20.doc

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Company Name
Division or Address
Division or Address
Statistical Techniques
Doc. No.
Rev. No.
Date: 6/28/2016
Page 1 of x
ISO Procedure
Statistical Techniques
Approved:
__________________________________________________
Name
title
Approved:
___________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Change Record
Rev
Date
Responsible
Person
Description of Change
A
6/28/2016
Name
Initial Release
Distribution List
(list the departments that receive controlled copies)
Controlled Copy, Do Not Duplicate
For Internal Use Only
Company Name
Division or Address
Division or Address
1.
2.
Statistical Techniques
Doc. No.
Rev. No.
Date: 6/28/2016
Page 2 of x
Purpose
•
To ensure consistent quality and appropriate process control through the
use of statistical techniques.
•
To collect, analyze, and interpret data relating to product and process
performance.
Scope
This procedure applies to data gathered from process, shipment, and inspections;
and from marketing analysis.
3.
Responsibilities
<Job title> collects data from in-process tests.
<Job title> samples the quality of received product.
<Job title> identifies all critical process control points and statistical methods to
be employed.
<Job title> collects test results from barcode readers.
Controlled Copy, Do Not Duplicate
For Internal Use Only
Company Name
Division or Address
Division or Address
4.
Statistical Techniques
Doc. No.
Rev. No.
Date: 6/28/2016
Page 3 of x
Procedure
4.1
Applications
The following table lists the inspections or tests from which data is
analyzed:
Test or Inspection Name
Responsible Person
Collection Method
(i.e., receiving inspection)
(i.e., inprocess)
(i.e., inspector)
(i.e., operator)
(i.e., visual)
(i.e., test equipment)
(i.e., Final system test)
(i.e., Manufacturing
Engineer)
(i.e., Software)
4.2
Process Analysis
The following table with the types of analysis, test, and record keeping:
Types of analysis
Tests /inspections
providing data
(i.e., first pass yield, burn-in <test>
failure rates, Pareto,
histogram)
Forms used to record data
<record>
The following table lists the person responsible for data collection,
frequency, and method:
Test
Responsible Person Frequency
Collection
Method
<Job title/departments> reviews and analyzes the data. The data is
disseminated by <method>.
4.3
Data Review
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For Internal Use Only
Company Name
Division or Address
Division or Address
Statistical Techniques
Doc. No.
Rev. No.
Date: 6/28/2016
Page 4 of x
<Job title> collects data. <Frequency>, at <name of meeting> attended by
<job titles> the data and causes of problems and corrective actions are
reviewed.
4.4
Market Analysis
<Job title> collects marketing data through <analysis>. <Job title>
reviews the marketing data.
4.5
Written Procedures
<Job title> documents the procedures for collecting and analyzing
statistical data. These procedures are maintained under the Document
Control system.
5.
Related Documentation
Contract Review
Process Control
Inspection and Testing
Servicing
<list work instructions>
Controlled Copy, Do Not Duplicate
For Internal Use Only
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