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ESC-2 INTERNAL AUDIT CHECKLIST 2008 Top Management Use as appropriate; not all topics may apply equally to all program areas. AUDITORS SHOULD ADD PROGRAM-SPECIFIC QUESTIONS BASED ON THE PROCEDURES AND WORK DONE IN ASSIGNED PROGRAM AREAS.
(C) in compliance; (R) more research needed; (NC) nonconformity; (OI) Opportunity for Improvement
4.2.3 4.2.3
Control of documents Define (in a written procedure) the controls needed to approve documents prior to issue, review, update and re-approved documents, identify changes and current revisions of documents, make relevant and current documents available at points of use, ensure that documents are legible and identifiable, identify and control the distribution of documents of external origin, and identify retained obsolete documents and prevent their unintended use.
Check all relevant program-area/centerlevel procedures. Are they up-to-date? Are any changes correctly made (listed in revision history, correct revision version shown in footer)? Are any program/departmentgenerated forms maintained properly (with revised date footer) and correctly listed on the Index of Forms?
4.2.4
Establish documented procedure for the identification, storage, protection, retrieval, retention time and disposition of records. Ensure that records remain legible, readily identifiable and retrievable. Are records listed for the program easily accessible? Are records readily retrievable (test by asking for retrieval of specific records)? a. Has the ISO 9001 QMS been beneficial, neutral, or a hindrance to the efficiency of ESC-2 operations? b. If I were an outsider looking in, knowing nothing about this organization, what would I see from this group that would make me think that you are committed to improving this organization and the systems that drive it? c. What improvements to the ISO QMS are you considering for the coming year? d. Tell me about your management reviews. How often are they conducted? Can you show me a record of one review?
4.2.4
5.1
Management Commitment top management shall provide evidence of its commitment to the development and implementation of the QMS and continually improving its effectiveness
5.2
Customer Focus. Top management shall ensure that customer requirements are determined and
Describe to me the processes that are in place that you manage that ensures that customer needs are met?
Would you say that process is effective? Can you show me data that indicates it is effective? (Can you prove it?) Have you considered how might this process be improved? If so, can you show me a record that indicates such a consideration? If not, why not?
5.3 5.3
Quality Policy The quality policy shall be appropriate to the purpose of the organization, include a commitment to comply with requirements and continually improve the quality management system, provide a framework for establishing the quality objectives, be communicated and be understood throughout the organization, and be reviewed for continuing suitability. On a scale of 1-10, how would you rate the effectiveness of our QMS and why would you give it that rating? What have you done/are you doing as a team to improve that rating? Can you show me records of those actions?
5.4
5.4.1 5.4.2
Planning
Quality Objectives Quality management system planning Do you think that our Quality Objectives need tweaking? If yes, can you show me a record of those issues being addressed in a management review? If no, why not?
5.5
6.2
Human resources
6.2.2.d
Ensure that personnel are aware of the relevance and importance of their work and how they contribute to the achievement of quality objectives. Product Realization Planning of product realization Determine quality objectives and requirements for the product. Establish production processes and documentation, and provide adequate equipment, operators and other resources specific to the product. Customer-related processes Determine product requirements specified by the customer (including delivery and postdelivery); not stated by the customer, but necessary for specified or intended use; Tell me about our processes for determining customer needs. Can you show me some minutes of some advisory committee meetings? Do you have any other documentation
7.2 7.2.1
Much of our QMS is related to delivering a quality product to our clients that meets the requirements and needs. How do you feel we are doing on that front? Are there areas that we can improve? Be specific? Have any of those areas been addressed in a management review? What outputs did that review result in? Have they been/will they be implemented?
7.2.3.a 7.2.3.b
Determine and implement arrangements for communicating product information, handling enquiries, orders and change orders. Determine and implement effective arrangements for communicating with customers regarding customer feedback and customer complaints. Design and development Plan design product design activities, to include the design stages; the review, verification and validation activities appropriate to each stage; and Thinking about the region improvement plan and the process that is followed to create it, how do you think that is working? Have changes been made to the process in the last year? If so, tell me about the Tell me about customer complaints. How are they handled when they happen? Is that process/procedure documented anywhere?
7.2.3.c
7.3 7.3.1
7.3.4
7.3.5
7.3.7
Review, verify, validate, as appropriate, and approve design changes before implementation. Evaluate the effect of the changes on constituent parts and on product already delivered. Maintain records of changes and of their reviews/evaluations and any necessary actions.
It seems that we have a lot of changes to workshop headers after they have been created. Do those changes ever affect clients? If so, how? What procedures are in place to minimize or manage changes and their impact on clients? Do you think those procedures are effective and how might we improve them?
7.4 7.4.1
Purchasing Control suppliers and the purchased product to ensure that the product conforms to specified purchase requirements. Our business procedures manual has some very detailed guidelines for purchasing and for hiring outside consultants. Can you think of any problems that we have had in the last year related to those two items? Are there things that we can do to improve those procedures or do you think they are working fine just as they are?
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7.4.3
8 8.1
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8.2 8.2.1
8.3
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Identify and control nonconforming Do you think that the nonconformity product to prevent its unintended use system is working as an effective tool or delivery. to help us improve? How, how not, why not? What are the barriers to this system working better? What changes need to be made? Have those changes been addressed at the cabinet level? If so, what has resulted from those discussions?
8.3
Re-verify reworked or repaired products to demonstrate their conformity. Analysis of data Collect and analyze data on the performance of the quality management system, to include customer satisfaction, product conformity, characteristics and trends of processes and products (including opportunities for preventive actions), and suppliers.
Review previous audit nonconformities of program, as well as the list of corrective actions org-wide to verify conformity, as applicable.
8.4 8.4
8.5 8.5.1
Improvement and corrective/preventive action Continually improve the effectiveness of the quality management system through the use of quality policy quality objectives, audit results, We have been living with and working under the QMS for a couple of years now. What kinds of changes have taken place in the QMS during that time? What kind of changes do you think need to take place going forward?
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8.5.3
Talk to me about any potential problem areas that you feel may eventually lead to a deficiency in meeting customer requirements. Have you as a team, discussed what can be done to prevent those things from occurring? Have you documented those discussions? Has a non-conformity report been completed related to that/those issues?
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