AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence

Establish, implement, maintain, and continually improve the QMS including the processes needed and their interactions.

• Process map
• Process owners list
• Interaction matrix
• Documented info index

• No process owners assigned
• Interactions implied not documented

Determine and select opportunities for improvement and implement actions to enhance customer satisfaction.

• Improvement projects
• Kaizen records
• Benefits realisation
• Lessons learned

• No proactive improvement projects
• Benefits not measured

React to NC, evaluate cause, implement actions, review effectiveness, update risks.

• CAR records
• RCA evidence
• Effectiveness verification
• Customer/regulatory NC submissions

• RCA superficial
• No effectiveness check

Top management demonstrates leadership and commitment to the QMS including product safety and conformity.

• Town hall minutes
• Quality policy
• Resource allocation evidence
• Executive attendance at reviews

• No visible top mgmt presence
• Policy not communicated

Establish, communicate, and maintain a quality policy appropriate to the organisation context.

• Signed quality policy
• Communication records
• Display photos
• Review history

• Policy unchanged for years
• Staff cannot articulate it

Assign and communicate responsibility and authority for relevant QMS roles including product safety.

• Org chart
• Job descriptions
• RACI matrix
• Quality manager appointment

• No designated product safety lead
• Authority limits unclear

Plan, implement, and control processes needed to meet requirements; control planned changes.

• Production plans
• Capacity analysis
• Resource allocation records
• Change control

• Capacity not analysed pre-commit
• Outsourced processes not planned

Plan and implement risk management processes including risk assessment criteria during operations.

• Project FMEA
• Mitigation evidence
• Acceptance approvals

• No risk criteria defined
• Mitigations not verified

Plan, implement, control configuration management process to ensure product configuration identification and traceability.

• CM plan
• Baselines
• ECN/ECO records
• As-built vs as-designed reconciliation
• Traceability matrix

• No CM plan
• Configuration drift in field

Plan, implement, control processes needed to assure product safety throughout the product life cycle.

• Safety hazard log
• Safety critical characteristics list
• Safety reporting procedure
• Field safety bulletins

• No SCC identification
• Field events not analysed

Plan and implement processes to prevent the use of suspect/counterfeit parts in product.

• Counterfeit prevention plan
• OCM/franchised distributor list
• Authentication/test records
• GIDEP alerts review
• Quarantine and reporting

• Independent distributors used without authentication
• No GIDEP monitoring

Determine, review, and change requirements for products and services with customers.

• RFQ/contract reviews
• Statutory/regulatory check
• Change communications

• Spec changes not reviewed
• Statutory check not documented

Apply controls to design and development process including reviews, verification, validation, transfer.

• Design reviews
• V&V plans/reports
• Transfer to manufacturing records
• Test reports

• V vs V confused
• No design transfer record

Determine and apply criteria for evaluation, selection, monitoring, and re-evaluation of external providers.

• Supplier qualification records
• Approved Supplier List
• Risk-based supplier audits
• Performance scorecards

• No re-evaluation cycle
• Risk-based oversight not applied

Determine controls based on risk to ensure externally provided processes/products meet requirements.

• Source inspection plans
• Receiving inspection sampling
• Supplier audit reports
• Delegated product release evidence

• No source inspection on critical parts
• Delegation criteria missing

Communicate to external providers requirements for processes, products, qualifications, key characteristics, traceability.

• PO quality clauses
• Specification flowdown matrix
• Key characteristic call-outs
• Right of access clauses

• DPD/MBD reqs not flowed
• Regulatory reqs missed

Use suitable means to identify outputs and maintain traceability throughout production.

• Lot/serial control
• Travelers
• Receiving tags
• Recall/genealogy records

• Lost traceability at assembly
• No CoC retention

Identify, verify, protect, and safeguard customer or external provider property under organisation control.

• Customer property log
• Damage/loss notifications
• Tooling/IP register

• No notification on damage
• IP not segregated

Meet requirements for post-delivery activities including warranty, maintenance, and field support.

• Warranty records
• Field service reports
• Customer complaint log
• Field returns analysis

• No feedback loop from field
• Warranty data not analysed

Establish, implement, maintain design and development process appropriate for aerospace products.

• Design plans
• Inputs/outputs records
• Design reviews
• V&V records
• Design changes

• No verification vs validation distinction
• Late changes uncontrolled

Ensure suppliers meet requirements; manage supplier selection, monitoring, and flowdown.

• AVL/ASL
• Supplier audits
• Performance scorecards
• Flowdown PO clauses
• Source inspection records

• No flowdown of customer reqs
• Supplier de-listing not executed

Identify and control nonconforming outputs to prevent unintended use, including dispositions.

• NCR log
• MRB minutes
• Quarantine evidence
• Customer concession requests
• Scrap controls

• No MRB for use-as-is
• Scrap not physically destroyed

Monitor customer perceptions including OASIS feedback, scorecards, and complaints.

• Survey results
• OASIS scorecards
• Complaint log
• Corrective actions on complaints

• No closed-loop on complaints
• OASIS not reviewed

Plan, establish, implement, and maintain audit program covering frequency, methods, responsibilities.

• Audit schedule
• Auditor qualification
• Audit reports
• CAR follow-up

• Audit not risk-based
• Process audits omitted

Plan actions to address risks and opportunities affecting QMS outcomes and product safety.

• Risk register
• Opportunity log
• Action plans
• Risk acceptance records

• Opportunities not tracked
• No risk appetite defined

Establish measurable quality objectives consistent with policy at relevant functions and levels.

• Objective KPI cascade
• Targets and baselines
• Quarterly review records

• Objectives not measurable
• Not cascaded to functions

Control documented information required by QMS and the standard including external origin docs.

• Master document list
• Revision history
• Access control
• Specification library (customer/regulatory)

• Obsolete docs on floor
• No control of external standards