Transcript TL 9000 Measurements Auditing Validation

TL 9000 Measurements
Auditing the Validation Process
Jerry Wilson
TL 9000 Program Manager / Lead Auditor
TÜV SÜD America, Inc.
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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
Collect
Report
Analyze
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Suppliers
Internal
Systems
Customers
Inputs
Y
Collect
Validate
Correct Data
Analyze
N
Outputs
Process
Inputs
Simplified Process Flow
Report to :
• MRS
• Organization
• Customers (if required)
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INPUTS
• The Auditor must gain an understanding of:
1.
the product categories being reported
2.
the inputs
• What customers or suppliers provide data?
• What data do they supply?
3.
The collection methodologies for each
• How do they supply it?
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INPUTS
• The Auditor must assess:
4.
the status of any ‘N/A’ or ‘Exempt’ and ensure
acceptability
5.
consistency with scope of registration
–
6.
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)
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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
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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)
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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
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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 or
counting rules
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Thank You
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