INTERNAL QUALITY AUDIT

THE NEED FOR AUDITING A quality management system is a management system designed to provide assurance of quality The system is documented in the quality manual quality procedures and instructions and it is necessary that such a quality management system meets the requirements the ISO 9001 2000 quality management system The question arise how how do you check that satisfactory quality management system is operating In other words how do you obtain assurance that quality management system is

1 Adequately defined documented and understood 2 Is being followed and effectively implemented 3 Provide the correct degree of assurance to our product or services You can only check these points by carrying out an audit of the quality management system Auditing is method of formally and systematically checking a quality management system to see if these three requirements are being met It is therefore one of the most important part of the quality management system because it provide the proof that the quality management system is adequate and meeting the requirements of the standard Consequently it also exposes inadequacies in the quality management system Auditing is a means of gaining information in an independent and unbiased manner Information about what we have achieved or about the means of achievement Auditing enables us to establish if our systems are being followed and if they are fully effective This information enables us to proceed with confidence Systems

ISO 9000 2000 definitions Audit ldquoSystematic independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilledrdquo Audit Criteria ldquoSet of polices procedures or requirements used as a referencerdquo Auditor ldquoPerson with the competence to conduct an auditrdquo

Quality System Audit A systematic investigation of the intent the implementation and the effectiveness of selected aspects of the quality system of an organization

In order to obtain information about how the work within various processes is actually performed it is possible to use process quality audits Audits of this type are carried out by studying the actual conditions that exist at each work stage and work station The various factors which influence the quality result of each process or operation are taken into account Examples of factors include - use of the right documentation such as job descriptions and process instructions - use of the right materials - compliance with the above documentation - execution of prescribed follow-up and control activities

By G R P K Perera Lecturer CoT Kandy

- conduction of equipment - checking and calibration of measuring devices and instruments - orderliness at the work station

TYPES OF AUDITS There are three types of audit bull First party bull Second party bull Third party First party (internal Audit) Definition An audit by the organization of its own systems and procedures Objective To assure maintenance development and improvement of the quality system Second Party (External Audit) Definition An audit by the organization on its suppliers and sub-contractors Objective - to determine suitability of suppliers - to appraise suppliersub contractors performance - to ensure that suppliers have the capability to supply product - to meet purchasing requirements Third party audit (External Audit) Definition an audit by a body which is commercially and contractually independent of the organization its suppliers and customers In this context an audit by certification body on a quality system standard Objective to determine whether an organizationrsquos quality system has been documentation and implemented in accordance with a specified standard

ISO 19011 AND AUDITOR COMPETENCE The standard provides guidance on audit principles the management of audit programmes audit conduct and auditor competency requirements It has been prepared in a general way so as to be applicable to different industries and organisations is equally applicable to First Second and Third Party auditing and is now used as the basis for audit approaches throughout the world and by a diverse range of organisations undertaking audits and assessments There are of course variations in the particular approaches adopted however it is generally acknowledged that ISO 19011 provides a good foundation for audit activities It is important to note that ISO 19011 makes it quite clear that an auditor always has a client and the sole purpose of undertaking an audit is to provide the client with information In other words audits are not undertaken to keep auditors employed or for the benefit of the auditors

Structure of ISO 19001 ISO 190011 provides guidance on the management of audit programmes audit conduct and auditor competency requirements It has been prepared in a general way so as to be applicable to different industries and organisations and provides guidance that is intended to be flexible in the way that it is applied dependent upon the size nature and complexity of the organisation to be audited as well as the objectives and scope of the audit to be conducted The guidance is provided in the following clauses Clause 4 - Principles of auditing

By G R P K Perera Lecturer CoT Kandy

Clause 5 - Guidance on managing audit programmes Clause 6 - Guidance on audit conduct Clause 7 - Guidance on competency requirements and auditor evaluation

Principles of auditing Reliance on a) Ethical conduct b) Fair presentation c) Due professional care d) Independence e) Evidence based approach

Managing Audit Programmes An audit programme comprises a series of audits undertaken over a specified period of time Such a programme needs to be effectively managed

Audit activities Initiating the audit (audits normally initiated by a client ndashhere by management or MR) Defining (or confirming) audit objectives scope and criteria Selecting the audit team Conducting document review and planning and the Preparing for the on-site audit activities audit activities (stage 1 of Audit) Conducting the on-site audit activities (stage 2 of an Audit) Preparing approving and distributing the audit report Completing the audit (normally considered complete once report issued) Conducting audit follow up (if requested to do so by the client)

THE AUDIT PROCESS It will be found that this approach is very similar to that detailed in ISO 19011 (guide to Quality Systems Auditing) and is believed to be a desirable approach to encourage The general assessment process involves the following

By G R P K Perera Lecturer CoT Kandy

Education work experience auditor training and audit experience Auditors should have a) education that provides a good foundation for their intended field of auditing coupled with appropriate knowledge and skills b) work experience in an environment that contributes to the development of their knowledge and skills Audit team leaders should have a) additional knowledge and skills in team audit leadership to facilitate efficient and effective conduct of an audit eg audit planning communication organising and directing reaching conclusions preventing and resolving conflict audit reporting

PROCESS MANAGEMENT

Monitoring and Improvement

ISO 9001 2000 focuses very much on the need for an organization to adopt a lsquoprocessrsquo approach when designing implementing and improving a quality management system and verification that this has been undertaken in an effective manner will place heavy demands on an assessment team leader to construct a suitable assessment schedule and associated audit samples for the various team members It will require the team leader tot develop a very good understanding of the organization the various processes that are in operation and how they interact with each other Process analysis will need to be performed in greater depth before the assessment schedule can be finalized Process analysis which should have been undertaken by auditors in the past will not be very necessary and an essential tool within the auditorrsquos toolbox This will need to be undertaken at two levels at the first level process analysis will involve looking at the organization at the macro level to understand the nature of the business the processes involved and the general sequence and interaction of these processes At the micro level it will involve the examination of individual processes to clearly understand how the process functions is managed and outputs measured against any performance standard

lsquoCross functional processrsquo are processes that lsquoflowrsquo through the different company lsquofunctionalrsquo areas or departments and auditors will need to consider to verify particular aspects of such processes There will also be important outputs from processes and it will be necessary for auditors to clearly understand what these outputs should be and if they are satisfying the appropriate criteria For a full assessment of an organization to verify conformity with ISO 9001 2000 it will be very necessary for significant identified lsquoprocessesrsquo as well as those specifically referred to in ISO 9001 to be carefully audited to ensure that there has been adequate and effective planning control and monitoring of such processes The assessment will need to focus on not only on the processes themselves but also the inputs and outputs from them to establish if specified requirements for each are being met In particular there will be some key quality management system processes that will need to be fully verified An assessment team leader will wish to verify rsquo41 General Requirements in relation to the most important (or significant) processes undertaken by the company

By G R P K Perera Lecturer CoT Kandy

There will also be feedback of performance from both the process and process output monitoring activities that will be used to continually improve the Process management activity Here there is an important link into 84 lsquoAnalysis of datarsquo which holds the key to an organizationrsquos improvement focus and activities relating to process improvement and subsequently leads in to 562 lsquoManagementrsquo Review where management need to work with the results of data analysis to determine the need for process and quality management system improvement For Process Management an auditor would wish to see that there has been adequate process planning and hence would wish to verify that the elements of lsquo41 General Requirementsrsquo have been applied PROCESSProcess Inputs Monitoring of the Process and Process outputs Management of the Process outputs Process outputs

Together with the general planning requirement of lsquo71 Planning of product realizationrsquo thus The auditor would then wish to verify that the planned actins are being implemented in an effective manner In relation to the Process monitoring again there are elements of lsquo41 General Requirementsrsquo that the auditor would wish to verify that is For the process output the auditor would need to verify lsquo824 Monitoring and measurement of Productrsquo and finally the auditor may wish to verify that use is being made of data provided from the process monitoring and product (process output) monitoring activities as an input to the continual improvement process Thus will require an auditor to establish if there is an adequate link between 823824 (taking due account of customer satisfaction) and 84 conforming with the organizations quality policy and related objectives and subsequently 56 Thus for any of the organizations processes there are some general requirements that the team leader may wish individual auditors to verify This may be undertaken on a general basis relating to the organizations Quality planning process or specifically to some of the most significant product realization processes undertaken by the organization The assessment team leader will need to decide which processes are to be the focus of audit attention and objective evidence of compliance Have the criteria and methods required to ensure the effective operation and control of the process been determined Have the necessary resources and information to support the operation of the process been determined Are the actins necessary to a planned results and continued improvement of the process being implemented Have the quality objectives and requirements for the product (process output) been determined Are necessary documents and resources specific to the product (process output) available to support eh process Have the required verification validation monitoring inspection and test activities specific to the product (process output) been determined Have the quality records needed to provide evidence that the process and the product (process output)meet requirements been determined 10487071048707Have the necessary resources and information to support eh monitoring of the process been determined 10487071048707Have the process measurement monitoring and analytical methods been determined 10487071048707together with the more specific elements of 823 Monitoring and measurement of processes 10487071048707Is the organization applying suitable methods for monitoring and or measurement of the process 10487071048707Do these methods demonstrate the ability of the process to achieve planned results 10487071048707Where processes are found to be nonconforming is corrective action taken to ensure conformity of product

By G R P K Perera Lecturer CoT Kandy

By G R P K Perera Lecturer CoT Kandy

- conduction of equipment - checking and calibration of measuring devices and instruments - orderliness at the work station

TYPES OF AUDITS There are three types of audit bull First party bull Second party bull Third party First party (internal Audit) Definition An audit by the organization of its own systems and procedures Objective To assure maintenance development and improvement of the quality system Second Party (External Audit) Definition An audit by the organization on its suppliers and sub-contractors Objective - to determine suitability of suppliers - to appraise suppliersub contractors performance - to ensure that suppliers have the capability to supply product - to meet purchasing requirements Third party audit (External Audit) Definition an audit by a body which is commercially and contractually independent of the organization its suppliers and customers In this context an audit by certification body on a quality system standard Objective to determine whether an organizationrsquos quality system has been documentation and implemented in accordance with a specified standard

ISO 19011 AND AUDITOR COMPETENCE The standard provides guidance on audit principles the management of audit programmes audit conduct and auditor competency requirements It has been prepared in a general way so as to be applicable to different industries and organisations is equally applicable to First Second and Third Party auditing and is now used as the basis for audit approaches throughout the world and by a diverse range of organisations undertaking audits and assessments There are of course variations in the particular approaches adopted however it is generally acknowledged that ISO 19011 provides a good foundation for audit activities It is important to note that ISO 19011 makes it quite clear that an auditor always has a client and the sole purpose of undertaking an audit is to provide the client with information In other words audits are not undertaken to keep auditors employed or for the benefit of the auditors

Structure of ISO 19001 ISO 190011 provides guidance on the management of audit programmes audit conduct and auditor competency requirements It has been prepared in a general way so as to be applicable to different industries and organisations and provides guidance that is intended to be flexible in the way that it is applied dependent upon the size nature and complexity of the organisation to be audited as well as the objectives and scope of the audit to be conducted The guidance is provided in the following clauses Clause 4 - Principles of auditing

By G R P K Perera Lecturer CoT Kandy

Clause 5 - Guidance on managing audit programmes Clause 6 - Guidance on audit conduct Clause 7 - Guidance on competency requirements and auditor evaluation

Principles of auditing Reliance on a) Ethical conduct b) Fair presentation c) Due professional care d) Independence e) Evidence based approach

Managing Audit Programmes An audit programme comprises a series of audits undertaken over a specified period of time Such a programme needs to be effectively managed

Audit activities Initiating the audit (audits normally initiated by a client ndashhere by management or MR) Defining (or confirming) audit objectives scope and criteria Selecting the audit team Conducting document review and planning and the Preparing for the on-site audit activities audit activities (stage 1 of Audit) Conducting the on-site audit activities (stage 2 of an Audit) Preparing approving and distributing the audit report Completing the audit (normally considered complete once report issued) Conducting audit follow up (if requested to do so by the client)

THE AUDIT PROCESS It will be found that this approach is very similar to that detailed in ISO 19011 (guide to Quality Systems Auditing) and is believed to be a desirable approach to encourage The general assessment process involves the following

By G R P K Perera Lecturer CoT Kandy

Education work experience auditor training and audit experience Auditors should have a) education that provides a good foundation for their intended field of auditing coupled with appropriate knowledge and skills b) work experience in an environment that contributes to the development of their knowledge and skills Audit team leaders should have a) additional knowledge and skills in team audit leadership to facilitate efficient and effective conduct of an audit eg audit planning communication organising and directing reaching conclusions preventing and resolving conflict audit reporting

PROCESS MANAGEMENT

Monitoring and Improvement

ISO 9001 2000 focuses very much on the need for an organization to adopt a lsquoprocessrsquo approach when designing implementing and improving a quality management system and verification that this has been undertaken in an effective manner will place heavy demands on an assessment team leader to construct a suitable assessment schedule and associated audit samples for the various team members It will require the team leader tot develop a very good understanding of the organization the various processes that are in operation and how they interact with each other Process analysis will need to be performed in greater depth before the assessment schedule can be finalized Process analysis which should have been undertaken by auditors in the past will not be very necessary and an essential tool within the auditorrsquos toolbox This will need to be undertaken at two levels at the first level process analysis will involve looking at the organization at the macro level to understand the nature of the business the processes involved and the general sequence and interaction of these processes At the micro level it will involve the examination of individual processes to clearly understand how the process functions is managed and outputs measured against any performance standard

lsquoCross functional processrsquo are processes that lsquoflowrsquo through the different company lsquofunctionalrsquo areas or departments and auditors will need to consider to verify particular aspects of such processes There will also be important outputs from processes and it will be necessary for auditors to clearly understand what these outputs should be and if they are satisfying the appropriate criteria For a full assessment of an organization to verify conformity with ISO 9001 2000 it will be very necessary for significant identified lsquoprocessesrsquo as well as those specifically referred to in ISO 9001 to be carefully audited to ensure that there has been adequate and effective planning control and monitoring of such processes The assessment will need to focus on not only on the processes themselves but also the inputs and outputs from them to establish if specified requirements for each are being met In particular there will be some key quality management system processes that will need to be fully verified An assessment team leader will wish to verify rsquo41 General Requirements in relation to the most important (or significant) processes undertaken by the company

By G R P K Perera Lecturer CoT Kandy

There will also be feedback of performance from both the process and process output monitoring activities that will be used to continually improve the Process management activity Here there is an important link into 84 lsquoAnalysis of datarsquo which holds the key to an organizationrsquos improvement focus and activities relating to process improvement and subsequently leads in to 562 lsquoManagementrsquo Review where management need to work with the results of data analysis to determine the need for process and quality management system improvement For Process Management an auditor would wish to see that there has been adequate process planning and hence would wish to verify that the elements of lsquo41 General Requirementsrsquo have been applied PROCESSProcess Inputs Monitoring of the Process and Process outputs Management of the Process outputs Process outputs

Together with the general planning requirement of lsquo71 Planning of product realizationrsquo thus The auditor would then wish to verify that the planned actins are being implemented in an effective manner In relation to the Process monitoring again there are elements of lsquo41 General Requirementsrsquo that the auditor would wish to verify that is For the process output the auditor would need to verify lsquo824 Monitoring and measurement of Productrsquo and finally the auditor may wish to verify that use is being made of data provided from the process monitoring and product (process output) monitoring activities as an input to the continual improvement process Thus will require an auditor to establish if there is an adequate link between 823824 (taking due account of customer satisfaction) and 84 conforming with the organizations quality policy and related objectives and subsequently 56 Thus for any of the organizations processes there are some general requirements that the team leader may wish individual auditors to verify This may be undertaken on a general basis relating to the organizations Quality planning process or specifically to some of the most significant product realization processes undertaken by the organization The assessment team leader will need to decide which processes are to be the focus of audit attention and objective evidence of compliance Have the criteria and methods required to ensure the effective operation and control of the process been determined Have the necessary resources and information to support the operation of the process been determined Are the actins necessary to a planned results and continued improvement of the process being implemented Have the quality objectives and requirements for the product (process output) been determined Are necessary documents and resources specific to the product (process output) available to support eh process Have the required verification validation monitoring inspection and test activities specific to the product (process output) been determined Have the quality records needed to provide evidence that the process and the product (process output)meet requirements been determined 10487071048707Have the necessary resources and information to support eh monitoring of the process been determined 10487071048707Have the process measurement monitoring and analytical methods been determined 10487071048707together with the more specific elements of 823 Monitoring and measurement of processes 10487071048707Is the organization applying suitable methods for monitoring and or measurement of the process 10487071048707Do these methods demonstrate the ability of the process to achieve planned results 10487071048707Where processes are found to be nonconforming is corrective action taken to ensure conformity of product

By G R P K Perera Lecturer CoT Kandy

By G R P K Perera Lecturer CoT Kandy

Clause 5 - Guidance on managing audit programmes Clause 6 - Guidance on audit conduct Clause 7 - Guidance on competency requirements and auditor evaluation

Principles of auditing Reliance on a) Ethical conduct b) Fair presentation c) Due professional care d) Independence e) Evidence based approach

Managing Audit Programmes An audit programme comprises a series of audits undertaken over a specified period of time Such a programme needs to be effectively managed

Audit activities Initiating the audit (audits normally initiated by a client ndashhere by management or MR) Defining (or confirming) audit objectives scope and criteria Selecting the audit team Conducting document review and planning and the Preparing for the on-site audit activities audit activities (stage 1 of Audit) Conducting the on-site audit activities (stage 2 of an Audit) Preparing approving and distributing the audit report Completing the audit (normally considered complete once report issued) Conducting audit follow up (if requested to do so by the client)

THE AUDIT PROCESS It will be found that this approach is very similar to that detailed in ISO 19011 (guide to Quality Systems Auditing) and is believed to be a desirable approach to encourage The general assessment process involves the following

By G R P K Perera Lecturer CoT Kandy

Education work experience auditor training and audit experience Auditors should have a) education that provides a good foundation for their intended field of auditing coupled with appropriate knowledge and skills b) work experience in an environment that contributes to the development of their knowledge and skills Audit team leaders should have a) additional knowledge and skills in team audit leadership to facilitate efficient and effective conduct of an audit eg audit planning communication organising and directing reaching conclusions preventing and resolving conflict audit reporting

PROCESS MANAGEMENT

Monitoring and Improvement

ISO 9001 2000 focuses very much on the need for an organization to adopt a lsquoprocessrsquo approach when designing implementing and improving a quality management system and verification that this has been undertaken in an effective manner will place heavy demands on an assessment team leader to construct a suitable assessment schedule and associated audit samples for the various team members It will require the team leader tot develop a very good understanding of the organization the various processes that are in operation and how they interact with each other Process analysis will need to be performed in greater depth before the assessment schedule can be finalized Process analysis which should have been undertaken by auditors in the past will not be very necessary and an essential tool within the auditorrsquos toolbox This will need to be undertaken at two levels at the first level process analysis will involve looking at the organization at the macro level to understand the nature of the business the processes involved and the general sequence and interaction of these processes At the micro level it will involve the examination of individual processes to clearly understand how the process functions is managed and outputs measured against any performance standard

lsquoCross functional processrsquo are processes that lsquoflowrsquo through the different company lsquofunctionalrsquo areas or departments and auditors will need to consider to verify particular aspects of such processes There will also be important outputs from processes and it will be necessary for auditors to clearly understand what these outputs should be and if they are satisfying the appropriate criteria For a full assessment of an organization to verify conformity with ISO 9001 2000 it will be very necessary for significant identified lsquoprocessesrsquo as well as those specifically referred to in ISO 9001 to be carefully audited to ensure that there has been adequate and effective planning control and monitoring of such processes The assessment will need to focus on not only on the processes themselves but also the inputs and outputs from them to establish if specified requirements for each are being met In particular there will be some key quality management system processes that will need to be fully verified An assessment team leader will wish to verify rsquo41 General Requirements in relation to the most important (or significant) processes undertaken by the company

By G R P K Perera Lecturer CoT Kandy

There will also be feedback of performance from both the process and process output monitoring activities that will be used to continually improve the Process management activity Here there is an important link into 84 lsquoAnalysis of datarsquo which holds the key to an organizationrsquos improvement focus and activities relating to process improvement and subsequently leads in to 562 lsquoManagementrsquo Review where management need to work with the results of data analysis to determine the need for process and quality management system improvement For Process Management an auditor would wish to see that there has been adequate process planning and hence would wish to verify that the elements of lsquo41 General Requirementsrsquo have been applied PROCESSProcess Inputs Monitoring of the Process and Process outputs Management of the Process outputs Process outputs

Together with the general planning requirement of lsquo71 Planning of product realizationrsquo thus The auditor would then wish to verify that the planned actins are being implemented in an effective manner In relation to the Process monitoring again there are elements of lsquo41 General Requirementsrsquo that the auditor would wish to verify that is For the process output the auditor would need to verify lsquo824 Monitoring and measurement of Productrsquo and finally the auditor may wish to verify that use is being made of data provided from the process monitoring and product (process output) monitoring activities as an input to the continual improvement process Thus will require an auditor to establish if there is an adequate link between 823824 (taking due account of customer satisfaction) and 84 conforming with the organizations quality policy and related objectives and subsequently 56 Thus for any of the organizations processes there are some general requirements that the team leader may wish individual auditors to verify This may be undertaken on a general basis relating to the organizations Quality planning process or specifically to some of the most significant product realization processes undertaken by the organization The assessment team leader will need to decide which processes are to be the focus of audit attention and objective evidence of compliance Have the criteria and methods required to ensure the effective operation and control of the process been determined Have the necessary resources and information to support the operation of the process been determined Are the actins necessary to a planned results and continued improvement of the process being implemented Have the quality objectives and requirements for the product (process output) been determined Are necessary documents and resources specific to the product (process output) available to support eh process Have the required verification validation monitoring inspection and test activities specific to the product (process output) been determined Have the quality records needed to provide evidence that the process and the product (process output)meet requirements been determined 10487071048707Have the necessary resources and information to support eh monitoring of the process been determined 10487071048707Have the process measurement monitoring and analytical methods been determined 10487071048707together with the more specific elements of 823 Monitoring and measurement of processes 10487071048707Is the organization applying suitable methods for monitoring and or measurement of the process 10487071048707Do these methods demonstrate the ability of the process to achieve planned results 10487071048707Where processes are found to be nonconforming is corrective action taken to ensure conformity of product

By G R P K Perera Lecturer CoT Kandy

By G R P K Perera Lecturer CoT Kandy

Education work experience auditor training and audit experience Auditors should have a) education that provides a good foundation for their intended field of auditing coupled with appropriate knowledge and skills b) work experience in an environment that contributes to the development of their knowledge and skills Audit team leaders should have a) additional knowledge and skills in team audit leadership to facilitate efficient and effective conduct of an audit eg audit planning communication organising and directing reaching conclusions preventing and resolving conflict audit reporting

PROCESS MANAGEMENT

Monitoring and Improvement

ISO 9001 2000 focuses very much on the need for an organization to adopt a lsquoprocessrsquo approach when designing implementing and improving a quality management system and verification that this has been undertaken in an effective manner will place heavy demands on an assessment team leader to construct a suitable assessment schedule and associated audit samples for the various team members It will require the team leader tot develop a very good understanding of the organization the various processes that are in operation and how they interact with each other Process analysis will need to be performed in greater depth before the assessment schedule can be finalized Process analysis which should have been undertaken by auditors in the past will not be very necessary and an essential tool within the auditorrsquos toolbox This will need to be undertaken at two levels at the first level process analysis will involve looking at the organization at the macro level to understand the nature of the business the processes involved and the general sequence and interaction of these processes At the micro level it will involve the examination of individual processes to clearly understand how the process functions is managed and outputs measured against any performance standard

lsquoCross functional processrsquo are processes that lsquoflowrsquo through the different company lsquofunctionalrsquo areas or departments and auditors will need to consider to verify particular aspects of such processes There will also be important outputs from processes and it will be necessary for auditors to clearly understand what these outputs should be and if they are satisfying the appropriate criteria For a full assessment of an organization to verify conformity with ISO 9001 2000 it will be very necessary for significant identified lsquoprocessesrsquo as well as those specifically referred to in ISO 9001 to be carefully audited to ensure that there has been adequate and effective planning control and monitoring of such processes The assessment will need to focus on not only on the processes themselves but also the inputs and outputs from them to establish if specified requirements for each are being met In particular there will be some key quality management system processes that will need to be fully verified An assessment team leader will wish to verify rsquo41 General Requirements in relation to the most important (or significant) processes undertaken by the company

By G R P K Perera Lecturer CoT Kandy

There will also be feedback of performance from both the process and process output monitoring activities that will be used to continually improve the Process management activity Here there is an important link into 84 lsquoAnalysis of datarsquo which holds the key to an organizationrsquos improvement focus and activities relating to process improvement and subsequently leads in to 562 lsquoManagementrsquo Review where management need to work with the results of data analysis to determine the need for process and quality management system improvement For Process Management an auditor would wish to see that there has been adequate process planning and hence would wish to verify that the elements of lsquo41 General Requirementsrsquo have been applied PROCESSProcess Inputs Monitoring of the Process and Process outputs Management of the Process outputs Process outputs

Together with the general planning requirement of lsquo71 Planning of product realizationrsquo thus The auditor would then wish to verify that the planned actins are being implemented in an effective manner In relation to the Process monitoring again there are elements of lsquo41 General Requirementsrsquo that the auditor would wish to verify that is For the process output the auditor would need to verify lsquo824 Monitoring and measurement of Productrsquo and finally the auditor may wish to verify that use is being made of data provided from the process monitoring and product (process output) monitoring activities as an input to the continual improvement process Thus will require an auditor to establish if there is an adequate link between 823824 (taking due account of customer satisfaction) and 84 conforming with the organizations quality policy and related objectives and subsequently 56 Thus for any of the organizations processes there are some general requirements that the team leader may wish individual auditors to verify This may be undertaken on a general basis relating to the organizations Quality planning process or specifically to some of the most significant product realization processes undertaken by the organization The assessment team leader will need to decide which processes are to be the focus of audit attention and objective evidence of compliance Have the criteria and methods required to ensure the effective operation and control of the process been determined Have the necessary resources and information to support the operation of the process been determined Are the actins necessary to a planned results and continued improvement of the process being implemented Have the quality objectives and requirements for the product (process output) been determined Are necessary documents and resources specific to the product (process output) available to support eh process Have the required verification validation monitoring inspection and test activities specific to the product (process output) been determined Have the quality records needed to provide evidence that the process and the product (process output)meet requirements been determined 10487071048707Have the necessary resources and information to support eh monitoring of the process been determined 10487071048707Have the process measurement monitoring and analytical methods been determined 10487071048707together with the more specific elements of 823 Monitoring and measurement of processes 10487071048707Is the organization applying suitable methods for monitoring and or measurement of the process 10487071048707Do these methods demonstrate the ability of the process to achieve planned results 10487071048707Where processes are found to be nonconforming is corrective action taken to ensure conformity of product

By G R P K Perera Lecturer CoT Kandy

By G R P K Perera Lecturer CoT Kandy

There will also be feedback of performance from both the process and process output monitoring activities that will be used to continually improve the Process management activity Here there is an important link into 84 lsquoAnalysis of datarsquo which holds the key to an organizationrsquos improvement focus and activities relating to process improvement and subsequently leads in to 562 lsquoManagementrsquo Review where management need to work with the results of data analysis to determine the need for process and quality management system improvement For Process Management an auditor would wish to see that there has been adequate process planning and hence would wish to verify that the elements of lsquo41 General Requirementsrsquo have been applied PROCESSProcess Inputs Monitoring of the Process and Process outputs Management of the Process outputs Process outputs

Together with the general planning requirement of lsquo71 Planning of product realizationrsquo thus The auditor would then wish to verify that the planned actins are being implemented in an effective manner In relation to the Process monitoring again there are elements of lsquo41 General Requirementsrsquo that the auditor would wish to verify that is For the process output the auditor would need to verify lsquo824 Monitoring and measurement of Productrsquo and finally the auditor may wish to verify that use is being made of data provided from the process monitoring and product (process output) monitoring activities as an input to the continual improvement process Thus will require an auditor to establish if there is an adequate link between 823824 (taking due account of customer satisfaction) and 84 conforming with the organizations quality policy and related objectives and subsequently 56 Thus for any of the organizations processes there are some general requirements that the team leader may wish individual auditors to verify This may be undertaken on a general basis relating to the organizations Quality planning process or specifically to some of the most significant product realization processes undertaken by the organization The assessment team leader will need to decide which processes are to be the focus of audit attention and objective evidence of compliance Have the criteria and methods required to ensure the effective operation and control of the process been determined Have the necessary resources and information to support the operation of the process been determined Are the actins necessary to a planned results and continued improvement of the process being implemented Have the quality objectives and requirements for the product (process output) been determined Are necessary documents and resources specific to the product (process output) available to support eh process Have the required verification validation monitoring inspection and test activities specific to the product (process output) been determined Have the quality records needed to provide evidence that the process and the product (process output)meet requirements been determined 10487071048707Have the necessary resources and information to support eh monitoring of the process been determined 10487071048707Have the process measurement monitoring and analytical methods been determined 10487071048707together with the more specific elements of 823 Monitoring and measurement of processes 10487071048707Is the organization applying suitable methods for monitoring and or measurement of the process 10487071048707Do these methods demonstrate the ability of the process to achieve planned results 10487071048707Where processes are found to be nonconforming is corrective action taken to ensure conformity of product

By G R P K Perera Lecturer CoT Kandy

By G R P K Perera Lecturer CoT Kandy

By G R P K Perera Lecturer CoT Kandy