Are they provided in a timely manner? Human Resources Has the organization evaluated the effectiveness of training provided? Has the organization ensured that its employees are aware of the relevance and importance of their activities and how they contribute to achievement of the quality objectives?
Planning Has the organization planned for realization of product? Does it include product quality objectives? Does it include the need to establish processes and documentation, provide resources and facilities specific to the product?
Does the plan for measurement and monitoring to ensure conformity and achieve improvement identify the need for and use of statistics? Customer Requirements Does the identification of customer requirements include product requirements not specified by the customer, but necessary for the intended or specified use obligations related to product, including regulatory and legal requirements Review of product requirements Does the organization confirm customer requirements when the customer does not provide a documented statement of requirement?
Customer Communication Has the organization identified and implemented arrangements for communication with customers relating to: product information inquiries contracts or order handling including amendments customer feedback including complaints Purchasing Control How has the organization determined the extent of control of purchasing processes? Customer Property Has the organization applied the care of customer supplied property to intellectual property? Preservation of Product Has the organization validated any process where resulting output cannot be verified?
Does verification include: qualification of process qualification of equipment and personnel use of defined methodologies and procedures requirements for records revalidation Customer Satisfaction Is the organization monitoring information on customer satisfaction and dissatisfaction? Where are the methodologies for obtaining and using this information defined? Has the organization analyzed appropriate data to determine: suitability and effectiveness of the quality management system actions to improve the quality system and its processes improvement of product related to customer requirements.
List two methods an organisation can use to determine the degree of customer satisfaction. Clause 8. List two verification activities that may be used by the design function of an organization. After noting a corrective action as documented information an auditor can:. This means that decisions are taken based facts on objective analysis of data and information, rather than hunches.
This means that data is collected, and effectively analysed to come up with factual information regarding a situation — and subsequently evidence-based decision making can be done.
Top management shall demonstrate leadership and commitment with respect to the quality management system by:. Corrective action has already been planned. It is therefore suggested that to audit this department again would add no value and asks if you could delete this department from the audit plan and spend more time in the production area.
Outline five issues you would include in the response you would give to this request. For each of your examples, identify the clause s of ISO that relate to this situation. Taking into account the requirements of clause Identify who is responsible for each element of the process and identify where in the corrective action process decisions need to be taken.
Outline in a checklist how you will perform this audit by developing a series of ten audit checkpoints. For each checkpoint, identify examples of the audit evidence you would want to gather and give the appropriate ISO reference. Note: 1 mark will be awarded per audit checkpoint, with 0. Questions in this section are designed to test your ability to analyse audit situations, evaluate audit evidence and apply knowledge of the audit criteria correctly.
Note: if you raise a nonconformity report when there is no nonconformity, 0 zero marks will be awarded. Note: If you complete the audit investigation template for a situation where there is evidence that a nonconformity exists, a maximum of 7 marks may be awarded as follows:. In the final inspection and despatch area you are examining the inspection and despatch records for order number This relates to product XYZ that is due to be sent out to a customer.
The Despatch Supervisor tells you that JW is one of the junior inspectors. You are auditing the design and development process in an organisation that designs and manufactures industrial equipment. They are currently dealing with a serious customer complaint relating to faulty safety mechanisms. They have sent engineers to this customer to repair some equipment they designed, manufactured and supplied two years earlier for contract number A You find a recent note on file that states that the engineers are currently having difficulty in repairing the equipment.
They have been issued with the latest drawings for the equipment serial number X, revision 3. The drawings do not contain a modification to the safety mechanism that was made prior to delivery and installation of the equipment.
You confirm with the Design Manager that revision 3 is the current version of the drawings and that revision 3 does not include the change to the safety mechanism. During an audit of an insurance company, you ask the Training Manager to show you the training records for three people who work in the Claims Department. Good auditors realize very early on that they are dealing with personalities as much as processes and systems.
Whilst the intent of the audit a serious one, often light humor, politeness and diplomacy are the best ways to build rapport. If you are new to auditing, acknowledge this fact, be open and honest.
It is also important to explain to the auditees that they are free to express their views during the audit. Remember that you, the auditor, are also there to learn. Always discuss the issues you have identified with the auditees and always provide guidance on what is expected in terms rectifying any non-conformances or closing out observations you raised. Let the auditees know they are welcome to read your notes and findings; the audit is not a secret.
Try not to be drawn into arguments concerning your observations. It is never appropriate to directly name people in the audit report as this may lead to defensiveness which is ultimately counter productive. It helps an organization accomplish its objectives by bringing a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control and governance processes.
Florida, USA, January There are common methods of internal auditing that may be used to determine compliance:.
The system audits are best undertaken using the internal audit checklist. The process audit is an in-depth analysis which verifies that the processes comprising the management system are performing and producing in accordance with desired outcomes. The process audit also identifies any opportunities for improvement and possible corrective actions.
Process audits are used to concentrate on any special, vulnerable, new or high-risk processes. The product audit may be a series of audits, at appropriate stages of design, production and delivery to verify conformity to any specified product requirements, such as dimensions, functionality, packaging and labeling, at a defined frequency. The internal audit tool will help you to assess the status of your existing management system and identify process weakness to allow a targeted approach to prioritizing corrective action to drive improvement.
It stands as a reference point before, during and after the audit process and if developed for a specific audit and used correctly will provide the following benefits:. It will greatly help you with the process of auditing and internal audit management. This procedure also defines the responsibilities for planning and conducting audits, reporting results and retaining associated records.
Before you invest all the hours reinventing the wheel, before you spend countless dollars outsourcing the task — try our Internal Audit Checklist. The gap analysis will likely be your first ISO internal audit.
The gap analysis checklist highlights the new requirements contained in ISO but it not intended to cover all of the requirements from ISO comprehensively. The unique knowledge obtained about the status your existing quality management system will be a key driver of the subsequent implementation approach.
Armed with this knowledge, it allows you to establish accurate budgets, time-lines and expectations which are proportional to the state of your current management system when directly compared to the requirements of the standards. Your organization may already have in place an ISO compliant quality management system or you might be running an uncertified system. If this is the case, you will want to determine how closely your system conforms to the requirements ISO The results of a gap analysis exercise will help to determine the differences, or gaps, between your existing management system and the new requirements.
Not only will the analysis template help you to identify the gaps, it will also allow you to recommend how those gaps should be filled. The gap analysis output also provides a valuable baseline for the implementation process as a whole and for measuring progress. Try to understand each business process in the context of each of the requirements by comparing different activities and processes with what the standard requires. At the end of this activity you will have a list of activities and processes that comply and ones that do not comply.
The latter list now becomes the target of your implementation plan. A good summary report is the output which is the value of the audit. It deserves an appropriate amount of attention and effort. As you moved through the audit, you should have noted the issues and improvements you saw.
These should have been marked clearly so you are now able to quickly review and capture them as you write the report. These findings and conclusions should be formally documented as part of the summary report. Too often, the audit report only recites back facts and data the managers already know. The value is in identifying issues and opportunities they do not know! This summary should be reviewed first with the lead auditor, then the Process Owner and Management Team.
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