Documenti di Didattica
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2017-01-27
IATF 16949 clause review and reference to QAD QMS module
4.3 Determining the scope of the quality management system Documents Document scope of QMS
Audit Can define processes and interactions to develop scope of QMS and output
as a document in Document Management
4.3.1 Determining the scope of the QMS supplemental Documents Document scope of QMS
Audit Can define processes and interactions to develop scope of QMS and output
as a document in Document Management
4.3.2 Customer specific requirements Documents Can define processes and interactions to develop scope of QMS and output
as a document in Document Management
Audit Document scope of QMS
4.4 Quality management system and its processes Audit Audit process covers items required in 4.4.1
APQP Project management will help address availabilty of resources if incorporated
as a task in the project
4.4.1.1 Conformance of products and processes Audit Audit process covers items required in 4.4.1.1
4.4.1.2 Product safety Documents Document the requirements for 4.4.1.1 as a procedure
APQP See OFI
CAPA & NCR See OFI
All See OFI
5.1.1 Leadership and commitment general All As a holistic approach, the eQMS system meets the requirements for this
clause. The system can be configured to utilize senior level management
dashboards. QAD/CEBOS recommend implementation of the following
modules to meet the minimum requirements of this caluse:
Documents
Training
Auditing
Risk Management
CAPA/NCMR
5.1.1.1 Corporate responsibility Documents Document corporate responsibility policies and add as skills
Training Apply skills to roles for training and tracking purposes
5.1.1.2 Process effectiveness and efficiency Audit This item is an OFI in the current eQMS
5.1.1.3 Process owners Audit
Training Skill for process understanding can be defined added to the role for the
employee
5.1.2 Customer focus Documents Quality Policy can be defined as a document.
See response for section 4.3.2
Audit
APQP FMEA utilization for Product risk
5.2.1 Establishing the quality policy Documents Add as a document with a review frequency and set up as a skill
5.2.2 Communicating the quality policy Training Apply the Quality Policy as a skill in training and apply to all roles
5.3 Organizational roles, responsibilities and authorities Training Create a training role with these requirements included and apply to relevent
job titles or individuals
5.3.1 Organizational roles, responsibilities and authorities- Training Create a training role with these requirements included and apply to relevent
supplemental job titles or individuals
5.3.2 Responsibility and authority for product requirements and Training Add a skill or skills to define responsibility and authority to be defined by top
corrective actions management within a role
CAPA & NCR Logging an NCR creates notification per 5.3.2 b
Inspection SPC Utilization of inspection allows failed product to be moved to nonshipable
inventory locations that are/can be integrated to ERP (dependent on
customer system)
6.1 Actions to address risks and opportunities Risk Management Risk management plans and items can be created for risks and opportunities
(by risk type)
Documents Contigency plans can be documented, approved and reviewed and added as
skills for training
Training Contingency plan documents/skills can be added to employee training roles
and implemented as part of the training process
APQP DFMEA and/or PFMEA can be utilized to define potential risks at a product or
process level
6.1.2.1 Risk analysis Risk Management
6.1.2.2 Preventive action CAPA & NCR
6.1.2.3 Contingency plans Documents Use documents to define contigency plans and link to skills for training
requirements and use to drive approval and review
6.2 Quality objectives and planning to achieve them Quality Objectives New module to be added to the MT
(New Module)
6.2.2.1 Quality objectives and planning to achieve them- supplemental Quality Objectives New module to be added to the MT
(New Module)
6.3 Planning of changes Documents
7.1.1 Resources-General Documents Documented Business plan with review frequency
7.1.2 People Documents Documented Business plan with review frequency
7.1.3 Infrastructure Documents Plant layout
QAD EAM To store information on buidings, equipment, information and communication
technology
7.1.3.1 Plant, facility and equipment planning Documents Plant layout and records of meetings
APQP Task Management with feasibility checklist for capacity analysis and impact
of change on currenct processes
Risk Management Risk identification, mitigation and re-evaluation
7.1.4 Environment for the operation of processes Documents HR Policies, EHS Policies
Quality Objectives Use of Objectives to monitor employee satisfaction
(New Module)
Audit Audits and LPA's for monitoring environment
7.1.4.1 Environment for operation of processes- Supplemental Audit LPA / 5S audit system
7.1.5.1 Monitoring and measuring resource-General Gauge Gage Calibration and MSA
Management
Equipment Preventive maintenance
Management
QAD EAM Ensure valid and reliable resulst when montioring/measuring is used to
verify the conformity of products
Ensure resources are resources maintained for continuing fitness for their
purpose
Retain documented information as evidence for fitness for purpose of the
monitoring and measurement resources.
7.1.5.1.1 Measurement system analysis Gauge MSA
Management
QAD EAM To record customer acceptance of alternative methods along with results
from alternative measurement systems analysis
7.1.5.2 Measurement traceability Gauge MT meets this requirement
Management
QAD EAM Provide confidence in the validity of measurement of results
Calibrated and/or verified at specified intervals against measurement
standards
Determine if the validity of previous measurements results has been
adversely affected when measuring equipment is found to be unfit
7.1.5.2.1 Calibration/verification records Gauge Records are maintained of calibrations / Verfications
Management
Documents Document system house procedured/processes
APQP A Charateristic that Identifies software required for product and/or process
control can be defined
Inspection SPC The Characteristic for software can be used in data collection as a
verification step
QAD EAM Process for managing calibration/verification records and activities
Revisions following ECN changes
Out-of-specification readings as received for calibration/verification
Assessment of risk caused by out-of-specification
Validity of previous measurement results when out-of-calibration or defective
Documented information on the validity of the process
Notification to the customer
Statement of conformity to spec after calibration or verification
Verification of the software version
Records of calibration and maintenance activities
7.1.5.3.1 Laboratory requirements-Internal laboratory Documents Documented scope of Lab and procedures for testing aligned with applicable
standards (including customer requirements). Test procedures have skills
aligned
Training Document related skills from test procedures applied to roles to identify
training needs
APQP Define test requirements for product/process in APQP and integrate with
Inspection
Inspection SPC Collect test results against APQP characteristics with review and approval on
collections
7.1.5.3.2 Laboratory requirements-External laboratory Supplier supplier certification can be monitored, Supplier audits can include scope of
Management lab
Documents Records of customer approved assessment methods can be maintained
7.1.6 Organizational knowledge Training Skills can be developed from all sources and added to training roles for use
7.2 Competence Training Use of Skills and training events to capture competence
7.2.1 Competence -Supplemental Audit
Training
7.2.2 Competence-On the job training Documents
Training
7.2.3 Internal auditor competency Audit Audit type defines required skills to be an auditor or lead auditor
Training
7.2.4 Second party auditor competency Supplier
Management
Training
7.3 Awareness Training Utilize training questions for items identified in standard
7.3.1 Awareness-Supplemental Training Utilize training questions for items identified in standard
7.3.2 Employee motivation and empowerment Audit Create a process in the process module to meet this requirement
7.4 Communication Documents Work instruction linked to a skill
Training
7.5.1 Documented information-General Documents
7.5.1.1 Quality management system documentation Documents Use the Manual process to add a Quality manual and add all relevent
documents and processes
7.5.2 Documentation-Creating and updating Documents
7.5.3 Control of documented information Documents Documents and records
7.5.3.2.1 Record retention Documents Record System
7.5..3.2.2 Engineering specifications Audit
Training Skill sets for auditing software development can developed and applied to
the audit type to ensure that auditors understand and are capable of auditing
to this clause
8.3.3 Design and development inputs APQP Use of project tasks to meet this requirement and the use of manufacturing
docuemnts meet these requirements
8.3.3.1 Product design inputs APQP Use of project tasks to meet this requiurement and the use of manufacturing
docuemnts meet these requirements
Audit Processes allow for integration to risk management in the process design
Risk Management
8.3.3.2 Manufacturing process design input APQP Use of project tasks to meet this requiurement and the use of manufacturing
docuemnts meet these requirements
Audit Processes allow for integration to risk management in the process design
Risk Management
QAD AS For error-proofing
8.3.3.3 Special characteristics APQP Manufacturing documents allow the linkage of SC designations to
characteristics and these flow through the process from characteristic to
FMEA to CP.
Inspection SPC SC can be included in the inspection events and SPC can be conducted and
reported on from this module
8.3.4 Design and development controls APQP Project plan for gate review and approval
DVP&R can be utlized to conduct validation steps
8.3.4.1 Monitoring APQP Project management allows for the review of performance of the project
Paperclips can be used to add evidence of monitoring activities
8.3.4.2 Design and development validation APQP Project plan task for validation activities
8.3.4.3 Prototype programme APQP Prototype control plans can be created and data can be collected against this
control plan
Inspection SPC Data can be collected against the approved control plan
8.3.4.4 Product approval process APQP PPAP - management of requirements and submissions.
Part submission requirement sets can be defined (if different per customer
Documents Records process can be used to document approvals of supplier PPAP's and
customer approvals
8.4.1 Control of externally provided processes, products and services Supplier Supplier management (Audits and monitoring)
Management
Documents Supplier manual, Drawings, record of contracts
APQP Inclusion in projects for change and new product resources
8.4.1.1 General-Supplemental Supplier Supplier management (Audits and monitoring)
Management
Documents Supplier manual, Drawings, record of contracts
APQP Inclusion in projects for change and new product resources
8.4.1.2 Supplier selection process Supplier Audit records of initial audit
Management Risk criteria can be applied to the supplier dependent on level of risk to the
organization
Documents Evaluation critieria and process can be included in the supplier quality
manual document and records of contracts
The use of MMOG/LE Basic can be leveraged for delivery evaluation
8.4.1.3 Customer directed sources See criteria for 8.4.1 and 8.4.1.1 and apply to customer directed sources
(Directed - Buy Supliers)
8.4.2 Type and extent of control Audit Processes can be defined for exerternaly provided processes
Supplier Audits can be defined against the externally provided processes.
Management Suppliers can be monitored for performs against specified requirements
APQP Requirements for Incoming inspection can be defined
Inspection SPC Incoming inspection can be performed and recorded in the system
8.4.2.1 Type and extent of control-Supplemental Audit Process can be defined to meet this requirement
Documents Supplier Quality manual can be developed in the documents module
Supplier Audit of supplier and corrective actions. Note that a risk category can be
Management applied to suppliers. Supplier performance is continually monitored in the
supplier management module
APQP Creation of controls for incoming inspection and output to inspection/SPC
Inspection SPC data collection against incoming receiving plans
8.4.2.2 Statutory and regulatory requirements Documents Supplier related documents, drawings, specs etc. can be established to
define controls and cascade these to the supplier.
Records can be created to supply objective evidence of conformance to this
clause
APQP Requirements for Incoming inspection can be defined
8.4.2.3 Supplier quality management system development Supplier Supplier audits can be conducted and certification(s) stored by supplier.
Management Alerts exist for supplier certification expirations
8.4.2.3.1 Automotive product related software or automotive product Supplier Audits can be defined for software development process. Supplier risk
with embedded software Management category can be applied to evaluate potential impact to customers.
Audit define a process to assess the supplier development process
8.4.2.4 Supplier monitoring Documents Records of contracts for Software suppliers with evidence of requirement to
maintain documented information of a software development capability self
assessment
8.4.2.4.1 Second party audits Supplier Records of second party audits can be maintained
Management
Documents Supplier quality manual can be developed in the documents module.
8.4.2.5 Supplier development Supplier Second party audit, SCAR and Supplier Certification records (including dates
Management for renewal)
Risk Management Supplier Risk Assessment
8.4.3 Information for external providers Documents Supplier Quality manual, drawigns, and records of contracts supplied. The
document approval will allow review for adequacy prior to communciation to
suppliers
8.4.3.1 Information for external providers - Supplemental Documents Include requirements for regulatory requirements in documents pertinent to
suppliers
8.5.1 Control of production and service provision APQP Manufacturing Documents and use of control plan and FMEA, PPAP
submissions and periodic resubmissions
Project management
Gauge For availability of monitoring and Measuring resources
Management
Training Employee training and certification
rev. 2017-01-27
IATF 16949 clause review and reference to QAD QMS module
8.5.1.1 Control plan APQP Control plans are developed as part of the Manufacturing Document
CAPA & NCR Links established to Manufacturing documents via the fialure mode - This
links to the controls applied
8.5.1.2 Standardised work APQP Operator instructions can added to manufacturing documents
Documents Operator instructions can added be created with a linkage to a skil
Training Training and employee skill level tracking combined with change
QAD EE management at document
Create inventory control
locations in QAD level
where on-hand inventory is not available
and non nettable.
Use Inventory Status Codes to restrict transactional activity for specific
locations, material lots, and specific types of items (e.g., obsolete,
engineering).
Internally define the set of restricted transactions against specific status
codes.
Inventory should be bar code scanned to provide real-time visibility and
reduce errors associated with manual data entry.
8.5.1.6 Maintenance of production tooling and manufacturing, test, Documents Can create documented procedure for tool control
inspection tooling and equipment Can create Drawings for tooling and control changes via change
management
Equipment Can Identify tools in the equipment management process and track useage
Management useage for perishable items
QAD EAM Establish a system for production tooling management
Maintenance and repair facilities
Storage and recovery
Set-up
Tool-change programs for perishable tools
Tool design modification documentation, including ECN level of the product
Tool modification and revision documentation
Tool identification (e.g., serial/asset number, status)
Implement a system to monitor these activities if they are outsourced
8.5.1.7 Production scheduling QAD EE To perform production scheding based on customer orders/demand, the
inventory tracking and store inspection status
QAD EAM To handle plant maintenance and calibration
QAD SP Displays supplier on time delivery performance
8.5.2 Identification and traceability Documents Procedure(s) for indentification and traceabiltlity can be defined
Inspection SPC Inspection can identify if a product is compliant or not, Utilization of
inspection allows failed product to be moved to nonshipable inventory
locations that are/can be integrated to ERP (dependent on customer system),
However Note from IATF indicates that non shippable loactions are not
enought to ID inspection and test status
QAD QAD's quality and attributes and can provide integration to the station
8.5.2.1 Identification and traceability-Supplemental Documents Traceability Plans can be logged to the document control system and added
as a skill for training
Training Documented skills can be added to roles and employee training can be
tracked
CAPA & NCR CAPA and NCR's can be created to track inventory affected by the problem
and supply records of conformity to this clause for segregation of NC product
8.6.1 Release of products and services-Supplemental Inspection SPC All testing and inspection requirements per the control plan can be recorded.
Electronic approval of release using password controlled approval
Audit Product audits can be run to ensure that requirements are being met per the
control plan
8.6.2 Layout inspection and functional testing Inspection SPC All testing and inspection requirements per the control plan can be recorded.
Electronic approval of release using password controlled approval
8.6.3 Appearance items Gauge Masters can be recorded and controled using the Gauge system
Management
Documents Work instruction linked to a skill can be used to document how to perform the
appearance inspection
Training Training and employee skill level tracking combined with change
management at document control level
Equipment Facility and equipment maintenance for the upkeep of evaluation equipment
Management
8.6.4 Verification and acceptance of conformity of externally provided Inspection SPC Suppliers can submit data directly to the inspection process or the
products and services organization can perform incoming inspection.
Supplier Second party audit, SCAR and Supplier Certification records (including dates
Management for renewal)
8.6.5 Statutory and regulatory conformity Inspection SPC Addition of this requirement to the control plan and inspection with approval
8.6.6 Acceptance criteria Inspection SPC Acceptance criteria is defined in APQP and is linked to inspection via the
control plan
8.7 Control of nonconforming outputs(Covers 8.7.1 and 8.7.2 CAPA & NCR Nonconformance control allows for review and dispostion of nonconformities,
escalation to CAPA and deviation control
QAD Base QAD EE for inventory locations to restrict transactional activity
8.7.1.1 Customer authorization for concessions CAPA & NCR Deviations can be utlized to control the extent, type and duration of a
temporary change. Customer approval of the change can be added to the
deviation
8.7.1.2 Control of nonconforming product- customer specified process CAPA & NCR Customer Specific items would need to b addressed on a as needed basis
during implementation
8.7.1.6 Customer notification CAPA & NCR The CAPA/NCR Module can be utilized to provide evidence of customer
Notification if nonconforming product has been shipped
8.7.1.7 Nonconforming product disposition Audit Nonconforming Product disposition Process can be added to the Audit
process
CAPA & NCR Nonconforming product can be dispositioned.
9.1.1 Performance evaluation General APQP Defines items to be monitored and measured from a Process and Product
Perspective
All Metrics and KPI's can be developed for all (Elements) processes and output
to dashboards. Reports can also be created for individual customers per their
requirements
Audit Audits can be utilized to evaluate the performance and effectiveness of the
QMS
9.1.1.1 Monitoring and measuring of manufacturing processes APQP Process flow, FMEA and control can be set up, PPAP's can be created.
Inspection SPC Inspection/SPC can be utilized to collect and calculate cPk and pPk
CAPA & NCR CAPA can be utilized to develop and implement corrective actions for
unstable/noncapable processes
QAD EAM
Documents Change Management process
Gauge Records of calibration are stored
Management
Equipment Records of Equipment repairs and tooling Changes can be documented.
Management
9.1.1.2 Identification of statistical tools APQP Project tasks can be set up to define appropriate statistical tools to be used,
these can then be input into the FMEA, and control plans in the system.
Training Skills sets for establishing appropriate statistical tools can be esablished and
applied to roles, Training effectiveness can then be monitored
9.1.1.3 Application of statistical concepts Training Skills sets for statistical concepts can be esablished and applied to roles,
Training effectiveness can then be monitored
9.1.2 Customer satisfaction Quality Objectives Customer Satisaction can be added to the Balanced score cards
(New Module)
Documents Records of other sources can be stored
9.1.2.1 Customer satisfaction-Supplemental Quality Objectives Customer Satisaction can be added to the Balanced score cards with review
(New Module) frequency
Training Employee training on customer scorecards can be added as a skill or skill set
APQP Defines items to be monitored and measured from a Process and Product
Perspective
Inspection SPC Data for product and process can be collected and analysed
CAPA & NCR CAPA can be utilized to address correction or improvement actions driven by
the customer
Documents Records of other sources can be stored as record that can be managed per
record control requirements
9.1.3 Analysis and evaluation Quality Objectives Processes can be monitored by metrics, KPI's, reports and action manager
(New Module) alerts
Inspection SPC Processes can be monitored by metrics, KPI's, reports and action manager
alerts
Audit Processes can be monitored by metrics, KPI's, reports and action manager
alerts
APQP Processes can be monitored by metrics, KPI's, reports and action manager
alerts
Supplier Processes can be monitored by metrics, KPI's, reports and action manager
Management alerts
CAPA & NCR Processes can be monitored by metrics, KPI's, reports and action manager
alerts
9.1.3.1 Prioritization Quality Objectives Objective and trends are recorded. These should impacted by the
(New Module) performance of the supporting processes. Actions can be generated and
prioritized
9.2 Internal audit (Covers 9.2.1 and 9.2.2) Audit Audit Module covers all requirements set out in the standard
9.2.2.1 Internal audit programme Audit Audits can be esablished for System, Process and Product audit types. The
Organization would have to esablish the priority or audits based on the IATF
criteria
9.2.2.4 Product audit Audit Product Audits can be established, conducted and monitored.These can be
conducted on all shifts.
Layered Process audits can also be established to address shift handover
Note: Customer Specifc requirements must be added to the management
standard process
10.2.3 Problem solving Audit Process for problem solving can be documented as a process
CAPA & NCR CAPA/NCR Module allows the use of mutliple problem solving techniques
10.2.4 Error proofing Audit Process for Error Proofing can be documented as a process
APQP PFMEA is utilized in APQP to document the use of error proofing
Control Plan is utilized to document the controls for error proofing devices
Inspection SPC Inspection plans in conjunction with APQP/Control plans can be used to
record the results of tests on error proofing devices
Documents In the event that APQP and inspection is not used by the customer, the
records process can be used to store results of tests on error proofing
devices
Gauge Gauge management can be used to manage error proofing devices and
Management store results of calibrations/verifications on these devices
QAD AS For error-proofing
10.2.5 Warranty management systems Audit Process for warranty management can be documented as a process
10.2.6 Customer complaints and field failure test analysis Audit Process for Nonconformance management including customer complaints
and field failures can be documented as a process
CAPA & NCR The NCR portion of CAPA / NCR allows customers to perform analysis of the
issue prior to deciding if escallation to CAPA is required
10.3 Continual improvement CAPA & NCR CAPA an NCR will address the requirements for correcting, preventing or
reducing undesired effects
10.3.1 Continual improvement-Supplemental Audit Process for Continual Improvement can be documented as a process
CAPA & NCR CAPA an NCR will address the requirements for correcting, preventing or
reducing undesired effects
APQP PFMEA is utilized in APQP for risk analysis
Inspection SPC Inspection data can be utilized to identify if the product/process requirements
are Predictable, Statistically capable and stable