Technical & Process Audits
Audit the Requirements That Matter to Your Product or Service
A traditional management-system audit may determine whether a procedure exists and whether the process follows that procedure.
A technical audit goes further.
It evaluates whether the organization is effectively controlling the technical requirements that determine product or service conformity.
QSI provides technical and process audits that can incorporate management-system, technical, customer, regulatory, contractual, and industry requirements.
What Is Technical Integrity?
Technical integrity is the confidence that products and services meet their specified requirements throughout their applicable lifecycle.
Requirements may originate from:
- Internal specifications
- Customer requirements
- Engineering requirements
- Regulatory requirements
- Codes and standards
- Industry specifications
- Product specifications
- Contractual requirements
These requirements must be identified, specified, communicated, implemented, verified, and maintained.
Technical Audit Areas
Depending on the scope, QSI can evaluate areas such as:
- Design and development
- Contract review
- Purchasing
- Supplier controls
- Receiving inspection
- Production
- Inspection and testing
- Calibration
- Special processes
- Welding
- Heat treatment
- Nondestructive examination
- Coating and plating
- Chemical analysis
- Mechanical testing
- Outsourced processes
- Product release
- Post-delivery activities
Process Auditing
QSI can evaluate processes based on their inputs, outputs, controls, resources, acceptance criteria, records, and performance.
This can help determine whether the process is not only documented, but capable of consistently producing the required result.
Specialized Audit Expertise
Technical audits may require knowledge beyond traditional management-system requirements.
Where appropriate, QSI can incorporate qualified personnel or subject-matter expertise into the audit approach.
The scope and depth of technical evaluation can be customized to the products, services, processes, and requirements being assessed.
Connecting Technical Requirements to the Management System
Technical requirements should not exist separately from the management system.
For example, requirements related to welding, heat treatment, inspection, testing, calibration, or nondestructive examination may involve:
- Personnel competence
- Equipment
- Procedures
- Work instructions
- Acceptance criteria
- Records
- Calibration
- Supplier controls
- Process validation
- Verification
- Revalidation
QSI can evaluate how these requirements are incorporated into the organization’s management system.