AS9100C(2009) Gap Analysis Tool

The following material will introduce our Plain English Gap Analysis Tool.
However, we will not present the complete product. Instead, we will show
you how our Gap Analysis Tool is organized and how it is used. In addition,
we will show you some examples of our approach. Once you've examined
our approach, we hope you'll consider purchasing our complete
AS9100C(2009) Plain English Gap Analysis Tool (Title 71).

Our Plain English Gap Analysis Tool can help you to identify the gaps
that exist between the new standard and your organization's processes.
Once you know exactly where your gaps are, you can take steps to
fill them. By using this approach, you will not only comply with the
new AS9100C standard, but you will also improve the overall
effectiveness of your quality management system (QMS).

Our Plain English Gap Analysis Tool is easy to understand and
ready to use. It is focused, detailed, and complete. We guarantee it!

Our Plain English Gap Analysis Tool has two phases.
The following material will introduce these two phases.

Phase One: Identify Gaps

Phase One asks you to identify gaps by performing a gap analysis.
Use our five gap analysis questionnaires (4 to 8) to carry out your
analysis. These five questionnaires list the five sets of requirements
that make up the AS9100C(2009) standard. However, instead of listing
requirements in the form of statements, they are listed as questions.

Each gap analysis question has either two or three possible answers.
Whenever a question refers to a requirement that must be met in order
to comply with AS9100C, we offer two possible answers: YES and NO.
A YES answer means that your organization has already met a
requirement while a NO answer points to a gap that must be filled.

However, whenever a requirement may be excluded or ignored, we offer
a third option: N/A. Select N/A if the requirement is not applicable in your
situation. The N/A option is added to every Part 7 question because you
may exclude or ignore any Part 7 requirement if you can justify doing so.

NO answers reveal gaps that exist between the AS9100C standard and
your organization's processes. Whenever you answer NO to a question,
you are stating that at least one process fails to meet an AS9100C(2009)
requirement. A NO answer tells you that at least one of your processes
needs some work. It tells you that at least one process needs to be
developed, modified, or improved. Therefore, whenever you answer
NO to a question, you must consider your processes, and decide
which ones need to be changed.

We use a process approach, not only because it makes good sense
to do so, but also because AS9100C has made it mandatory. Clause 4.1
of AS9100C makes it very clear that organizations must identify and
manage the processes that make up their quality systems.

Since the process approach is now central to AS9100, we have
tried to identify the processes that make up a quality management
system (QMS). Some of these processes are listed below:

Quality management process
Resource management process
Training and awareness process
Product purchasing management process
Design and development process
Risk management process
Work transfer control process
Production management process
Service provision process
Product management process
Customer relationship management process
Internal quality management audit process
Monitoring and measuring process
Management review process

Of course, this does not exhaust the list of possible processes that
could be used to establish a QMS, nor does it exhaust the many ways
in which processes can be grouped into larger processes or subdivided
into smaller ones. Your organization’s list of processes may be different
from the ones we have listed.

Phase Two: Fill Gaps

Once you've identified all of your gaps (NO answers), you can begin
to fill them. In general, you fill your gaps by preparing and implementing
Process Development Plans using the following Process Development
Forms:

Quality management process development form
Resource management process development form
Training and awareness process development form
Product purchasing management process development form
Design and development process development form
Risk management process development form
Work transfer control process development form
Production management process development form
Service provision process development form
Product management process development form
Customer relationship management process development form
Internal quality management audit process development form
Monitoring and measuring process development form
Management review process development form

Use these Process Development Forms to prepare your Process
Development Plans. Each form is used to list the remedial actions
that should be taken to fill your gaps.

While we have identified 14 processes, you don’t have to agree with the
way in which we’ve divided things up. If your list of processes differs from
ours, that’s fine (we’ve provided a blank form for this purpose). Just make
sure that your list can accommodate every relevant AS9100C requirement,
and that it also meets your organization’s needs.

Of course, before you can list your remedial actions, you need to formulate
them. In general, remedial action statements can be formulated by turning
our gap analysis questions into simple action statements.

For example, a gap analysis question might ask: "Do you protect your
monitoring and measuring equipment?" In order to prepare a remedial
action statement, all you have to do is re-write it as follows: "Protect
monitoring and measuring equipment". This remedial action statement
is then listed on our Monitoring and Measuring Process Development
Form (13 above). In most cases, that's all there is to it. However, in some
cases, you may need to be more specific, or you may need to formulate
a slightly different action statement for several different processes.

As you list your remedial actions using our 14 process development
forms, you will assign a Remedial Action Number (RAN) to each action,
and record cross references to the corresponding AS9100C clause numbers
(see the AS column) and gap analysis question (see the Q column).
Also, specify who was given the responsibility to ensure that the
remedial action is carried out. Then use these forms to monitor
and control implementation.

Once you’ve done this for all gaps, you will have several Process
Development Plans which, taken together, make up a detailed Process-
based Quality Management System Development Plan that will be unique
to your organization. And once you’ve implemented your Process-based
QMS Development Plan, you will have an AS9100C(2009) compliant
process-based quality management system.

You can also use your Process-based QMS Development Plan to help
you figure out how much time it will take and how much it will cost to
bring your QMS into compliance with the new standard.

The following example will show you what our
Gap Analysis Tool looks like. It is taken from
Part 7: Realization Gap Analysis Tool.

Our AS9100C Gap Analysis Tool uses a black font to identify ISO 9001 questions
while this blue font is used to identify questions that are unique to AS9100C.

AS9100C(2009) GAP ANALYSIS TOOL
7. PRODUCT REALIZATION GAP ANALYSIS QUESTIONNAIRE
7.1 CONTROL PRODUCT REALIZATION PLANNING PROCESS
7.1.1 ESTABLISH A PROJECT MANAGEMENT PROCESS
1	Do you plan your product realization projects?				YES	NO	N/A
2		Is your project planning method appropriate?			YES	NO	N/A
3			Is it appropriate to your organization?		YES	NO	N/A
4			Is it appropriate to your product?		YES	NO	N/A
5		Is your project management method appropriate?			YES	NO	N/A
6			Is it appropriate to your organization?		YES	NO	N/A
7			Is it appropriate to your product?		YES	NO	N/A
8	Do you manage your product realization projects?				YES	NO	N/A
9		Do you control how product realization projects are structured and managed?			YES	NO	N/A
10			Do you meet product realization requirements within acceptable risk constraints?		YES	NO	N/A
11			Do you meet product realization requirements within acceptable schedule constraints?		YES	NO	N/A
12			Do you meet product realization requirements within acceptable resource constraints?		YES	NO	N/A
7.1.2 ESTABLISH A RISK MANAGEMENT PROCESS
13	Have you established a process to manage the risk associated with the achievement of your organization’s product realization requirements?				YES	NO	N/A
14		Have you figured out how you’re going to assign risk management responsibilities?			YES	NO	N/A
15		Have you figured out how you’re going to define your organization’s risk criteria?			YES	NO	N/A
16			Have you figured out how you’re going to determine the likelihood that an undesirable situation or circumstance will actually occur?		YES	NO	N/A
17			Have you figured out how you’re going to evaluate potentially negative consequences?		YES	NO	N/A
18			Have you figured out how you’re going to make risk acceptance decisions?		YES	NO	N/A
19		Have you figured out how you’re going to manage risks?			YES	NO	N/A
20			Have you figured out how you’re going to identify risks?		YES	NO	N/A
21			Have you figured out how you’re going to assess risks?		YES	NO	N/A
22			Have you figured out how you’re going to communicate risks?		YES	NO	N/A
23		Have you figured out how you’re going to manage the actions that must be taken to mitigate the risks that exceed limits set by your risk acceptance criteria?			YES	NO	N/A
24			Have you figured out how you’re going to identify the actions that must be taken to mitigate risks?		YES	NO	N/A
25			Have you figured out how you’re going to implement the actions that must be taken to mitigate risks?		YES	NO	N/A
26		Have you figured out how you’re going to control the acceptable risks that remain after you’ve taken action to mitigate unacceptable risks?			YES	NO	N/A
27	Did you implement your risk management process?				YES	NO	N/A
28		Did you assign risk management responsibilities?			YES	NO	N/A
29		Do you manage product realization risks?			YES	NO	N/A
30			Do you identify product realization risks?		YES	NO	N/A
31			Do you assess product realization risks?		YES	NO	N/A
32				Do you determine the likelihood that an undesirable situation or circumstance will actually occur?	YES	NO	N/A
33				Do you evaluate potentially negative consequences?	YES	NO	N/A
34				Do you make risk acceptance decisions?	YES	NO	N/A
35			Do you communicate product realization risks?		YES	NO	N/A
36		Do you manage the actions that must be taken to mitigate the risks that exceed the limits set by your risk acceptance criteria?			YES	NO	N/A
37			Do you identify the actions that must be taken to mitigate risks?		YES	NO	N/A
38			Do you implement the actions that must be taken to mitigate risks?		YES	NO	N/A
39		Do you control the risks that remain after you’ve implemented actions to mitigate unacceptable risks?			YES	NO	N/A
40	Do you maintain your risk management process?				YES	NO	N/A
41		Do you make sure that your risk management process continues to be appropriate for your organization?			YES	NO	N/A
42		Do you make sure that your risk management process continues to be appropriate for your products?			YES	NO	N/A
43	Etcetera ...				YES	NO	N/A

AS9100C(2009) GAP ANALYSIS TOOL
PART	TITLE 71 TABLE OF CONTENTS	PAGE
1	Profile of Gap Analysis Project	3
2	Introduction to AS9100C(2009)	4
3	Explanation of Gap Analysis Process	11
4	General Gap Analysis Questionnaire	15
5	Management Gap Analysis Questionnaire	24
6	Resource Gap Analysis Questionnaire	31
7	Realization Gap Analysis Questionnaire	<SAMPLE
8	Remedial Gap Analysis Questionnaire	89
9	Process-based QMS Development Plan	115
10	Quality Management Terminology	130
11	Legal and Contact Information	156
AUG 2009	COPYRIGHT © 2009 PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.	EDITION 1.0

OVERVIEW OF GAP ANALYSIS PROCESS
	PHASE ONE: IDENTIFY GAPS
	ANSWER EACH GAP ANALYSIS QUESTION
	ANSWER "YES" REQUIREMENT HAS BEEN MET NO ACTION REQUIRED	ANSWER "NO" GAP HAS BEEN IDENTIFIED REMEDIAL ACTION SHOULD BE TAKEN	ANSWER "N/A" REQUIREMENT IS NOT APPLICABLE JUSTIFY EXCLUSIONS
	FOR EACH "NO" ANSWER SELECT THE QUALITY PROCESSES THAT NEED FURTHER DEVELOPMENT
	PHASE TWO: FILL GAPS
	PREPARE PROCESS DEVELOPMENT PLANS USING OUR PROCESS DEVELOPMENT FORMS
	IMPLEMENT YOUR PROCESS DEVELOPMENT PLANS AND TRACK IMPLEMENTATION USING OUR PROCESS DEVELOPMENT FORMS

ORGANIZATION:	YOUR LOCATION:
COMPLETED BY:	DATE COMPLETED:
REVIEWED BY:	DATE REVIEWED:

AUG 2009	COPYRIGHT © 2009 PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.	EDITION 1.0
PART 7	GAP ANALYSIS QUESTIONNAIRES	PAGE 39

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Updated on July 16, 2012. First published on August 31, 2009.
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