Why Audit is Essential?

​The purpose of audit:

• Requirement of ISO 9001
• Evaluation of product quality/process performance according to internal quality standard that fulfills at least the customer's requirements
• Identification of potential improvements
• Assessment of the product or process from the customers' perspective (internal/external)
• Evidence of Reliability requirements
• Evidence of interplay of product Characteristics
• Evidence of characteristics that are not covered in the control plan
• Evidence of compliance with product characteristics that may influence customer satisfaction
• Evidence of product characteristics that are examined in in-process tests by means of equivalents
• Evidence of packaging and labeling

When Audit need?

Input to trigger an audit:

• Customer requirements (specified)
• Customer expectations recognized by the company that have a significant effect on customer satisfaction (not specified)
• Product, process and facility change
• low maturity level of product and process
• complaint from internal and external customers (e.g. early failures, warranty data, field data)
• Findings from risk assessments (e.g. FMEA)
• Result of customer satisfaction surveys
• Test Report
• Results, conclusion, and measures from previous product / process audit
• Statutory and regulatory requirements on the product
• Strategic importance of the product, opportunities and risks for the organization.

In addition, special in-plant condition/incidents must be considered an audit:

• Changes of machines/equipment
• Staff turnovers, substitutions, shifts
• Relocations, changes of supplier
• Deviations that are difficult to detect or concealed
• Technical characteristics of the product (complexity)
• Product variants
• Batch size (large series, small series, individual production)
• Production line (variance of production process)
• Critical manufacturing and measurement process

What will be covered during audit?

The following will be covered during audit:

• Material
• Dimensions
• Weight
• Appearance, odor, and haptics
• functionality (electric/mechanical)
• Software quality
• Connectivity
• Fitness
• Reliability / Durability (corrosion resistance, temperature behavior, static and dynamic behavior)
• Safety
• Labeling
• Packaging

The following documents will be the foundation to conduct audit:

• Legal and statutory requirements
• standards
• reports of previous product audit
• Drawing and other specification documents
• Customer requirements/customer requirements profile
• Supply agreements (packaging and labeling requirements)
• Control plan, production flow chart, process descriptions
• Test specification
• FMEAs
• Failure catalogs
• boundary samples
• Specification for methods of analysis
• assessment / quality 
• material data sheets
• Approved production deviation (special approval)
• Complaint classification 

Qualification of CQS Auditor?

As CQS auditor/inspector, the following skills & expertise will be regular review and evaluated.

Specialist requirements :

• Experience in manufacturing
• Product, manufacturing, and process knowledge
• Use of the audited product
• Testing technology
• Measuring technology
• Basic terms of Q- methodology
• Knowledge about complaints
• knowledge about customer requirements on the product
• Report generation
• Evaluation of products based on product-specific requirements （Evaluation standards)
• Foreign language skill

Personal qualities:

• Social skills
• objectivity
• Physical aptitude
• personal reliability

​
Training

• Training in a specific profession

HOW Audit carry out?

---

Case Study

Any Question?

start now with our expertise to enhance your supply base management and drive for business success