Process Identification Tool95-2000

ISO/TS 16949:2002 Process Identification Tool (Purpose and Contents)
Notes: The ISO/TS 16949:2002 Process Identification Tool is abbreviated to the "Tool" in the following descriptions. ISO/TS TS 16949:2002 is abbreviated to "Specification". THIS TOOL IS NOT MANDATORY, IT IS ONE EXAMPLE OF HOW TO REFERENCE THE ORGANIZATION'S PROCESSES TO THE REQUIREMENTS OF ISO/TS 16949:2002 Purpose of this Tool To provide a step by step approach to address all the requirements of ISO/TS 16949:2002 in the organization's processes. The Tool leads the Quality Professional through an understanding of the broad functional areas of the Specification to a mapping of organization's processes to all required areas of the Specification. The Tool will aid the organization in the initial Document Review, highlighting areas of the Specification both addressed and not addressed by the organization's processes. Identifying which areas of the Specification are not addressed by the organization's processes will aid the organization to achieve full coverage of the requirements of the Specification in the organization's processes. The Tool provides the organization with a method to list the processes affecting the quality of the product.
What this Tool is NOT

This Tool is not an audit planning tool, nor is it to be used as a checklist to show full audit coverage of the Specification. Functionality note: This file is saved in Excel 2000 / 97 / 95 format. This means that you should be able to open it in any of those versions of Excel. However, not all links may work if opened in Excel 95, and you will need to select the tabs manually
Table of Contents
Description of Section Provides Purpose and description of tabbed Sections Summary of suggested steps to map the organization's processes to the requirements of the Specification Details of process definitions and suggested methods of use of the Tool Worksheet of the summaries of the requirements for each major Section of the Specification with data input areas to list the Organization processes that address the requirements of those major Sections. A fully functional example of one of the 11 major Sections of the Specification, showing the types of information suitable for each step of the mapping of organizational processes to the requirements of the Specification. An area where major customer specific requirements are to be listed, allowing the organization to map customer requirements to the organization's processes to address all major customer requirements. Summaries of the requirements of the 11 major Sections of the Specification with corresponding paragraph numbers from the Specification, to permit reference to the full text of the Specification. Note: the full and official requirements of the Specification are available in the English version of ISO/TS 16949:2002 (see the IAOB website http://www.iaob.org/.) Only summaries of requirements or requirement topics are listed in this Tool. Tab title (i) Table of Contents (ii) How to use this tool (iii) Detailed Instructions (iv) Major Process Matrix
(v) Example Section
Customer Specifics
Tabs 4 through 8.5 and Annex A
Ford Motor Co., DaimlerChrysler and General Motors 2003
(i) Table of Contents
25 February, 2003
How to use this process identification tool

TIP: PRINT OUT THIS PAGE AND THEN FOLLOW THE INSTRUCTIONS BY OPENING THE APPROPRIATE TAB
THIS IS TO BE USED ONLY FOR INITIAL MAPPING OF PROCESSES TO THE REQUIREMENTS OF ISO/TS 16949:2002. This is NOT to be used as an audit tool. Note: Detailed instructions on each of the following steps are found in the "Detailed Instructions" tab.
Step 1 Look at the tabs (Sections) in this workbook and understand their definitions (definitions of each Section are provided in the "Detailed
Instructions" and in the Major Process Matrix Section). Complete the customer specific Section by listing your automotive customers accepting ISO/TS 16949:2002 and their major customer specific requirements (not just what is published as a "specific requirement to ISO/TS 16949:2002, look at the statement of work, purchase order, etc.).
2 Fill in the table in the Major Process Matrix (more reference detail available in the Detailed Instructions).
List all your organization's major processes in the gray shaded header row of the Major Process Matrix, one major process per cell, an example is provided. Tip: only list the very high level processes, it is possible that your organization may have only 4 major processes (e.g. Marketing and Sales, Purchasing, Product / Process Development and Manufacturing), that is OK. Your organization may have 12 major processes, that is OK, but 40 (for example) may indicate that low level processes have also been included. There is no hard and fast rule on the number of major processes. For each Section listed in the Major Process Matrix, determine which major processes in your organization are applicable to that Section's definition / intent. An X is suggested, an example is provided. (Repeat for each of the 11 Sections, including customer specifics)
3
Select one Section in the workbook, and identify the lower level processes that meet the intent of each of the highlighted headings. Examples of this have been given in the Example Section tab. Lower level processes are still processes, not procedure steps. Machining would be an example of a lower level process under Manufacturing.
Note: The summaries / intents the of highlighted headings are shaded
yellow
(Repeat for all 11 Sections of the workbook tabs, and the customer specifics). TIP: when identifying the lower level processes, align them with the most appropriate high level process, as shown in the Example Section tab, such as Machining under Manufacturing or Supplier Support under Purchasing.
4 Expand one of the highlighted headings in the Section, (click on the + sign to the left of the heading to expand all topics per highlighted
heading). Identify the process steps, records, etc., which show that your company's processes address each and every topic in ISO/TS 16949:2002. These are the detailed steps of procedures, processes, etc., e.g. requirement 7.4.3 of procedure 97-34. There is no need to repeat the proceduralized requirement in the matrix, the line reference number or equivalent is enough. As procedures / processes are updated, this matrix would also have to be updated to remain aligned. TIP: once a highlighted heading section is expanded, click on the "-" sign by the shaded heading summary to compress the detailed requirements again. All input will be retained when the file is saved. (Repeat for each of the highlighted headings in the Section) Note: the ISO/TS 16949:2002 Specification provides the detailed requirements, listed in this Tool are only the topics of those requirements.
5 If some topics, highlighted headings or Major sections are not addressed, your organization is not ready for review by a registrar.
The Tool (or equivalent) must be complete showing full coverage of all requirements of the Specification in your quality system. Each item not addressed would result in a non conformance during a full registration audit. Therefore you can prepare your organization more thoroughly by providing full coverage of all the topics and requirements in the Specification through use of this Tool or equivalent.
6 Repeat Step 4 for each Section (including customer specifics). 7 Once you have demonstrated that you have met all the requirements of ISO/TS 16949:2002 (including customer specifics), retain this
document as proof that your quality management system requirements address all ISO/TS 16949:2002 items This document may be provided to your ISO/TS 16949:2002 registrar to assist in document review and to list processes.
(ii) How to use this tool
25 February, 2003
Double click on this Word document to open the detailed instructions which provide, among other items, the attributes of a process
(iii) Detailed Instructions
25 February, 2003
THIS IS TO BE USED ONLY FOR INITIAL MAPPING OF PROCESSES TO THE REQUIREMENTS OF ISO/TS 16949:2002.
Note 1: identify your major processes one process per cell horizontally Note 2: Your organization may have 3 or 4 or 10 major processes. This must be defined by your organization.
Example Section: Measuring Devices Section Number Title of Section from ISO/TS (tab in Excel 16949:2002 workbook) Customer Specifics 4 Quality Management System
Example header line Example
Title of Section
Summary intent of Section
Manufacturing
Marketing and Sales
Process 3 (if applicable)
The organization shall manage its measurement systems/equipment to ensure that appropriate measurement capability is used. Summary intent of Section
x
Organizations major process 1
N/A
N/A
x
Organizations major Add major process 6 processes if appropriate
Organizations major Organizations major Organizations major Organizations process 2 process 3 process 4 major process 5
5 Management Responsibility
6 Resource Management
7.1-7.2
Realization and Processes
7.3 Design and Development
7.4 Purchasing
7.5 Production & Service
7.6 Measuring Devices
8.1-8.4
Measurement and Analysis
8.5 Improvement
Annex A
Control Plan
Capture all major customer requirements in one area The organization documents its requirements as appropriate. The quality system includes: quality manual, controlled documents, specifications and records. Management establishes systems to drive the organization to meet customer requirements. Significant Management involvement is required (walk the talk) Management ensures that the appropriate personnel, skills, infrastructure, facilities, materials and equipment are available to complete the job to specification. All product realization (making the product) is planned, have requirements and acceptance criteria and have communications with the customer to ensure complete understanding of all requirements and expectations. All processes and product are designed using appropriate planning techniques, including, for example, FMEAs, and control plans. All customer requirements are managed, including special characteristics. All changes to the approved processes and product are reviewed by the customer. The organization ensures that purchased products and services meet requirements. Compliance checks may include incoming quality, onsite reviews and other methods of supplier monitoring and /or development. The organization manages its production processes through control plans, work instructions, job setup, and focuses on preventive measures of production management rather than reactive correction. The organization manages its measurement systems/equipment, to ensure that appropriate measurement capability is used. The organization measures process inputs, outputs and applicable process steps using appropriate equipment, audits. or other methods. This information is analyzed using the appropriate statistical or other techniques. Corrective action is used to ensure issues are not repeated. Preventive measures are used to eliminate potential issues before they occur. For Example: lessons learned and/or best practices may be applicable to both corrective and preventive actions. Controls plans are managed and contain elements as specified by the Specification.
(iv) Major Process Matrix
25 February, 2003
THIS IS ONLY TO BE USED FOR INITIAL MAPPING OF PROCESSES TO THE REQUIREMENTS OF ISO/TS 16949:2002
Major Process names in organization. ISO/TS Item number Marketing and Sales Process 3 (if applicable) Process 4 (if applicable) Process 5 (if applicable) Process 6 (if applicable)
A zero indicates that this process has NO input of applicability on the Major Process Matrix for this Section.
Summarized ISO/TS 16949:2002 requirement

Applicability of the Major Process to this Major Section
ISO/TS section name
Manufacturing
N/A
N/A
Clicking the "+" sign in the border expands the highlighted heading topics. Line 4.1 has example entries in the detail. Once expanded, click the "-" sign to compress again
General requirements
4.1 4.2.1
Manage and Maintain a quality system including processes and measurements General The quality system has procedures, policy, manual, and records
Link to or identify where the requirement is met Manufacturing process control, instructions 109, 402, 369.
Link to or identify Link to or identify where the where the requirement is met requirement is met Marketing instructions 987, 190.
Link to or identify where the requirement is met
Major processes (including major COPs) and applicability are copied from the Major Process Matrix tab.
Marketing and Sales have chosen to use the corporate master document list and quality manual in place of local documents.
Master Document list Corporate quality manual
Master Document list Corporate quality manual Here a process is missing and needs to be addressed by using a corporate process or a locally defined process for document control.
4.2.2
Quality manual The quality manual contains scope, procedures and processes / interactions
4.2.3
Control of documents Documents are controlled, approved, reviewed, version controlled, identified
Document control 01-001
4.2.4
Control of records Records are controlled, legible, stored, retrievable, managed
Record control 01- Marketing 357 instruction 016
Note: summaries of highlighted headings are shaded yellow NOTE: FULL REQUIREMENTS ARE AVAILABLE IN THE SPECIFICATION Note box color legend
Requirement not met by the quality system processes
Identification of the process which meets the requirement
(v) Example Section
25 February, 2003
List your customer "major" specific requirements, using the format of the other Sections
Note: Your organization needs to define major customer specific requirements (e.g. use PPAP). Steps; 1 List all your automotive customers (OEMs + any tier) who accept certification to ISO/TS 16949:2002 2 Group requirements by customer.
Automotive Requirement customer number Example (major processes) Example customer Ford 4.39.3
Description of requirement Manufacturing Internal auditor training requirements N/A Sales N/A Product Human Development Resources etc N/A X Organizati ons major process 5 Organizati ons major process 6 Add major processes if appropriat e
Automotive customer
Requirement number
Description of requirement
Organizati Organizations ons Organization Organizatio major process major s major ns major 1 process 2 process 3 process 4
Customer Specifics
25 February, 2003
Major Process names in organization.
ISO/TS Item number

ISO/TS section name
Organizations major Organizations process 3 major process 4
Organizati Organizati Add major ons major ons major processes if process 5 process 6 appropriate
0
4.1
General requirements 4.1 General requirements Implement a quality management system. Manage and Maintain a quality system including processes and measurements
Link to or identify Link to or identify Link to or identify where the where the where the requirement is met requirement is met requirement is met
4.2.1
General The quality system has procedures, policy, manual, policy, and records. Quality manual The quality manual contains scope, procedures, and processes/interactions. Control of documents Documents are controlled, approved, reviewed, version-controlled, and identified.
4.2.2
4.2.3
4.2.4
Control of records Records are controlled, legible, stored, retrievable, and managed.
Note: summaries of highlighted headings are shaded
yellow
NOTE: FULL REQUIREMENTS ARE AVAILABLE IN THE SPECIFICATION
4 - Quality Management System
25 February, 2003
Major Process names in organization. Organizati ons major process 4 Organizati ons major process 5 Organizati ons Add major major processes if process 6 appropriate

ISO/TS Item number ISO/TS section name
5 5.1
5 Management responsibility
Management commitment Management is engaged in the quality system, policy, objectives, and reviews. Customer focus Customer requirements are determined and met Quality policy The quality policy is appropriate, improves quality, has objectives, and is cascaded. Planning / Quality objectives Objectives and measurements are used to meet quality planning goals Responsibility, authority and communication Responsibilities are defined, have management rep, communicate internal/ external Management review Conduct management review of performance output to specified inputs.
Link to or identify Link to or identify where the where the requirement is met requirement is met
5.2
5.3
5.4
5.5
5.6
Note: summaries of highlighted headings are shaded yellow NOTE: FULL REQUIREMENTS ARE AVAILABLE IN THE SPECIFICATION
5 - Management Responsibility
25 February, 2003

Organizati ons major process 4
Add major processes if appropriat e
6 6.1
6 Resource management
Provision of resources Provide resources sufficient to meet customer requirements Human resources Personnel have appropriate training/skills and are empowered. Infrastructure Adequate infrastructure is to be maintained, including that for contingencies. Work environment Work environment is appropriate for product and personnel safety
6.2
6.3
6.4
6 - Resource Management
25 February, 2003

Link to or identify Link to or identify where the where the requirement is met requirement is met 7 Product realization Product realization planning includes requirements, validation, and change control. Customer-related processes Customer requirements are understood, communicated, and feasible. Note: summaries of highlighted headings are shaded yellow NOTE: FULL REQUIREMENTS ARE AVAILABLE IN THE SPECIFICATION
7.2
7.1, 7.2 Realization, Processes
25 February, 2003

Link to or identify Link to or identify where the where the requirement is met requirement is met 7.3 Design and development Design is planned, validated, managed and employs a multidisciplinary approach Design and development inputs Process and product design inputs are understood, including characteristics Design and development outputs Process and product design outputs are robust and meet all requirements Design and development review Design progress to target is monitored and included in management review Design validation and verification Design is verified and validated, including prototypes, per customer requirements 7.3.7 Control of design and development changes Design changes are controlled and actions/verifications recorded. Note: summaries of highlighted headings are shaded yellow NOTE: FULL REQUIREMENTS ARE AVAILABLE IN THE SPECIFICATION
7.3.2
7.3.3
7.3.4
7.3 Design and Development
25 February, 2003

Organizati ons Add major major processes if process 6 appropriate
Link to or identify Link to or identify where the where the requirement is met requirement is met 7.4 7.4.1
Purchasing Purchasing process Purchased product meets requirements; suppliers are selected and managed. Purchasing information Purchasing information addresses product, personnel skills and quality system Verification of purchased product Purchased product is verified by incoming quality or on-site supplier monitoring.
7.4.2
7.4.3
7.4 Purchasing
25 February, 2003

ISO/TS Item ISO/TS section name number 7.5 Production and service provision
7.5 7.5.1
Link to or identify Link to or identify where the where the requirement is met requirement is met Control of production and service provision Production processes are managed: control plans, instructions and set-up checks Preventive and predictive maintenance Equipment and tooling are maintained and preventive maintenance is scheduled. Feedback of information from service Service issues are known and managed, including production process validation Identification and traceability Product is identified, traceable, managed, preserved and stored appropriately
7.5.1.4
7.5.1.7
7.5.3
7.5 Production and Service
25 February, 2003

ISO/TS Item number ISO/TS section number and name Control of monitoring and measuring devices 7.6
Measuring devices are calibrated, identified, protected and not constantly adjusted
7.6.1
Measurement system analysis
Measurement capability is managed and records of calibration are kept

7.6.3
Laboratory requirements Internal and calibration / testing laboratories meet customer requirements
7.6 Measuring Devices
25 February, 2003

Add major processe s if appropriat e
Measurement, analysis and improvement Product and processes are monitored/managed through appropriate statistics. Monitoring and measurement Customer satisfaction is monitored at all stages within the organization's scope Internal audit Internal audits of processes and product are managed by qualified personnel Monitoring and measurement of processes Processes are monitored and corrected when not meeting customer requirements
8.2
8.2.2
8.2.3
8.2.4
Monitoring and measurement of product Product is monitored, including dimensions and appearance, for conformance. Control of nonconforming product Nonconforming product is isolated, rework processes managed, & customer told Customer waiver Customer approval is required for any changes from approved process Analysis of data Data collected are analyzed for current and future trends in customer satisfaction. Note: summaries of highlighted headings are shaded yellow NOTE: FULL REQUIREMENTS ARE AVAILABLE IN THE SPECIFICATION
8.3
8.3.4
8.4
8.1 - 8.4 Measurement, analysis
25 February, 2003
ISO/TS Item number

ISO/TS section name
0
8.5
Improvement Organization customer satisfaction continually improves in all key areas Corrective action Nonconformances and root causes are corrected to prevent recurrence Preventive action To prevent issues, sources of potential nonconformances are eliminated
8.5.2
8.5.3
8.5 Improvement
25 February, 2003

ISO/TS Item number ISO/TS section name A
Annex A Control plan (normative) required

A.1
Phases of the control plan Control plan covers prototype, pre-launch, and production phases. Elements of the control plan Control plan includes product information, process control, methods and reactions
A.2
Annex A
25 February, 2003
Major Section Links 4 - Quality Management Systems 5 - Management Responsibility 6 - Resource Management 71.,7.2 - Realization, Processes 7.3 - Design and Development 7.4 - Purchasing 7.5 - Production and Service 7.6 - Measuring Devices 8.1 - 8.4 Measurement and Analysis 8.5 - Improvement Annex A
Section links
25 February, 2003

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ISO/TS 16949:2002 Process Identification Tool (Purpose and Contents)

What this Tool is NOT

(v) Example Section

Tabs 4 through 8.5 and Annex A

Ford Motor Co., DaimlerChrysler and General Motors 2003

(i) Table of Contents

How to use this process identification tool

Ford Motor Co., DaimlerChrysler and General Motors 2003

(ii) How to use this tool

Ford Motor Co., DaimlerChrysler and General Motors 2003

(iii) Detailed Instructions

Example header line Example

Summary intent of Section

Marketing and Sales

Process 3 (if applicable)

Process 4 (if applicable)

Process 5 (if applicable)

Process 6 (if applicable)

Realization and Processes

7.3 Design and Development

7.5 Production & Service

7.6 Measuring Devices

Measurement and Analysis

Ford Motor Co., DaimlerChrysler and General Motors 2003

(iv) Major Process Matrix

Summarized ISO/TS 16949:2002 requirement

Link to or identify where the requirement is met

Master Document list Corporate quality manual

Document control 01-001

Control of records Records are controlled, legible, stored, retrievable, managed

Record control 01- Marketing 357 instruction 016

Requirement not met by the quality system processes

Identification of the process which meets the requirement

Ford Motor Co., DaimlerChrysler and General Motors 2003

(v) Example Section

Ford Motor Co., DaimlerChrysler and General Motors 2003

ISO/TS Item number

Summarized ISO/TS 16949:2002 requirement

Organizations major process 1

Organizations major process 2

Organizations major Organizations process 3 major process 4

Note: summaries of highlighted headings are shaded

NOTE: FULL REQUIREMENTS ARE AVAILABLE IN THE SPECIFICATION

Ford Motor Co., DaimlerChrysler and General Motors 2003

4 - Quality Management System

Summarized ISO/TS 16949:2002 requirement

Organizations major process 1

Organizations major process 2

Organizations major process 3

Link to or identify where the requirement is met

Ford Motor Co., DaimlerChrysler and General Motors 2003

Summarized ISO/TS 16949:2002 requirement

Organizations major process 1

Organizations major process 2

Organizations major process 3

Organizati ons major process 4

Organizati ons major process 5

Organizati ons major process 6

Add major processes if appropriat e

Link to or identify where the requirement is met

Ford Motor Co., DaimlerChrysler and General Motors 2003

Summarized ISO/TS 16949:2002 requirement

Organizations major process 1

Organizations major process 2