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Filled AS9100 Sample Standard

The document provides instructions for controlling quality system documents at a company. It outlines responsibilities for document management and control. Key steps include assigning document numbers, maintaining a master list, distributing documents, and approving revisions. Control of related software, records, and risk management are also addressed.

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0% found this document useful (0 votes)
286 views

Filled AS9100 Sample Standard

The document provides instructions for controlling quality system documents at a company. It outlines responsibilities for document management and control. Key steps include assigning document numbers, maintaining a master list, distributing documents, and approving revisions. Control of related software, records, and risk management are also addressed.

Uploaded by

xq2y6j5kj5
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 30

INSERT YOUR COMPANY NAME HERE

Quality Manual QM-9110-C


__________________________________________________________________

AS 9110 Rev. C

Quality Management Systems

Quality Manual / Documented Information

Document No. QM-9110-C

Street Address

City, State, Zip

Tel,

Cell Phone:

Email:

Web Site:

________________________________________________________________________
Quality Manual- Rev-A
QM-9110 -C Approved by: _________________ Date: __________ 1
INSERT YOUR COMPANY NAME HERE
Quality Manual QM-9110-C
__________________________________________________________________
Instructions:

This manual is used as a template in developing your AS 9110 C Quality Management


System.
 Methods and systems used in the development and operation of the QMS vary
widely from company to company.

 The blue text and suggestions displayed in the manual are intended to offer some
options and to highlight the areas that need attention / update / replacement.

 Review the text and suggestions and at a minimum replace or update them to reflect
the unique / customized information of your quality system requirements.

 Delete the blue text after each task is completed.

 Use replace function – enter “Your Company” in find space, enter your company
name in replace space – system should make changes throughout the entire
document.

 Additional details and instructions in the use of the QM-9110-C manual template are
included in a separate file “QMS-Template-Instructions”.
Additional documentation review.
 Similarly, the blue text and suggestions displayed in the QMS documentation (that
will follow) for the procedures, instructions, attachments, forms, and flow diagrams
are intended to offer some options and to highlight the areas that require update or
replacement.

________________________________________________________________________
Quality Manual- Rev-A
QM-9110 -C Approved by: _________________ Date: __________ 2
INSERT YOUR COMPANY NAME HERE
Quality Manual QM-9110-C
__________________________________________________________________
Table of Contents – (this page)

Introduction

Section A Scope of the Quality Management System

Section B References
a. Normative reference
b. Definitions

Quality Management System Requirements

Section C Document Information

a. Distribution Control List

b. Revision Status

c. Quality Policy, Quality Objective, Strategic Direction,

d. Safety Policy

e. Organization Chart

f. Company Background - Products and Services

g. Process Flow Diagram

Section D List of Documented Information for the AS standard clauses 4 through 10

Clause 4 Context of the Organization

Clause 5 Leadership

Clause 6 Planning

Clause 7 Support

Clause 8 Operation

Clause 9 Performance Evaluation

Clause 10 Improvement

Sections E, F, G, etc. Spares

Section R Records Documentation Matrix

________________________________________________________________________
Quality Manual- Rev-A
QM-9110 -C Approved by: _________________ Date: __________ 3
INSERT YOUR COMPANY LOGO/NAME HERE
P-423-A
Document Control Sample

1.0 Purpose

1.1 This procedure describes the process for controlling quality system documents.

2.0 Responsibilities

2.1 Management is responsible to ensure that personnel have access to and are
aware of relevant quality management system (QMS) documentation and
changes.
2.2 Management is responsible for assigning authors for documents.
2.3 The author is responsible for writing the document, creating related forms, getting
a document number and submitting the document to the department manager for
review.
2.4 Department managers are responsible for approving documents for their area of
responsibility and ensure that they are legible, identifiable and available where
needed.
2.5 The document control coordinator is responsible for assigning document
numbers, maintaining the master list, posting new and revised documents on the
network, distributing hard copies of documents and revising documents.
2.6 All employees are responsible for reviewing the documents as they use them and
submitting document change requests to update documents as necessary.
2.7 The network administrator is responsible for backing up the network daily.
2.8 Engineers are responsible for maintaining programs that control equipment. (If
you have programs, controllers with programs or other software controlling your
processes, the programs must be controlled.)

3.0 Definitions

3.1 Procedure: Document outlining specific work processes and how the
requirements of the AS9110B standard are being met.
3.2 Work Instructions: Step by step directions on how a task should be done.
3.3 Attachments: Documents used to further clarify or show examples of information
described in the procedures and work instructions.
3.4 Forms: Documents used to make a record of completing all or part of the
process described in procedures and work instructions.
3.5 Records: Completed forms or information generated as a result of the process
described in a document and retained as indicated in the Control of Quality
Records Procedure.
3.6 References: external documents or sources used in preparing documentation
and completing work.
3.7 Related Documents: Other documents that may need to be altered if the current
Document Control Page 1 of 2
Date printed 5/6/13 3:28 PM
INSERT YOUR COMPANY LOGO/NAME HERE
P-423-A
Document Control

3.8 P-720 Customer Related Processes

4.0 References

4.1 None

5.0 Revisions

Revision Date Section Paragraph Summary of change Authorized by

A Initial issue

Document Control Page 2 of 2


Date printed 5/6/13 3:28 PM
INSERT YOUR COMPANY LOGO/NAME HERE
F-610-001
Risk and Opportunity Worksheet

Risks and Opportunities Guidelines


 The risks and opportunities are determined and addressed in order to ensure that the QMS can
achieve its intended result(s), prevent, or reduce, undesired effects, and achieve continual
improvement.
 Options to address risks and opportunities can include: avoiding risk, taking risk in order to pursue an
opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or
retaining risk by informed decision.
 Actions to address the risks and opportunities are planned in order to integrate and implement them
into the processes and to evaluate the effectiveness of these actions.
 Actions taken to address risks and opportunities are proportionate to the potential impact on the
conformity of products and services.
 With inputs from the Quality team / ISO steering committee, this risk and opportunity worksheet is
prepared by the Quality team leader / ISO management representative.
 The Quality team / ISO steering committee is responsible to set priorities for projects where risks and
opportunities need to be addressed and to assign risk or opportunity project responsibilities.
------------------------------------------------------------------------------------------------------------------------------------------

The following instructions are used to assess the risks associated with the planning of the QMS processes
and to assign priorities for the actions needed to address the risks and opportunities.

To determine the risks and opportunities that need to be addressed:


 In table below identify the activities/processes that are risk and opportunity candidates,
 Assign a value for each assessment category,
 R-values of 1 and 2 represent Risks/Threats, and O-values of 3 and 4 represent Opportunities.
 The project planning worksheet F-810-002 is used to plan high priority projects.

Customer Impact: How much does the customer care?


1 = Low customer priority
4 = Very important to the customer

Changeability Index: Can you fix it?


1 = Very Difficult / Expensive to fix
4 = Relatively easy / cheap to fix

Performance Status: How broken is it?


1 = Only a few problems in the past
4 = Always seems to be causing problems

Business Impact: How important is it to the business?


1 = Has little impact on the business
4 = Is very important to the business

Work Impact: What resources are available?


1 = People who have capability to work on this activity are scarce
4 = People who have capability to work on this activity can be available
INSERT YOUR COMPANY LOGO/NAME HERE
F-610-001
Risk and Opportunity Worksheet
Process / Activity Customer Changeability Performance Business Work Impact Rank
Impact Index Status Impact R O

Review and Approval

Prepared by: Quality team leader / SO management rep. Date:

Reviewed by: Quality team / ISO steering committee Date:

Approved by: President Date:

The worksheet form F-610-001 provides for options / methods for risk analysis. Choose the option that is best suited for you – refer next page.
QMS - PROCESS IDENTIFICATION WORKSHEET - for AS 9110 Rev C - QUALITY MANAGEMENT SYSTEM – Form F-440-001 1
_________________________________________________________________________________________________________________________________________________

Example of completed worksheet


This worksheet is used to identify the processes required for the Quality Management System. It is designed to ensure that all the requirements of
the AS 9110 C standard are addressed and documented information available. In addition, the worksheet can be used as a training tool to help
interested parties, such as employees, customers, auditors, and registrar understand your QMS.

PROCESS INPUTS - AS 9110 C PROCESS OUTPUTS DOCUMENTED RESPONSIBILITY


for Key Processes INFORMATION for Processes REMARKS
Aviation Maintenance Organizations for Processes
Quality management systems - Requirements
1 Scope QMS-Manual QM-9110-C President
2 Normative references Manual p.5
3 Terms and definitions Manual p.6

4 Context of the organization Context of the organization QMS-Section D -----

4.1 Understanding the organization and its context Organizational context P-400 President

Context P-400 par 5.1

Context of the organization F-440-002 AS committee


worksheet

4.2 Understanding the needs and expectations of Needs and expectations P-400 par 5.2
interested parties
4.3 Determining the scope of the quality management Scope of the QMS P-400 par 5.4
system
4.4 Quality management system and its processes Process interactions P-400 par 5.5

Flow diagram FD-440-001

QMS Process Identification F-440-001 Management This Form


representative
4.4.1 The organization … Process support, confidence, P-400, par 5.6 – 5.7
and
4.4.2 To the extent … documented information

IAQC 2016-Input-Output worksheet 1


QMS - PROCESS IDENTIFICATION WORKSHEET - for AS 9110 Rev C - QUALITY MANAGEMENT SYSTEM – Form F-440-001 2
_________________________________________________________________________________________________________________________________________________

5 Leadership Leadership QMS-Section D -----

5.1 Leadership and commitment Leadership P-500 President

5.1.1 General Leadership and commitment P-500, par 5.1

Business process map FD-510-001 AS Committee

5.1.2 Customer focus Customer focus P-500, par 5.2

5.2 Policy Quality policy P-500, par 5.3 AS Committee

5.2.1 Establishing the quality policy Quality policy – attachment A-520-001

5.2.2 Communicating the quality policy Communication P-500, par 5.3.5

5.2.3 Establishing and communicating the safety Safety policy P-500 par 5.4 AS Committee
policy
Safety policy - attachment A-520-002

5.3 Organizational roles, responsibilities, and Roles, responsibility, and P-500 par 5.5
authorities authority
Management representative P-500 par 5.5.2
5.3.1 Accountable manager Accountable manager P-500 par 5.5.3
5.3.2 Quality manager Quality manager P-500 par 5.5.4
5.3.3 Other appointed managers Other managers P-500 par 5.5.5

Organization chart A-530-001 H R manager

6 Planning Planning for the QMS QMS-Section-D -----

6.1 Actions to address risks and opportunities Planning for the QMS P-600 Management rep

6.1.1 When planning for the QMS… Planning the QMS P-600, par 5.1

6.1.2 The organization shall plan … Risk management- QMS P-600, par. 5.3
Planning

IAQC 2016-Input-Output worksheet 2


INSERT COMPANY NAME/LOGO HERE
A-840-001

GUIDELINES – Evaluation and Selection of Date Approved Data Form


External Providers ___________ A-840-001
Providers are evaluated and selected by one of the following methods:
Review methods listed below at par 1.1 to 1.6 and select one or more that are appropriate for
your company.
If you have goods or services that vary in its impact on quality you may want to set up
categories, the higher the impact the more comprehensive the method. You may need to
combine more than one method, for example an audit and samples for inspection and test.
1.1 The provider is, at a minimum, registered to ISO 9001:2015.
 Purchasing department staff reviews and maintains a copy of their certificate and
quality manual on file.
 Purchasing / Quality management staff performs quality system development with the
objective of provider conformance to ISO 9001:2015 and leading to AS 9100 D.
1.2 The provider provides graded or classed material, and provides certificate of analysis with
the material or item.
1.3 Samples of the materials or items are provided for inspection and test, with satisfactory
results.
 The person requesting the purchase documents the sample size required and the
inspection and test to be performed on the purchasing documents.
 Completed inspection and test records show the criteria for acceptance and the actual
results. If they are acceptable, the requisitioner sends them to purchasing to be kept in
the provider’s file.
1.4 An audit of the provider confirms that required elements of a quality system are in place
and results documented in the provider assessment report F-840-001.
 The Quality manager assigns an individual or team to perform the audit.
 The Quality manager reviews the completed audit checklist, and determines if the
supplier meets requirements.
 If the provider meets requirements, the purchasing manager indicates acceptance on
the provider assessment report and keeps the audit checklist in the provider’s file.
 The approved provider is added to the List of acceptable sources, form F-840-002.
1.5 The provider is specified by the customer contract. The use of customer designated
providers does not relieve Your Company of the responsibility to ensure quality.
1.6 The Purchasing department places a trial order.
 Purchasing department orders the material or item, and the requisitioner uses the material,
and measures the results.
 If the results are not acceptable, the product that it was used for is controlled according to
the control of nonconforming product procedure, P-870.
 If the results are acceptable, they are documented and kept in the provider’s file.
INSERT COMPANY NAME/LOGO HERE
AS 9110 Rev C - Quality Management Systems – The Gap Analysis Checklist
___________________________________________________________________________________________________________________
This gap analysis checklist is prepared for use in evaluating a Quality Management System (QMS) against the requirements of the new
Aerospace standard AS 9110 Rev C. Each requirement is expressed as a question that the user (auditor / assessor) can use to evaluate your
QMS capabilities. You will need to have a copy of the AS 9110 C standard to use along with this checklist so that you can refer to the
requirements and the clarification sections of Annex A. The intent of the main clauses of the new standard is shown in blue font.
After you have prepared an audit schedule, and assigned responsibility to your auditors for different areas or processes to audit, copy each
section of the checklist for the auditors working with that section. As you work through the checklist take notes on what is in place, and what
needs to be developed.
In the space for ‘currently in place’, list or reference the procedures or other documents, or evidence that you have reviewed and that will provide
information for the new QMS. Take notes on the status of the documents, that is, will they need to be revised for the new system, or can they be
used as is? Also, note where processes are in place, but documentation is needed. Focus on what is in place, and what needs to be developed.
While you do want to know if documented information is in place and if procedures and processes are being complied with, compliance is not
your focus for this audit. Remember that the outcome of this audit should be a list of things that your company needs to do to comply with the
AS 9110 Rev C standard.
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

--- QUALITY MANAGEMENT SYSTEMS Currently Compliant If No - % Items


REQUIREMENTS YES / NO? Completed
in Place Needed

4 CONTEXT OF THE ORGANIZATION

Intend This first clause introduces two sub-clauses relating to the context of the organization, (1) understanding the organization and its
of context and (2) understanding the needs and expectations of interested parties. Together they require that you determine the issues
clause and requirements that can impact on the planning of the Quality Management System (QMS). In addition, the scope of the QMS and
the QMS processes along with their applicability and interactions need to be determined.

4.1 Understanding the organization and its context

Does your company determine the external and internal


issues that are relevant to your purpose and strategic
direction?

Do you consider the relevant issues that affect your


ability to achieve the intended results of the Quality
______________________________________________________________________________________________________________________________

IAQG-Nov-2016 - Audit conducted by: ________________________ Date: _____________ to ______________ Copyright © AS9100Store Page 1 of 71
INSERT COMPANY NAME/LOGO HERE
AS 9110 Rev C - Quality Management Systems – The Gap Analysis Checklist
___________________________________________________________________________________________________________________
8 OPERATION

Intent This clause requires that your company plan, implement and control the processes required for the QMS and to implement the
of actions to address risks associated with operational processes. Operational planning and control include systems for configuration
clause management, product safety, prevention of counterfeit and unapproved part, installation of approved parts. In addition, systems for
customer related processes, design and development, control of external providers, control of production and service provision, and
including identification and traceability, preservation of products, and control of nonconforming outputs are required.

8.1 Operational planning and control

Does your company plan, implement and control the


processes needed to meet requirements for the
provision of products and services and to implement the
actions to address risks and opportunities by:

• Determining requirements for the product and


services?

See the 1st Note in section 8.1:

When determining the requirements for products and


services do you consider:
• Personal and product safety?
• Suitability of parts and materials used in the product?
• Product obsolescence?
• Prevention, detection, and removal of foreign
objects?
• Handling, packaging, and preservation?
• Work performed off-site from fixed location?
• Recycling or final disposal of the product at the end

______________________________________________________________________________________________________________________________

IAQG-Nov-2016 - Audit conducted by: ________________________ Date: _____________ to ______________ Copyright © AS9100Store Page 26 of 71
INSERT COMPANY NAME/LOGO HERE
AS 9110 Rev C - Quality Management Systems – The Gap Analysis Checklist
___________________________________________________________________________________________________________________
of its life?

• Establishing criteria for the processes and for the


acceptance of products and services?

• Determining the resources needed to achieve


conformity to product and service requirements?

• Determining the resources needed to meet on-time


delivery of products and services?

• Implementing control of the processes in accordance


with the criteria?

• Retaining documented information to provide the


confidence that the processes have been carried out
as planned and to demonstrate conformity of products
and services to requirements?

• Maintaining the processes to manage maintenance


tasks identified as critical by the customer or the type
certificate holder?

• Engaging representatives of affected functions of the


company for operational planning and control?

• Determining the process and resources to support the


use and maintenance of the products and services?

• Determining the products and services to be obtained


from external providers?

• Establishing the controls needed to prevent the


delivery of nonconforming products and services to

______________________________________________________________________________________________________________________________

IAQG-Nov-2016 - Audit conducted by: ________________________ Date: _____________ to ______________ Copyright © AS9100Store Page 27 of 71
INSERT COMPANY NAME/LOGO HERE
AS 9110 Rev C - Quality Management Systems – The Gap Analysis Checklist
___________________________________________________________________________________________________________________
the customer?

Within schedule and resource constraints, have you


planned and managed product and service provision in
a structured and controlled manner including scheduled
events performed in a planned sequence to meet
requirements at acceptable risk?

See the 2nd Note in section 8.1:

Do you refer to the above as project planning, project


management, or program management?

Do you provide the output of the planning in a format


that is suitable to your operations?

See the 3rd Note in section 8.1:

• Is the output of this planning with documented


information specifying the processes of the QMS and
the resources to be applied to a specific product,
service, project, or contract considered as a quality
plan?

How do you control planned changes and review the


consequences of unintended changes?

• When required, do you take action to mitigate any


adverse effects?

Does your company ensure that outsourced processes


are controlled in accordance with clause 8.4)?

8.1.1 Operational Risk Management

______________________________________________________________________________________________________________________________

IAQG-Nov-2016 - Audit conducted by: ________________________ Date: _____________ to ______________ Copyright © AS9100Store Page 28 of 71
INSERT COMPANY NAME/LOGO HERE
AS 9110 Rev C - Quality Management Systems – The Internal Audit Checklist
___________________________________________________________________________________________________________________
This checklist is based on the information provided in the 2016-11 revision of the AS 9110 Rev C, SAE international aerospace standard. The
checklist is best used by trained and practicing auditors to evaluate or assess Quality Management Systems requirements based on the
standard. You will see questions on the checklist that refer to the standard and for each clause, provisions are made for additional questions.

The auditors are expected to keep in mind that the standard does not require mandatory procedures for the various QMS processes; however,
the auditors will expect documented information to be available because in the clauses of the standard, the phrase such as ‘documented
procedures’ is used to specify that a process, a method, a system, a work instruction, or an arrangement be documented.

The auditors must use a great deal of discretion and therefore must be careful and thoughtful prior to establishing a deficiency against a
requirement. Evidence for visible top management leadership, commitment and quality management action must be looked for.

The bold numbers and tittles used in the first two columns of the checklist indicate the “Requirements” and may be referred to on nonconformity
reports prepared by the auditor.

During assessment of each requirement, auditors record the status of the evaluation by indicating in the right-hand column a

Yes - for Acceptable Condition or No - for Deficient Condition


-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

--- QUALITY MANAGEMENT SYSTEM OBSERVATIONS / COMMENTS STATUS

4 CONTEXT OF THE ORGANIZATION

4.1 Understanding the organization and its context

Does your company determine the external and internal


issues that are relevant to your purpose and strategic
direction?

Do you consider the relevant issues that affect your


ability to achieve the intended results of the Quality
Management System (QMS)?

Does your company monitor and review the information


______________________________________________________________________________________________________________________________

IAQG-Nov-2016 - Audit conducted by: ________________________ Date: _____________ to ______________ Copyright © AS9110Store Page 1 of 77
INSERT COMPANY NAME/LOGO HERE
AS 9110 Rev C - Quality Management Systems – The Internal Audit Checklist
___________________________________________________________________________________________________________________
related to the external and internal issues?

Additional Questions

4.2 Understanding the needs and expectations of interested parties

With consideration given to their impact or potential


impact on your company’s ability to consistently provide
products and services that meet customer and
applicable statutory and regulatory requirements, do
you determine:

 The interested parties that are relevant to the QMS?

 The requirements of these interested parties that are


relevant to the QMS?

Does your company monitor and review the information


about these interested parties and their relevant
requirements?

Additional Questions

4.3 Determining the scope of the quality management system

To establish the scope of the QMS, does your company


determine the boundaries and applicability of the QMS?

When determining the scope of the QMS, do you


consider the:

______________________________________________________________________________________________________________________________

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INSERT COMPANY NAME/LOGO HERE
AS 9110 Rev C - Quality Management Systems – The Internal Audit Checklist
___________________________________________________________________________________________________________________
 External and internal issues (per 4.1)?

 Requirements of relevant interested parties (per 4.2)?

 The products and services of your company?

When a requirement of AS 9110 C can be applied, is


the requirement applied by your company?

When requirements cannot be applied, and to claim


conformity to AS 9110 C, how do you determine if your
ability or responsibility to ensure conformity of products
and services are not affected?

Is the scope of the QMS available and maintained as


documented information?

Does the scope state the products and services


covered by the QMS?

Does your company provide justification for any


instance where a requirement of the standard cannot
be applied?

Additional Questions

4.4 Quality management system and its processes

4.4.1 As required by the standard, do you establish,


document, implement, maintain, and continually
improve the QMS?

______________________________________________________________________________________________________________________________

IAQG-Nov-2016 - Audit conducted by: ________________________ Date: _____________ to ______________ Copyright © AS9110Store Page 3 of 77
INSERT COMPANY NAME/LOGO HERE
AS 9110 Rev C - Quality Management Systems – The Internal Audit Checklist
___________________________________________________________________________________________________________________
Does the QMS also address customer and applicable
statutory and regulatory quality management system
requirements?

Are approvals, certificates, ratings, capability list, and


licenses also addressed in the QMS?

Does your company determine the processes needed


for the QMS, their interactions and applications
throughout your company?

That is, for the QMS processes do you determine the:

 Inputs required and the outputs expected from the


processes?

 Sequence and interaction of the processes?

 Criteria, methods, including measurements and


related performance indicators needed to ensure the
effective operation, and control of the processes?

 Resources needed and ensure they are available?

 Assignment of the responsibilities and authorities for


these processes?

 Risks and opportunities (per 6.1), and plans to


implement the appropriate actions to address them?
See also Operational risk management (per 8.1.1).

 Methods for monitoring, measuring, and evaluation of


processes and, if needed, the changes to processes

______________________________________________________________________________________________________________________________

IAQG-Nov-2016 - Audit conducted by: ________________________ Date: _____________ to ______________ Copyright © AS9110Store Page 4 of 77
INSERT COMPANY NAME/LOGO HERE
AS 9110 Rev C - Quality Management Systems – The Internal Audit Checklist
___________________________________________________________________________________________________________________
to ensure that they achieve intended results?

 Opportunities for improvement of the processes and


the QMS?

4.4.2 Does your company maintain the necessary


documented information to support the operation of
processes?

Does your company maintain and retain the necessary


documented information to provide the confidence that
the processes are being carried out as planned?

Does your company establish and maintain


documented information, as required by the competent
authority?

Does the documented information include:

 General description of relevant interested parties, per


see 4.2 a?

 Scope of the QMS, including boundaries and


applicability, per see 4.3?

 Description of the processes needed for the QMS and


their application throughout the organization?

 Sequence and interaction of the processes?

 Assignment of the responsibilities and authorities for


these processes?

 Details of the system used to maintain and retain


______________________________________________________________________________________________________________________________

IAQG-Nov-2016 - Audit conducted by: ________________________ Date: _____________ to ______________ Copyright © AS9110Store Page 5 of 77
Risk-Based-Thinking

in

AS 9110 Rev C

Risk Management / Analysis of Risk

©copyright 2017 AS9110store.com 1


Risk Management

Every version of the AS 9110 standard has advocated risk avoidance


and risk management. The new AS 9110 Rev C standard continues to
expect organizations to identify and address risks affecting compliance
of products and services, resulting in improved customer satisfaction.

Besides identifying the risks, organizations should address


opportunities for improvements and corrective actions based on the
risk analysis.

Note that while nonconformity and corrective action are requirements


of AS 9110 Rev C, the concept of preventive action can be addressed
through a risk-based approach where risks are determined and actions
to address risks and opportunities are taken.

This risk analysis exercise is intended to outline several approaches /


options for the management of risk at your company.

To prepare for the change, it is time to begin understanding Risk


Based Thinking and begin looking at your processes in terms of risks.

Risk is defined as the combination of the probability of occurrence of


harm and the severity of that harm.

When evaluating risk, it is helpful to address it using two (2) metrics or


parameters:

1. Severity (if harm happens, how serious is the event)


2. Likelihood (what is the probability of a harmful event occurring)

Because this topic is so important, it will have an impact on your QMS.

©copyright 2017 AS9110store.com 2


Risk-Based Thinking

The main risk management requirements of AS 9110 C are outlined in


two clauses.

 Clause 6.1, Actions to address risks and opportunities.


This clause addresses the risks and opportunities when planning
for the quality management system
 Clause 8.1.1, Operational risk management.
This clause addresses the risks associated with the operational
processes needed for the provision of products and services.

The new AS 9110 REV C introduces Risk-Based Thinking in section


0.3.3 and mentions risk in other clauses of the standard; for example,
in clause 5.1.2 dealing with customer requirements and satisfaction,
clause 8.1.3 on product safety, clause 8.2.2 dealing with customer
requirements and clause 8.4.1 on external provider-purchasing
activities.

The objective of the emphasis on risk is to have the organization,


through its QMS, address uncertainty in processes that will affect the
quality of the delivered goods or services to customers.

When addressing risk in your Quality Management System, be sure


that you look beyond determining the "chance" that something
happens to "the effect of an uncertainty" on your business objectives.

There are five (5) attributes to enhance risk management:

1. An organization should accept accountability for their risks and


develop comprehensive controls and risk abatement strategies.

2. Risk management should be a part of an organization's continual


improvement strategy. Organizations should set performance goals
and then review and modify processes as required. An organization
should review and modify its systems, resources, and capability /
skills to ensure continual improvement.

©copyright 2017 AS9110store.com 3


3. Identify and train individuals with accountability for risk
management. These individuals should have appropriate skills,
have adequate resources to check and improve controls, monitor
risks, and have the ability to communicate effectively with all the
interested parties / stakeholders.

4. Decision making within the organization should include


consideration of risks and the application of the risk management
process where appropriate.

5. Maintain consistent and periodic reporting to all interested parties of


the organization’s risk management performance.

©copyright 2017 AS9110store.com 4


INSERT YOUR COMPANY LOGO/NAME HERE

Risk and Opportunity Worksheet

Work Impact: What resources are available?


1 = People who have capability to work on this activity are scarce
4 = People who have capability to work on this activity can be available

Customer Changeability Performance Business Work Rank


Process / Activity Impact Index Status Impact Impact R O

Review and Approval

Prepared by: Quality team leader Date:

Reviewed by: Quality team Date:

Approved by: President Date:

©copyright 2017 AS9110store.com 32


248 page Training
Guide Included

AS 9110 Rev C
Internal Auditor Training

Trainer’s Guide
AS9110Store

Overview
These course materials are meant to train people to conduct internal quality audits within
your organization, which are necessary to meet the internal audit requirements of the
AS 9110 REV C standard.

The course is divided into two sections:


1. The first section will familiarize the students with the AS 9110 REV C requirements
for quality management system.
x Allow 4 hours for this section.
2. The second section is devoted to the auditing process. The students will go through
all the steps required for an audit, with hands on involvement in performing each
step by conducting a mock audit of a fictitious company.
x Allow 8 hours for this section.

We recommend that you print this guide as you’ll need the PowerPoint speaker notes to
lead the class. This guide contains everything the instructor needs to lead the class.

Notes:
x It is assumed that the instructor has certified Lead Auditor credentials or equivalent
experience. This is not meant as a self study course.

x It is recommended that the first audit the student is involved with be under the
leadership of a lead auditor who has audit experience.

2017 © Copyright The9110Store


AS9110Store
AeroFix Co Documented Information
_________________________________________________________
AeroFix Co Documented Information – Contents
__________________________________________________________________________

Qty Documents and Records No. of


Pages
1 QM-9110-C Quality Manual 9
1 F-750-001 List of Documented Information 2
1 Internal Audit Master Schedule 1
1 P-500 Leadership Procedure 2
1 A-520-001 Quality Policy, Strategic Direction, and Safety Policy 1
1 P-810 Operational Planning and Control Procedure 2
1 F-610-001 Risk and Opportunity Worksheet 1
2 F-810-001 Project Planning Worksheet 3
1 P-820 Customer Related Processes Procedure 3
1 F-820-001 Client Assessment Report 1
2 F-820-010 AFC Quotation / Proposal 2
1 P-840 Control of External Providers Procedure 3
1 F-840-002 List of Approved Sources 1
3 F-840-005 AFC Purchase Order / Amended Purchase Order 3
1 F-840-010 External provider Problem Log Form 1
1 P-1020 Nonconformity and Corrective Action Procedure 2
1 F-912-001 Customer satisfaction survey 1
1 R-1020 Register of Improvement Action Reports - NCR-CAR 1
1 F-1020-001 Corrective Action Request Form (CAR) 1
1 NCR – Section 1 Corrective Action Requests 1
1 CAR – Section 2 Corrective Action Requests 1
1 P-930 Management Review Procedure 2
1 F-930-001 Management Review Meeting Agenda 1
1 F-930-002 Minutes of Management Review 2

2017 © Copyright The9110Store


Includes speaker's notes

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Introduction to AS 9110 C - Employee Newsletter #11

AS 9110 Rev C: Introduction to the Requirements


Requirements of AS 9110 C Internal audit.
Section 4: Context of the Organization Our company conducts internal audits on
Section 5: Leadership a regular basis to ensure that the QMS
Section 6: Planning conforms to requirements, is effectively
Section 7: Support implemented, and maintained, and
Section 8: Operation continues to be suitable and adequate.
Section 9: Performance Evaluation This means that a team of our employees
Section 10: Improvement will be trained to evaluate processes in
the different areas of the company. They
Section 9: Performance Evaluation will look at the planned, documented
This clause requires that our company processes and see if the work is being
plan, implement and control the done accordingly. They will see if the
monitoring, measurement, analysis, and documented process is consistently
evaluation processes. Performance leading to quality maintenance services,
evaluation includes systems for the and meeting customer requirements.
evaluation of customer satisfaction,
analysis and evaluation of data, internal Management review.
audits, and management review, all Our top management will also be
aimed at improved quality performance holding regular meetings to evaluate
and an effective QMS. how the QMS is working. When the
**** QMS is complete, processes will be
Monitoring, measurement, analysis, monitored, progress towards quality
and evaluation. goals will be measured, and management
For our maintenance services, we will hold review meetings to see how the
determine what needs to be monitored QMS is working and how it can be
and measured, identify, and implement improved. During the meetings, top
the methods for valid results, specify management will look at items such as:
when the monitoring and measuring is to  Data on how processes are working
be performed, and when the results are  Action items for improvement
analyzed and evaluated. Methods will  Follow-up on action items from
include the use of statistical techniques previous management reviews
and root cause analysis.  Changes that could affect the QMS
 The Quality Policy

Performance Evaluation Procedures


listed below provide Clause 9 details.
P-910, Monitoring, measurement,
Customer satisfaction. analysis, and evaluation,
To determine how satisfied or P-912, Customer satisfaction,
dissatisfied our customers are, P-913, Statistical techniques,
management monitors information P-914, Root cause analysis,
relative to the customer perceptions of P-920, Internal audit,
how well their needs and expectations P-930, Management review.
are met.

Watch for our next newsletter for more introduction to AS 9110 C, what it will mean to
you and your coworkers.

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