Iatf 16949:2016 checklist
Iatf 16949:2016
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Questo modulo contiene 59 sezioni:
4.1 Understanding the organization and its context
- Verify how the organization has determined external and internal issues relevant to its purpose and strategic direction.
- Verify how these issues affect the ability to achieve the intended result of the QMS.
- Verify how the organization monitors and reviews information about these internal and external issues.
4.2 Understanding the needs and expectations of interested parties
- Verify how organization determined relevant interested parties to QMS.
- Verify how the organization has determined the relevant needs and expectations of interested parties.
- Verify how the organization has determined the impact or potential impact of the interested parties.
- Verify how the organization monitors and reviews information about interested parties and their relevant requirements.
4.3 Determining the scope of the quality management system
- Verify the QMS scope considers the following:
4.3.1 Determining the scope of the quality management system - supplemental
- Verify support functions included in scope
- If exemption taken, verify that it is for ISO 9001, Section 8.3. Also verify that permitted exclusion does not include manufacturing process design.
4.3.2 Customer-specific requirements
- Verify customer-specific requirements evaluated and included in scope
4.4 Quality management system and its processes
- Show me how the processes have been determined and how they interact.
- Verify how the processes for the QMS were determine. Verify the inputs and outputs to the processes.
- Verify the sequence and interaction of of the processes.
- Verify the criteria, methods, measurement and related performance indicators needed to operate and control the processes.
- Verify how resources are determined and allocated.
- Verify how responsibilities and authorities are determined.
- Verify how risks and opportunities are considered and what actions are taken to address them.
- Verify what methods are used to monitor, measure and evaluate processes. Verify changes, if needed, are implemented to achieve intended results.
- Verify how opportunities for improvement for the QMS and its processes are determined.
- Reviewed documented information created to support the operation of its processes.
4.4.1.1 Conformance of products and processes
- Verify conformance to all applicable customer, statutory and regulatory requirements
4.4.1.2 Product Safety
- Verify documented process
- Where applicable, shall include:
5.1 Leadership and commitment
- Top management is identified
- Verify top management demonstrates leadership and commitment by
5.2 Policy
- Verify the quality policy ...
5.3 Organizational roles, responsibilities and authorities
- Verify responsibilities and authorities for relevant roles are assigned and communicated within the organization
- Verify top management assigns responsibility and authority for..
6.1 Actions to address risks and opportunities
- Verify how the internal and external issues and interested parties are considered when planning for the QMS?
- Verify how risks and opportunities are determined and addressed so the QMS can achieve its intended results, prevent and reduce undesired effects and achieve continual improvement
- Verify how actions are planned to address risks and opportunities.
- Verify how actions are integrated and implemented into the QMS processes.
- Verify how the organization evaluates the effectiveness of the actions.
- Verify how actions are taken to address risks and opportunities determined as being appropriate to the potential impact on the conformity of products and services.
- Verify risk analysis includes, at a minimum, lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap and rework.
- Verify retained documented information
- Verify preventive action process
- Verify contingency plans are documented
- Verify contingency plans are prepared for continuity of supply in the event of:
6.2 Quality objectives and planning to achieve them
- Verify top management ensures that quality objectives are defined, established and maintained at relevant functions, levels and processes.
- Verify the quality objectives are..
6.3 Planning of changes
- Verify how QMS changes are planned systematically.
- Verify how the organization demonstrates the purpose and potential consequences of changes.
- Verify how the organization considers the integrity of the QMS.
- Verify how resources are made available.
- Verify how responsibility and authority is allocated and reallocated.
7.1.1 General - 7.1.3 Infrastructure
- Verify how resources are determined for the organization.
- Show me how the capabilities and constraints on internal resources are considered.
- Show me how needs from external providers are considered.
- Verify how the organization provides persons necessary to consistently meet customer, applicable statutory and regulatory requirements for the QMS including the necessary processes.
- Verify how the organization determines, provides and maintains the infrastructure for the operation of processes to achieve products and services conformity.
- Verify design layout optimizes material flow, material handling and value-added use of floor space
- Verify assessments of manufacturing feasibility and evaluation of capacity planning as inputs into Management Review
7.1.4 Environment for the operation of processes
- Verify how the organization determines, provides and maintains the environment for the operation of processes to achieve products and service conformity.
- Verify premises are in a state of order, cleanliness and repair
7.1.5 Monitoring and measuring resources
- Verify how resources are determined to ensure valid and reliable monitoring and measuring results.
- Verify how the organization ensures that the resources provided are suitable for the specific type of monitoring and measurement activities being undertaken and that they are maintained to ensure continued fitness of purpose.
- Verify documented information that shows evidence of fitness for purpose of monitoring and measurement resources.
- Show me how measurement instruments are verified or calibrated at specific intervals against national or international standards. If no standards, show me documented information which is used as the basis for calibration or verification.
- Show me how measurement instruments are identified.
- Show me how measurement instruments are safeguarded from adjustments, damage and deterioration.
- Verify how the organization determines the validity of previous measurements if you find an instrument to be defective during verification or calibration. Verify any actions taken.
- Verify MSA
- Verify criteria used conforms to those in reference manuals on MSA
- Verify documented process for managing calibration/verification records
- Verify calibration/verification activities and records shall include:
7.1.6 Organizational knowledge
- Verify how the organization determines the necessary knowledge for the operation of processes and achieves conformity of products and services.
- Verify how knowledge is maintained and made available to the extent necessary.
- Verify how the organization determines current knowledge and how its acquires additional knowledge when addressing changing needs and trends.
7.2 Competence
- Show me how you determine the necessary competence of people doing work under your control that affects quality performance.
- Show me how you determine competence on the basis of appropriate education, training or experience.
- Show me how you take actions to acquire necessary competence where applicable and how do you evaluate the effectiveness of those actions.
- Verify documented information as evidence of competence where appropriate.
- Verify documented process(es) for identifying training needs including awareness and achieving competence
- Verify on-the-job training process
- Verify documented process(es) to verify internal and second-party auditors are competent and can demonstrate
7.3 Awareness
- Verify people doing work under the organization's control are aware of
7.4 Communication
- Verify internal and external communication process (what, when, with whom and how to communicate).
7.5 Documented information
- Verify documented information required by the ISO 9001:2015 standard.
- Verify documented information that shows the effectiveness of the QMS.
- Show me that your documented information contains appropriate identification, format (language, software version, graphics, ...) and media (paper, electronic, ...).
- Show me how the documented information is reviewed and approved for suitability and adequacy.
- Show me how you control documented information and make it available and suitable for use. Tell me how you protect your documented information.
- Verify how the organization controls the distribution, access, retrieval, use, storage, preservation, legibility, control of changes, retention and disposition of documented information.
- Verify documented information of external origin is identified, as appropriate, and controlled.
- Verify quality manual and it includes, at a minimum:
8.1 Operational planning and control
- Verify how the organization has planned, implemented and controlled processes needed to meet the requirements of products and services.
- Verify how requirements for products and services are determined.
- Verify how criteria for processes and acceptance for products and services are determined.
- Verify how resources are determined.
- Verify how process control is implemented.
- Show me documented information that demonstrates processes have been carried out as planned and can demonstrate conformity of products and services.
- Determine how output from the planning process is suitable for operations.
- Verify how planned changes are controlled. Verify how unintended changes are reviewed and what actions are taken to mitigate any adverse effects, as necessary.
- Verify how outsourced processes are controlled.
- Verify topics shall be included in planning for product realization:
8.2 Determination of requirements for products and services
- Verify processes created for communicating with customers on information relating to products, services, enquiries, contracts, order handling, customer views, perceptions and complaints, handling or treatment of customer property and specific requirements for contingency actions.
- Verify process to determine the requirements for products and services to be offered to potential customers and how the process is established, implemented and maintained.
- Verify how product and service requirements including statutory and regulatory requirements are defined. Verify that the organization has the ability to meet the defined requirements and substantiate any claims for its products and services.
- Verify how the organization reviews..
8.3.1 General
- Verify how the design and development process is established, implemented and maintained.
- Verify product and manufacturing design is focused on error prevention rather than detection
8.3.2 Design and development planning
- In determining the stages and control for design and development, verify the organization considers..
8.3.3 Design and development inputs
- In determining requirements essential for the type of products and services being designed and developed, the organization shall consider..
8.3.4 Design and development controls
- Verify the organization applies controls to the design and development process to ensure that..
8.3.5 Design and development outputs
- Verify the organization ensures the design and development outputs..
8.3.6 Design and development changes
- Verify the organization identifies, reviews and controls changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements.
- Verify documented information on design and development changes, the result of reviews, the authorization of changes and the actions taken to prevent adverse impacts are retained.
- Verify organization evaluates design changes after initial product approval
- Verify documented approval or waiver from the customer prior to production implementation (if required)
- Verify revision level of embedded software and hardware
8.4 Control of externally provided processes, products and services
- Verify the organization has a documented supplier selection process and it includes..
8.5.1 Control of production and service provision
- Verify the organization has documented information that defines the characteristics of the products to be produced, the services to be provided or the activities to be performed and the results to be achieved.
- Verify the availability and use of suitable monitoring and measuring resources.
- Verify the implementation of monitoring and measuring activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met.
- Verify the use of suitable infrastructure and environment for the operation of processes.
- Verify the appointment of competent persons, including any required qualification.
- Verify the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement.
- Verify the implementation of actions to prevent human error (i.e. poke yoke, visual locations, checklist, emergency stops, templates, document control, ...)
- Verify the implementation of release, delivery and post-delivery activities.
8.5.1.1 Control Plan
- Verify control plans (in accordance with Annex A) include..
8.5.1.2 Standardized work - operator instructions and visual standards
- Verify standardized work documents are..
8.5.1.3 Verification of job set-ups / 8.5.1.4 Verification after shutdown
- Verify organization verifies job setups
- Verify documentation is maintained for set-up personnel
- Verify organization uses statistical methods of verification, where applicable
- Verify first-off/last-off part validation
- Verify records are retained for process and product approval following set-up and first-off/last-off validations
- Verify organization ensure compliance with requirements after a planned or unplanned production shutdown period
8.5.1.5 Total productive maintenance
- Verify total productive maintenance system is documented and includes..
8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and equipment
- Verify production tooling management system (customer-owned or organization-owned) includes..
8.5.1.7 Production scheduling
- Verify production is scheduled to meet customer orders/demands such as JIT
- Verify production scheduling is supported by an information system
8.5.2 Identification and traceability
- Verify how organization identifies outputs from the process to ensure conformity.
- How does the organization identify the status of process outputs.
- Verify how the organization controls the unique identification of process outputs when traceability is required. Verify documented information of traceability, where required.
- Verify traceability plans..
8.5.3 Property belonging to customers or external providers
- What care is provided to customers' or external providers' property?
- Verify how the organization identifies, verifies, protects and safeguards customers' or external providers' property which is provided for use or incorporation into the organization's products or services.
- Verify retained documented information for property that is damaged or otherwise found to be unsuitable for use.
8.5.4 Preservation
- Verify how the organization ensures preservation of the process outputs to ensure conformity to requirements.
- Verify organization assesses product in stock, the place/type of storage container and the storage environment at planned intervals
- Verify organization uses inventory management system to optimize inventory turns over time and ensure stock rotation (i.e. FIFO)
- Verify obsolete product is controlled similar to that of nonconforming product
- Verify organization complies with customer requirements for preservation, packaging, shipping and labeling
8.5.5 Post-delivery activities
- Verify the organization considers the following to meet post-delivery activities.
8.5.6 Control of changes
- Verify how the organization reviews and controls changes for production or service provision.
- Verify retained documented information describing the results of the review of changes, the person(s) authorizing the change and any necessary actions arising from the review.
8.5.6.1 Control of changes - supplemental
- Verify documented process
- Verify organization...
8.5.6.1.1 Temporary change of process controls
- Verify organization has a list of primary and approved back-up/alternate process controls
- Verify alternate method is documented
- Verify alternate control method is approved internally prior to production implementation and by the customer (if required)
- Verify alternative control methods are identified in the Control Plan and are reviewed periodically
- Verify standard work instructions are created for alternative control methods
- Verify alternative process controls are reviewed on a daily basis (at a minimum)
- Verify restart verification is documented for a defined period
- Verify traceability of all product produced with alternative process control devices or processes
8.6 Release of products and services
- Verify at appropriate stages product and service requirements have been met.
- Verify products and services are not released to the customer until the planned arrangements have been satisfactorily completed, unless otherwise approved by relevant authority and, as applicable, by the customer.
- Verify retained documented information that shows evidence of conformity with acceptance criteria and traceability to person(s) authorizing the release.
- Verify verification of product and service requirements are documented as specified in the Control Plan
- Verify a layout inspection and functional inspection is performed per the Control Plan and are available for customer review
- For appearance items, verify the organizations provides..
8.7 Control of nonconforming outputs
- Verify that outputs that do not conform to requirements are identified and controlled.
- Verify appropriate action is taken for nonconforming products and services (also include after delivery of product or during/after the provision of services).
8.7.1.1 Customer authorization for concession - 8.7.1.3 Control of suspect product
- Verify concession or deviation permit approved by customer prior to further processing from what is currently approved
- Verify organization obtains customer authorization prior to further processing for "use as is" and rework dispositions of nonconforming product (including sub-components)
- Verify records are maintained of expiration date and quantity authorized under concession
- Verify material shipped under concession is appropriately identified
- Verify product with unidentified or suspect status is classified and controlled as nonconforming product
- Verify appropriate manufacturing personnel are trained for containment of suspect and nonconforming product
8.7.1.4 Control of reworked product - 8.7.1.5 Control of repaired product
- Verify documented process for rework confirmation
- Verify instructions for disassembly or rework, including re-inspection and traceability requirements
- Verify documented process for repair confirmation
- Verify instructions for disassembly or repair, including re-inspection and traceability requirements
- Verify documented customer authorization for concession for the product to be repaired
- Verify retained documentation on the disposition of rework including quantity, disposition, disposition date and applicable traceability information
8.7.1.6 Customer notification - 8.7.1.7 Nonconforming product disposition
- Verify customer is immediately notified if nonconforming product is shipped
- Verify detailed documentation of the event followed initial communication
- Verify documented process for disposition of nonconforming product not subject to rework or repair
- Verify nonconforming product is rendered unusable prior to disposal
9.1 Monitoring, measurement, analysis and evaluation
- Verify the organization has determined what needs to be monitored and measured, the methods to be used, when it will be performed, analyzed and evaluated.
- Verify the organization evaluates the performance and effectiveness of its QMS.
- Review retained appropriate documented information
- Verify the organization performs process studies on all new manufacturing processes to verify process capability
- Verify adherence to..
9.2 Internal audit
- Verify internal audit process is documented
- Verify audits are conducted at planned intervals
- Verify organization has established, implemented, and maintains an internal audit program
- Verify the importance of the process, changes affecting the organization and the results of previous audits are considered
- Verify audit criteria and scope are created for each audit
- Auditors are objective and impartial
- Audit results reported to relevant management
- Verify appropriate correction and corrective actions are taken without delay
- Review retained documented information
- Verify QMS processes are audited over three-year calendar period
- Verify manufacturing processes are audited over three-year calendar period
- Verify all shifts are audited
- Verify products are audited using customer-specific required approaches
9.3 Management review (go through entire standard and add to inputs)
- Verify management reviews QMS at least annually
- Verify inputs to management review includes:
10.1 General
- Verify the organization determines and selects opportunities for improvement to improve products and services, corrects, prevents or reduces undesired effects and improves the performance and effectiveness of the QMS.
10.2 Nonconformity and corrective action
- Verify how organization reacts to nonconformity, including complaints, by evaluating how its takes action to control and correct it and how it deals with the consequences.
- Verify how the organization evaluates the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere.
- Verify how organization implements necessary actions.
- Verify how organization evaluates the effectiveness of actions taken.
- Verify the organization updates risks and opportunities determined during planning, if necessary.
- Verify any changes made to the QMS, if necessary.
- Verify retained documented information that provides evidence of the nature of the nonconformity and any subsequent actions taken and the results of any corrective actions
10.2.3 Problem solving
- Verify document process that includes..
10.2.4 Error-proofing
- Verify documented process to determine the use of appropriate error-proofing methodologies
- Verify details of error-proofing method used is documented in the process risk analysis (PFMEA) and test frequencies documented in the Control Plan
- Verify records of testing of error-proofing devices
- Verify challenge parts are identified, controlled, verified and calibrated (where feasible)
- Verify reaction plans for error-proofing device failures
10.2.5 Warranty management systems - 10.2.6 Customer complaints and field failure test analysis
- Verify warranty management process (if required)
- Verify method for warranty part analysis, including NTF (no trouble found)
- Verify that the organization has performed analysis on customer complaints and field failures (include embedded software
- Verify problem solving and corrective action initiated
- Verify the organization communicates the results of testing/analysis to the customer and also within the organization
10.3 Continual improvement
- Verify how the organization continually improves. Does it consider the results of analysis and evaluation and the outputs from management review to determine if there are needs or opportunities that shall be addressed as part of continual improvement?
- Verify documented process for continual improvement includes..
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