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:
In addition, special in-plant condition/incidents must be considered 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:
The following documents will be the foundation to conduct 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 :
Personal qualities:
Training
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
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Any Question?
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