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Interpretation of IATF16949 standard
This is a mind map about the interpretation of the IATF16949 standard. It has a detailed introduction and comprehensive description. I hope it can help interested friends learn.
Edited at 2023-11-23 19:38:32
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Interpretation of IATF16949 standard
- bacteria
This is a mind map about bacteria, and its main contents include: overview, morphology, types, structure, reproduction, distribution, application, and expansion. The summary is comprehensive and meticulous, suitable as review materials.
- Plant asexual reproduction
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- Reproductive development of animals
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IATF16949 system training
IATF16949=ISO9001:2005+Special requirements of the automotive industry+Special requirements of specific automotive customers
CSR-customer specific requirements
Interpretation of specific standard clauses or supplementary requirements related to such clauses
Product related and not customer specific requirements
For management and related processes
special characteristics
100% inspected
Have measures or means to prevent mistakes and foolproof
Product and process related
Use SPC tools for control
Control the deterioration of important parameters and prevent problems in advance
IATF16949 quality management system objectives
Emphasis on defect prevention
Reduce variation and waste
Through process control
keep improve
Continuously make improvements or breakthroughs while the process is stable
Five core quality tools
APQP&CP
CP=T/6Σ
Whether CPK can be achieved depends on the denominator Σ and the degree of data dispersion (standard deviation)
Good consistency and small product fluctuation; in the case of tolerance characteristics, the greater the CP (CPK)
When new customers formulate CPK, they can refer to similar product cpk
APQP
Purpose
Used during new product development stage
dominant party
Project management leadership
five stages
FMEA
Designers use
Used by craftsmen
2019/06 Fifth Edition FMEA (AIAG&VDA)
MSA
quality or laboratory
Instrument managers take the lead and are responsible
To ensure data accuracy, measurement system analysis is necessary
SPC
Development stages from top to bottom
The feasibility of mass production can be confirmed through SPC tools during the development phase.
Design and management first, research, improve, and calculate cpk in small batches
Confirm whether it meets the conditions for mass production
Mass production stage from bottom to top
Used by manufacturing site personnel to draw control charts and collect data for automatic drawing
After collecting basic data, feedback to quality, technology, and management about data anomalies
Quality assistance with data analysis
PPAP
Dual control of product and process
VDA6.3 for process audit
PPAP is a process-approved activity that follows a certain logic
Validate the process through trial production activities
More than just a deliverable
Use mass production equipment to produce a certain number of products within a certain period of time according to mass production conditions.
The mass production process pays more attention to rhythm and yield, and engineers follow the line to collect data.
Achieve management goals through tools (Effective methods are extracted through summary)
IATF16949:2016 Scope
90,000 certificates worldwide, 50,000 in China
Production parts
Directly load normal production parts or components onto the vehicle
service parts
Manufactured in accordance with OEM specifications
aftermarket parts
Provided by non-OEM manufacturers
Challenge piece
Standard parts for verification machines or instruments and error-proofing devices (Go-No-Go)
To manage accordingly
Poka-yoke devices are verified daily
Interpretation of IATF16949:2016 standard
Chapter 1: Scope
Chapter 2: Normative Reference Documents
Chapter 3: Terms and Definitions
Chapter 4: Organizational Environment (4)
Planning (understanding needs and expectations)
4.1 Understand the organization and its environment
Understand the company’s strategic goals and direction
Identify internal and external factors that influence the expected results of the quality system
Make mid- and long-term strategic plans and business plans through identification
Conduct regular review activities and update business plans (company-level business goals determine department plans and goals)
SWOT analysis matrix
Advantages
Weak W
Opportunity O
Threat T
4.2 Understand stakeholder needs and expectations
5 dimensions: shareholders (representing management), employees, customers, suppliers/partners, and society
Only by coordinating the needs and expectations of all parties can the event proceed smoothly.
eg: A certain requirement is not recognized and understood, resulting in increased costs, delayed delivery, etc.
4.3 Determine the scope of QMS
confirm boundaries
Product Range
address range
Confirm workshop or address
Scope of activities
Support function
Should be included within the scope of QMS control
PDCA data must have corresponding records
Staff support, etc.
Onsite or outsourced
Design center, company headquarters, distribution center, etc.
Input and output need to be confirmed and supervised
Many problems occur due to poor interfaces
Any IATF16949 certification must have development
product development or process development
Logistics route development, etc. are all considered
The only deletion allowed
Product design and development requirements in Article 8.3
First identify whether the company has development or design
Deletions should be documented and maintained
The customer has no requirements, I have relevant requirements
Pure OEM allows deletion
eg: The formula is designed by itself, or the tolerances are tightened, and the technical standards are different.
4.3.2 Customer special requirements CSR
Identify Form List
Matrix (process correspondence)
eg: The customer requires that the after-sales service be continued for 5 years after EOP.
Three major nodes
SOP
Start of mass production
Start of production
After mass production, there will be a ramp up to mass production.
EOP
The end of mass production
End of production
EOL
Reach the end of the promised lifecycle
End of life
Prepare after-sales accessories, otherwise there may be loopholes
In order to achieve after-sales parts supply, drawings and development record management should be kept in EOL for an additional year.
Work fixture drawings and physical management
Materials, supply chain management, signing after-sales years with suppliers
Evaluation (evidence of implementation)
Check whether it is implemented
Mandatory sampling for process audits
Internal auditors need to know the client’s special requirements
4.4 Quality management system and its processes
process
Basic unit of automobile management system
Definition: An activity that converts input into output
Input (customer request)
Output (customer satisfaction)
Customers include internal customers and external customers
Processes and processes form a complete system through a series of activities
Improper management of the interface between processes (similar to between departments) will lead to potential risks and should be focused on management and control.
16949 No detailed control over the interface
VDA6.3 has detailed requirements for interface management
eg: Interface between the development department and the manufacturing department
eg: Change management is not implemented in place: Interface management is not in place
Confirm input information before launching an activity
Establish starting point and end point
represents the boundaries of the process
Request
Supplementary information
eg: Production planning: In addition to customer order planning, equipment tooling, equipment utilization rate, etc. must also be considered.
Transform input information into output
sample
drawing
Technical Information
test data, test data
Usually exists in the form of files, information, etc.
SIPOC (Quality Management Model)
S_Supplier (input source, supplier)
I_Input (input)
P_Process(process)
O_Output (output)
C_Client (customer)
process category
COP customer orientation process
C1 sales
C2 Contract/Order Review
C3 design and development
C4 production process
C5 product delivery
C6 Customer Service
MP management process
M1 Operations and Management
M2 internal audit
All processes are subject to internal audits
M3 Management Review
For all company processes
M4 continues to improve
Leverage data analytics for continuous improvement
SP support process
S1 file record management
S2 Human Resources Management
S3 equipment and tooling management
S4 Monitoring and Measurement Equipment Management
S5 Supplier and Procurement Management
S6 product inspection
S7 nonconforming product management
S8 warehouse management
Process Analysis Method "Turtle Diagram"
what resources to use
By whom? (Responsible person, facilitator’s ability and qualifications)
What will we receive?
Input (customer/regulatory/organizational requirements)
How to implement?
Procedures/methods/instructions/technical standards, etc.
Standardization is inseparable from documents
What are the key guidelines?
Measure/Assess/Performance/Metrics
development process
cost
quality
Delivery date
Design and development input
The size of the process is not defined
Customer requirements for products
development target requirements
Requirements of laws and regulations
Previous experience requirement
Design and development output
Given to process development as input to process development
What will we deliver?
Output (products and services)
decision form
Documentation format
drawing
Specifications
sample data
sample
process
Only through effective management of process elements can the process ensure effective output.
Resource management
material resources
Responsibility management
Which positions are involved?
Input management
Data to be converted
Material to be converted
The input is not made up out of thin air.
Method confirmation
target monitoring
Output confirmation
Confirm the output using certain methods
Design and development must ensure the quality of design
QC
QA
Identifying the Customer Orientation Process_Octopus Diagram
4.4.1.1 Product and process conformity
Ensure compliance of all products and processes
Includes service parts, outsourced products and processes
Comply with all applicable regulatory and customer requirements
The new three guarantees law for automobiles will be implemented on 10/1/2022
Meet changed information and requirements
4.4.1.2 Product safety
Identify customer and regulatory requirements
"Technical Conditions for Motor Vehicle Operation Safety" GB7258-2017
GB38031-2020 "Safety Requirements for Power Batteries for Electric Vehicles"
Notify customers of the above requirements
DFMEA Special Approval
Identify product safety features
Identify process characteristics
eg: When making flame retardant parts, increase the amount of flame retardant added as a process characteristic control
CP and PFMEA Special Approval
Response plan
Upgrade mechanism
The response plan can be reflected in the CP. Do not deal with it privately, but upgrade and report it.
Responsibilities, escalation process and information flow
Product safety related personnel training
Approval before change
Supply chain product security requirements shift
Traceability throughout the supply chain
Traceable to individual parts
Experience & Lessons
Chapter 5: Leadership (3)
5.1 Leadership and commitment
5.1.1.1 Corporate Responsibility
Anti-bribery
Employee Code of Conduct
Code of ethics upgrade
5.1.1.2 Process effectiveness and efficiency
Set goals for the process
effectiveness goals
efficiency goals
PPH
Utilization rate
focus on efficiency
Not every process pursues efficiency!
Establish process performance indicators
Management review, data analysis evaluation & improvement
5.1.1.3 Process owner
5.2 Quality Policy
5.2.1
Adaptable to the purpose of the organization & the environment in which it operates
Support its strategic development direction
5.2.2
Communicate quality policy
5.3 Position functions, responsibilities and authorities of the organization
5.3.1 Supplementary roles, responsibilities and authorities of the organization
management representative
Documented appointment
agent
5.3.2 Responsibilities & authorities for product requirements and corrective actions
quality representative
Chapter 6: Planning (3)
Planning of the entire system
Advance planning for changes
6.1 Measures to deal with risks and opportunities
Risk Definition: Uncertain Impact
risk level
Operational level
system level
Product/Process
How to identify risks
SWOT
Process turtle diagram
DFMEA/PFMEA
control pathway
bussiness plan
System files
Control Plan
risk-based process thinking
Conduct project risk assessment before developing new projects
cost
quality
schedule
6.1.2.1Risk analysis
Before risk analysis, lessons must be learned from the following dimensions:
product recall
product check
Use on-site returns and repairs
Invalid at 0 km
On-site use (end user)
complaint
Scrap & Rework
The organization shall retain documented information as evidence of the results of the risk analysis
6.1.2.2 Preventive measures
Continue to retain ISO9001:2008 terms
6.1.2.3 Emergency plan
Key words
Identify and assess risks
Make a contingency plan
business continuity
Customer Notice
When there are special situations that need to be identified, inform customers according to the rhythm set in advance.
Regular testing
Emergency plans should be tested regularly
Paper review also counts
Practical exercises also count
Adopt multi-party argumentation method
Preserve documented information
Downtime verification
Verification must be done after shutdown under special circumstances.
How many samples are needed for trial production?
Standard recommended emergency management projects (7 2):
Critical equipment failure (8.5.6.1.1)
supply chain disruption
common natural disasters
fire
utility outages
labor shortage
infrastructure damage
Network/information system is disrupted by attack
epidemic
COVID-19
Dimensions
Have a spare tire ready
The number of spare tires depends on the company’s investment
6.2 Quality objectives and implementation planning
6.2.1 The organization should set quality objectives for relevant functions, levels & processes required by the quality management system
Organization
Set company-level goals first and then break them down to departments
Based on user requirements
6.2.2 Plan how to achieve quality goals
6.2.2.1 Quality objectives and planning for their implementation (supplementary)
Goals meet customer requirements/stakeholder requirements
Reviewed annually (at least)
6.3 Change planning
The new plan has not been fully verified
The implementation process of changes must be controlled
Change management process
Identify this change
Who proposes changes
control
Review
5M1E dimensions
verify
confirm
implement
Breakpoint control
The absence of breakpoint management is a major deficiency in the automotive industry (serious non-compliance)
Before mass production
design freeze
After mass production
breakpoint/node
Initial implementation of changes (after customer approval)
GP12
Measures to prevent leakage
Use initial production to expose and solve problems
Managers follow up
Upgrade Countermeasures
Supply to European car companies
Safe landing
Supervision for 3~6 months
Change point management baseline
9.1.1.1 Monitoring of manufacturing processes
SPC control
Traceability management
Chapter 7: Support (5)
7.1 Resources
7.1.1 General provisions
The organization should identify and provide the required resources
Organizations should consider
Capabilities and limitations of existing internal resources
Resources required from external suppliers
7.1.2 Personnel
The organization should have the necessary personnel to effectively implement the quality management system
7.1.3 Infrastructure
The organization shall identify, provide and maintain the required infrastructure to operate the process
7.1.3.1 Planning of factories, facilities and equipment
Risk Analysis
When setting up your factory layout: optimal material handling, synchronized flow, rational use of space
For new products and processes: Assessing manufacturing feasibility should include capacity planning
Maintain process effectiveness and conduct regular risk assessments
Manufacturing feasibility and capacity planning as management review inputs
7.1.4 Process operating environment
social factors
psychological factors
physical factors
7.1.5 Monitoring and measuring resources
7.1.5.1 Measurement system analysis
Prioritization of measurement system analysis studies should focus on critical or special product or process characteristics
Monitoring (periodic calibration)
Other analytical methods and acceptance criteria may be used if approved by the customer.
Alternative method customer acceptance records are retained along with the results of the alternative measurement system analysis
Measuring instruments must also be regularly calibrated and confirmed to confirm whether the variation meets product measurement requirements.
A calibration report is required after instrument measurement and calibration.
The difference between measurement system and instrument calibration
Instrument calibration mainly focuses on the instrument itself
In addition to the instrument itself, the measurement system analysis also needs to consider the errors caused by factors such as the man-machine, material, method, and environment of the measurement system.
Relative value, not absolute value
The ideal GRR is ≤10%, and the worst is no more than 30%.
Measurement system variation
Repeatability
Differences between repeated measurements of standard parts
Reproducibility
Different people measure differences
different environments
different work clothes
GRR/TV≤10%
GRR is done during small batch production
When doing SPC, T/cpk (1.67) is recognized by the German system
Whether the error size/accuracy is acceptable depends on the usage scenario and usage
GRR considers the relative error
The minimum requirement for instrument resolution/accuracy is to collect 1/10 of the tolerance.
When doing SPC control statistics, the accuracy of the instrument requires tolerance/10*1.67
SPC control line: 1.33=4/3, 1.67=5/3, 2=6/3
Measurement system 5 performance 1 rate
accuracy
Repeatability
Reproducibility
stability
consistency
KAPPA
>0.75
Statistical studies should be conducted to analyze the variation present in the results for each inspection, measurement and test equipment system identified in the control plan
American GRR
German CgK
Instrument Capability Index
Find a benchmark value for a product, measure it repeatedly with an instrument, calculate the standard deviation, and calculate the average value
7.1.5.2 Measurement traceability
See ISO9001:2005 standard
7.1.5.2.1 Calibration/Verification Records
7.1.5.3 Laboratory requirements
7.1.5.3.1 Internal laboratory
An organization's internal laboratory facilities should have a defined scope;
The laboratory needs to be traceable to relevant process standards (eg: ASTM, EN, etc.)
If no national or international standards are available, the organization shall define and implement a method for verifying the capabilities of the measurement system;
7.1.5.3.2 External laboratories
The laboratory should be accredited by ISO/IEC17025 or equivalent national standards (such as CNAS-CL01)
7.1.6 Organizational knowledge
Enterprise knowledge sources
Corporate knowledge
social knowledge
school education
Books and periodicals website
Professional Training
Job experience and knowledge
Job specifications
Job experience accumulation
Job results
Job skills training
Enterprise data knowledge
financial data
business data
customer data
7.2 Capabilities
7.2.1 Capabilities (Supplementary)
investigation
plan
training
7.2.2 Competencies - on-the-job training
Evaluation quantification
Continuously track for a period of time and assess from dimensions such as yield, tempo, and skill proficiency.
The training time is different for different positions
Trainer qualifications
Who trains and who assesses
Matrix diagram
7.2.3 Internal auditor capabilities
risk thinking
process approach
Customer special requirements
IATF standards
Core tools and manufacturing processes
Manufacturing processes can be audited using 5M1E dimensions
VDA6.3 review
Hierarchical review
Product review VDA6.5
Customer representative does
review process
7.2.4 Second-party auditor capabilities
Second house auditors suggest that it is best to be an internal auditor first
risk thinking
process approach
Customer special requirements
IATF standards
Core tools and manufacturing processes
review process
Customer requirements for auditor competency
7.3 Awareness
7.3.1 Consciousness (Supplementary)
Zhang Ruimin’s story
parachute story
Make personnel very sensitive to problems and enhance their sensitivity to quality
Case Lessons
Increase the number of customer complaints for this process in the work instructions. If the SOP exceeds a certain number, it needs to be redone.
On-site training needs to make front-line operators familiar with the possible risks of this process and the customer complaints that have occurred
Advertising is forcibly implanted on MES---the invalid picture needs to be clicked to confirm
7.3.2 Employee motivation and empowerment
7.4 Communication
Determine communication related to QMS
internal and external (scope)
What to communicate (content)
communication plan
When to communicate (timing)
Project milestone?
Verification and confirmation link
Customer demand survey node
Who to communicate with (object)
How to communicate (method)
Who will communicate (responsible person)
7.5 Documented information
7.5.1.1 Quality management system documents
purpose of document
standardization
The file content is appropriate
easily accessible
7.5.2 Create and update
See the requirements of ISO9001:2005
Identification and instructions
Title, date, author, index number
Format
Unified format and version
Language, software version, graphics
carrier
Paper, electronic version
review and approval
Maintain suitability and adequacy
Review and countersign
SIPOC model, find the right countersigning department and personnel
The purpose of review and countersigning is mainly to confirm that the content of the document is appropriate and accurate.
Review and countersign objects
Upstream and downstream, process owner
Approval is a means, not an end
7.5.3 Control of documented information
7.5.3.1&7.5.3.2 see ISO9001:2005 requirements
7.5.3.2.1 Record keeping
PPAP records
Workwear related records
Mold
fixture
Jig
Inspection tools
Product R&D and process development records
APQP
Purchase Order & Contract Records
7.5.3.2.2 Engineering specifications
Review, distribution and implementation of engineering standards & specifications and related revisions from customers
The review should be completed within 10 working days after receiving the notification of changes to the engineering standards and specifications.
Design changes, see 8.3.6
Process changes, see 8.5.6.1
Changes affect PPAP and PPAP needs to be resubmitted.
Chapter 8: Run (7)
Product realization (from order to delivery)
8.1 Operation planning and control
8.1.1 Operation planning and control - supplement
Customer product requirements
Material requirements
Acceptance criteria
Manufacturing feasibility
8.2.3.1.1
Project planning
8.3.2
8.1.2 Confidentiality
Customer contract project & product information confidentiality
Prevent information from leaking out
External mail
computer permissions
27001 Information Security Systems
8.2 Product and service requirements
8.2.1 Customer communication (see ISO9001:2005 requirements)
8.2.2 Determination of product and service requirements
Products and services are specified
The products and services provided meet the stated requirements
8.2.3 Review of product and service requirements
Customer requirements include requirements for delivery and post-delivery activities
Customer demand confirmation form
8.2.3.1 See ISO
8.2.3.1.1 Supplementary review of product and service requirements
8.2.3.1.2 Special characteristics specified by the customer
8.2.3.1.3 Organizational manufacturing feasibility
Multiple arguments
Manufacturing, new product technologies and changes require feasibility analysis
Changes must be recognized promptly
Timely follow up on customer needs and information tracking during the development process
Confirm production capacity through trial production, benchmark comparison and other methods
Claims for line shutdowns from OEMs are calculated in minutes.
8.2.4 Changes in product and service requirements
make sure
Relevant written information has been modified
Relevant personnel are aware of the requirements for the change
8.3 Design and development of products and services
8.3.1 General provisions
needs and expectations
Require
product development
process development
8.3.2 Design and development planning
8.3.2.2 Product design skills
Designer skills are determined based on customers, regulations, and own requirements
8.3.2.3 Development of products with embedded software
CMMI
8.3.3
Product design and development input
8.3.3.1 Product design and development input
Product specifications (including features)
Boundary and docking requirements
Identification & Traceability
Design alternatives
Input requirements risk assessment
Product requirements compliance goals
laws and regulations
Embedded software requirements
Development Plan
cost budget
Previous design project experience and data
Competitive product analysis
Supplier feedback
Internal input, on-site problem feedback
8.3.3.2 Manufacturing process design input
Product development output (including features)
Capacity target
process capability goals
cost target
Manufacturing Technology Alternative Considerations
Customer requirements
Previous development experience
New material evaluation
Ergonomics
Manufacturing Design & Assembly Design
8.3.3.3 Special characteristics
Product characteristics or manufacturing process parameters that may affect safety or product regulatory compliance, assembleability, functionality, performance, requirements or subsequent processing of the product.
internal identification
Customer input
laws and regulations
Characteristics are recorded into drawings, FMEA, CP, SOP
8.3.5.1 Design and development output - Supplementary
DFMEA
8.3.5.2 Manufacturing process design output
Specifications and drawings
Product and process special characteristics
Identification of process input variables that influence characteristics
cmk
Poka-yoke Checklist
PFC、Layout
Capacity analysis
PFMEA
maintenance plan
CP；SOP
8.3.4 Design and Development Control
design review
Design verification
Design confirmation
8.3.4.1 Monitoring
Report to managers/clients
8.3.4.2 Design and Development Confirmation
Meet customer requirements
8.3.4.3 Prototype solution
Consistent with mass production
8.3.4.4 Product Approval Process
Reference PPAP Manual
Have the supplier submit the PPAP before submitting the PPAP to the customer
PPAP has 5 levels, the default level is 3 if the customer does not require it
PPAP classification
Client submits PPAP
Internal PPAP
Submit PPAP to client
PPAP is a process, not a deliverable
PPAP start
PPAP document pre-review
PPAP production preparation
PPAP production verification
PPAP deliverable submission
PPAP approved
8.3.6.1 Design and Development Changes - Supplement
Confirm against customer requirements and obtain internal approval before production implementation
Before design freeze
Review record
Change approval
change log
8.4 Control of externally provided processes, products and services
8.4.1 General provisions
Suppliers of raw materials
evaluate
choose
Regular monitoring of performance
Re-evaluate
Outsourcing Supplier (OEM)
Outsource some processes
8.4.1.1 General - Supplement
All services that affect customer requirements are brought under control
8.4.1.2 Supplier selection process
Procedure files should have a documented selection process
Evaluate product compliance
Sample evaluation
Productivity & Process Stability
Product & Process Audit
System audit
Automobile business volume
financial stability
Complexity of purchased products, materials or services
Required technology (product or process)
Available resources
People, infrastructure, etc.
Design and development capabilities
Includes project management
Personnel Matrix
Test equipment
development system
Manufacturing capacity
Factory building
Craftsmanship
equipment
Change management
system
process
manage
implement
emergency capability
emergency plan
Disaster preparedness
Logistics capabilities
customer service capability
team
Staffing
8.1.4.3 Customer designated source of goods (directed purchasing)
8.4.2 Type and degree of control
8.4.2.1 Supplement
8.4.2.2 Legal and regulatory requirements
8.4.2.3 Supplier quality management system development
8.4.2.4 Monitoring of suppliers
8.4.2.5 Supplier development
8.4.3 Information provided to external suppliers
Internal review and approval prior to provision
8.4.3.1 External supplier information - supplement
Legal and regulatory requirements must be passed on
Product and process specific characteristics must be communicated to the supplier
Special features need to be marked on drawings given to suppliers
8.5 Control of production and service provision
Special processes require corresponding confirmation
Manage special processes
Validation of process parameters
Monitoring equipment for calibration
DOE parameter verification
8.5.1.1Control plan
8.5.1.2 Standard operations - operating instructions and visual standards
SOP should contain safety rules
Visualization
Rework and repair
bad warning
Customer complaint logo
Poka-yoke instructions
Equipment may have error-proofing numbers on it
There are instructions for error-proofing devices on the SOP.
Requirements for daily verification by on-site personnel
Inspection records
8.5.1.3 Verification of job preparation
Job preparation verification when executing job preparation
Verify the production process according to a certain frequency of time
There should be documentation on job readiness verification at the production site
8.5.1.4 Verification after shutdown
Replacement after fault repair
Verify cmk after overhaul
Small batch trial production after overhaul
First article frequency and triggering situations are identified based on product
Not planned
do unplanned
8.5.1.5 Total Productive Maintenance (TPM)
Documented Total Production Maintenance System
Documented maintenance objectives
OEE
OEE and 6 big losses
Equipment failure
Installation adjustment
Idle and briefly stop
Speed reduced
Processing waste
Initial defect
Availability = actual running time/(calendar time (planned production time) - planned downtime)
Performance = ideal cycle time/(operating time/total output)
Quality index = number of qualified products/processing volume
OEE=availability*performance*quality index
MTBF (mean time between failures)
MTTR (mean time to repair)
Periodic review of maintenance plans and objectives and documented action plans
Periodic maintenance
Disassembly and maintenance of equipment modules
Some require assistance from external vendors
Includes preventive and predictive maintenance
According to the actual performance of the equipment
through data analysis
SPC collection exception
Critical equipment identification
Affect yield
Consumable parts list
Consumable parts inventory
Maintenance tools, maintenance resource management
Tool and measuring tool protection
fulfill customer's request
8.5.1.6 Management of production tooling and manufacturing, testing, and inspection tooling and equipment
Workwear management system
need
design
make
verify
try out
Warehouse
logo
Receive
maintainance
check
repair
scrapped
8.5.1.7 Production Scheduling (PMC)
Meet customer needs, JIT
Information system support
Contains relevant planning information during production scheduling
customer order
Supplier on-time delivery performance
Capacity
Collinear process
lead time
inventory levels
Preventive maintenance and calibration
8.5.2 Identification and traceability
8.5.2.1 Identification and traceability - Supplement
Product Identification
Status ID
traceability identification
8.5.3 Customer property
8.5.4 Product protection
Protection throughout the entire process from supplier to customer
supplier
raw materials
intermediate products
Package
Final product
deliver
customer
process
1 logo
2Disposal
3Pollution control
4 pack
5 save
6transmission
7Transportation
8 protection
8.5.4.1 Protection - Supplementary
Regularly check storage containers and storage environment
Inventory management system
FIFO (first in first out)
The purpose is to shorten the time of materials in storage
Make sure the validity period does not expire
FEFO
The system will identify the time when the validity period arrives first, and automatically determine that the material with the earliest validity period will be shipped first.
Suppliers also need to perform first-in, first-out management
8.5.5 Post-delivery activities
8.5.5.1 Service information feedback
8.5.5.2 Service agreement with customer
8.5.6 Change Control
8.5.6.1 Control of changes - Supplementary
8.5.6.1.1 Temporary changes to process controls
Develop a process control list (including backup or alternative methods)
List of alternatives
Risk analysis of alternative methods and approval prior to implementation
Alternative method products, customer approved where necessary
Alternative methods should be reflected in the control plan and reviewed
Alternative methods also require SOP
daily review
Such as hierarchical review
daily leadership meeting
Product traceability during substitution
8.6 Release of products and services
8.6.1 Supplement
8.6.2 Full-scale inspection and functional test
As stipulated in the CP, each product is subject to full-scale inspection and functional verification based on the customer's engineering materials and performance standards.
8.6.3 Appearance items
8.6.4 Verification and receipt of external supplier products and services
Require suppliers to provide regular cpk reports
Regular inspection of suppliers based on performance
Find a third party to audit the supplier
Send supplier products to third-party laboratories for verification
Other methods agreed to by the customer
8.6.5 Compliance with laws and regulations
8.6.6 Acceptance criteria
For sampling of count data, the acceptance level is 0 defects
C=0 sampling plan MIL-STD-1916
8.7 Control of unqualified output
Prevent unintended use and leakage
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Record
isolation
Review
Dispose
8.7.1.1 Customer’s concession authorization
8.7.1.2 Control of nonconforming products - customer specified process
Follow customer procedures
8.7.1.3 Control of suspicious items
Identify suspicious items in advance for each process and define suspicious items
The floor-to-ceiling products are questionable.
Manufacturing personnel should receive training on the containment of suspect and non-conforming products
Products that are unlabeled or in questionable condition are classified as nonconforming.
8.7.1.4 Rework product control
FMEA analysis before rework, if required by the customer, customer approval before rework
Documentation of rework confirmation
Traceability of rework documents
Rework: Take measures to make the non-conforming products meet the specified requirements
Rework: Take measures to make the defective products meet the requirements of the intended use.
Rework/rework does not necessarily require FMEA
8.7.1.5 Control of returned products:
FMEA analysis before repair
customer approval
Documented
Traceability
Documentation of customer concession acceptance
8.7.1.6 Customer notification
1. When non-conforming products are shipped, the customer should be notified immediately
2. The initial notification should be accompanied by detailed documentation of the incident.
8.7.1.7 Disposal of nonconforming products
There are procedures to stipulate physical dismantling and damage before scrapping.
Sheet 9: Performance Evaluation (3)
9.1 Monitoring, measurement, analysis and evaluation
customer satisfaction
bussiness plan
Process technical indicators
Process specific monitoring & auditing
9.1.1 General provisions
See the requirements of ISO9001:2005
9.1.1.1 Manufacturing process monitoring and measurement
SPC
Statistical predictions by collecting data when the process is stable
Utilizing control charts during mass production
The upper specification line
lower control line
process capability diagramming
Anticipate the ability to continue to provide stable quality products in the future
Through data analysis (cpk-stable process capability index)
Initial process capability study cpk>1.67
Cp=T/6σ
Cp≈Cpk without variation
process control concept
Control Charts
Principle: Standard Normal Distribution
For quantitative data, it roughly conforms to the normal distribution;
It can be seen from the properties of the normal distribution that the probability of quality data appearing outside the mean ±3 standard deviations is only 0.27%, which is a very small probability.
Standard deviation calculation: After calculating the average value of the data, take the root sign (standard deviation σ = square root of the variance)
Provide statistical signals when special causes of variation occur, so that appropriate local measures can be taken for the special causes.
The control lines are verified in advance by engineers during the development process.
The mathematical evolution of control charts
Computing power cpk
When process capabilities are insufficient, take measures to reduce common causes of variation by taking measures on the system; improve process capabilities so that products meet specifications
Judgment criteria for control charts (it is recommended to use the first 3 items) National Standard
1 point is far from the center line, more than 3 standard deviations (3σ)
9 consecutive points on the same side of the center line, probability 49.87% (9 times) = 0.191% <0.27% (small probability event)
Abnormal
new operators
Wrong method
6 consecutive points of increment or decrement
Tools gradually wear out
Maintenance levels gradually decrease
Operator skills gradually improve
Alternating rise and fall of 14 consecutive points
2 out of 3 consecutive points fall in the outer area of the center line
4 of 5 consecutive points fall outside area C on the same side of the center line
14 consecutive points fall within one standard deviation on both sides of the center line
Calculation Performance Index PPK
Use Cpk when the process is stable
No abnormal points occurred
There is no small probability event
within bounds
The process capability is unstable or you don’t know how to use Ppk
In the trial production stage, the amount of data is insufficient
Cpk and Ppk are both >1.67 in the research stage and >1.33 in the mass production stage, except for special customer requirements.
9.1.1.2 Determination of statistical tools
Tools include the use of statistical tools and are planned during the APQP phase
Design Risk Analysis (DFMEA)
In the design stage, statistical tools need to be used to verify the rationality of the design.
Process Risk Analysis (PFMEA)
Control Plan
9.1.1.3 Application of statistical concepts
Training of relevant personnel
Deterioration
stability
Are there any fluctuations due to special reasons?
Process Capability
Process fluctuations relative to customer-given product tolerances
over adjustment
Overkill
9.1.2 Customer satisfaction
See ISO9001:2005 requirements
9.1.2.1 Customer satisfaction (monitoring) - supplement
Monitor customer satisfaction with the organization using continuous evaluation of internal & external performance indicators
Performance indicators should be based on objective evidence (including but not limited to)
Quality performance of delivered parts
Disruption to customers
Utilize on-site returns, recalls and warranties (where applicable)
Delivery schedule performance (including excess freight)
Customer notifications related to quality or delivery issues, including special status
The organization shall monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and process efficiency.
Customer performance data review
customer scorecard
9.1.3 Analysis and evaluation
See ISO19001:2005 requirements
Through various monitoring and measurement tools and data analysis and extraction
9.2 Internal audit
System audit
object
Quality management system
Purpose
Check QMS compliance and whether it is effectively implemented and maintained
frequency
1 time/1 year
Research Features
QMS requirements (COP, MP, SP processes)
process audit
object
Product birth process/mass production
Purpose
Assessment of process quality capabilities
frequency
Recommended once/year (audit all processes every 3 calendar years)
The process can be audited multiple times
Research Features
Process quality capabilities
product check
object
Products to be shipped
Purpose
Assess product quality characteristics, check whether the product meets technical specifications & customer requirements, and discover defects
frequency
It is recommended to cover typical products within 1 year
Research Features
Product quality characteristics
special characteristics
Function
performance
Package
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9.3 Management review
9.3.1.1 Management review - supplement
frequency
Do this at least once a year
Management Review Implementation Plan
Records are management review data
quality cost
prevention cost
Statistics are not required
quality planning
Quality training
process optimization
quality analysis
appraisal cost
Inspection planning
laboratory test
process control
Quality audit
Destructive testing
Maintenance and calibration of measuring & monitoring equipment, instruments, etc.
internal failure costs
Scrap
Rework and repair
Downgrade
Process quality issues
Re-examination
Retest
Downtime losses
Internal transportation and storage damage
Extra operations
external failure costs
After the product is shipped
Caused by product failure
Customer Complaint
return the goods
After-sales service fee
Free replacement
guarantee
compensation
Damage caused by transportation
Claims arising from delivery of non-conforming products
Cost of additional operations
Chapter 10: Improvement (3)
Correction & continuous improvement
10.1 General provisions
Breaking from within is life
Breaking from the outside is the real thing
10.2 Nonconformities and corrective actions
10.2.1&10.2.2
See ISO9001:2005 requirements
10.2.3 Problem solving
There should be a documented problem resolution process
For problems of all types and sizes
New products development
Current process issues
failure analysis
Audit findings
Containment of defective products
Temporary measures
Implementation of systemic corrective actions
Validity verification
Document review (updated if necessary)
10.2.4 Poka-yoke
Eliminate the cause of the error
Even if you make a mistake, there will be no consequences
Prevent defective products from flowing out
Documentation process
Proper error-proofing methods
PFMEA
Error-proofing can be reflected in SOPs
The test frequency of error-proofing devices should be reflected in the CP
Poka-yoke failure or simulated failure verification
How often to verify definitions
Challenge parts need to be marked, controlled, verified & calibrated
Internal calibration available with customer approval
There should be a response plan for failure of poka-yoke devices
shutdown
isolation
Enable backup plan
Assess the impact on your product
Internal changes can be documented internally and approved by the customer
10.2.5 Warranty management system
There should be NTF failure analysis method documents
Refer to VDA FIELD FAILURE ANALYSIS field failure analysis
Descend to the product level
There are warranty management methods
Warranty service standards and documents
10.2.6 Customer complaints and on-site failure test analysis
Customer complaints or terminal failure analysis
corrective prevention
10.3 Continuous improvement
10.3.1 Continuous improvement - supplement
system level
method
Target
Measurement
monitor
effectiveness
document
process
Review
renew
process level
Reduce variation
Quality tool usage
reduce waste
product level
FMEA
Defect prevention
regular review
IATF16949:2016 Internal System Audit
3.1 Related concepts of audit
review
A systematic, independent and documented process for obtaining audit evidence and objectively evaluating it to determine that audit criteria are met
Audit criteria
a set of policies, procedures or requirements
IATF standards
Applicable laws and regulations
Industry norms
Management system documents
Customer CSR
Audit evidence
related to audit criteria
records that can be verified
statement of facts
other information
Audit findings
Evaluate and record audit findings against audit criteria
Compliant items
nonconformity
Opportunities for improvement
Audit conclusion
3.2 Types of audits
1 party
2nd party
3rd party
independent agency
3.3 Timing of review
Routine internal audit
Review the plan first
Upcoming 2-party, 3-party audits
Additional internal audit under special circumstances
A major problem occurs
Customer Complaint
There are major changes in the organization
corporate relocation
high-level decision-making
3.4 Internal audit steps
3.4.1 Internal auditor
auditor
Trained and qualified --- certified
Have relevant experience
Be independent from the party under review
You can't judge yourself
Review days
There is a requirement that each auditor conduct at least one audit per year
Continuous training
Auditors receive ongoing training
Have management authorization
Grant internal audit authority
Audit team leader
Have organizational and coordination skills
Not necessarily involved in the review
external auditor
Qualified for registration
experience
expertise
3.4.2 Internal audit plan
Contents of the audit plan
Purpose
scope
Audit criteria
member
review time
schedule
independence
logical
Do not schedule cross-reviews
Try to put the input and output units in the same unit.
empirical
Arrange personnel who understand the relevant processes to review the corresponding content
temporality
Day and night shift
The handover time for day and night shifts must also be reviewed
3.4.3 Internal audit checklist
Checklist function
Keep goals clear and specific
Keep content thoughtful and complete
Maintain review rhythm and continuity
Reduce auditors’ personal bias and randomness
The automobile industry audit form has a fixed format, so you don’t need to make it separately.
The main job of the internal auditor is to write records and check whether actual implementation complies with standards.
turtle diagram
3.4.4 Implementation of internal audit checklist
in accordance with
standard
System files
Problems in the past
Management focus
3.4.5 Audit methods
CAPD review logic
C: Who is the customer?
A: Corrective measures? Risk classification? Improvements?
P: Planning for risk measures? How is the documentation process defined?
D: Execute according to file?
Sampling is moderately balanced
The sample must be representative
Auditors personally select samples
random sampling
Guarantee a certain sampling number
stratified sampling
association and retrospection
entry point
Lateral tracing
Longitudinal tracing
Will this process issue be addressed in the next process?
Ways to obtain evidence
Seven-character formula for audit operations
read
Read the regulations of the system and other relevant documents (including laws and regulations)
ask
Ask questions about work methods and operating requirements
talk
Talk to specific people
listen
Pay attention to the key points of the answer
look
Watch it in action
product status
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check
Check data
chart
Report
physical object
Confirm whether what you write is consistent with what you do
remember
Document activities that have been proven
Questioning skills
What questions to ask?
active question
Extended questions
Opinion-seeking questions
hypothetical questions
Recording skills
time
Place
Audit object
observed facts
Voucher materials
Involving documents
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Take photos on site
3.4.6 First and last review meeting
3.4.7 Review non-conforming items
Severely inconsistent with
Systematic/regional deficiencies in the system
No relevant government approval
Regulations not met
Causing defective products to be shipped to customers
Target indicators not achieved and not reviewed
Generally non-compliant and not corrected on time
Generally does not meet
Meet QMS documents
By chance
minor phenomenon
minor issues
Observations
human negligence
Suggestions on what could be done better
3.4.8 Audit considerations
3.4.9 Audit report
Identification, control, upgrade, training, supply chain delivery, record archiving