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Published byLindsey Whitehead Modified over 9 years ago
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Version 1.0 2015 Advanced User Training
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Instructions This training module contains additional key concepts that are an extension to the concepts in the User Training Module. The key concepts are presented on slides. Move through the slides using the navigational buttons. At several locations, progression to the next slide is only possible after correctly answering a quiz question. The question may be repeated an unlimited number of times and no penalty is recorded for an incorrect answer.
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In practical terms, corrective action and preventive action procedures are identical, since there is only one flow chart to describe both. Item 2-1 Of all the classifications of PCA records, only one is preventive action (i.e. Opportunity for improvement). All the rest are corrective action. Item 2-2 PCA records are internal documents which shall not be sent to external parties. The work specified by a PCA record can involve external parties, however the work is always managed by an internal employee. Item 2-3
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In the QMS, a digital signature can only be cancelled by another digital signature. A digitally signed PCA record can’t be disregarded following an agreement reached via email correspondence. A second digital signature is required to indicate either completion or cancellation. Item 2-4 A new “record number generator” is available to staff for the purpose of generating unique identifying numbers that can be attached to a PCA record by the Initiator as the very first step when filling out a PCA form. Item 2-5 PCA record numbers do not have to be in series, i.e. some numbers can be left out. It is important, however, that each number is used only once and that they are used in ascending order. Item 2-6
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PCA records for supplier nonconformities can be generated when a supplier gives a product to AE Projects that does not meet our requirements. In these cases, we have the opportunity to log this event as a PCA record using the classification of “supplier nonconformity”. There are several advantages of doing this: a permanent record of the supplier nonconformity is generated; the nonconformity is tracked through to rectification; an analysis of the cause is undertaken; and a register of the history of such nonconformities is guaranteed to show up on the radar of Top Management. Item 2-7 One of the PCA record classifications is “customer complaint”. Note that this type of PCA record is not filled out by the customer. It is filled out by an internal member of staff acting upon a complaint made by a customer. Item 2-8
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Which one of the following PCA record classifications is for preventive action? a) internal audit b) returned product c) opportunity for improvement Quiz questions Who manages the work specified by a PCA record? a) an internal employee b) an external party c) both of the above When should the PCA record classification of “supplier nonconformity” be used? a) when a supplier delivers a product to AE Projects that does not meet our requirements b) when we deliver a product to a client that does not meet their requirements c) either of the above
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When external parties request information regarding ASPEC Quality, follow the steps below in order: 1) transmit a copy of the ISO 9001 certificate and make reference to the JAS-ANZ listing on the internet 2) transmit a project-specific Quality Plan 3) defer any further action to the Office Leader or the Quality Rep. Note: do not transmit the AE Projects Quality Manual to external parties. Item 2-9 The procedure flow charts in the Quality Manual specify a role for each activity. A role is undertaken by a single person within the organisation. The personnel tables prior to each flow chart address the question: what roles can be undertaken by the same person? The tables indicate all permitted role substitutions. Some roles don’t have a permitted substitution, and this leads to the minimum personnel requirement shown below the table. For example, a common requirement is for input from a minimum of two people: an Approver and the Quality Rep. Item 2-10
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The word ‘product’ has a special meaning: it is essentially the tangible item that the client is paying for. In the case of AE Projects, our tangible products are electronic PDF files, and there can be legally significant assumptions associated with using purely electronic files as the basis of settlement of contractual obligations (for example, we may assume that the client has a computer and Acrobat software, and we may assume that their software is capable of reproducing our product exactly as we intended it to be seen, and we may assume that the PDF encoding that we used when creating the file will still be readily accessible for some time into the future). In some cases a client will insist on paper-copy delivery of products, and we can do this without conflicting with our Quality Management System. In 2008 Adobe Systems Incorporated relinquished control of the PDF file format to ISO, who are now in charge of publishing and updating the technical specification of the PDF file format (Refer to ISO 32000-1:2008). Item 2-11
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Which one of the following documents CAN NOT be sent externally following a request for information regarding AE Projects Quality? a) a project-specific Quality Plan b) the ISO 9001 certificate c) the Quality manual Quiz questions The procedures in the Quality Manual commonly require input from a minimum of how many people? a) 1 b) 2 c) 3 Which organisation is in charge of publishing and updating the technical specification of the PDF file format? a) Engineers Australia b) ISO c) Adobe Systems Incorporated
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Digital signatures include a timestamp. The timestamp can serve 2 different purposes, and there are 2 corresponding ways of applying the timestamp: Method 1: Timestamps can be used to prove that a document was signed at a certain time. For example, this is useful when there is a cut-off time for signing an agreement. In this case, the timestamp needs to be retrieved via the internet from a neutral and official 3rd party timestamp server; Method 2: The timestamp is used as a way for the Approver to convey the time when the document was signed, using a tamper-proof method of communication. In this case, the timestamp can be generated from the clock on the Approver’s computer. Our implementation of digital signatures at AE Projects use method 2 only, and method 1 is never used. Item 2-12
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“Object evidence” is a phrase that is used when auditing. It means: what did you observe that enabled you to reach your conclusion? Objective evidence is linked to the concept of multiple auditors being able to reach similar conclusions independently of each other. In the case of a detected nonconformity, the objective evidence provides a record of an issue that can be acted upon. Item 2-13
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What time source is utilised at AE Projects when applying digital signatures? a) a neutral and official 3rd party timestamp server b) the clock on the Approver’s computer c) the clock on the Atlantic Digital server Quiz questions “Objective evidence” is a phrase that is used in relation to what process of the QMS? a) nonconforming product control b) document control c) auditing
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