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McDonald's audit



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  • 1. McDonald's Corporation Equipment Supplier Audit Company Name: Atkins Temptec Company Address: 1855 NE 12th Ave., Suite A (street) Gainesville, FL 32641 USA (city, State, zip code) Company Phone: 352.378.5555 Company Fax: 352.335.6736 Date of Audit: 06/15/01 Person Conducting the Audit: Dan Fullerton – Quality Assurance (name and department) Name, Department and Title of Supplier Personnel Audited: Name Department Title Tim Luhrman Quality Assurance / Engineering Manager (both depts.) Scott Gilman Engineering Standards / Metrology Engineer Graham Cuthbert Quality Assurance ISO 9001 Coordinator Linda Swilley Quality Assurance Internal Audit & Training Coord. Dan Fullerton Quality Assurance Quality Assurance Engineer 8/31/95 File: Audit Quality System /mnt/temp/unoconv/20130729174352/mcdonaldsaudit-130729124352-phpapp01.doc Page 1 of 7
  • 2. Describe your quality system. Does it comply with any nationally recognized standards? (Example: ISO 9000, MIL-Q-9858, Q-101, etc.) We are an ISO 9001:1994 registered company. Is your quality system approved or certified by any 3rd party organizations? We are registered by International Management Systems, Inc., an ANSI-RAB accredited registrar. Do you have a quality manual? Who is responsible for it? Yes, it is maintained and controlled by document control. Do you have a quality policy? Has it been disseminated to all personnel? How? Yes, there are copies in employee cubicles and posted throughout the building. All new hires receive a copy. How does upper management support the quality system? (Example: periodic reviews, appointing management representative who is responsible for quality, etc.) We have a QA Dept. consisting of a QA Manager, an ISO Coordinator, a QA Engineer, an Internal Audit and Training Coordinator, and Inspectors. We also have a Standards and Metrology Engineer. There are 3 Internal Quality System Reviews each year by Management and two Semi-annual RAB registrar audits. Is there a documented long term quality plan? Please give a brief explanation? (Example: Reduce rework by 80% by 1998, eliminate final inspection by 1999, Be certified to ISO 9001/9002 by 1997 etc.) Be certified to ISO9001:2000 by 2002. Already registered to ISO9001:1994. Are quality tools such as process flow charts, failure modes and effects analysis (FMEAs) and control plans utilized? Which ones do you use? Who is responsible for initiating and updating them? How often are they reviewed? Quality Assurance Engineer maintains Internal Corrective/Preventative Action Program, Repair/Rework Data Analysis Graphs, and Vendor Perfomance Measurements. Please explain the reporting structure of the quality department. (manager, engineers, inspectors etc.; copy of an organization chart) See attached Atkins Temptec Organizational Chart. /mnt/temp/unoconv/20130729174352/mcdonaldsaudit-130729124352-phpapp01.doc Page 2 of 7
  • 3. Design Control Please outline the steps of your design development process from concept to production. (Tools, techniques, frequency of reviews, verifications, validations, etc.) Design projects typically involve the following stages: new product proposal, economic and engineering feasibility research, conceptual review, design and development, prototype asembly and testing, pre-production assembly and test validation, and product release for manufacture. Not all projects will include each stage and that is determined by complexity of product to be decided by Engineering Manager and other project team members. How do you process modifications or enhancements that occur after the product is released to manufacturing? (Example: Engineering release system, engineering change notice) Use Product Change Request Form, Request For Action Form, and Engineering Drawing Revision Procedure. How do you notify customers of modifications/enhancements that are initiated by you the supplier? Engineer notifies our Marketing/Sales staff regarding design changes. Marketing/Sales staff initiate communication as applicable. Is the quality of a new product adequately assessed prior to production? Is customer approval obtained? Yes, we have standardized test and validation procedures for engineering of all new products. In some cases, prototypes are provided to customers for evaluation. Document and Data Control Is there a system in place that assures and controls that blueprints, specifications, procedures etc. are current, and that all obsolete documents have been removed? Please describe it. We have an ISO 9001 qualified document control system which insures above mentioned documents are current and obsolete documents have been removed. Product Identification and Traceability Is there a procedure in place that allows for the identification of product from receipt through production to delivery? Please describe. All manufactured products have unique serial numbers affixed to them which identifies such items as model, date of manufacture, etc. Do you have a traceability system for product from receipt through installation? Please describe. We manufacture hand-held thermometers which do not require installation. /mnt/temp/unoconv/20130729174352/mcdonaldsaudit-130729124352-phpapp01.doc Page 3 of 7
  • 4. Process Control Are there procedures defining manufacturing processes? How are they disseminated on the shop floor. (Example: Reference books at stations, posted instructions etc. - Ask to see) We utilize Demand Flow Technology which provides assembly and quality standards through method sheets and job tasks with checklists and data sheets. These are distributed and controlled by document control. Describe the system for initiating, reviewing, updating and distributing these procedures? Who is responsible for the system? Engineering creates and approves drawings and related materials. Document Control distributes to specified locations throughout the facility. QA Manager oversees Document Control and Quality System. Describe your program for preventative maintenance on production equipment? Who administers the program? (Type of PM, frequency of PM) We have a documented maintenance program facilitated by Maintenance Technician. Inspection and Testing Do you perform receiving inspection on all incoming product? Please describe the method (Example: 100% inspection, sample inspection {ask which sampling plan they use} etc.). We inspect 100% of all received goods. Sample level is determined by part and supplier history. How are the features and frequency of receiving inspection determined? QA Manager oversees periodic review of inspection criteria. If receiving inspection does not take place, how do you assure materials conform to your requirements? (Example: Product certification, certificates of conformance, statistical data {control charts, Cpks}, supplier surveillance etc.) Materials are always inspected. Do you perform in-process inspection and testing as specified by quality plans/documented procedures? (Quality plans/documented procedures = documented inspection procedures, control plans, process flow diagrams etc.) Engineering defines acceptance/test criteria for all in-process manufactured goods. Do you perform final inspection and testing on all product? If yes, please describe the method (Example: 100% inspection, sample inspection {ask which sampling plan they use} etc.). Yes, 100% of all products manufactured must pass acceptance testing determined by Engineering. How are the features and frequency of final inspection determined? Engineering and Quality Assurance determine final inspection requirements. These are periodically reviewed. If final inspection and testing does not take place, how do you ensure that the product meets your customers' requirements and specifications? /mnt/temp/unoconv/20130729174352/mcdonaldsaudit-130729124352-phpapp01.doc Page 4 of 7
  • 5. All products are final inspected. How do you provide proof that product has been inspected and tested? We have internal final QA records for each manufacturing order and all instruments receive a certificate of calibration. Control of Inspection, Measuring, and Test Equipment Who selects the equipment used for measuring the dimensions or criteria selected? Engineering approves all test, inspection, and measurement equipment requirements. Is there a system for controlling, calibrating and maintaining inspection, measuring and test equipment to nationally recognized and traceable standard? Please describe the system. (Look for method of equipment recall, standard traceability (ANSI/NIST), calibration environment {temperature, humidity, cleanliness}) There is a documented standards and metrology program which facilitates and maintains the calibration schedule for standards equipment (N.I.S.T. traceable). How does your company identify equipment that is in the calibration program and how is the calibration status of the equipment determined? All equipment has unique ID stickers which show date of calibration and date due. We maintain a recall sheet with equipment and calibration due dates. Are individual records maintained for each piece of equipment? Yes. How do you assess the validity of previous inspections when a piece of equipment is found to be out of calibration? (Example: Assessing the severity of the out of calibration, should product be quarantined/recalled etc.) We maintain an internal calibration system. Calibration equipment found out of calibration is removed immediately. Product is evaluated by QA and Engineering to determine course of action. Inspection and Test Status /mnt/temp/unoconv/20130729174352/mcdonaldsaudit-130729124352-phpapp01.doc Page 5 of 7
  • 6. How is the inspection status of product identified and does it indicate the conformance/non-conformance of the product? Products have shop traveller/QA sheets which track pass/rework/reject status. Approved product is placed in finished goods area. Non-conforming products are reworked or rejected and scrapped. Control of Non-conforming Product How does your company prevent non-conforming product from unintended use or installation? There are marked containers in manufacturing for non-conforming product to be reviewed by the QA Engineer. There is a quarentine area for non-conforming material. Who is responsible for reviewing and dispositioning non-conforming product? The QA Engineer and Purchasing Manager determine status and disposition of non-conforming product. Corrective Action Do you employ a structured approach to problem solving? Please describe. Yes, we have a formal corrective/preventative action program (SQPC). SQPCs can be generated by company employees or customers. QA oversees resolution and maintains records. If not do you have plans to implement one? Already have a program. Packaging and Delivery Are packaging procedures documented? Customer specific requirements? Yes, drawings are maintained in shipping area and internal order software flags specific requirements. Are packaging procedures reviewed for effectiveness? Who is responsible for this task and how often is it performed? Shipping department is subject to internal audits. This is performed by internal auditors at least twice per year. Control of Quality Records What method does your company have for establishing, maintaining, accessing and storing quality records? (Examples: inspection records, material certifications, calibration records, test reports etc.) Records storage is compliant with ISO9001 standard. Internal Quality Audits /mnt/temp/unoconv/20130729174352/mcdonaldsaudit-130729124352-phpapp01.doc Page 6 of 7
  • 7. Do you perform internal quality audits on a regularly scheduled basis? If yes, how frequently and what method/guidelines do you follow? We follow the American National Standards Institute guidelines. All elements of the standard are audited at least twice per year. Training Do you establish and maintain records identifying training needs and completion of required training? We have a formal employee training and records system. Statistical Techniques Do you have a method for identifying and employing statistical techniques needed for establishing, controlling and verifying process capability and product characteristics? Yes, QA publishes monthly rework/reject product reports. Which techniques do you utilize? (Example: Control charts, histograms, Pareto Analysis, capability studies etc.) Graphs, SPC methods, Cause and Effect analysis, Manufacturing Performance measurement and analysis, and Vendor Performance rating system. Additional Comments /mnt/temp/unoconv/20130729174352/mcdonaldsaudit-130729124352-phpapp01.doc Page 7 of 7