"What a headache" - that's surely what every employee think to himself when they receive the massage of an internal audit approaching. There is a reason why. They know that someone is coming to poke their deeds... The internal audit chapter is included under chapter 8.2 - Monitoring and measurement. So it is clear that the purpose of the internal audit is to perform Monitoring and measurement within the organization. Internal audits, sometimes called first-party, are conducted by, or on behalf of, the organization itself for internal purposes and can form the basis for an organization's self-declaration of conformity. The organization is required to conduct the audits within scheduled time frames to ensure that the quality management system is:
* Maintained according to the ISO 9001 Standard requirements
* Maintained according to the organization's requirements and audit's criteria
What are an audit's criteria? Set of policies, procedures or requirements used as a reference.
We believe that in the end of the day the internal audit is actually an internal inspection that the organization conducts upon itself. Within the organization structure, it is hard for the top management to view of what is going on down the organization. It's not enough to step down to the manufacture halls, logistic centers or service centers and view the employees or the goods on the shelves. It is necessary to sample processes and to examine whether they hold against pre defined criteria. Only high resolution sampling can provide with the real organization's status. What are the criterions? The ISO 9001 standard requirements, working procedures, quality plans, quality objectives - the characteristics of the quality management system.
Since the internal audit topic is very serious and wide, we would not include it all in one article. In this article we will focus with the ISO 9001 Standard requirements for maintaining internal audit system with reference to the ISO 19011 Standard - a guide line Standard for auditing quality or environmental systems. The Standard was published in 2002 and besides outlining guideline for conducting audits, it also refer to the auditor's skills and activities. Unfortunately, the ISO 9001 Standard sets requirements but it does not guide us how to conduct an effective audit - one that would not only apply the requirements but would also assist the organization. We would deal with that in another article (we just can't give you all the secrets in one article. Sorry. Company's policy).
The ISO 9001 requirements for internal audit interanl audit procedure
The ISO 9001 Standard requires that you maintain a documented procedure describing the method for conducting an internal audit process. This is not a recommendation but a requirement. The documented procedure must define:
* Who must conduct the audit - who is responsible for executing the internal audit process.
* What organizational units are under the scope - departments, specific processes, activities, sites, function, etc.
* Describing the process itself - who meets with whom and where and what should everybody bring with them.
* The supervision after the internal audit plan (don't get excited, we will go into details soon). Where the audit's evidence are documented.
It is possible to add as annex the audit's plan and all sort of forms and documentation regarding to the process.
The auditor
The auditor must be objective related to the organizational unit he is auditing. This is a hard thing to achieve, when the quality manager is the auditor. Then he is part of the organization. He will always conduct an audit to his colleagues (the ones he sits and eats lunch with, drinks coffee or smokes a cigarette). Besides that, the auditor must be skilled for conducting an audit and document the situation correctly. Remember, an audit is an emotional event where the employees are examined about the quality of their performance. The audit's approach is highly important for the audit's progressing. Beside his personal approach, the audit must have a minimum acquaintance with the field, in order to evaluate the processes and their quality beyond the working procedures (the documented criteria). That kind of knowledge can give him the ability and the consideration to evaluate the situation while he identifies any nonconformities or faults. Within the ISO 19011 Standard there is a specification for the auditor's qualities required:
* Ethics - credibility, integrity and honesty.
* Open minded - willing to listen, learn and accept new ideas.
* Diplomatic - polite with high manners to his colleagues - after all he is working with people and he is the representative of the top management.
* Observer - owns the ability to recognize what he sees and understand without interrogating.
* Perspective - owns the ability to evaluate situations beyond appearance and with a wide systematic view of things - has the ability to understand the organizational consequences of his evidence.
* Versatile - owns the ability to mobilize from one situation to another without losing direction.
* Persistence - must be persistence with his objectives and to not stray away.
* Decisive - ready to make decision
* Independent - must have his own opinion of things and to not be influenced by the environment.
We also recommend an infinitive patience. During the audits people would try everything (but everything) to divert the auditor from the subject, from all sorts of reasons: they want to conceal their activities, they are afraid or just don't like when other people look through their draws. The auditor must remain patient and always wait until his question is answered. Mostly the audit clients answer completely other answers. Sometime things get out of hand and go into arguments and disputes. The auditor must remain cool, patient - we are use to say "business as usual" - the audit must make it clear; the audit is not for any arguments but a decision made by the top management. The auditor has one objective - to present with the top management the real status of the organization. He must not be concerned about time schedules as well. This is merely a tool and not the objective.
The audit's program
The organization must maintain a documented program for conducting the audits. The program must be documented according to the ISO 9001 requirement. This is not a recommendation but a requirement! The purpose of this program is to ensure that the audits are conducted as planned. So, first, you need a program. The ISO 9001 Standard requires performing the audits within scheduled and fixed time frames. This requirement ensures that employees would know that the audit is a part of the quality management system and not a momentarily capricious decision made by the top management. It is recommended to publish the audit schedules. And for "surprise" audits - you need to define the time frames, just don't publish them. The audits program must cover:
* Quality plans for the products - For any requirement for product realization, you must evaluate if it is performed as planned. The best way is to sample. Pick the product, review its quality plan, and check whether the product was realized according to the plan. Document the results then.
* The ISO 9001 Standard requirements -Including the documentation requirements (customer complaints, purchasing information, CAPA, training, etc). The examination must be conducted throughout the entire organizational units which related to product realization or are under the quality managment scope. Any unit must be examined at least once a year.
* Processes and procedures - the audit must evaluate whether the processes that are related to the product realization are performed as required. It could be a correlated with quality plans. But generally an audit must sample processes and evaluate its performance.
* Quality objectives - the audit must examine whether the organization is achieving his quality objectives. He evaluates the objectives - whether they are related to the product and evaluates the results. Where he revealed that the objectives are not fulfilled - he must be presented with reasons and measures.
It's not easy being an auditor. It also not so easy to maintain all of the above without some help.
Audit's evidences and findings
At the end of the audit the auditor must deliver a specific report about the audits evidences and findings. The report must specify:
* Who were the participants - it is recommended to document who participated during the audit. The purpose is when top management would like to conduct its inquiry - they would know to whom they must approach.
* The auditee - the organization or unit that were audited.
* General detail to shed light upon the auditee: how many workers, special projects, special recent events - information that would support the evidences.
* Reference to prior audits and prior findings - the auditor must verify that all nonconformities that were revealed during the last audit are eliminated the treatment was documented and most important, they are not repeated.
* The audits findings according to the evidences - that mean what the auditor discovered and how is it referred to the criteria: good, requires improvement action or requires corrective action (we would not deal in this article with classification of findings). Actually this is the most important part of the report. It specifies what the auditor saw, and how it was. The auditor must document the evidences as accurate as possible.
* Recommendations - for every finding the audit may pay his recommendation.
A sum of all nonconformities discovered during the audit - the purpose for that is: To gather all the nonconformities for the top management for review To trace the corrective action for the next audit This sum will become a corrective action report - but that is a whole different topic. Bear in mind - this report is designated for the top management and the function that is responsible for the auditee. That report is a tool for him to understand the status. Therefore it is recommended that the report would in a format that is easy for him to understand.
Summary
* The purpose of the audit is to ensure that the quality management system is as required by the ISO 9001 Standard and appropriately maintained.
* You are required to maintain a documented procedure specifying the process of the internal audit.
* The auditor bears a lot of responsibility. Therefore he must be perspective to the environment that he is auditing, must own the skills for evaluating and examining, with a wide view of things.
* The auditor must be polite with high manners, be patient and persistent. The audit is not an easy task to perform. The organization must maintain an audit program. The purpose of the program is to ensure that the audits are conducted as planned.
* At the end of the audit the auditor must deliver a specified report about the audit. This report is designated to the function that is responsible for the auditee.
Source: http://ezinearticles.com/
Monday, October 25, 2010
Sunday, October 24, 2010
Preventive Action - The ISO 9001 Standard Requirements
The requirement for preventive action (the PA - from the CAPA) is included within chapter 8.5 - Improvement. Within the most basic requirement, the purpose of the preventive action is to eliminate problems/Nonconformities and to achieve improvement within processe
The organization is required to take actions to eliminate potential Nonconformities - this is improvement. Why? Something could go wrong; you detected it, eliminated it and made sure it would not happen. How to achieve? With the PA (from the CAPA). The ISO 9001 Standard requires you to locate the potential Nonconformities and to eliminate the cause. The purpose is to prevent them from happening before they occurred. And yes, you are required to maintain a procedure describing the process of preventing the Nonconformities and to document the process itself. It is not a recommendation but an ISO 9001 Standard requirement.
THE PREVENTIVE ACTION DOCUMENTATION
The description for Preventive action - an action taken to eliminate a potential event that might cause Nonconformity. In this case the Nonconformity has not occurred yet. After you identified the cause that would generate Nonconformity, you are required to initiate an action to eliminate it: The PA. You must also document it. Why must you document it? For supervision. After a defined period of time (documented within a procedure) you must examine whether the PA was sufficient, effective and the Nonconformity had not occurred like expected.
Preventive action objectives - you must define what is required by the preventive action taken. The objective could be a numerical, quantitative or a quality requirement - whatever is appropriate for your organization. It is not a recommendation but an ISO 9001 Standard requirement.
Before executing the preventive action, it is required to consider cost effective of the preventive action. Some action may cost a lot. You must examine whether it is cost effective to carry out the action. Sometimes it would not be worth taking an action. It would be too expensive. The organization would rather live with the nonconformity - as long as the customer's requirements are maintained!! But, you must document the fact that you initiated a preventive action, examined it and decided to withdraw. Again, documentation here is required by the ISO 9001 Standard.
Closing date for the preventive action - All preventive actions should be limited within time frames in order to measure its effectiveness. You performed a preventive action. That is good but not enough. According to the ISO 9001 Standard requirements, you must define time frames (according to your needs) to examine its effectiveness. The date indicates when the preventive action would be examined.
The results - the ISO 9001 Standard requires you to observe the action taken and to verify its objectives. You must indicate (and document) the status. You must document what are its results: success, failure or perhaps more time is required to examine its effectiveness - that is also possible. Bottom line, you must examine (and document) that the predicted nonconformity was indeed prevented. Then and only then, you may close the action. When a preventive action was found as not successful it is recommended to open a new one. It is not required by the ISO 9001 Standard but an unsuccessful action indicates that a potential Nonconformity is still hanging over your heads - and that is forbidden by the ISO 9001 Standard (unless you defined it otherwise - that you considered and reached a decision - the cost effective topic).
We remind you again; you must maintain a documented procedure defining the process of initiating a PA:
* Recognizing a potential Nonconformity
* Where and how to document it
* The investigation of the cause
* The action taken
* The closing
This procedure would be one of your Quality procedures required to maintained by the ISO 9001 Standard.
You must also maintain documentation of the process itself:
* The nonconformity detected
* The cause
* The actions taken
* Its objectives (including time frames)
* The results
So, two documentations are required; a procedure and the records. The next step for you is to try and translate the requirements into your own organization and processes. Good luck.
Source: http://ezinearticles.com/
The organization is required to take actions to eliminate potential Nonconformities - this is improvement. Why? Something could go wrong; you detected it, eliminated it and made sure it would not happen. How to achieve? With the PA (from the CAPA). The ISO 9001 Standard requires you to locate the potential Nonconformities and to eliminate the cause. The purpose is to prevent them from happening before they occurred. And yes, you are required to maintain a procedure describing the process of preventing the Nonconformities and to document the process itself. It is not a recommendation but an ISO 9001 Standard requirement.
THE PREVENTIVE ACTION DOCUMENTATION
The description for Preventive action - an action taken to eliminate a potential event that might cause Nonconformity. In this case the Nonconformity has not occurred yet. After you identified the cause that would generate Nonconformity, you are required to initiate an action to eliminate it: The PA. You must also document it. Why must you document it? For supervision. After a defined period of time (documented within a procedure) you must examine whether the PA was sufficient, effective and the Nonconformity had not occurred like expected.
Preventive action objectives - you must define what is required by the preventive action taken. The objective could be a numerical, quantitative or a quality requirement - whatever is appropriate for your organization. It is not a recommendation but an ISO 9001 Standard requirement.
Before executing the preventive action, it is required to consider cost effective of the preventive action. Some action may cost a lot. You must examine whether it is cost effective to carry out the action. Sometimes it would not be worth taking an action. It would be too expensive. The organization would rather live with the nonconformity - as long as the customer's requirements are maintained!! But, you must document the fact that you initiated a preventive action, examined it and decided to withdraw. Again, documentation here is required by the ISO 9001 Standard.
Closing date for the preventive action - All preventive actions should be limited within time frames in order to measure its effectiveness. You performed a preventive action. That is good but not enough. According to the ISO 9001 Standard requirements, you must define time frames (according to your needs) to examine its effectiveness. The date indicates when the preventive action would be examined.
The results - the ISO 9001 Standard requires you to observe the action taken and to verify its objectives. You must indicate (and document) the status. You must document what are its results: success, failure or perhaps more time is required to examine its effectiveness - that is also possible. Bottom line, you must examine (and document) that the predicted nonconformity was indeed prevented. Then and only then, you may close the action. When a preventive action was found as not successful it is recommended to open a new one. It is not required by the ISO 9001 Standard but an unsuccessful action indicates that a potential Nonconformity is still hanging over your heads - and that is forbidden by the ISO 9001 Standard (unless you defined it otherwise - that you considered and reached a decision - the cost effective topic).
We remind you again; you must maintain a documented procedure defining the process of initiating a PA:
* Recognizing a potential Nonconformity
* Where and how to document it
* The investigation of the cause
* The action taken
* The closing
This procedure would be one of your Quality procedures required to maintained by the ISO 9001 Standard.
You must also maintain documentation of the process itself:
* The nonconformity detected
* The cause
* The actions taken
* Its objectives (including time frames)
* The results
So, two documentations are required; a procedure and the records. The next step for you is to try and translate the requirements into your own organization and processes. Good luck.
Source: http://ezinearticles.com/
Saturday, October 23, 2010
ISO 9001 Record Requirements
A record is a document stating results achieved or providing objective evidence of activities performed. Records establish evidence of conformance to requirements. Organizations must retain records which are legible, readily identifiable and retrievable to meet the ISO 9001 requirements for records.
During an ISO audit, the auditor will be asking for records or evidence the quality system being audited has effectively maintained the records required. For example, when an auditor is reviewing the corrective and preventive action system, he or she will be looking for a CAPA Report to provide evidence that the CAPA system has met the requirements for section 8.52 Corrective Action and 8.5.3 Preventive Action.
The ISO 9001:2008 Quality Management System Standard has many references to 4.2.4 Control of Records. Everywhere ISO 9001 references 4.2.4, there must be a record. Although the ISO 9001:2008 only requires six procedures the standard has twenty one (21) references to Control of Records (4.2.4). Note: Section 7.6 of the standard contains two references.
These references occur in the following sections of the standard:
* 4.2.3 - Control of Documents
* 5.6.1 - Management Review, General
* 6.2.2 - Competence, Training and Awareness
* 7.1 - Planning of Product Realization
* 7.2.2 - Review of Requirements related to the product
* 7.3.2 - Design and Development Inputs
* 7.3.4 - Design and Development Review
* 7.3.5 - Design and Development Verification
* 7.3.6 - Design and Development Validation
* 7.3.7 - Control of Design and Development Changes
* 7.4.1 - Purchasing Process
* 7.5.2 - Validation of processes for production and service provision
* 7.5.3 - Identification and Traceability
* 7.5.4 - Customer Property
* 7.6 - Control of Monitoring and Measuring (2 References)
* 8.2.2 - Internal Audit
* 8.2.4 - Monitoring and Measurement of Product
* 8.3 - Control of Non-Conforming Product
* 8.5.2 - Corrective Action
* 8.5.3 - Preventive Action
Do the exercise and find the 4.2.4 references.
Source: http://ezinearticles.com/
During an ISO audit, the auditor will be asking for records or evidence the quality system being audited has effectively maintained the records required. For example, when an auditor is reviewing the corrective and preventive action system, he or she will be looking for a CAPA Report to provide evidence that the CAPA system has met the requirements for section 8.52 Corrective Action and 8.5.3 Preventive Action.
The ISO 9001:2008 Quality Management System Standard has many references to 4.2.4 Control of Records. Everywhere ISO 9001 references 4.2.4, there must be a record. Although the ISO 9001:2008 only requires six procedures the standard has twenty one (21) references to Control of Records (4.2.4). Note: Section 7.6 of the standard contains two references.
These references occur in the following sections of the standard:
* 4.2.3 - Control of Documents
* 5.6.1 - Management Review, General
* 6.2.2 - Competence, Training and Awareness
* 7.1 - Planning of Product Realization
* 7.2.2 - Review of Requirements related to the product
* 7.3.2 - Design and Development Inputs
* 7.3.4 - Design and Development Review
* 7.3.5 - Design and Development Verification
* 7.3.6 - Design and Development Validation
* 7.3.7 - Control of Design and Development Changes
* 7.4.1 - Purchasing Process
* 7.5.2 - Validation of processes for production and service provision
* 7.5.3 - Identification and Traceability
* 7.5.4 - Customer Property
* 7.6 - Control of Monitoring and Measuring (2 References)
* 8.2.2 - Internal Audit
* 8.2.4 - Monitoring and Measurement of Product
* 8.3 - Control of Non-Conforming Product
* 8.5.2 - Corrective Action
* 8.5.3 - Preventive Action
Do the exercise and find the 4.2.4 references.
Source: http://ezinearticles.com/
Friday, October 22, 2010
Thursday, October 21, 2010
Wednesday, October 20, 2010
Tuesday, October 19, 2010
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• ISO 9001:2008 | Quality Management System | Requirements
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Give your fullest attention to Clause 4 of the standard. This clause describes your QMS in its entirety. The first part (4.1) describes what you need to do ...
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Sunday, October 17, 2010
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Saturday, October 16, 2010
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Friday, October 15, 2010
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