Introduction:

This Process Street checklist was built to be used as a guide when transitioning from AS9100C to the AS9100D standard for aerospace quality management.

The checklist walks you step-by-step, specifically through all the revisions made to the standard, and is not a checklist of the entire requirements of AS9100D standard. So, this process is intended for businesses who already have AS9100C  requirements in place and would like to know exactly what in their QMS needs to be updated to adhere to the revised AS9100D standard.

The checklist walks you carefully through the entire process, and is supplemented with further information within each task to help build context. It also utilizes form fields to input all your necessary information to make sure that all AS9100C to AS9100D transition requirements are being met.

Though the checklist offers a strong framework with all you need to know for a successful transition, we recommend that your edit the checklist to what would best suit you and your company's needs.

Enter checklist details

Before you get started, take some time to record some basic details about the checklist and who's running it using the form fields below.

Preparation:

Update 1 Scope in line with AS9100D

Transitioning from AS9100C to AS9100D offers a great time to review and make changes to the scope of your system to ensure it's up-to-date and accurate.

AS9100D requires that you:

  • 1
    Create a plan-do-check-act model
  • 2
    Add risk-based thinking

Use the form field below to record the changes you made to the scope of your system.

Update 3 Terms and Definitions

AS9100D asks that you add "product safety" and "counterfeit product" to the standard terms and definitions.

Use the form fields below to record your definitions.

4 Context of the Organization:

Update 4.1 Understanding the Organization and its Context

To be in line with AS9100D, the 4.1 Understanding the Organization and its Context section should be updated to accommodate the following changes:

  • 1
    Emphasis on defining the QMS and context of the organization
  • 2
    Exclusions not listed; clauses are applicable or not applicable with justification

Use the form field below to record the changes you made to the 4.1 Understanding the Organization and its Context section.

Revise 4.3 Determining the Scope of the QMS

Review your 4.3 Determining the Scope of the QMS section and make sure what the organization does is clearly documented.

Use the form field below to record what your organization does.

Rework 4.4 Quality Management System and its Processes

The updated 4.4 Quality Management System and its Processes section will basically serve as a Quality Manual with more descriptions.

It should include:

  • 1
    A general description of relevant interested parties
  • 2
    Sequence of interactions
  • 3
    Description of processes needed for the QMS

Use the form field below to record the changes you made to the 4.4 Quality Management System and its Processes section.

5 Leadership:

Revise 5.1 Leadership and Commitment

Review your 5.1 Leadership and Commitment section and make sure the top management is clearly documented.

Use the form field below to list your top management.

Update 5.1.2 Customer Focus

Your 5.1.2 Customer Focus section should be updated to include a statement that explains product and service conformity and OTD will be measured and actions will be taken if planned results are not achieved.

Use the form field below to formulate the statement.

6 Planning:

Rework 6.1 Actions to Address Risks and Opportunities

To be in line with AS9100D, the 6.1 Actions to Address Risks and Opportunities section should be updated to accommodate the following changes:

  • 1
    Need to describe how risk is met in all contexts, not just in planning or contract review
  • 2
    Increase requirements

A formal risk management process is required to manage operational risk in clause 8.1.1

Use the form field below to record changes made to the 6.1 Actions to Address Risks and Opportunities section.

7 Support:

Update 7.1.2 People

Review your 7.1.2 People section and make sure to add requirements for human factors.

Use the form field below to record the changes you made to the 7.1.2 People section.

Revise 7.1.4 Environment for the Operation of Processes

In the updated 7.1.4 Environment for the Operation of Processes, "Suitable environment" refers to the combination of human and physical factors, such as social, psychological, and physical.

Use the form field below to record any changes made to the 7.1.4 Environment for the Operation of Processes section.

Revise 7.1.5 Monitoring and Measuring Resources

Update your 7.1.5 Monitoring and Measuring Resources section to ensure that provided resources are suitable and maintained to ensure continuing fitness.

"Documented Information" refers to Records.

Use the form field below to record changes made to the 7.1.5 Monitoring and Measuring Resources changes.

Update 7.1.6 Organization Knowledge

Update your 7.1.6 Organization Knowledge section to include:

  • 1
    Sharing of organizational knowledge and experience.
  • 2
    Results of improvements in products, processes, and services.

Can also be from external sources (conferences, standards, customers, consultants, etc.)

Use the form field below to record changes made to the 7.1.6 Organization Knowledge section.

Review 7.2 Competence

Make sure the 7.2 Competence section specifies consideration for periodic review of necessary competence.

Use the form field below to record changes made to the 7.2 Competence section.

Update 7.3 Awareness

Update the 7.3 Awareness section to include:

  • 1
    QMS procedures/manual and changes
  • 2
    Contribution to product or service conformity
  • 3
    Safety
  • 4
    Importance of ethical behavior

Use the form field below to record changes made to the 7.3 Awareness section.

Rework 7.4 Communication

Rework the 7.4 Communication section to include:

  • 1
    Internal feedback relevant to the QMS
  • 2
    External feedback relevant to the QMS

Use the form field below to record changes made to the 7.4 Communication.

Review 7.5.2 Creating and Updating

In the 7.5.2 Creating and Updating section, "Approval" implies authorized persons and approval methods identified (an approval matrix-who can approve what and how).

Use the form field below to record changes made to the 7.5.2 Creating and Updating section.

Update 7.5.3 Control of Documented Information

Update the 7.5.3 Control of Documented Information section to include:

  • 1
    Adequate protection from loss of confidentiality, improper use or loss of integrity
  • 2
    Electronic data protection—loss, unauthorized changes, unintended alteration, corruption, and physical damage

Use the form field below to record changes made to the 7.5.3 Control of Documented Information section.

8 Operation:

Update 8.1 Operational Planning and Control

Update the 8.1 Operational Planning and Control section to include the following requirements to consider:

  • 1
    Personal & product safety
  • 2
    Producibility & inspectability  
  • 3
    Reliability, availability, and maintainability  
  • 4
    Suitability of part & materials used in the product  
  • 5
    Selection & development of embedded software  
  • 6
    Product obsolescence  
  • 7
    Prevention, detection, removal of foreign objects  
  • 8
    Handling, packaging & preservation  
  • 9
    Recycling or final disposal of product at life end  
  • 10
    Use of statistical techniques for design verification, process control (key characteristics), critical items, design of experiments, failure mode, effects and criticality analysis  
  • 11
    Determine resources for product conformity and to meet on time delivery of products and services  
  • 12
    Determining the products and services from external providers  
  • 13
    Controls to prevent the delivery of nonconforming products/services  
  • 14
    Planned sequence to meet requirements of acceptable risk

Use the form field below to record changes made to the 8.1 Operational Planning and Control section.

Include 8.1.1 Operation Risk Management

In the updated AS9100D, a new clause was introduced dedicated to addressing operational risk management (8.1.1 Operation Risk Management).

For operational risk management, you should:  

  • 1
    Assign responsibilities
  • 2
    Define risk criteria  
  • 3
    Identify, assess and communicate risk  
  • 4
    Manage risks that exceed defined risk criteria  
  • 5
    Acceptance of remaining risks

Use the form field below to record the finished 8.1.1 Operation Risk Management section.

Revise 8.1.2 Configuration Management

In the updated 8.1.2 Configuration Management section, configuration audits are no longer required.

But you should:

  • 1
    Ensure identification & control of physical and functional attributes
  • 2
    Control product identity and traceability, including changes  
  • 3
    Ensure records are consistent with attributes of products and services

Use the form field below to record changes made to the 8.1.2 Configuration Management section.

Update 8.1.3 Product Safety

In the updated 8.1.3 Product Safety section, you must plan, implement & control processes for product safety including:  

  • 1
    Assessment of hazards and associated risks
  • 2
    Mange safety critical items  
  • 3
    Analysis and reporting of events affecting safety  
  • 4
    Communication of event  
  • 5
    Employee training

Use the form field below to record changes made to the 8.1.3 Product Safety section.

Update 8.1.4 Prevention of Counterfeit Products

In the updated 8.1.4 Prevention of Counterfeit Products section, you must plan, implement and control processes to prevent the introduction of CP including:  

  • 1
    Training for awareness and prevention of CP
  • 2
    Parts obsolescence monitoring  
  • 3
    Controls for purchasing from original or authorized sources  
  • 4
    Requirements for assuring traceability of parts and components to original or authorized manufacturers  
  • 5
    Verification and testing to detect CP  
  • 6
    Monitoring of CP reporting  
  • 7
    Quarantine and reporting of suspect to detected CP

Use the form field below to record changes made to the 8.1.4 Prevention of Counterfeit Products section.

Revise 8.2.1 Customer Communication

The updated 8.2.1 Customer Communication section requires:

  • 1
    Handling or controlling customer property
  • 2
    Requirements for contingency actions

Use the form field below to record changes made to the 8.2.1 Customer Communication section.

Update 8.3.2 Design and Development Planning

The updated 8.3.2 Design and Development Planning section requires that you divide D&D efforts into distinct activities and define tasks, resources responsibilities, design content and inputs/outputs for each.

Use the form field below to record changes made to the 8.3.2 Design and Development Planning section.

Revise 8.3.3 Design and Development Inputs

The updated 8.3.3 Design and Development Inputs section requires that you clearly address potential consequences of obsolescence.

Use the form field below to record changes made to the 8.3.3 Design and Development Inputs section.

Rework 8.3.4 Design and Development Controls

The updated 8.3.4 Design and Development Controls section requires that you include the following:

  • 1
    Progression to next stage authorization
  • 2
    Participants include representative from all functions  
  • 3
    Plan control and review tests for verification and validation  
  • 4
    Test procedures describe test methods, how to perform and how to record 
  • 5
    Ensure correct configuration of test item  
  • 6
    Requirements of test plan and test procedures are observed  
  • 7
    Acceptance criteria are met  
  • 8
    Control of monitoring/measuring devices  
  • 9
    Reports to demonstrate that the design meets requirements for all operational conditions

Use the form field below to record changes made to the 8.3.4 Design and Development Controls section.

Update 8.3.5 Design and Development Outputs

The updated 8.3.5 Design and Development Outputs section requires that you implement the following changes:

  • 1
    Outputs include any critical items, key characteristics and specific actions for them
  • 2
    Outputs are approved by authorized persons prior to release  
  • 3
    Data required to allow product to be identified, manufactured, verified, used and maintained

Use the form field below to record changes made to the 8.3.5 Design and Development Outputs section.

Revise 8.3.6 Design and Development Changes

The updated 8.3.6 Design and Development Changes section requires that you include the following:

  • 1
    Process in place for notifying customers of changes that could affect them prior to implementation
  • 2
    Changes controlled IAW configuration management process

Use the form field below to record changes made to the 8.3.6 Design and Development Changes section.

Update 8.4.1 General

The updated 8.4.1 General section requires that you apply appropriate controls to direct and sub-tier external providers as well as selection and use of external providers.

Use the form field below to record changes made to the 8.4.1 General section.

Update 8.4.2 Type and Extent of Control

The 8.4.2 Type and Extent of Control section (Formerly titled Verification of Purchased Product) must include:

  • 1
    Verification activities performed according to identified risks
  • 2
    Include inspection or periodic testing when high risk of nonconformities and counterfeit parts  
  • 3
    Review of production part approval process data  
  • 4
    Review of delegations of product verification  
  • 5
    Define process for pre-release of product  
  • 6
    Evaluate data in test reports to confirm product meets requirements  
  • 7
    When purchase of raw material is a significant operations risk, implement a process to validate the accuracy of test reports

Use the form field below to record changes made to the 8.4.2 Type and Extent of Control section.

Revise 8.4.3 Information for External Providers

The updated 8.4.3 Information for External Providers section should be revised to provide communicate external providers with the following information:  

  • 1
    Relevant technical data
  • 2
    Design and development control  
  • 3
    Special requirements  
  • 4
    Prevent the use of counterfeit parts  
  • 5
    Ensuring that supplier personnel are aware of their contribution to product/service conformity, safety and ethical behavior

Use the form field below to record changes made to the 8.4.3 Information for External Providers section.

Update 8.5.1 Control of Production and Service Provision

For the updated 8.5.1 Control of Production and Service Provision section, you should ensure that documented information, such as, procedures, work instructions for monitoring and measurement (M&M) activity for product acceptance, includes the following:  

  • 1
    Criteria for acceptance and rejection
  • 2
    Where in sequence verification operations occur  
  • 3
    Measurement results to be retained  
  • 4
    Any specific M&M equipment required and instructions for their use

Use the form field below to record changes made to the 8.5.1 Control of Production and Service Provision section.

Revise 8.5.1.3 Production Process Verification

For the updated 8.5.1.3 Production Process Verification section, the first article inspection records must be retained.

Use the form field below to record changes made to the 8.5.1.3 Production Process Verification section.

Revise 8.5.2 Identification and Traceability

For the updated 8.5.2 Identification and Traceability section, you must maintain the identification of the configuration of products and services in order to identify any differences between the actual configuration and required configuration.

Use the form field below to record changes made to the 8.5.2 Identification and Traceability section.

Update 8.5.5 Post-Delivery Activities

Next, you must revise the 8.5.5 Post-Delivery Activities section so that post-delivery activities include: control, updating, and provision of technical documentation relating to product use, maintenance, repair, and overhaul.

Use the form field below to record changes made to the 8.5.5 Post-Delivery Activities section.

Update 8.6 Release of Products and Services

The updated 8.6 Release of Products and Services section includes a new sub clause to address the verification of product/service at appropriate stages.

To abide by its conditions, you must retain documented information on the release of products/services including evidence of conformity and traceability to person authorizing the release.

Use the form field below to record changes made to the 8.6 Release of Products and Services section.

Update 8.7 Control of Nonconforming Outputs

The updated 8.7 Control of Nonconforming Outputs section replaces nonconforming “Product” with “Output”, and calls for the following updates:

  • 1
    Include provisions for defining corrective actions for nonconforming products and services detected after delivery, as appropriate to their impacts
  • 2
    Dispositions for use-as-is or repair to include obtaining authorization for acceptance under concession by a relevant authority and, when applicable, by the customer.  
  • 3
    After authorization by the customer, if the nonconformity results in a departure from the contract requirements  
  • 4
    Counterfeit, or suspect counterfeit, parts to be controlled to prevent reentry into the supply chain.

Use the form field below to record changes made to the 8.7 Control of Nonconforming Outputs.

9 Performance evaluation:

Revise 9.1 Monitoring, Measurement, Analysis and Evaluation

In the updated 9.1 Monitoring, Measurement, Analysis and Evaluation section, the organization is responsible to determine monitoring, measurement, analysis and evaluation.

Use the form field below to record changes made to the 9.1 Monitoring, Measurement, Analysis and Evaluation section.

Update 9.1.3 Analysis and Evaluation

The updated 9.1.3 Analysis and Evaluation section must include the following:

  • 1
    What needs to be monitored & measured (M&M)
  • 2
    Methods for M&M and evaluation needed to ensure valid results  
  • 3
    When M&M is performed  
  • 4
    When results from M&M is analyzed and evaluated  
  • 5
    Records of M&M to be retained as appropriate

Use the form field below to record changes made to the 9.1.3 Analysis and Evaluation section.

Revise 9.3.2 Management Review Input

The updated 9.3.2 Management Review Input section must have inputs to include on time delivery performance.

Use the form field below to record changes made to the 9.3.2 Management Review Input section.

Revise 9.3.3 Management Review Output

The updated 9.3.3 Management Review Output section must have outputs to include identified risks.

Use the form field below to record changes made to the 9.3.3 Management Review Output section.

10 Improvement:

Update 10.2 Nonconformity and Corrective Action

The updated 10.2 Nonconformity and Corrective Action clause is a combination of Nonconformity and Corrective action. When an unconformity occurs, the organization must:

  • 1
    React, take action to control & correct
  • 2
    Deal with the consequences  
  • 3
    Evaluate need for action, review and analyze the nonconformity  
  • 4
    Determine causes, including those related to human factors

Human factors involve gathering information about human abilities, limitations, and other characteristics and applying it to tools, machines, systems, tasks, jobs, and environments to produce safe, comfortable, and effective human use.

If nonconformities occur, the organization is to determine if/what human factors are involved.

Use the form field below to record changes made to the 10.2 Nonconformity and Corrective Action section.

Revise 10.3 Continual Improvement

In the updated 10.3 Continual Improvement section, the organization is responsible to monitor the implementation of improvement activities and evaluate the effectiveness of results.

Use the form field below to record changes made to the 10.3 Continual Improvement section.

Approval: Final approval

Will be submitted for approval:
  • Enter checklist details
    Will be submitted
  • Update 1 Scope in line with AS9100D
    Will be submitted
  • Update 3 Terms and Definitions
    Will be submitted
  • Update 4.1 Understanding the Organization and its Context
    Will be submitted
  • Revise 4.3 Determining the Scope of the QMS
    Will be submitted
  • Rework 4.4 Quality Management System and its Processes
    Will be submitted
  • Revise 5.1 Leadership and Commitment
    Will be submitted
  • Update 5.1.2 Customer Focus
    Will be submitted
  • Rework 6.1 Actions to Address Risks and Opportunities
    Will be submitted
  • Update 7.1.2 People
    Will be submitted
  • Revise 7.1.4 Environment for the Operation of Processes
    Will be submitted
  • Revise 7.1.5 Monitoring and Measuring Resources
    Will be submitted
  • Update 7.1.6 Organization Knowledge
    Will be submitted
  • Review 7.2 Competence
    Will be submitted
  • Update 7.3 Awareness
    Will be submitted
  • Rework 7.4 Communication
    Will be submitted
  • Review 7.5.2 Creating and Updating
    Will be submitted
  • Update 7.5.3 Control of Documented Information
    Will be submitted
  • Update 8.1 Operational Planning and Control
    Will be submitted
  • Include 8.1.1 Operation Risk Management
    Will be submitted
  • Revise 8.1.2 Configuration Management
    Will be submitted
  • Update 8.1.3 Product Safety
    Will be submitted
  • Update 8.1.4 Prevention of Counterfeit Products
    Will be submitted
  • Revise 8.2.1 Customer Communication
    Will be submitted
  • Revise 8.2.2 Determination of Requirements Related to Products and Services
    Will be submitted
  • Revise 8.2.3 Review of Requirements Related to Products and Services
    Will be submitted
  • Update 8.3.2 Design and Development Planning
    Will be submitted
  • Revise 8.3.3 Design and Development Inputs
    Will be submitted
  • Rework 8.3.4 Design and Development Controls
    Will be submitted
  • Update 8.3.5 Design and Development Outputs
    Will be submitted
  • Revise 8.3.6 Design and Development Changes
    Will be submitted
  • Update 8.4.1 General
    Will be submitted
  • Update 8.4.2 Type and Extent of Control
    Will be submitted
  • Revise 8.4.3 Information for External Providers
    Will be submitted
  • Update 8.5.1 Control of Production and Service Provision
    Will be submitted
  • Revise 8.5.1.3 Production Process Verification
    Will be submitted
  • Revise 8.5.2 Identification and Traceability
    Will be submitted
  • Update 8.5.5 Post-Delivery Activities
    Will be submitted
  • Update 8.6 Release of Products and Services
    Will be submitted
  • Update 8.7 Control of Nonconforming Outputs
    Will be submitted
  • Revise 9.1 Monitoring, Measurement, Analysis and Evaluation
    Will be submitted
  • Update 9.1.3 Analysis and Evaluation
    Will be submitted
  • Revise 9.3.2 Management Review Input
    Will be submitted
  • Revise 9.3.3 Management Review Output
    Will be submitted
  • Update 10.2 Nonconformity and Corrective Action
    Will be submitted
  • Revise 10.3 Continual Improvement
    Will be submitted

Sources:

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