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Note: 1.
2.
This Quality Management System Workbook is suitable for use with the
AS9100C standard for quality management systems.
This Quality Management System Workbook is best utilized with the AS
implementation training tools as provided in a series of ppt presentations.
Visit www.as9100store.com for the presentation package that matches the
workbook sections.
Management
Task 2:
Management
Task 3:
Management
Task 4:
Management
Task 5:
AS Steering Team
Task 6:
AS Steering Team
Task 7:
Quality Team
Task 8:
AS Steering Team
Task 9:
AS Steering Team
Task 10:
Quality Team /
AS Steering Team
Note: *Interrelated requirements identified with Task 10 take into consideration the
applicable requirements associated with customer, regulatory, statutory, legal and other
requirements along with special requirements, critical items and key characteristics.
Task 1
Task 2
DECIDE on the MANAGEMENT SYSTEM for your COMPANY:
_________________________________________________________________
Options for Management Systems:
Task 3
Comments:
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Prepared by; __________________________ Date: ______________
Task 4
Appoint the Management Representative and the AS9100 Steering
Team
The paragraph 5.5.2 of AS9100 outlines the requirements for a Management
representative and is paraphrased below:
A Management representative needs to be selected from the management group
and appointed to coordinate the development and implementation of the QMS.
The representative needs to be knowledgeable of quality assurance principles and
be familiar with the companys operations, processes, customer and regulatory
requirements.
The management representative must have the organizational freedom and
unrestricted access to top management to resolve quality management issues.
========================================================
AS9100 MANAGEMENT REPRESENTATIVE
At _____________________________________ (your company),
The person best suited to carry out the responsibilities of Management
Representative is:
Comments:
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Prepared by; __________________________ Date: ______________
Task 4 (contd)
========================================================
AS9100 Steering Team
The members of the AS9100 Steering Team are:
Management representative
Name
Title
Name
Title
Name
Title
Name
Title
Name
Title
Name
Title
Name
Title
Name
Title
Comments:
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------See also Quality Team selection at Task 6
Prepared by; __________________________ Date: ______________
10
Task 5
PRESIDENT OWNER
QUALITY
MANAGEMENT
REPRESENTATIVE
Comments:
.
Prepared by; __________________________ Date: ______________
11
Task 6
NAME
Personnel Manager
Comments:
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Prepared by; __________________________ Date: ______________
12
Task 7
Comments:
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
13
Task 8
QUALITY POLICY
With integrity in the workplace, dedicated employees, and innovative services, our
QUALITY POLICY is to satisfy our customers with a full range of your AS & D
activities / products / services that meet the needs and expectations of international
and domestic customers.
******
14
Task 8 (contd)
Define the objectives for: ___________________________ (COMPANY)
The main objectives for years _______, ________, ________, _______.
Objectives
5.
6. .........................................................................................................................................
.........................................................................................................................................
.........................................................................................................................................
.........................................................................................................................................
Prepared by: __________________________________ Date: _____________
15
Task 9
16
Task 10
Name of Product or
Service
Identification
Part Number
Change Configuration
Chg Let
Date
Class
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
..
Comments:
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Prepared by: _________________________ Date: _______________
17
Identification
Part Number
Change Configuration
Change
Letter/Number
Date
Class
I, II
..
..
..
..
..
..
..
..
..
..
..
..
..
..
Comments:
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Prepared by: _________________________ Date: _______________
18
Part
#
Change
Configuration
Chg
Date Class
Let
I or II
Critical
Items
Key
Characteristics
Comments:
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Prepared by: _________________________ Date: _______________
Copyright2009 Lorne Duquette Distributed by as9100store.com
19
Critical Items:
Critical items include functions, parts, characteristics, processes that have
significant effect on product realization and use of the product such as
safety, performance, form, fit, function, etc, that require specific actions to ensure
that they are adequately managed. Critical items include safety critical items,
fracture critical items and key characteristics.
Critical items and special requirements can be identified when reviewing the
requirements related to the product.
Go to your customer input data (contracts, drawings, specifications, etc.) to define and
identify interrelated requirements. For your products or services, indicate the YES or NO
status of interrelated requirements relative to critical items.
Design output can include the identification of critical items that require specific actions to
ensure that they are managed adequately.
Note that a procedure EP-730c for design and development is available in our AS9100C
QMS Documentation package.
Visit http://www.as9100store.com/as9100-procedures.aspx for more information.
Name
of
Product
or
Service
Part
#
Change
Configuration
Chg
Date Class
Let
I or II
Key
Character
istics
Critical Items
Comments:
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Prepared by: _________________________ Date: _______________
20
Key Characteristics:
A key characteristic is described as an attribute or feature where variation has a
significant effect on product fit, form, function, performance, service life, or
manufacturability that requires particular attention for the purpose of controlling
variation.
Go to your customer input data (contracts, drawings, specifications, etc.) to define and
identify interrelated requirements. For your products or services, indicate the YES or NO
status of interrelated requirements relative to key characteristics.
Design output can include the identification of critical items that require specific actions to
ensure that they are managed adequately. Some critical items can further be classified
as key characteristics because their variation needs to be controlled.
Note that a procedure EP-731c for key characteristics is available in our AS9100C QMS
Documentation package.
Visit http://www.as9100store.com/as9100-procedures.aspx for more information.
Name
of
Product
or
Service
Part
#
Change
Configuration
Chg
Date Class
Let
I or II
Critical
Items
Key
Characteristics
Comments:
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Prepared by: _________________________ Date: _______________
21
Part
#
Change
Configuration
Chg Date Class
Let
Other Interrelated
Requirements
Special Critical
Key
Reqts
Items
Charact
eristics
Applicable
Regulations
Latest
Date
.. .
.
.
..
..
.. .
.
.
..
..
.. .
.
.
..
..
.. .
..
22
Task 10
Maintain a registry to summarize the interrelated requirements that are relevant to your organization.
Name of
Product or
Service
Identification
Part
Number
Change Configuration
Chg
Let
Date
Class
Special
Reqts
Critical
Items
Key
Characteristics
Applicable
Regulations
Latest
Date
..
..
..
..
.. .
.
.
..
..
..
..
..
..
..
.
.
.
..
..
..
..
..
..
.
.
.
..
..
..
..
..
..
.
.
..
..
..
..
.. ..
.
.
23
24
Quality Team
Task 12
AS Steering Team
Task 13:
Quality Team
Task 14:
AS Steering Team
Task 15:
AS Steering Team
Task 16:
AS Steering Team
Task 17:
AS Steering Team
Task 18:
AS Steering Team
Task 19:
AS Steering Team
Task 20:
AS Steering Team
Task 21:
AS Steering Team
25
Task 11a
Most Businesses have similar basic processes that are controlled and incorporated in a
QMS.
They are listed as:
Review the list and determine if your organization has the same, or similar,
or different functions. Add your comments in areas below:
Public relations, Sales and order management,
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Purchasing and material control,
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Production and shipping,
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Management and administration,
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Review and improvement.
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Make use of Task 11b Process description worksheet to further detail your individual
activities.
Prepared by _________________________ Date _____________
26
C
U
S
T
O
M
E
R
Satisfaction
Preparing quotations / proposals
and service promotions;
Selling and accepting orders
from customers;
Entering orders into the
system for production and delivery;
Providing customer support services;
Communicating with customers to
determine what they need
and their level of satisfaction;
Monitoring competition for new
service / product and
market intelligence.
C
U
S
T
O
M
E
R
27
___________________________
Satisfaction
Activities include:
C
U
S
T
O
M
E
R
C
U
S
T
O
M
E
R
28
___________________________
C
U
S
T
O
M
E
R
Activities include:
Managing work in process;
Providing work instructions and
related information to development staff;
Maintaining development / production equipment;
Planning and scheduling work in process;
Supervising and training staff;
Planning and controlling inspection
and quality control activities;
Delivering service products;
Satisfaction
C
U
S
T
O
M
E
R
10
29
___________________________
Activities include:
Satisfaction
C
U
S
T
O
M
E
R
C
U
S
T
O
M
E
R
11
30
___________________________
Process Description
5- Review and improvement
Requirements
C
U
S
T
O
M
E
R
Satisfaction
Activities include:
Perform management reviews;
Conduct internal quality audits;
Control nonconformities;
Analyse data for continual improvement;
Analyse statistical techniques;
Implement corrective and preventive actions
C
U
S
T
O
M
E
R
12
31
Task 11c
Purchase
Receive
Storage
Comments:
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Prepared by; __________________________ Date: ______________
32
Task 12
33
This checklist is based on the requirements specified in the 5 main clauses of AS9100C
standard for Quality Management Systems and can be used by auditors / inspectors to
conduct preliminary assessments of Quality Management Systems in Aviation, Space
and Defense (AS & D) organizations.
2.
This checklist is used to identify the many good activities that are currently In Control
and to highlight the areas that Need Attention.
3.
The box beside each item can be checked to indicate that a "situation is in control," or
one that needs further attention, or one that is not applicable. The space at the end of
each topic or the back of the page can be used to make comments and provide details.
4.
After completing the assessment, the completed document can serve as a tool for the
responsible personnel to plan and implement improvement / corrective actions.
Comments:
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------A more comprehensive assessment can be completed with the use of a Gap-Analysis
checklist.
Visit as9100store.com for further information.
Prepared by; __________________________ Date: ______________
34
This checklist is based on the requirements specified in the 5 main clauses ofAS9100C standard
for Quality Management Systems and can be used by auditors / inspectors to conduct
preliminary assessments of Quality Management Systems in Aviation, Space and Defense
organizations.
2.
This checklist is used to identify the many good activities that are currently In Control and to
highlight the areas that Need Attention.
3.
The box beside each item can be checked to indicate that a "situation is in control," or one that
needs further attention, or one that is not applicable. The space at the end of each topic or the
back of the page can be used to make comments and provide details.
4.
After completing the assessment, the completed document can serve as a tool for the responsible
personnel to plan and implement improvement / corrective actions.
Needs
Attention
Within your existing system, are your activities controlled through some type of
quality control / inspection system that provides you with the confidence that
the customer will be satisfied?
Can you provide some examples of improvement in the activities of the
company?
If you out-source / sub-contract processes, are these processes identified &
controlled?
When problems are identified, are actions taken to correct the problems?
Does your quality management system address customer and applicable
statutory and regulatory requirements?
Does your organization maintain a record / registry of interrelated requirements
(customer, regulatory, statutory, legal and other requirements)?
Does your organization have a quality manual?
Does your organization ensure that personnel have access to and are
aware of relevant QMS documentation and changes?
Does your organization have a documented procedure regarding the control
of documents?
35
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------5-MANAGEMENT RESPONSIBILITY
Has top management demonstrated commitment to both the development and
implementation of the QMS?
Does top management ensure that product conformity and on-time delivery
performance are measured and that appropriate actions are taken if planned
results are not or will not be achieved?
Does your organization have a process in place to identify your customer
requirements?
Does your organization have a process in place to identify the regulatory
requirements?
Has management formulated and approved a Quality Policy?
Is the quality policy communicated and understood at all levels of the
organization?
Has management established the quality objectives for the organization?
Do you have a method / process for the planning of the QMS?
Are responsibilities, authorities and their interrelation defined and
communicated within your organization?
Has top management appointed a management representative to deal with
matters concerning the QMS?
Does the management representative have the organizational freedom and
unrestricted access to top management to resolve quality management
issues?
Has a communication process been established within your company?
Are management reviews of the quality system conducted by top
management?
Does management review include inputs relative to the improvement of the
QMS?
Does the output from management review include the decisions and
actions related to improvement of the effectiveness of the QMS?
Copyright2009 Lorne Duquette Distributed by as9100store.com
36
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
6 RESOURCE MANAGEMENT
Has your organization provided the resources needed to Implement and
maintain the effectiveness of the QMS?
Have you provided the resources needed to make sure that the customers
are satisfied by consistently meeting their requirements?
Have you provided the resources needed to make sure that the regulatory
requirements are consistently met?
People represent a very valuable asset for companies.
How many people do you have in your organization? We have ___ PEOPLE
Are personnel with assigned responsibilities competent on the basis of
appropriate education, training, skills, and experience?
Has your organization determined the competence required for personnel
performing work affecting product quality?
Has your organization provided QMS / AS training to the personnel?
Are records of competence, awareness and training maintained?
Has your organization provided the facilities / infrastructure needed to meet
service / product requirements?
Do you have a maintenance program for the equipment?
Has your organization determined the work environment needed to achieve
conformity to service / product requirements?
Do you have a program to maintain an environment conducive to the
development and delivery of quality services and products?
.. Does the program include good practices and requirements relative to
health, cleanliness, protective clothing, etc?
Do you have a maintenance program for the equipment?
37
38
39
How does your organization plan and control production and service
operations?
.. Description of product characteristics, procedures, instructions, suitable
equipment, measuring devices, release, delivery, post-delivery service,
labelling and packaging.
Does the planning for control of production and service provision consider
the processes to manage critical items including process controls where key
characteristics have been identified?
Is first article inspection of a representative item used to verify the
production process and repeated when significant changes occur?
Are the personnel authorized to approve changes to production processes
identified?
Are the production equipment, tools and software programs used to
automate and control/monitor product realization processes validated prior to
release?
Does your post-delivery support include items such as the collection and
analysis of in-service data, controls required for off-site work done at the
customers location?
Does your organization have any special processes for production or service
where the output cannot be verified by monitoring or measurement?
How do you validate these processes?
How does your organization identify the product throughout production?
Maintenance of configuration, batch number, name of product, date of
manufacture, etc
Is the product (good or bad) status maintained throughout production,
storage, installation and servicing activities to ensure that only acceptable
products are released?
Do you have a system for the traceability of product?
... Is the identification required for traceability purposes such that it can be
maintained throughout the life of the product?
Do you have the ability to trace products manufactured from the same
batch of raw material, or from the same manufacturing batch, to the delivery
destination or to scrap?
How does your organization maintain the customer (intellectual) property while
it is under your control?
Does your organization protect / preserve the conformity of the products /
documents during internal processing and delivery?
40
..
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT
Has your organization planned and implemented the monitoring,
measurement, analysis and improvement processes for the QMS?
Do you make use of statistical techniques as a measurement method?
Does your organization receive feedback and monitor information on customer
perception regarding customer satisfaction?
Has your organization developed and implemented plans for customer
satisfaction improvements that address customer concerns?
Is there a documented procedure for internal QUALITY audits?
Are internal audits conducted at planned intervals to determine if the QMS
is effectively implemented and maintained?
Are auditors selected to ensure the audits and auditors are objective and
impartial in the audit process?
Does your organization have methods for monitoring of the QMS processes?
When the results are not achieved, are corrective actions taken to confirm
conformity of the product?
Does your organization monitor and measure the characteristics of the
product to verify product requirements are met?
Copyright2009 Lorne Duquette Distributed by as9100store.com
41
When critical items, including key characteristics are identified, are they
controlled and monitored in accordance with the established processes?
... When sampling plans are used to accept product, are the plans justified on
the basis of recognized statistical principles and appropriate to the capability
of the process and the criticality of the product?
... In the event that product is released prior to the completion of all inspection
and tests, can the product be recalled for replacement should subsequent
results show that requirements are not met?
Do you have records available indicating the person authorizing release of
product as it is processed through the operations?
Do you ensure that the documents required to accompany the products are
present at delivery?
Is there a documented procedure for control of non conformity?
How does your organization ensure that product which does not conform to
requirements is identified & controlled to prevent unintended / accidental use?
Are the controls and responsibilities and authorities for nonconforming
product defined in a documented procedure?
Are records maintained for nonconformities, actions taken and (if
applicable) approvals obtained for authority to use as is (deviations /
concessions)?
Does your organization recognize that the dispositions of use-as-is or
repair can not be used unless specifically authorized by the customer if the
nonconformity results in a departure from the contractual requirements?
Does your organization recognize that the dispositions of use-as-is or
repair can only be used after approval by an authorized representative
responsible for the design?
Does the disposition of scrap product include permanent marking and the
positive control until it is rendered physically unusable?
Do you document the instructions for the rework process when products
need to be reworked?
Do the instructions include the same authorization and approval as the
original instructions?
Does your organization collect and analyze existing data to demonstrate the
suitability and effectiveness of the QMS?
Does your organization collect and analyze data to identify and implement the
changes needed to ensure and maintain a suitable and effective QMS?
42
Summary:
___ Short Term Improvement Actions within 1 month
___ Mid-Term Improvement Actions within 2 to 6 months
___ Long Term Improvement Actions within 7 to 12 months
SUMMARY OF FINDINGS
Clause 4-QUALITY MANAGEMENT SYSTEM
Clause 5-MANAGEMENT RESPONSIBILITY
Clause 6 RESOURCE MANAGEMENT
Clause 7 PRODUCT REALIZATION
Clause 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT
TOTAL SITUATIONS
IN CONTROL
43
The ___ areas that NEED ATTENTION are reviewed & improvement actions identified as:
Improvement Action
Assigned to
Promise
Date
Actual
Date
Comments
1
2
3
4
MEDIUM TERM IMPROVEMENT ACTIONS To be implemented within 2 to 6 months
#
Improvement Action
Assigned to
Promise
Date
Actual
Date
Comments
1
2
3
4
LONG TERM IMPROVEMENT ACTIONS - To be implemented within 6 to 12 months
#
Improvement Action
Assigned to
Promise
Date
Actual
Date
Comments
1
2
3
4
Comments:
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
44
With the exact same instructions given to the 2 or more people, do you expect the results to be
exactly the same?
No !!! of course not !!!
The instructions were not specific enough.
****
A general rule:
Instructions are required where in their absence problems are
likely to occur.
45
Use the AS workbook and have your personnel identified as members of the AS
Steering Team and the Quality Team go through the Task 15 Exercises on their
own and bring questions and concerns to the weekly Quality Team meetings.
2.
Use the AS workbook over several workshop sessions and have your personnel
identified as members of the AS Steering Team and the Quality Team go through
the Task 15 Exercises as a group and have questions and concerns addressed.
Above 2 options are more suited for small and medium size companies.
3.
April 1
April 8
April 15
April 22
April 29
May
6
Clause 4
Exercise B
Clause 5
C
Clause 6
D
Clause 7
E
Clause 8
F
Risk Analysis
G
Comments:
46
AS9100
Instructions for the review of the
Requirements
requirements
Clause #
4 Quality Management System
Task 15
QMS
Workshop
Exercise B
Clause
4.1 to 4.2
4
Quality
management
system
4.1
General
requirements
4.2
Documentation
requirements
4.2.1
General
4.2.2
Quality manual
47
-- YES -In
Compliance
-- NO -Needs
Attention
------
------
4.2.3
Control of
documents
4.2.4
Control of
records
48
AS9100
Instructions for the review of the
Requirements
requirements
Clause #
5 Management Responsibility
Task 15
QMS
Workshop
Exercise C
Clause
5.1 to 5.6
5
Management
responsibility
5.1
Management
commitment
5.2
Customer focus
5.3
Quality policy
49
-- YES -In
Compliance
-- NO -Needs
Attention
------
------
5.4
Planning
5.4.1
Quality
objectives
5.4.2
Quality
management
system
planning
5.5
Responsibility,
authority and
communication
5.5.1
Responsibility
and authority
5.5.2
Management
representative
50
5.5.3
Internal
communication
5.6
Management
review
5.6.1
General
5.6.2
Review input
5.6.3
Review output
51
AS9100
Instructions for the review of the
Requirements
requirements
Clause #
6 Resource Management
Task 15
QMS
Workshop
Exercise D
Clause
6.1 to 6.4
6
Resource
management
6.1
Provision of
resources
6.2
Human
resources
6.2.1
General
6.2.2
Competence,
awareness and
training
52
-- YES -In
Compliance
-- NO -Needs
Attention
------
------
6..3
Infrastructure
6.4
Work
environment
53
AS9100C
Requirements
Clause #
Task 15
QMS
Workshop
Exercise E
Clause
7.1 to 7.6
7
Product
realization
7.1
Planning of
product
realization
------------------------------------------7.1.1
Project
management
7.1.2
Risk
management
..
..
...
54
-- YES -In
Compliance
-- NO -Needs
Attention
------
------
7.1.3
Configuration
management
7.1.4
Control of work
transfers
7.2
Customerrelated
processes
7.2.1
Determination
of
requirements
related to the
product
7.2.2
Review of
requirements
related to the
product
7.2.3
Customer
communication
..
.
55
------------------------------------------7.3.2
Design and
development
inputs
7.3.3
Design and
development
outputs
7.3.4
Design and
development
review
56
7.3.5
Design and
development
verification
7.3.6
Design and
development
validation
7.3.6.1
Design and
development
verification and
validation
testing
7.3.6.2
Design and
development
verification and
validation
documentation
7.3.7
Control of
design and
development
changes
..
57
7.4.2
Purchasing
information
7.4.3
Verification of
purchased
product
7.5
Production and
service
provision
7.5.1
Control of
production and
service
provision
58
7.5.1.1
Production
process
verification
7.5.1.2
Control of
production
process
changes
7.5.1.3
Control of
production
equipment,
tools and
software
programs
7.5.1.4
Post-delivery
support
7.5.2
Validation of
processes for
production and
service
provision
59
7.5.3
Identification
and traceability
7.5.4
Customer
property
7.5.5
Preservation of
product
7.6
Control of
monitoring and
measuring
devices
60
Clause 7 Product Realization Inclusion / Exclusion Justification Worksheet see also Task 9 b
AS9100C
Clause 7
Requirements
7.0
PRODUCT REALIZATION
7.1
7.2
7.3
7.4
Purchasing
7.5
7.5.2
7.5.4
Customer property
7.6
61
Requirement
applicable
Yes - No
Remarks
--
---
Requirements
Requirement
applicable
Yes - No
Remarks
--
---
7.0
PRODUCT REALIZATION
7.1
Planning is required
Yes
7.2
Yes
7.3
Yes
7.4
Purchasing
Yes
7.5
Yes
7.5.2
7.5.4
7.6
62
example
Yes
F-400-1
As identified
in F-400-1
No
--
No
---
AS9100C
Requirements
Clause #
Task 15
QMS
Workshop
Exercise F
Clause
8.1 to 8.5
8
Measurement,
analysis and
improvement
8.1
General
--------------------------------------------8.2.2
Internal audit
63
-- YES -In
Compliance
-- NO -Needs
Attention
------
------
--------------------------------------------8.2.3
Monitoring and
measurement
of processes
8.2.4
Monitoring and
measurement
of product
8.3
Control of
nonconforming
product
8.4
Analysis of
data
8.5
Improvement
64
8.5.1
Continual
improvement
---------------------------------------------8.5.2
Corrective
action
8.5.3
Preventive
action
65
Task 15 Exercise G
Risk Management
Exercise G deals with risk management and the analysis of risks throughout
clause 7 for product realization.
66
Task 15 Exercise G
Risk Management
Instructions:
Conduct Risk Analysis for product realization steps required for your
products. Consider the production steps and the activities/steps for all
functions in your organization.
Prepare process flow diagrams to describe the activities / steps.
Make use of the Risk Management Worksheet to systematically conduct a
risk analysis for each of the steps identified in each process flow diagram.
Refer to worksheet.
Column 1 Transfer from the flow diagrams, the steps required for the process.
Column 2 Identify what may be present or could be introduced as a risk.
Column 3 Describe the risks that may be existing or could be introduced.
Column 4 Assess the significance of the described risk.
Indicate in sub-column 1, the severity of the risk as L for low, M for
medium, and H for high.
Indicate in sub-column 2, the likelihood of occurrence as Low,
Medium or High.
When both the Severity and Likelihood are High, the Significance
in sub-column 3 is High, the process step is at risk, it requires
attention and corrective action is required and indicated in the last
column.
When one or both severity and likelihood are indicated as medium,
additional reviews are required and resulting actions justified (with
inputs in columns 5 & 6.
Contd ..
67
Column 5 For Low, Medium, and High significance risks, indicate if the risk can
be eliminated or reduced in a next step in the process.
Column 6 For all risks, describe what controls are in place to reduce or
eliminate the risk.
Column 7 The Quality Team considers the inputs from columns 1 through 6 and
indicates with a NO or a YES whether or not the process step is a
risk.
Column 8 With a NO decision, a corrective action request (CAR) is not needed
and N/A is indicated in this column.
With a YES conclusion, the Management Representative (ref Task
4), enters a CAR # in the last column and prepares and issues a
Corrective Action Request to the individual responsible for the
process step.
Notes:
1.
It is important to make sure that if you do not have sufficient experience in
your company to make the above determinations you involve outside
expertise or use external sources of information to make the decisions.
2.
68
Receive
Storage
Comments:
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Prepared by; __________________________ Date: ______________
69
Task 15 Exercise G
The first 6 columns of this form are used to list the Potential Risks and Assess the Significance of the Risks
The last 2 column of this form are used to indicate whether or not the Process Step is at risk and requires attention.
* Refer to the process flow diagram(s).
** Where both the Severity and the Likelihood are high, the risk is significant and the Process Step requires corrective action.
*
Step
---
What is
present or
could be
introduced
as a risk?
---
**
2
What
Is the
Does a next
controls
Process
step in
process
exist to Step at risk?
eliminate address the Yes / No
the risk?
risk?
Justifications
70
** If YES,
Issue the
Correctiv
e Action
Request
CAR #
Task 15 Exercise G
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
* Step
Input
Is the
Process
Step at
risk?
Yes / No
** If YES,
Issue the
Corrective
Action
Request
---
---
Description Significance
of Risk
----
Does a
What
next step in
controls
1 = Severity
exist to
process
2 = Likelihood
eliminate
address the
3 = Significance
the risk?
risk?
**
Justifications
1
2
3
Explanatory Notes for the Actions required at each Column are provided ..
71
CAR #
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
* Step
Input
Description of
Risk
---
----
---
ACTION 1
Is the
Does a next
What controls
step in
exist to
Process Step
1 = Severity
process
address the
at risk?
risk?
2 = Likelihood
eliminate the
Yes / No
risk?
3 = Significance
**
1
2
3
Justifications
Significance
** If YES,
Issue the
Corrective
Action
Request
CAR #
Each process step identified in the process flow diagrams* at Task 11 needs to be transferred
to this worksheet and numbered and named in the same sequence as the flow diagram.
This is to ensure that all aspects of the process are visible and controlled, not just the items
that are at risk.
Process Flow Diagrams can describe not only process steps in a production environment, but
also sequential steps for administration and other management activities .. eg purchasing.
This risk management worksheet can be used to analyze the risks associated with those
activities.
72
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
* Step
Inputs
Description
of Risk
---
ACTION 2
---
----
Significance
1 = Severity
2 = Likelihood
3 = Significance
**
1
2
3
Does a next
What
Is the
** If YES, Issue
step in
controls exist Process Step the Corrective
process
to address
at risk?
Action
eliminate the
the risk?
Yes / No
Request
risk?
Justifications
CAR #
INPUTS
What exists or what could be introduced at this process step that could result in a problem
and create a risk?
73
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
* Step
Inputs
Description of
Risk
---
ACTION 3
---
----
Significance
1 = Severity
2 = Likelihood
3 = Significance
**
1
2
3
Does a next
step in
process
eliminate the
risk?
What controls
Is the
** If YES, Issue
exist to
Process Step the Corrective
at risk?
Action Request
address the
risk?
Yes / No
Justifications
Describe the risks when non-complying product characteristics result in areas of:
DIMENSIONAL (item too big, too small, too wide, too narrow, etc)
MATERIAL (too hard, too soft, etc)
APPEARANCE (too dark, too light, too rough, too smooth, etc)
FUNCTION ..
Others ..
74
CAR #
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
* Step
Inputs
Descriptio
n of Risk
---
---
----
ACTION 4
Significance
1 = Severity
2 = Likelihood
3 = Significance
**
1
2
3
Does a
next step
in process
eliminate
the risk?
What controls
Is the
exist to
Process
address the Step at risk?
risk?
Yes / No
Justifications
** If YES,
Issue the
Corrective
Action
Request
CAR #
What is the severity of the risk in question and what is the possibility that it will occur at this
step?
What is the significance of the identified risk to the product?
These questions are critical to the outcome of the Risk Analysis. Answers to the questions
require sound understanding of the product and its processes by the Quality Team.
... contd
75
76
Significance of Risks
A variation in the method to analyze the Severity and Likelihood and assess the
Significance or risk associated with the process step.
LOW
77
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
* Step
Inputs
Descriptio
n of Risk
---
---
----
Significance
1 = Severity
2 = Likelihood
3 = Significance **
1
2
3
Does a
next step
in process
eliminate
the risk?
What controls
Is the
exist to
Process
address the Step at risk?
risk?
Yes / No
Justifications
** If YES,
Issue the
Corrective
Action
Request
CAR #
78
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
* Step
Inputs
---
---
Action 5
Descriptio Significance
n of Risk 1 = Severity
2=
Likelihood
3=
Significance
**
---1
2
3
What controls
Is the
** If YES,
exist to
Process
Issue the
address the Step at risk? Corrective Action
risk?
Yes / No
Request
CAR #
Justifications
Will a subsequent step in your process eliminate or reduce the risk to an acceptable level?
If yes, and for all risks identified, describe the subsequent steps in your process that will
eliminate or reduce the risks.
If no, the process step is at risk and is a candidate for corrective action.
79
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
* Step
Inputs
Does a next
step in
process
eliminate the
risk?
What controls
exist to address
the risk?
---
---
Descriptio Significance
n of Risk 1 = Severity
2=
Likelihood
3=
Significance
**
---1
2
3
** If YES,
Is the
Issue the
Process
Step at risk? Corrective Action
Yes / No
Request
Justifications
CAR #
80
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
* Step
Inputs
Is the Process
Step at risk?
Yes / No
** If YES,
Issue the
Corrective Action
Request
---
---
ACTION 7
What
Descriptio Significance Does a next
step in
controls
n of Risk 1 = Severity
exist to
2=
process
eliminate
address the
Likelihood
3=
the risk?
risk?
Significance
**
---1
2
3
Justifications
CAR #
Answers to this critical question require sound understanding of the product and its
processes by the Quality team.
Answers depend on the Significance and Justifications provided at Actions 4, 5 & 6.
The Quality Team considers the inputs from columns 1 through 6 and needs to decide and
indicate whether or not the process step is at risk and requires further attention.
However, a general rule is that *** when both the severity and likelihood are indicated as
high at Action 4, the significance of the risk is high and the process step is a risk point.
81
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
* Step
Inputs
Is the Process
Step at risk?
Yes / No
** If YES,
Issue the
Corrective Action
Request
---
---
CAR #
82
Task 15 Exercise G
As demonstrated in the previous pages, the 8-column risk management worksheet can be an
effective tool to systematically work through the actions required and record the specific
information that will lead to a practical resolution to the elimination or reduction of risks.
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
ACTION
* Step
Input
Does a next
step in
process
eliminate
the risk?
What
controls
exist to
address the
risk?
Is the
Process
Step at
risk?
Yes / No
** If YES,
Issue the
Corrective
Action
Request
Description of Significance
Risk
1 = Severity
2 = Likelihood
3 = Significance
---
---
----
**
2
Justifications
CAR #
When applicable for preventive actions, risks can be managed and minimized through the use of
the FMEA methodology ... See next page for additional information.
83
Task 15 Exercise G
Product Realization and Risk Management in clause 7 contd
In AS9100C, Risk Management is a requirement that is mentioned at par 7.1.2 where:
As appropriate to your company and your product, you will need to establish, implement and
maintain a process for managing risk while achieving conformity to applicable requirements
that includes:
a) assignment of responsibility for risk management
b) definition of risk criteria, for example likelihood, consequences, risk acceptance
c) identification, assessment and communication of risks throughout product realization
d) identification, implementation and management of actions to mitigate risks that exceed the
defined acceptance criteria,
e) acceptance of risks remaining after implementing mitigating actions.
However, since risk management is part of product realization par 7.1.2 and is referenced in
the review of requirements related to products at par 7.2.2 and noted in the preventive action
par 8.5.3, the FMEA can become the methodology to document the requirement for risk
management.
Therefore in addition to analyzing risks at the production steps and at the activities / steps for
all functions through the use of the 8-column risk management worksheet, risk management
can be identified during the review of requirements related to products and considered in the
preventive action process.
Process FMEA stands for Process Failure Mode & Effects Analysis. It is a tool typically used
by Engineering and/or Quality that identifies and quantifies risk associated with potential
product and process failures.
View the FMEA tutorial
_____________________________________________________________
84
Task 15 Exercise G
Product Realization and Risk Management - Conclusion
_________________________________________________________________________
To complete this task, direction from the AS9100 Steering Team is required to
determine:
a.
b.
Comment
85
Comments:
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
86
Task 17 - AS9100
QMS Timing Chart
#
IDENTIFIED TASK
3
4
5
8
9
10
11
12
13
14
15
16
4-5
5-7
8-9
10-11
87
12
13
14
15
16
17
20
21
22
24
24a
24b
24c
24d
24e
24f
24g
24h
24i
Etc.
25
18
19
23
26
Task
2
----
----
----
88
27a
27b
27c
28
89
Collect any formal or informal Forms and Tags that are currently used in your
operations.
A short note (on a post-it label) can summarize what the form or tag is used
for, what it does, and who uses it.
________________________________________________________________________
Part 2
Collect any formal or informal Procedures and Instructions currently used by
the departments of the company.
Provide a short summary of the procedures or instructions to describe what
they are and what they are used for.
________________________________________________________________________
A collection of this Information:
Forms, Tags, Instructions and Procedures will be very useful in the development of the
AS9100 Quality Management System.
- Information will be needed and used during the procedure development phase.
Comments:
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Info collected by: __________________________ Date: ______________
90
Task 19 Perform a financial study / review to Justify the Costs versus the
Benefits
Comments:
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Prepared by: __________________________ Date: ______________
91
Task 20
RE-CONFIRM the AS DECISION for your COMPANY: ___________________________
Options for Management Systems:
The complexity of most of the processes that are operated in industry and the services
place them beyond the control of any one individual.
The only way to tackle problems concerning such processes is through the use of some
form of teamwork.
The use of the team approach to problem solving is an essential component of the
implementation of a Quality Management System, because it builds up trust, improves
communications and develops inter-dependence.
Encouragement of ideas and suggestions from the workforce, particularly through their
involvement in team or group activities, requires investment but the rewards are total
92
involvement, both inside the organization and outside through the supplier and
customer networks.
T.E.A.M
T = Together
E = Everyone
A = Accomplishes
M = More
_______________________________________________________________
List some ways that you can use to promote & practice TEAMWORK in
your company:
Motivation
Commitment
93
94
Task 23:
Task 24:
Task 25:
Task 26:
Task 27:
Task 28:
95
Comments:
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
96
Purpose
Scope
Responsibility
Instructions / Procedure
Documentation
Revisions
A total of 6 to 9 months will likely be required for all final internal approvals to be
in place.
Follow the sequence of activities as shown on Process Input-output Worksheet
#F- 400-1 and take into account the inputs from the AS exercises B thru F to
develop the documentation.
Follow-Up on the activities through the weekly Quality Team meetings, (Task 7).
Comments:
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Prepared by; __________________________ Date: ______________
97
President
Management Representative
Management Rep
Management Rep
Personnel Manager
24. f etc
Comments:
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Prepared by; __________________________ Date: ______________
98
PROCESS OUTPUTS
Identification of key processes &
sub-processes
DOCUMENTATION
for Processes
From Exercise B
[
[
[
[
[
Consider the
Documentation
Package from
as9100store.com
From Exercise C
[
[
[
[
5.4 Planning
99
RESPONSIBILITY REMARKS
for Processes
5.4.1Quality objectives
5.4.2 Quality management system planning
5.5 Responsibility, authority & communication
5.5.1 Responsibility and authority
5.5.2 Management representative
5.5.3 Internal communication
5.6 Management Review
5.6.1 General
5.6.2 Review input
5.6.3 Review output
From Exercise D
[
[
[
6.3 Infrastructure
6.4 Work environment
From Exercise E
[
[
[
[
[
[
[
100
101
From Exercise F
[
[
[
[
[
102
Comments:
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
103
Comments:
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
104
Date: ____________
105
Comments:
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
106
Stage 1 The purpose of this review is to confirm the readiness of your organization for full
registration assessment.
The assessor will:
produce an assessment plan and confirm a date for the Stage 2 assessment visit
Stage 2 The purpose of this audit is to confirm that the quality management system
conforms to the requirements of AS 9100 in practice.
The assessor will:
undertake sample audits of the processes and activities defined in the scope of
assessment,
produce a surveillance plan and confirm a date for the first surveillance visit,
If the assessor identifies any major non-conformance, your organization cannot be
registered until corrective action is taken and verified.
107
Comments:
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
108