ISO 9001 Awareness Training.

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Presentation transcript:

ISO 9001 Awareness Training

What is ISO? ISO is a worldwide federation of national standards bodies who work together in order to prepare International Standards, such ISO 9001:2000, the standard in which XYZ has followed in establishing the Quality Management System which controls our production and service operations.

What is ISO 9001:2000? Is the International Standard companies in the manufacturing and service sectors adhere to when implementing a Quality Management System. In short, the ISO 9001:2000 standard is a compilation of all the general elements a company’s quality management system must contain and the associated requirements that the company must adhere to in order to demonstrate conformance to the standard.

Why follow ISO? Primary Reasons ISO provides a way for us to deliver consistent and reproducible products and services. To demonstrate our ability to provide products and services that fulfill customer requirements with an aim to enhance customer satisfaction. ISO provides a means to control and improve processes via continuous measurement and improvement. Secondary ISO can be used as a marketing tool. Propagates a common Quality approach within all of XYZ.

Required ISO 9001 Documentation Summarizes the procedures we (XYZ) have implemented in order to meet the requirements of the standard. Level Ⅰ Quality Manual Connect “what we say we do” to “how we do it”. Operating Procedures Level Ⅱ Who, What, When, Where, Why Proof that we “did what we said” Work Instructions Level Ⅲ Detail of how you do specific tasks Level Ⅳ – Quality Records

Access to ISO Documentation XYZ ERP/MRP Access Work Instructions and Forms used during production operations Intranet Document Control Access Work Instructions, Forms, ISO documents, drawings, and specifications

Quality Policy XYZ is committed to meeting the requirements of ISO 9001:2000, continual improvement and meeting customer expectations for design, product, quality, technical support and delivery. ***Printed on cards attached to each employees ID badge.***

Quality Objectives Quality Objectives explain how a company goes about meeting customer requirements. XYZ Quality Objectives are listed below: 1. On-time delivery of product and service, based upon contract completion guarantee. 2. Meet contractual power performance requirements for output and efficiency. Each employee should be aware of how their job affects XYZ efforts to achieve these objectives as well as the Quality Policy.

Important Elements of the QMS each employee should be aware of: Control of Documents Control of Records Control of Production and Service Provision Control of Measurement Devices Preservation of Product Identification and Traceabillity Control of Nonconforming Product Corrective and Preventive Action

1 - Control of Documents All documents used during or in support of production and service operations must be controlled. Assigned a unique document number Identified with a revision level Documents which do not have a unique document number or revision level are considered UNCONTROLLED and should not be used unless they are clearly identified as REFERENCE ONLY. No employee may alter the content of a document without initiating the Document Revision Process (form XYZ-G001). See also procedure XYZ-0001.

2 - Control of Records Records are considered to be any form of evidence that demonstrates XYZ efforts to fulfill customer requirements or ISO requirements. Examples include: Shop Travelers Completed forms, data sheets and inspection maps Quotations and proposals Purchase Orders Records must be preserved during all production and service operations. Typically, records are kept with the traveler packages in the shop, Field Service Reports for service operations or in customer/vendor files in the office.

3 - Control of Production and Service Provision XYZ controls production activities in the shop via the Shop Traveler. No employee may deviate from the instruction provided through the shop traveler for any reason. Only Component engineers are permitted to alter Shop Travelers or the work instructions/forms referenced therein. XYZ controls field service and support activities through work instructions and procedures. Much like the shop, field service and front office personnel must adhere to the instructions communicated through the applicable procedures and work instructions.

4 - Control of Measurement Devices All devices used to verify quality characteristics (e.g. dimensions, process requirements or other part data) must be controlled and calibrated at predetermined frequencies. All tools and gauges are assigned a unique identification number. All tools and gauges must have the date on which the item was calibrated and the date when it is due for recalibration. No employee may use an un-calibrated tool or gauge to disposition product. If out-of-calibration equipment is discovered, discontinue its use and inform your supervisor or lead immediately.

5 - Preservation of Product All product handled through the shop activities or in the field must be preserved and protected at all times. Care must be taken to avoid any damage to customer or XYZ owned product (parts).

6 - Identification and Traceability All parts are identified through the shop traveler or other document which also contains information related to the parts status. All parts must be identified at all times, meaning that no product is allowed on the shop floor which does not contain the appropriate, identifying paperwork. If unidentified product is found, inform your lead or supervisor immediately.

7 - Control of Nonconforming Product During the course of production and service operations, product may be identified as nonconforming, meaning some aspect of the part does not meet the necessary quality requirements. All nonconforming product must be clearly identified and segregated from acceptable product so as to prevent its unintended use or delivery. All nonconforming conditions must be repaired or otherwise dispositioned by the Engineering and/or Quality Function. It is each employees responsibility to report such nonconformances to the applicable lead, supervisor, Inspector or Engineer to ensure the problem is properly handled.

8 - Corrective and Preventive Action Preventive actions are taken when an employee recognizes the possibility of a nonconformity occurring if proper measures are not taken to prevent it. (Nonconformities may either be product or process related). Corrective actions are taken to prevent a nonconformity from reoccurring. Any employee may recommend the issuance of a Corrective or Preventive action at any time. Simply contact your lead, supervisor or the Quality Department.

Audits

Why Audit? To verify the adequacy and adherence to stated requirements. Implementation is the key to managing the Quality System. Allows for measurement of results. Allows for consistency and reproducible results. Allows for process improvement initiatives. Implementation – “Say what you do, do what you say”

Audit Interviews Review all relevant procedures with your supervisor/ISO coordinator prior to the audit. Provide answers and supporting documents on a timely basis during the audit. Answer questions completely and honestly. Know where your procedures and documents are located. Know the XYZ Quality Policy and Quality Objectives as well as how you contribute to them.

Audit Findings (NCRs) Nonconforming conditions may be found during the audit process. When this happens, cognizant supervision is responsible to assure the following steps are taken to remedy the problem. Example of finding: Drawing - no release signature. Sign the drawing. Determine root cause Initiate corrective action to preclude recurrence Follow-up to determine effectiveness of C/A

Quality Representatives If you should have any questions regarding the Quality Management System or any other quality issue, you may contact any of the following people: XYZ: – John Q. Public