Introduction:

In order to last and grow, companies need to consistently meet of needs of their customers through their products and services. And to do this, companies need to implement an effective quality management system

That's why we, at Process Street, built this AS9100D Checklist (Mandatory Documentation for AS9100D) template; to be used as a guide to correctly implement your AS9100D aerospace quality management system.

The checklist walks you, step-by-step, through each of the requirements of AS9100D standard. Each task is packed with information to help you build a whole understanding of the AS9100D standard and its qualifications.

There are also lots of form fields throughout the process, to make it easy and convenient for you to input all your necessary information and make sure that all AS9100D requirements are being met.

Preparing for the implementation:

Record basic details

First, before beginning preparations for the implementation, you need to record some basic details in the form fields below.

If completing this checklist will involve multiple people, you can use the members form field to assign individual team members to specific tasks.

Allocate roles and responsibilities

Use the form fields below to assign roles to team members in order to give them access to specific tasks throughout the process.

Estimate costs of implementation

Take some time to review the implementation steps and determine the overall costs necessary to complete the implementation process.

Use the form fields below to take notes and record the final cost estimate.

Estimate time frame for implementation

Similarly, review the implementation steps and determine an estimated time frame for the completion of the implementation process.

Use the form fields below to take notes and record the final time frame estimate.

Determine success factors of implementation

Next, you should take some time to determine and record success factors of the implementation process.

Answer the following questions, to help get you on the right track and more easily able to pinpoint your goals. Then, record for final success factors.

Conduct a gap analysis

Now, you should conduct a gap analysis.

A gap analysis is the comparison of the business' current performance state and the desired future performance state.

The gaps can include the following:

  • 1
    The difference between the current daily performance and the daily performance goal
  • 2
    The difference between actual targets met and target goals
  • 3
    The difference between your business' actual performance and the performance of best-in-business organizations

Use the form fields below to take notes and record the gap analysis results.

Develop documentation strategy

After you've conducted a gap analysis, you should develop a documentation strategy for your organization's information.

The documented information could encompass things like:

  • 1
    Processes (either recorded on paper or with software)
  • 2
    Management system documents and records
  • 3
    Audit reports
  • 4
    Any other vital company information

Use the form fields below to take notes and record the finalized documentation strategy.

Understand scope of AS9100D

Review Section 1: Scope of AS9100D and make sure you fully understand the scope of the standard before moving forward.

Feel free to take notes in the form field below if needed.

Prepare necessary references & definitions

If your organization has any specific references and/or definitions that are necessary to the understanding of its processes/management system, record them in the form fields below.

First steps towards implementation:

Understand the context of your company

The first step towards implementation is to understand the context of your organization

Understanding the context of the organization is important because it allows you to pinpoint, analyze, and better understand the business environment in which your organization operates.

You should review and analyze your organization and its stakeholders to determine the strategic direction of the company. This will require you to understand the internal and external issues that may be of concern to your organization and its interested parties.

Use the form fields below to take notes and record the finalized context of your company.

List interested parties and their expectations

Now that you understand the context of your organization, you should put together a list of your interested parties and their expectations.

“Interested parties” refers to stakeholders who receive your company's products/services, or may be affected by them, or, alternatively, parties who may have a strong interest in your company.

This information will be useful to senior management when determining the organization's strategic direction. 

Use the form fields below to take notes and record the finalized list of your interested parties and their expectations.

Define the QMS scope

The next step is to define your organization's quality management system.

A QMS scope refers to a descriptive summary of the organization's processes, procedures, and product(s)/service(s) that the QMS regulates.

Use the form fields below to take notes and record the finalized QMS scope.

Establish requirements from top management

Make sure to consult with relevant stakeholders and top level management with regards to any specific requirements for AS9100D implementation.

Record any such specific requirements in the form fields below.

Write your quality policy

After establishing your top level management requirements, you should write the quality policy for your organization.

It's important to clearly define your quality policy, as this is a requirement of AS9100D. 

Use the form fields below to take notes and then upload the finalized quality policy document.

Essential elements of a successful QMS:

Establish process for managing documents and records

One of the essential elements of a successful QMS is an effective process for managing your organization's documents and records.

All of your important documents and records should be kept organized and easily accessible to the appropriate team members if needed.

Use the form fields below to take notes and then record the finalized process for managing documents and records.

Ensure adequate training for all relevant employees

Review your employee records and ensure that adequate training has been provided for all relevant employees in order to close any potential knowledge gaps within the team. 

If there are any employees that have not had the adequate training, arrange for them to do so immediately.

Communicate importance of QMS to all employees

Conduct a meeting with your employees to discuss the importance of a successful QMS

Communicating this to your team is not only an AS9100D requirement, but also gives your employees a better understanding of why certain changes should be made and the effect these changes will have on the business.

Use the form fields below to record the meeting date and any notes.

Aligning the QMS with your company objectives:

Set clear quality objectives

Next is to set clear quality objectives for your organization.

Clearly defined quality objectives help in achieving your quality policy and should be reviewed annually to make sure it remains relevant. These quality objectives should be measurable and used to compare with performance goals at management review meetings.

An effective set of quality objectives should be:

  • 1
    Consistent with your quality policy
  • 2
    Measurable
  • 3
    Stating any relevant requirements
  • 4
    Relevant to conformity of product(s)/service(s)
  • 5
    Monitored and maintained
  • 6
    Communicated with employees

Use the form fields below to take notes and then upload the finalized quality objectives document.

Document your core policies and procedures

After recording your quality objectives, AS9100D requires that you take some time to document your organization's core policies and procedures.

Use the form fields below to take notes and then upload the finalized policy and procedure document.

Perform a SWOT analysis

Next, you should perform a SWOT analysis.

A SWOT analysis is a technique designed to help an organization pinpoint Strengths, Weaknesses, Opportunities, and Threats (SWOT) in relation to market competition or internal process effectiveness.

To first determine your organization's strengths, answer the following questions:

  • What do your customers love about your product/service?
  • What does your company do best when compared to others in the market?
  • What is something that your organization uniquely offer?
  • What resources do you have access to that your competitors don't?

Record your organization strengths below.

Now, to determine your organization's weaknesses, answer the following questions:

  • What do your customers complain most about your product/service?
  • Why do your customers churn?
  • In what areas could your company improve?
  • What resources do your competitors have access to that you don't?

Record your organization weaknesses below.

To determine your organization's opportunities, answer the following questions:

  • What can you do to improve customer experience?
  • How could you strengthen your relationships with influential brand advocates?
  • Are your organization's resources being allocated effectively?
  • Which kinds of advertising offered the best results? 

Record your organization opportunities below.

In determining threats to your organization, it's not always necessary to answer questions because these are typically more obvious. Think of your market competitors, high staff turnover, etc.

Record your organization threats below.

Aligning the QMS with your products and services:

Determine requirements for products and services 8.2

After performing a SWOT analysis, you should determine the requirements for your organization's products and services.

The requirements for the products and services should include any applicable statutory and regulatory requirements and other requirements that are necessary to your organization, as well as operational risks, capability and capacity, and delivery times. And most importantly, make sure that you can meet the claims for the products and services it offers. 

Use the form fields below to take notes and then upload the finalized product and services requirements document.

Assess design and development procedures 8.3

Next, review and assess your organization's design and development procedures.

Make sure they are detailed, aligns with your QMS, and kept updated.

Use the form fields below to take notes and then record any changes made to the design and development procedures, if needed.

Assess design change management procedures 8.4

Next, review and assess your organization's design change management procedures.

Make sure they are detailed, aligns with your QMS, and kept updated.

Use the form fields below to take notes and then record any changes made to the design change management procedures, if needed.

Assess how you provide your products and services 8.5 8.6

Next, review and assess how you provide your products and services.

Make sure they are detailed, aligns with your QMS, and kept updated.

Use the form fields below to take notes and then record any changes made to how you provide your products and services, if needed.

Assess control of nonconforming outputs 8.7

Next, review and assess your organization's control of nonconforming outputs.

Make sure they are detailed, aligns with your QMS, and kept updated.

Use the form fields below to take notes and then record any changes made to the control of nonconforming outputs, if needed.

Implementing and managing production controls:

Implement operational risk management

After aligning the QMS with your products and services, you should implement operational risk management.

Your top level management should assign responsibility for the project management team and make sure the product production is planned and well managed, meets requirements, and operates within the set resource and schedule constraints.

The organization's risks should be managed according to the operational risk management procedure.

The risk management process should include the following:

  • 1
    Designated responsibilities for risk management
  • 2
    Clearly defined risk criteria
  • 3
    Detailed identification, assessment and communication of risks
  • 4
    Detailed identification, utilization and upkeep of risk mitigation actions
  • 5
    Acceptance of remaining risks after the introduction of mitigation actions

Use the form fields below to take notes and then upload the finalized operational risk management document.

Implement configuration management

Next, you should implement configuration management.

Refer back to the "Determine requirements for products and services 8.2" task to review your finalized requirements and compare them against your organization's product and service performance.

Configuration audits should be completed monthly to ensure quality standards are being met consistently.

Use the form fields below to take notes and then record any inconsistencies found in your product and service performance.

Assess product safety

After implementing configuration management, you need to asses product safety.

Product safety is an incredibly important part of the aerospace industry, and this is why AS9100D added new requirements for this concept. 

You should begin by thinking about your product/service(s) throughout its lifetime in attempts to pinpoint any potential safety risks that should be addressed. After this, you and your team should devise a solution to address any of these potential safety hazards. It's possible that you may come across no safety risks at all.

Depending on your product/service(s), you may need to include some of the following processes:

  • 1
    Assessing and managing safety risks
  • 2
    Managing safety critical items
  • 3
    Assessing when safety events occur
  • 4
    Proper safety training

Use the form fields below to take notes and then record any safety risks found in your product/service(s).

Ensure measures are taken for counterfeit prevention

Next, you should ensure that measures have been taken to prevent counterfeit part use and their inclusion in the product delivered to your customer.

Some options that you should consider when determining what processes to implement include:

  • 1
    Employee training
  • 2
    The use of authorized manufacturers
  • 3
    Verification and testing or parts
  • 4
    Monitoring reports from external sources
  • 5
    Quarantine and reporting of counterfeit parts

Use the form fields below to take notes and then upload the finalized counterfeit prevention document.

Establish and validate special processes

After you've ensured that measures have been taken for counterfeit prevention, you need to establish and validate special processes.

You should make sure that the processes deployed by your vendors are validated and re-validated, whenever necessary.

Answer the following questions to help get you on the right track:

Use the form fields below to take notes, if needed.

Verify production processes

Next you should verify your organization's production processes.

Your production processes should be verified using a sample item from the first production run of a new part/assembly to check that the process is capable of producing quality parts consistency.

This verification should be repeated every time changes occur in the production process that could invalidate the original results. 

Use the form fields below to take notes and then record any inconsistencies found in your production processes.

Recurring QMS tasks:

Establish a daily QMS process

Now that you've implemented and managed your production controls, you need to establish a daily QMS process.

Take some time to record your organization's recurring, daily tasks to ensure day-to-day consistency in production quality.

Use the form fields below to take notes and then upload the finalized daily QMS process document.

Establish a change management process for the QMS

In order to maintain effective quality production under potentially changing circumstances, you need to establish a change management process for your organization's QMS.

Change management ensures that any changes you make in your organization correctly implemented and maintained. 

Some things to keep in mind when establishing your change management process:

  • 1
    Define your specific change
  • 2
    Use easy-to-understand language
  • 3
    Assume the reader has little to no background knowledge on the subject
  • 4
    Connect the changes to their corresponding strategic and/or emotional benefits
  • 5
    Encourage shifts in behavior in addition to actions
  • 6
    Build a formal framework to support your changes

Use the form fields below to take notes and then upload the finalized change management process.

Establish a process for maintaining documentation

An important AS9100D requirement is to establish an ongoing process for maintaining documentation of recurring QMS tasks.

This will not only be necessary for your employees and management to keep track of the work being done, but also when conducting audits on your organization. The auditor can easily look back on the organization's processes to asses them.

Use the form fields below to take notes and then upload the finalized process for maintaining documentation.

Establish a process for external services and products

Next, you need to establish a process for external products/services.

To begin, you should review your organization's external products/services to see where additional processes may be beneficial (i.e. onboarding, communication, feedback, etc.). Once you've decided on some processes to focus on, work with your team to build them out.

Use the form fields below to take notes and then upload the finalized process for external services and products.

Monitoring and measuring your QMS:

Establish clear monitoring methodology

After you've established processes for your recurring QMS tasks, you need to establish a clear monitoring methodology in order to effectively maintain these processes you've built.

Use the form fields below to take notes and then upload the finalized monitoring methodology.

Conduct a management review

Next, you should conduct a management review on the recurring processes that you're monitoring.

The monitoring methodology you established in the previous task will allow your management team to easily be able to look over the work and assess its performance. 

Management reviews should be conducted regularly in order to maintain performance consistency.

Use the form fields below to schedule a management review date and to record the review findings.

Establish a process for dealing with nonconformities

Now that you've conducted a management review and recorded your findings, you need to establish a process for dealing with the nonconformities that you came across, if any.

Work together with your team to find solutions for the problems you came across. and implement them.

Use the form fields below to take notes and then upload the finalized process for dealing with nonconformities.

Establish a policy of continuous improvement

Next, you need to establish a policy of continuous improvement.

Your organization should continually improve the effectiveness of the QMS with the aid of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review. 

Use the form fields below to take notes and then upload the finalized policy of continuous improvement.

Audit preparation:

Determine what type of audit is best for you

Now that you've established processes for monitoring and measuring your QMS, you need to prepare for an audit. 

There are two types of audits: internal and external.

Internal audits are conducted by an objective employee that works within the organization being audited and then reports to its audit committee. The internal auditor's work is continuous and usually based on the internal control systems of the organization.

External audits are conducted by third-party auditors independent of the organization and report to the company’s shareholders rather than the audit committee. The external auditor offers an experienced opinion on the legitimacy of the organization's financial statements and conduct tests to assess the systems in place.

Use the form field below to determine what type of audit is best for you.

[Conditional] Prepare for internal audit

Now that you've decided to conduct an internal audit, you need to prepare for it.

Use the following tips to help prepare your organization to be internally audited:

  • 1
    Assess your processes to pinpoint and correct any nonconformities.
  • 2
    Make sure that your processes are written clearly and could be understood by outsiders.
  • 3
    During the interview process, carefully assess the auditor's level of knowledge with your area of business and help fill any gaps of knowledge.
  • 4
    Communicate with your team and prepare them with the adequate training.
  • 5
    After your internal audit, share the findings with your team to keep everyone on the same page.

[Conditional] Prepare for external audit

Now that you've decided to conduct an external audit, you need to prepare for it.

Use the following tips to help prepare your organization to be externally audited:

  • 1
    Make sure you fully understand the AS9100D standard.
  • 2
    Identify your internal subject matter experts (SMEs) and have them work with the auditor.
  • 3
    Make sure that you've allocated the sufficient resources to your SMEs, so they can be immediately responsive to audit requests. 
  • 4
    Review and asses your internal processes to pinpoint and correct any nonconformities. 
  • 5
    Gather all of the documentation for your processes.

Determine success factors for all sections

Now, you should determine the success factors of a successful AS9100D implementation.

Use the form fields below to list your KPIs for this AS9100D implementation.

Approval: Final approval

Will be submitted for approval:
  • Determine success factors for all sections
    Will be submitted

Sources:

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