IATF 16949 summary, page 3
Chapter 9:Performance Evaluation
The company must check the performance and the effectiveness of their quality management system at the same time retaining proper documented information.
The company must perform process studies on all modern production processes to validate their ability to contribute to standard compliance and improvement functions.
Quality management system monitoring plan factors:
- Measurement methods
- Sample plans
- Acceptance criteria
- Records
- Plans and processes
The company must develop and implement a correction plan for all production processes to ensure stability and statistical capability.
This plan must be reviewed by the customer.
Essential tools must have an appropriate use as they are incorporated in quality and monitoring planning and process and product risk analyses.
The personnel assigned for collecting and analyzing statistical data may employ concepts such as variation, stability, process capability, and over-turning consequences.
The company must utilize customer perception techniques such as customer surveys, feedback, meetings, market-share analysis, and compliments.
Customer may evaluate the company’s performance applying the following indicators:
- Parts and delivery performance
- Customer breakages, returns, reminders, and warrants
- Special notifications such as delivery issues
The company must assess:
- Products and services conformity
- Customer satisfaction
- Quality management system
- Effective implementation of planning
- External providers execution
- Need for progress
The company must force the enhancement of customer satisfaction as one of the chief priorities.
The company must conduct planned internal audits to supply data to confirm if the quality management system is effectively administered and preserved.
The company must establish and sustain an audit programme with results that are relevant and useful to the management.
The internal audit programme must consist of the entire quality management system, production processes, and product audits.
The audit programme must consider all the risks, internal and external completion processes and its critical ability.
The company must select specific customer quality management system requirements for its audits to verify conformity.
The company must observe the customer’s approach with certain phases in the production process and delivery service.
Top management must review the company’s quality management system to assure its continued stability, adequacy, and effectiveness.
This review must be fulfilled at least once a year due to the impacts of internal and external changes on the quality management system and production problems.
Management review must be completed with the following elements:
- Status of actions and their effects
- Internal and external issues modifications
- Data regarding the performance and effectiveness of the quality management system
- Adequacy of resources
- Chances for progress
Input factors of the management review:
- Non-compliance costs
- Efficiency measures
- Product compliance
- Feasibility studies
- Customer satisfaction
- Warranty performance
- Customer’s supplier analysis
- Potential returns
- Customer incidents
Output components of the management review:
- Chances for progress
- Need for changes
- Resources
Management must prepare an action plan in case the company may not fulfill the objectives laid by the customer.
Chapter 10:Improvement
The company must identify and select opportunities for any progress and enforce necessary steps to fulfill customer demands and boost customer satisfaction.
If nonconformity occurs usually from customer complaints, the company must:
- React as applicable
- Evaluate the need for actions
- Implement those actions
- Review its effectiveness
- Updates risks and chances
- Produce changes to the quality management system
The company must always retain documented information of the nonconformity and the results of the actions taken.
The problem-solving process consists of:
- Approaches for every type and sizes of problems
- Control techniques
- Root cause analysis, methods and their results
- Verification process of the effectiveness
- Monitoring plan and updates
The use of anti-error devices must be properly documented, involving the testing, failures, results, necessary details, and response plans.
If required, the company must have a warranty management process that consists of a way of analyzing the warranty parts such as NTF.
The company must examine all customer complaints, product failures, and customer returns.
They must initiate a resolution and take corrective actions to avoid recurrence.
The company must pursue improving the suitability, sufficiency and success of the quality management system.
Continuous improvement process:
- Determining of methodologies executed
- Production process upgrade schemes
- Risk analysis such as FMEA
Annex A: Clarification of new structure, terminology and concepts
Several clauses and terminologies utilized in this standard have been shifted to align the other management systems standards.
It is unnecessary that the company employ the same set of terminologies in their quality management system.
The structure of the clauses intends to render a coherent presentation of requirements relevant to the users if it relates to the users’ own collection of processes.
The company may select their own terms that suit best their processes and operations.
The term products and services refer to all output categories. Services are the output realized at the interface with the customer.
It is not a requirement in this international standard that the company has to extend their scope of the quality management system to their external suppliers and interested parties.
The application of risk-based thinking is in the planning and implementation of the company’s quality management system processes and the assistance in determining the extent of necessary documented information.
The risk-based thinking applied in this standard has permitted deductions in the prescriptive and performance-based requirements.
A quality management system acts as a preventive tool for the company.
The company may adjust the requirements depending on their size and complexity, management model, activities range, and nature of the risks and chances it may encounter.
As part of the alignment of this standard to other quality management system standards, the term documented information has been adopted.
It is a requirement for the company to maintain documented information at the same time retaining it for a particular purpose.
There are requirements because of:
- The purpose to safeguard necessary information
- The purpose to always seek for additional information
The company may opt to outsource essential characteristics of services.
The company may enforce risk-based thinking to identify the type and extent of controls of external suppliers.
Annex B: Monitoring Plan
Stages of the monitoring plan:
- Prototype – a description of the dimensional measurements and materials used for the product
- Pre-production – a pre-series stage after the prototype and before mass production
- Production – documentation of the product and its characteristics , process controls and tests performed
Elements of the monitoring plan:
- General – surveillance plan number, customer information, part references
- Product control – special product features, tolerance
- Process control – process parameter,manufacturing machines and tools
- Methods – anti-error device, sample size and frequency
- Response plan and corrective actions
Annex C: Other International Standards on quality management and quality management systems developed by ISO/TC 176
The three core standards developed by ISO/TC 176:
- ISO 9000 Quality management systems – Fundamentals and vocabulary – forms the foundation of the requirements of this standard. It gives the company essential background for proper understanding and implementation of this international standard.
- ISO 9001 (this standard) – states the requirements that aims at giving more confidence in the company’s outputs to enhance customer satisfaction which if properly enforced, comes with other positive benefits
- ISO 9004 Managing for the sustained success of an organization – A quality management approach – provides requirements for the company to progress beyond this international standard
The following international standards supplies the company a chance to improve their quality management system:
ISO 10001 Quality management — Customer satisfaction — Guidelines for codes of conduct for organizations
ISO 10002 Quality management — Customer satisfaction — Guidelines for complaints handling in organizations
ISO 10003 Quality management — Customer satisfaction — Guidelines for dispute resolution external to organizations
ISO 10004 Quality management — Customer satisfaction — Guidelines for monitoring and measuring
ISO 10005 Quality management systems — Guidelines for quality plans
ISO 10006 Quality management systems — Guidelines for quality management in projects
ISO 10007 Quality management systems — Guidelines for configuration management
ISO 10008 Quality management — Customer satisfaction — Guidelines for business-to-consumer electronic commerce transactions
ISO 10012 Measurement management systems — Requirements for measurement processes and measuring equipment
ISO/TR 10013 Guidelines for quality management system documentation
ISO 10014 Quality management — Guidelines for realizing financial and economic benefits
ISO 10015 Quality management — Guidelines for training
ISO/TR 10017 Guidance on statistical techniques for ISO 9001:2000
ISO 10018 Quality management — Guidelines on people involvement and competence
ISO 10019 Guidelines for the selection of quality management system consultants and use of their services
ISO 19011 Guidelines for auditing management systems