the standard, theQMS of about one million organizations have been audited and certified by independentcertification bodies (also known in some countries as registration bodies) to ISO 9001:2000.ISO 9001 certification is frequently used in both private and public sectors to increaseconfidence in the products and services provided by certified organizations, between partnersin business-to-business relations, in the selection of suppliers in supply chains and in the rightto tender for procurement contracts.ISO is the developer and publisher of ISO 9001, but does not itself carry out auditing andcertification. These services are performed independently of ISO by certification bodies. ISOdoes not control such bodies, but does develop voluntary International Standards toencourage good practice in their activities on a worldwide basis. For example, ISO/IEC17021:2006 specifies the requirements for bodies providing auditing and certification ofmanagement systems.Certification bodies that wish to provide further confidence in their services may apply to be“accredited” as competent by an IAF recognized national accreditation body. ISO/IEC17011:2004 specifies the requirements for carrying out such accreditation. IAF is aninternational association whose membership includes the national accreditation bodies of 49economies.ISO technical committee ISO/TC 176, Quality management and quality assurance, which isresponsible for the ISO 9000 family of standards, is preparing a number of support documentsexplaining what the differences are between ISO 9001:2008 and the year 2000 version, whyand what they mean for users. Once approved, these documents will be posted on the ISOWeb site – probably in October 2008.
ISO (International Organization for Standardization) and the IAF (International AccreditationForum) have agreed an implementation plan to ensure a smooth migration of accreditedcertification to ISO 9001:2008, after consultation with international groupings representingquality system or auditor certification bodies, and industry users of ISO 9001 certificationservices.ISO 9001:2008 does not contain any new requirementsThey have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008only introduces clarifications to the existing requirements of ISO 9001:2000 based on eightyears of experience of implementing the standard world wide with about one millioncertificates issued in 170 countries to date. It also introduces changes intended to improveconsistency with ISO14001:2004The agreed implementation plan in relation to accredited certification is therefore thefollowing:Accredited certification to the ISO 9001:2008 shall not be granted until the publication of ISO9001:2008 as an International Standard.Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issuedafter official publication of ISO 9001:2008 (which should take place before the end of 2008)and after a routine surveillance or recertification audit against ISO 9001:2008.Validity of certifications to ISO 9001:2000One year after publication of ISO 9001:2008 all accredited certifications issued (newcertifications or recertifications) shall be to ISO 9001:2008.Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issuedto ISO 9001:2000 shall not be valid.
The International Accreditation Forum (IAF) and the International Organization forStandardization (ISO) have agreed on an implementation plan to ensure a smooth transition ofaccredited certification to ISO 9001:2008, the latest version of the world’s most widely usedstandard for quality management systems (QMS). The details of the plan are given in the jointcommuniqué by the two organizations which appears below.Like all of ISO’s more than 17 000 standards, ISO 9001 is periodically reviewed to ensure that itis maintained at the state of the art and a decision taken to confirm, withdraw or revise thedocument.ISO 9001:2008, which is due to be published before the end of the year, will replace the year2000 version of the standard which is implemented by both business and public sectororganizations in 170 countries. Although certification is not a requirement of the standard, theQMS of about one million organizations have been audited and certified by independentcertification bodies (also known in some countries as registration bodies) to ISO 9001:2000.ISO 9001 certification is frequently used in both private and public sectors to increaseconfidence in the products and services provided by certified organizations, between partnersin business-to-business relations, in the selection of suppliers in supply chains and in the rightto tender for procurement contracts.ISO is the developer and publisher of ISO 9001, but does not itself carry out auditing andcertification. These services are performed independently of ISO by certification bodies. ISOdoes not control such bodies, but does develop voluntary International Standards toencourage good practice in their activities on a worldwide basis. For example, ISO/IEC17021:2006 specifies the requirements for bodies providing auditing and certification ofmanagement systems.Certification bodies that wish to provide further confidence in their services may apply to be“accredited” as competent by an IAF recognized national accreditation body. ISO/IEC17011:2004 specifies the requirements for carrying out such accreditation. IAF is aninternational association whose membership includes the national accreditation bodies of 49economies.ISO technical committee ISO/TC 176, Quality management and quality assurance, which isresponsible for the ISO 9000 family of standards, is preparing a number of support documentsexplaining what the differences are between ISO 9001:2008 and the year 2000 version, whyand what they mean for users. Once approved, these documents will be posted on the ISOWeb site – probably in October 2008.
ISO (International Organization for Standardization) and the IAF (International AccreditationForum) have agreed an implementation plan to ensure a smooth migration of accreditedcertification to ISO 9001:2008, after consultation with international groupings representingquality system or auditor certification bodies, and industry users of ISO 9001 certificationservices.ISO 9001:2008 does not contain any new requirementsThey have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008only introduces clarifications to the existing requirements of ISO 9001:2000 based on eightyears of experience of implementing the standard world wide with about one millioncertificates issued in 170 countries to date. It also introduces changes intended to improveconsistency with ISO14001:2004The agreed implementation plan in relation to accredited certification is therefore thefollowing:Accredited certification to the ISO 9001:2008 shall not be granted until the publication of ISO9001:2008 as an International Standard.Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issuedafter official publication of ISO 9001:2008 (which should take place before the end of 2008)and after a routine surveillance or recertification audit against ISO 9001:2008.Validity of certifications to ISO 9001:2000One year after publication of ISO 9001:2008 all accredited certifications issued (newcertifications or recertifications) shall be to ISO 9001:2008.Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issuedto ISO 9001:2000 shall not be valid.
Nonconformity, Corrective Action and Preventive Action in ISO 14001 EMS
The intent of §4.5.3 is that the organization put in place procedures for 1) identifying actual and potential nonconformities to EMS requirements, 2) taking appropriate corrective or preventive action, and 3) reviewing the effectiveness of corrective or preventive actions taken.The nonconformity requirement of ISO 14001:1996 was a passive requirement in that it was only triggered when a nonconformity came to the attention of the organization through one of the other EMS procedures, such as the EMS audit or management review. ISO 14001:2004, however, requires that the organization establish and maintain procedures to identify actual or potential nonconformities, determine their causes, take action to avoid recurrence or occurrence, record results, and review effectiveness of corrective or preventive actions.
How the organization goes about identifying actual or potential nonconformities is up to it to determine. From the standpoint of registration auditors, it would seem that they would want to see a specific procedure requiring members of the organization to conduct some kind of periodic checklist driven, walk-through inspection for nonconformities. In addition, the procedure should allow for submission of nonconformities by any member of the organization. Actual nonconformities are usually fairly evident and relatively easy to investigate because there is a tangible occurrence with which to deal. The organization should also want to evaluate minor instances of nonconformity that, while not significant in and of themselves, if they occurred under different circumstances, could lead to a significant deviation from the EMS. Such “near misses” could be identified by the occurrence of a sudden, unexpected event, a failure to achieve an objective or target, or a deviation from the Environmental Policy.Potential nonconformities are more difficult to identify and correct. Here, application of Failure Mode and Effects Analysis would be appropriate for organizations having that capability.
When investigating nonconformities, organizations should focus on identifying underlying root causes, not just the immediate manifestation of the problem. If a chemical storage drum leaks, the organization should take action, first, to mitigate the damage and, then, to determine why the leak occurred; e.g., improper or negligent handling, mechanical failure, or lack of a leak detection system. Corrective or preventive actions should then focus on eliminating the cause through training, communication of procedures, use of leak-resistant drums, or installation of a leak detection system.
Other ISO 14001 sections, principally Emergency Preparedness and Response, Internal Audit, and Management Review, are tools that the organization implements in order to help identify instances of actual or potential nonconformity. The underlying principle of these sections is that the identification of nonconformities should be made by the organization through diligent application of these tools, not from the occurrence of an environmental event, a customer or community complaint, or investigation by a regulatory authority. While §4.5.3 does not specifically mention disciplinary action, in many cases disciplinary action or the threat of disciplinary action is appropriate to prevention of future nonconformities. Many organizations have written codes of conduct that give employees notice that deviations from the codes will not be tolerated and that prescribed penalties can result for infractions. These codes can be expanded to include penalties for deviations from the EMS. If so, penalties should be commensurate with the violation itself and should acknowledge the nature of the environmental damage, the degree of negligence, prior conduct, and the forthrightness of the employee being disciplined. Any such code and its remedies should be administered fairly and consistently and should have as its objective correction and prevention of EMS nonconformities, not punishment of employees.Finally, identification, investigation, and correction of nonconformities leads to the need to revise documented procedures.
How the organization goes about identifying actual or potential nonconformities is up to it to determine. From the standpoint of registration auditors, it would seem that they would want to see a specific procedure requiring members of the organization to conduct some kind of periodic checklist driven, walk-through inspection for nonconformities. In addition, the procedure should allow for submission of nonconformities by any member of the organization. Actual nonconformities are usually fairly evident and relatively easy to investigate because there is a tangible occurrence with which to deal. The organization should also want to evaluate minor instances of nonconformity that, while not significant in and of themselves, if they occurred under different circumstances, could lead to a significant deviation from the EMS. Such “near misses” could be identified by the occurrence of a sudden, unexpected event, a failure to achieve an objective or target, or a deviation from the Environmental Policy.Potential nonconformities are more difficult to identify and correct. Here, application of Failure Mode and Effects Analysis would be appropriate for organizations having that capability.
When investigating nonconformities, organizations should focus on identifying underlying root causes, not just the immediate manifestation of the problem. If a chemical storage drum leaks, the organization should take action, first, to mitigate the damage and, then, to determine why the leak occurred; e.g., improper or negligent handling, mechanical failure, or lack of a leak detection system. Corrective or preventive actions should then focus on eliminating the cause through training, communication of procedures, use of leak-resistant drums, or installation of a leak detection system.
Other ISO 14001 sections, principally Emergency Preparedness and Response, Internal Audit, and Management Review, are tools that the organization implements in order to help identify instances of actual or potential nonconformity. The underlying principle of these sections is that the identification of nonconformities should be made by the organization through diligent application of these tools, not from the occurrence of an environmental event, a customer or community complaint, or investigation by a regulatory authority. While §4.5.3 does not specifically mention disciplinary action, in many cases disciplinary action or the threat of disciplinary action is appropriate to prevention of future nonconformities. Many organizations have written codes of conduct that give employees notice that deviations from the codes will not be tolerated and that prescribed penalties can result for infractions. These codes can be expanded to include penalties for deviations from the EMS. If so, penalties should be commensurate with the violation itself and should acknowledge the nature of the environmental damage, the degree of negligence, prior conduct, and the forthrightness of the employee being disciplined. Any such code and its remedies should be administered fairly and consistently and should have as its objective correction and prevention of EMS nonconformities, not punishment of employees.Finally, identification, investigation, and correction of nonconformities leads to the need to revise documented procedures.
Evaluation Of Compliance Of ISO 14001 EMS
The requirement to establish a procedure for periodically evaluating compliance with applicable legal and other requirements falls short of specifically requiring regulatory compliance audits but, in fact, a system of regular regulatory compliance audits may be the most practical means for meeting this requirement of the standard. In the U.S., determination of whether to conduct a compliance audit will be governed in part by the particular jurisdiction’s approach to allowing a legal privilege for the self-assessment audit.
Evaluation vs. Audit – The difference between an evaluation and audit can only be determined by looking outside of ISO 14001. Consulting a dictionary reveals that an evaluation involves a determination of value or worth and that an audit is an examination of accounts done by persons appointed for the purpose. A better definition `is the more specific ISO 19011:2002, Guidelines for Quality and/or Environmental Management Systems Auditing, which defines an audit as a “systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.” Many organizations do not have a system for evaluating regulatory compliance other than their own records and the inspections of regulatory officials. This lack of a verification system can be a risky way to operate. Reports of enforcement actions and consent agreements show that many organizations are blindsided by rogue employees who violate rules and falsify documents to cover up environmental misdeeds. Although ISO 14001 does not prescribe a specific approach to evaluation of regulatory compliance, organizations should consider methods for going beyond verification of records by collecting and evaluating physical evidence.
Evaluation vs. Audit – The difference between an evaluation and audit can only be determined by looking outside of ISO 14001. Consulting a dictionary reveals that an evaluation involves a determination of value or worth and that an audit is an examination of accounts done by persons appointed for the purpose. A better definition `is the more specific ISO 19011:2002, Guidelines for Quality and/or Environmental Management Systems Auditing, which defines an audit as a “systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.” Many organizations do not have a system for evaluating regulatory compliance other than their own records and the inspections of regulatory officials. This lack of a verification system can be a risky way to operate. Reports of enforcement actions and consent agreements show that many organizations are blindsided by rogue employees who violate rules and falsify documents to cover up environmental misdeeds. Although ISO 14001 does not prescribe a specific approach to evaluation of regulatory compliance, organizations should consider methods for going beyond verification of records by collecting and evaluating physical evidence.
Continual improvement in the quality management In ISO 9001
Continual improvement in the quality management system and its processes In ISO 9001
The standard requires the organization to continually improve the effectiveness of the quality management system in accordance with the requirements of ISO 9001 and to implement action necessary to achieve planned results andcontinual improvement of the identified processes.
ISO 9000 defines continual improvement as a recurring activity to increase the ability to fulfil requirements. As the organization’s objectives are its requirements, continually improving the effectiveness of the management system means continually increasing the ability of the organization to fulfil its objectives.
This requirement responds to the Continual Improvement principle. If the management system is enabling the organization to accomplish its objectives when that is its purpose, why improve? The need for improvement arises out of a need to become more effective at what you do, more efficient in the utilization of resources so that the organization becomes best in its class. The purpose of measuring process performance is to establish whether or not the objectives are being achieved and if not to take action on the difference. If the performance targets are being achieved, opportunities may well exist to raise standards and increase efficiency and effectiveness.
If the performance of a process parameter is currently meeting the standard that has been established, there are several improvement actions you can take:Raise the standard e.g. if the norm for the sales ratio of orders won to all orders bid is 60%, an improvement programme could be developed for raising the standard to 75% or higherIncrease efficiency e.g. if the time to process an order is within limits, identify and eliminate wasted resources Increase effectiveness e.g. if you bid against all customer requests, by only bidding for those you know you can win you improve your hit rate
You can call all these actions improvement actions because they clearly improve performance. However, we need to distinguish between being better at what we do now and doing new things. Some may argue that improving efficiency is being better at what we do now, and so it is – but if in order to improve efficiency we have to be innovative we are truly reaching new standards. Forty years ago, supervisors in industry would cut an eraser in half in the name of efficiency rather than hand out two erasers. Clearly this was a lack of trust disguised as efficiency improvement and it had quite the opposite effect. In fact they were not only increasing waste but also creating a hostile environment.
Each of the improvement actions is dealt with later in the book and the subject of continual improvement addressed again under Quality planning in Chapter 5. There are several steps to undertaking continual improvement (Juran, J. M., 1995)12 .1 Determine current performance2 Establish the need for change3 Obtain commitment and define the improvement objectives4 Organize diagnostic resources5 Carry out research and analysis to discover the cause of currentperformance6 Define and test solutions that will accomplish the improvementobjectives7 Product improvement plans which specify how and by whom the changeswill be implemented8 Identify and overcome any resistance to change9 Implement the change10 Put in place controls to hold new levels of performance and repeat step one.
The standard requires the organization to continually improve the effectiveness of the quality management system in accordance with the requirements of ISO 9001 and to implement action necessary to achieve planned results andcontinual improvement of the identified processes.
ISO 9000 defines continual improvement as a recurring activity to increase the ability to fulfil requirements. As the organization’s objectives are its requirements, continually improving the effectiveness of the management system means continually increasing the ability of the organization to fulfil its objectives.
This requirement responds to the Continual Improvement principle. If the management system is enabling the organization to accomplish its objectives when that is its purpose, why improve? The need for improvement arises out of a need to become more effective at what you do, more efficient in the utilization of resources so that the organization becomes best in its class. The purpose of measuring process performance is to establish whether or not the objectives are being achieved and if not to take action on the difference. If the performance targets are being achieved, opportunities may well exist to raise standards and increase efficiency and effectiveness.
If the performance of a process parameter is currently meeting the standard that has been established, there are several improvement actions you can take:Raise the standard e.g. if the norm for the sales ratio of orders won to all orders bid is 60%, an improvement programme could be developed for raising the standard to 75% or higherIncrease efficiency e.g. if the time to process an order is within limits, identify and eliminate wasted resources Increase effectiveness e.g. if you bid against all customer requests, by only bidding for those you know you can win you improve your hit rate
You can call all these actions improvement actions because they clearly improve performance. However, we need to distinguish between being better at what we do now and doing new things. Some may argue that improving efficiency is being better at what we do now, and so it is – but if in order to improve efficiency we have to be innovative we are truly reaching new standards. Forty years ago, supervisors in industry would cut an eraser in half in the name of efficiency rather than hand out two erasers. Clearly this was a lack of trust disguised as efficiency improvement and it had quite the opposite effect. In fact they were not only increasing waste but also creating a hostile environment.
Each of the improvement actions is dealt with later in the book and the subject of continual improvement addressed again under Quality planning in Chapter 5. There are several steps to undertaking continual improvement (Juran, J. M., 1995)12 .1 Determine current performance2 Establish the need for change3 Obtain commitment and define the improvement objectives4 Organize diagnostic resources5 Carry out research and analysis to discover the cause of currentperformance6 Define and test solutions that will accomplish the improvementobjectives7 Product improvement plans which specify how and by whom the changeswill be implemented8 Identify and overcome any resistance to change9 Implement the change10 Put in place controls to hold new levels of performance and repeat step one.
Preparing the ISO 9001 quality manual
The standard requires a quality manual to be establishedand maintained that includes the scope of the qualitymanagement system, the documented procedures or refer-ence to them and a description of the sequence andinteraction of processes included in the quality manage-ment system.
ISO 9000 defines a quality manual as a documentspecifying the quality management system of an organi-zation. It is therefore not intended that themanual be a response to the requirements ofISO 9001. As the top-level document describingthe management system it is a system descriptiondescribing how the organization is managed.Countless quality manuals produced to satisfy ISO 9000 :2008, were nomore than 20 sections that paraphrased the requirements of the standard.Such documentation adds no value. They are of no use to managers, staff orauditors. Often thought to be useful to customers, organizations would gainno more confidence from customers than would be obtained from theirregistration certificate.
This requirement responds to the System Approach Principle.A description of the management system is necessary as a means of showinghow all the processes are interconnected and how they collectively deliver thebusiness outputs. It has several uses as :a means to communicate the vision, values, mission, policies and objectivesof the organizationa means of showing how the system has been designeda means of showing linkages between processesa means of showing who does whatan aid to training new peoplea tool in the analysis of potential improvementsa means of demonstrating compliance with external standards and regulations
When formulating the policies, objectives and identifying the processes toachieve them, the manual provides a convenient vehicle for containing suchinformation. If left as separate pieces of information, it may be more difficult tosee the linkages.The requirement provides the framework for the manual. Its content maytherefore include the following:1 Introduction(a) Purpose (of the manual)(b) Scope (of the manual)(c) Applicability (of the manual)(d) Definitions (of terms used in the manual)2 Business overview(a) Nature of the business/organization – its scope of activity, its productsand services(b) The organization’s interested parties (customers, employees, regulators,shareholders, suppliers, owners etc.)(c) The context diagram showing the organization relative to its externalenvironment(d) Vision, values(e) Mission3 Organization(a) Function descriptions(b) Organization chart(c) Locations with scope of activity4 Business processes(a) The system model showing the key business processes and how they areinterconnected(b) System performance indicators and method of measurement(c) Business planning process description(d) Resource management process description(e) Marketing process description(f) Product/service generation processes description(g) Sales process description(h) Order fulfilment process description5 Function matrix (Relationship of functions to processes)6 Location matrix (Relationship of locations to processes)7 Requirement deployment matrices(a) ISO 9001 compliance matrix(b) ISO 14001 compliance matrix(c) Regulation compliance matrices (FDA, Environment, Health, Safety,CAA etc.)8 Approvals (List of current product, process and system approvals)
ISO 9000 defines a quality manual as a documentspecifying the quality management system of an organi-zation. It is therefore not intended that themanual be a response to the requirements ofISO 9001. As the top-level document describingthe management system it is a system descriptiondescribing how the organization is managed.Countless quality manuals produced to satisfy ISO 9000 :2008, were nomore than 20 sections that paraphrased the requirements of the standard.Such documentation adds no value. They are of no use to managers, staff orauditors. Often thought to be useful to customers, organizations would gainno more confidence from customers than would be obtained from theirregistration certificate.
This requirement responds to the System Approach Principle.A description of the management system is necessary as a means of showinghow all the processes are interconnected and how they collectively deliver thebusiness outputs. It has several uses as :a means to communicate the vision, values, mission, policies and objectivesof the organizationa means of showing how the system has been designeda means of showing linkages between processesa means of showing who does whatan aid to training new peoplea tool in the analysis of potential improvementsa means of demonstrating compliance with external standards and regulations
When formulating the policies, objectives and identifying the processes toachieve them, the manual provides a convenient vehicle for containing suchinformation. If left as separate pieces of information, it may be more difficult tosee the linkages.The requirement provides the framework for the manual. Its content maytherefore include the following:1 Introduction(a) Purpose (of the manual)(b) Scope (of the manual)(c) Applicability (of the manual)(d) Definitions (of terms used in the manual)2 Business overview(a) Nature of the business/organization – its scope of activity, its productsand services(b) The organization’s interested parties (customers, employees, regulators,shareholders, suppliers, owners etc.)(c) The context diagram showing the organization relative to its externalenvironment(d) Vision, values(e) Mission3 Organization(a) Function descriptions(b) Organization chart(c) Locations with scope of activity4 Business processes(a) The system model showing the key business processes and how they areinterconnected(b) System performance indicators and method of measurement(c) Business planning process description(d) Resource management process description(e) Marketing process description(f) Product/service generation processes description(g) Sales process description(h) Order fulfilment process description5 Function matrix (Relationship of functions to processes)6 Location matrix (Relationship of locations to processes)7 Requirement deployment matrices(a) ISO 9001 compliance matrix(b) ISO 14001 compliance matrix(c) Regulation compliance matrices (FDA, Environment, Health, Safety,CAA etc.)8 Approvals (List of current product, process and system approvals)
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