Q1 Manufacturing Process Matrix

Edit: Q1 Manufacturing Process Matrix

Track compliance status and add summaries for each clause and section of the AS9100 Rev D standard. (C: Compliant, N: Non-Compliant, N/E: Not Evaluated, N/A: Not Applicable)

Matrix Name

Linked Checklist Audit Number

Status

Clause	Title/Subsection	Description/Summary	Status
4	Context of the Organization	Context of the Organization, clauses 4.1-4.4, focuses on identifying factors/issues impacting the QMS.	C N N/E N/A
4.1	Understanding the Organization and its Context	Identifies positive/negative factors in the organizational context.	C N N/E N/A
4.2	Understanding the Needs and Expectations of Interested Parties	Focuses on identifying needs and expectations of relevant parties.	C N N/E N/A
4.3	Determining the Scope of the Quality Management System	Defines the scope of QMS activities and responsibilities.	C N N/E N/A
4.4	Quality Management System and its Processes	Defines how QMS processes interact and are managed.	C N N/E N/A
4.4.1	Quality Management System and its Processes	Highlights process flows within the QMS.	C N N/E N/A
4.4.2	Documented Information for QMS Processes	Focuses on maintaining and managing documentation for QMS processes.	C N N/E N/A
	Section 4 Summary	Section 4 generally well understood and implemented, though documentation for 4.4.2 needs review.
5	Leadership	Leadership ensures focus on customer satisfaction and defines managerial roles and contributions.	C N N/E N/A
5.1	Leadership and Commitment	Ensures top management demonstrates commitment to QMS requirements.	C N N/E N/A
5.1.1	General	General leadership responsibilities relevant to the QMS.	C N N/E N/A
5.1.2	Customer Focus	Ensures customer requirements are met and satisfaction is achieved.	C N N/E N/A
5.2	Policy	Sets and communicates the organization's Quality Policy.	C N N/E N/A
5.2.1	Establishing the Quality Policy	Ensures the Quality Policy aligns with the organization's objectives.	C N N/E N/A
5.2.2	Communicating the Quality Policy	Focuses on disseminating the Quality Policy effectively across the organization.	C N N/E N/A
5.3	Organizational Roles, Responsibilities, and Authorities	Roles and responsibilities are clearly defined in the QMS.	C N N/E N/A
	Section 5 Summary
6	Planning	Planning actions to address risks, achieve objectives, and manage changes.	C N N/E N/A
6.1	Actions to Address Risks and Opportunities	Tracks risks/opportunities with mitigation plans covered in management reviews.	C N N/E N/A
6.1.1	Determine risks and opportunities	Risk evaluation based on internal/external factors.	C N N/E N/A
6.1.2	Actions to address risks and opportunities	Establishes action plans for risks/opportunities.	C N N/E N/A
6.2	Quality Objectives and Planning to Achieve Them	Defines measurable quality objectives and related planning activities.	C N N/E N/A
6.2.1	Quality objectives	Specific quality goals and targets.	C N N/E N/A
6.2.2	Planning quality objectives	Outlines how quality objectives will be achieved.	C N N/E N/A
6.3	Planning of Changes	Ensures all changes are planned and controlled.	C N N/E N/A
	Section 6 Summary
7	Support	Covers resources, competence, awareness, infrastructure, and documentation processes.	C N N/E N/A
7.1	Resources	Highlights the resources necessary for effective QMS implementation.	C N N/E N/A
7.1.1	General (Resources)	General review of QMS resources.	C N N/E N/A
7.1.2	People	Human resource considerations for the QMS.	C N N/E N/A
7.1.3	Infrastructure	Outlines infrastructure and facilities for QMS processes.	C N N/E N/A
7.1.4	Environment for the Operation of Processes	Ensures environmental conditions support effective QMS operation.	C N N/E N/A
7.1.5	Monitoring and Measuring Resources	Ensures proper tools for monitoring and measurement activities.	C N N/E N/A
7.2	Competence	Focuses on personnel competence in implementing QMS.	C N N/E N/A
7.3	Awareness	Ensures employee awareness regarding their QMS roles and objectives.	C N N/E N/A
7.4	Communication	Focuses on effective internal and external communication strategies.	C N N/E N/A
7.5	Documented Information	Management of document control processes and QMS-related records.	C N N/E N/A
	Section 7 Summary
8	Operation	Operational processes including planning, design, production, and control of external providers.	C N N/E N/A
8.1	Operational Planning and Control	Planning and controlling the processes needed to meet product/service requirements.	C N N/E N/A
8.4	Control of Externally Provided Processes, Products and Services	Ensuring conformity of externally provided items.	C N N/E N/A
8.5	Production and Service Provision	Controlling production and service provision activities.	C N N/E N/A
	Section 8 Summary	Operational controls are in place. Supplier controls (8.4) were not fully evaluated in this specific audit scope.
9	Performance Evaluation	Monitoring, measuring, audits, and reviews of QMS performance.	C N N/E N/A
9.1	Monitoring, Measurement, Analysis, and Evaluation	Collects and analyzes data to track QMS performance.	C N N/E N/A
9.2	Internal Audit	Ensures internal auditing meets planned schedules and scope.	C N N/E N/A
9.3	Management Review	Reviews inputs/results to evaluate QMS effectiveness.	C N N/E N/A
	Section 9 Summary
10	Improvement	Focuses on corrective actions, continual improvement, and preventive measures.	C N N/E N/A
10.1	General (Improvement)	Highlights improvement goals of the QMS.	C N N/E N/A
10.2	Nonconformity and Corrective Action	Processes corrections for identified nonconformities.	C N N/E N/A
10.3	Continual Improvement	Implements strategies for long-term improvement.	C N N/E N/A
	Section 10 Summary

Audit Datum

Q1 Manufacturing Process Matrix