Technical Integrity in Auditing

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What is Technical Integrity?

Technical integrity is the confidence that products and services meet Design and Specified Requirements, including their specified lifecycle.

What are design & specified requirements?

Technical integrity may be further extended into subcategories to the extent necessary, for example:

Dimensional stability (e.g., calibration to ISO 17025)
Design input (comprehensive input containing all specified requirements)
Product realization equipment maintenance, maintaining product tolerances
Post-delivery, user manuals, maintenance requirements, product or service life cycle
Production processes and processes requiring validation

Technical Integrity applies to all industries, product and services (i.e., to the point of realization: understanding)

Technical Integrity is focused on prevention.

TRAGEDY
- Product or system failures
- Catastrophic disaster (e.g., explosions, fires, pollution, contamination, spills to environment, death)
LEGAL
- Statutory, regulatory
- Loss of product technical integrity
- Conformance vs. compliance
- Contractual
- Nonproductive time
SYSTEMIC
- Customer dissatisfaction
- Supply chain quality
- Product escapes
- Risk reduction

Technical integrity extends to all departments, for example engineering, sales and marketing, purchasing, quality, operations, field services.

Ensuring all departments understand how specified requirements are identified, through:

Clear definition of the organization’s product or service
Incorporation of other specified requirements into its product or service and processes (i.e., customer, regulatory, industry)
How each department communicates that as part of its input and output, for example:
- Engineering through design input and output
- Sales through clearly documenting customer requirements
- Purchasing through maintaining technical requirement flow-down to the supply chain
- Quality through verification points such as receiving inspection, participation in contract review meetings
- Production through incorporating industry or design specified requirements from codes and/or standards
- Field Service through installation, test, service and maintenance requirements

In auditing, Technical Integrity will include technical + quality requirements.

From the Oil & Gas Industry, including manufacturing and metals industries

#	Topic	Requirement Specified Through	Via
1.	QMS Requirements	Applicable QMS: 9001, Q1, Q2	Specified Standard
2.	Personnel Competence	ASNT-TC-1A Qualification of NDT Personnel American Society for Nondestructive Testing	Spec 6A
3.	Method: Magnetic Particle Inspection	ASTM E709 ASTM International Standard Guide for Magnetic Particle Testing	Spec 6A
4.	Acceptance Criteria	Specified by API Product Specifications such as API Spec 6A, Specification for Wellhead and Tree Equipment	Spec 6A

Notes:

Pay attention to the interaction of external requirements that may have to be integrated into your processes.
In this example there are 3 different external documents that have been identified.
Determine how they have been integrated into your quality management system.

#	Standard	Title
1.	Standard 20D	Qualification of Nondestructive Examination Services
2.	Standard 20G	Welding Services
3.	Standard 20H	Heat Treatment Services – Batch Type Furnaces
4.	Standard 20J	Qualification of Distributors of Metallic Materials
5.	Standard 20L	Qualification of Polymeric Seal Manufacturers
6.	Standard 20M	Qualification of Suppliers of Machining Services
7.	Standard 20N	Heat Treatment Services – Continuous Line
8.	Standard 20S	Qualification of Additively Manufactured Metallic Materials

Through specifying the following and maintaining consistency in all aspects of your quality management system.

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