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TL 9000 Measurements Auditing the Validation Process

TL 9000 Measurements Auditing the Validation Process. Jerry Wilson TL 9000 Program Manager / Lead Auditor TÜV SÜD America , Inc. Focus.

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TL 9000 Measurements Auditing the Validation Process

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  1. TL 9000 MeasurementsAuditing the Validation Process Jerry Wilson TL 9000 Program Manager / Lead Auditor TÜV SÜD America, Inc.

  2. Focus There are 4 basic components to the TL 9000 measurements process as shown below. Today we will focus on the Validate step and review a few of the things that are verified during an audit of this process step. • Data Sources • Customer • Supplier • Internal system

  3. Simplified Process Flow Inputs Process Validate Y Collect Analyze N Correct Data Outputs • Report to : • MRS • Organization • Customers (if required)

  4. INPUTS • The Auditor must gain an understanding of: • the product categories being reported • the inputs • What customers or suppliers provide data? • What data do they supply? • The collection methodologies for each • How do they supply it?

  5. INPUTS The Auditor must assess: the status of any ‘N/A’ or ‘Exempt’ and ensure acceptability consistency with scope of registration Example: All Common and Hardware measurements are collected if the organizations scope is H Review corrective actions if organization has previously been on ‘suspended’ or ‘probation’ status(ref: Alert 06-003A)

  6. PROCESS • Look for : • documented validation process (measurements handbook 3.5.2. a)) • responsibilities for review and approval • handling of invalid data • access to the source data is available for validation • verification that the output from any software application or spreadsheet has been verified (7.1.C.4 Tools Management) • ensure correct calculations and proper use of the counting and exclusion rules • Sample calculations, counting, and exclusion rules • Ensure that validation personnel are trained and understand the counting rules

  7. PROCESS CHANGE • Look for: • Evidence that when changes are made to software applications / spreadsheets used to consolidate the information that there is verification that the output is acceptable (7.1.C.4 Tools Management) • verify correct calculations • verify data filters are working correctly (counting rules vs. exclusions)

  8. OUTPUT • Look for : • evidence data validation occurs prior to each reporting period • acceptable DCR’s for each category • sample the summary data and comparing to DCR’s

  9. Indicators • Possible Indicators • Management Reviews show consistent poor results • DCR’s indicating zero for NPR / SPR (especially for several consecutive months) • may indicate that the linkage between the reporting method and collection system is broken • Large variations in quantities reported • Issues related to the date filters orcounting rules

  10. Thank You

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