Plan and establish controls for all operational processes.
Define requirements for products and services to ensure claims for products and services are met.
Establish, implement and maintain an appropriate design and development process - EXCLUDED.
Ensure externally provided processes, products and services conform to requirements.
Production and service provision must be performed under controlled conditions.
Products and services are not to be released until after verification that requirements have been met.
Non-conforming outputs are to be identified, controlled and addressed.
Triad shall plan, implement and control the processes needed to meet the requirements for the provision of products and services by establishing criteria, identifying resources required, implementing control of processes and documenting information as required. In addition, identifying any critical items, engaging all impacted areas, engaging in external provider support and preventing nonconformances.
8.1 a Plan and determine the requirements for the products and services
See 4.4, 6.1
8.1 b1 Establish criteria
For processes
8.1 b2 Establish the criteria
For the acceptance of conforming products and services
8.1 c Determine necessary resources
8.1 d Control the processes
According to 8.1 b1 and 8.1 b2
8.1 e1 Determine, maintain and retain the documented information on process control
See 7.5
8.1 e2 Determine, maintain and retain the documented information on product and service conformity
Meet applicable requirements, see 7.5
8.1 f Determine the processes and controls needed to manage critical items
Including production process inspections when key characteristics are modified
8.1 g Engage representatives of affected functions
In order to ensure operational planning and control
8.1 h Determine the processes and resources
To support the use and maintenance of the products and services
8.1 i Determine the products and services to be obtained from external providers
See 8.4
8.1 j Establish the controls needed
To prevent non-conformance
8.1 Plan and manage product and service provision in a structured and controlled manner
Project planning, program management
8.1 Adapt planning outputs to internal operating methods
See 4.4, 6.1
8.1 Control planned and unplanned changes
Analyze consequences of unplanned changes, actions to limit the effects
8.1 Control the outsourced processes
See 8.4
8.1 Establish, implement and maintain a process to transfer work (sub-contract)
8.1 Manage work transfer impacts and risks
See 8.1.1
8.1.1 Operational Risk Management
Triad has planned, implemented and established controls for managing operation risks to the achievement of requirements as applies to Triad and the products or services we provide.
8.1.1 a Plan, implement and control a process for managing operational risks by assignment of responsibilities
8.1.1 b Plan, implement and control a process for managing operational risks by definition of risk assessment criteria
CalcuQuote risk review process
8.1.1 c Plan, implement and control a process for managing operational risks by identification, assessment and communication or risks
From RFQ through build
8.1.1 d Plan, implement and control a process for managing operational risks by identification, implementation and management of actions
8.1.1 e Plan, implement and control a process for managing operational risks by acceptance of residual risks
8.1.2 Configuration management
Triad has planned, implemented and established controls for the configuration management process specific to data.
8.1.2 Plan, implement and control a process for configuration management
8.1.2 a Control product identity and traceability
8.1.2 b Ensure that the documented information is consistent with the actual attributes of the products and services
Requirements, design, verification, validation and/or acceptance criteria
8.1.3 Product Safety
Triad shall proactively identify, assess, and mitigate potential safety risks associated with the products we produce throughout their life cycle, as appropriate to the product and Triad's role.
8.1.3 Plan, implement and control the processes to ensure product safety during the life cycle as applicable
8.1.4 Prevention of counterfeit parts
Triad has planned, implemented and established control of a process appropriate to our role in preventing and identifying suspect counterfeit part use to prevent delivery to the customer.
8.1.4 Plan, implement and control processes for the prevention of counterfeit parts
8.2.1 Customer communication shall include:
8.2.1 a Provide information to customers
8.2.1 b Control communication with customers
Contracts, orders, changes and consultations
8.2.1 c Control communication with customers
Regarding perception, opinions, complaints and recommendations
8.2.1 d Control communication with customers
Regarding their property
8.2.1 e Control communication with customers
Regarding specific requirements for contingency actions
8.2.2 Determining the requirements related to products and services
When determining the product and service requirements to be offered to customers, Triad shall:
8.2.2 a1 Develop specific activities for products and services
To clarify statutory and regulatory requirements
8.2.2 a2 Define internal requirements
Related to processes, products and services. Verify these can be met.
8.2.2 b Be able to respond to claims
With facts and data
8.2.2 c Determine special requirements for products and services
High level risks
8.2.2 d Identify operational risks
See 8.1.1, e.g. new technology, expedited delivery
8.2.3 Review of requirements related to products and services
Prior to order acceptance/confirmation, Triad shall ensure it has the ability to meet the requirements for the products and services requested by Customers. We shall conduct this review during the RFQ phase and prior to order confirmation as follows and retain all documented information:
8.2.3.1 Be able to respond to customers
Regarding requirements of proposed products and services
8.2.3.1 a Review explicit customer requirements
Before order acceptance; includes delivery and post-delivery requirements
8.2.3.1 b Review implicit customer requirements
Before order acceptance; unformulated requirements
8.2.3.1 c Review internal requirements
Between requirements of an order and those previously disclosed
8.2.3.1 d Review statutory and regulatory requirements
Applicable to the products and services
8.2.3.1 e Review gaps
Changes to contract that were NOT included in scope of RFQ
8.2.3.1 f Resolve gaps
Before order acceptance and commitment; must be in writing
8.2.3.1 Coordinate the review
8.2.3.1 Negotiate a mutually acceptable requirement with the customer
When review indicates that some customer requirements cannot be met or only in part
8.2.3.1 Confirm requirements before accepting order
8.2.3.2 a Retain the documented information on the results of the review
See 7.5
8.2.3.2 b Retain the documented information on any new or changed requirement
See 7.5
8.2.4 Changes to requirements for products and services
Triad shall ensure that relevant documented information is amended and that relevant persons are made aware of the changed requirements, when product or service scope has changed.
8.2.4 Communicate changes to relevant persons
8.4.1 General
Triad ensures external providers conform to our requirements. We are ultimately responsible for any service that is provided by a downflow supplier. For purchased material/product from distribution (including broker) Triad shall follow the KEY approved supplier list, while identifying and managing risks associated with the provider process.
8.4.1 Ensure that the outputs of external providers meet specified requirements
8.4.1 Be responsible for the conformity of all externally provided processes, products and services
Including customer provided sources
8.4.1 Ensure, when required, that customer designated or approved external providers are used
These providers may not be on the Triad AVL
8.4.1 Identify and manage the risks associated with the external provision of processes, products and services
Including the selection and use of external providers
8.4.1 Require that external providers apply appropriate controls should they sub-tier to another external supplier
To ensure requirements are met; flow-down requirements
8.4.1 a Apply the requirements for the control of products and services provided by external providers
When the products and services are integrated internally
8.4.1 b Apply the requirements for the control of products and services
When provided directly to Triad customers
8.4.1 c Apply the requirements for the control of process done by external providers
When outsourcing is required
8.4.1 Establish and implement evaluation and selection criteria of external providers and monitor their performance
Including regular re-evaluation
8.4.1 Retain the documented information on the results of evaluation and monitoring
See 7.5
8.4.1.1 a Define the process, responsibilities and authority for the approval status decision, changes of the approval status
To determine the use of external providers based on their status
8.4.1.1 b Maintain a register of external providers that includes approval status (KEY, KEY-LIMITED, NON-KEY, INACTIVE, DISQUALIFIED)
8.4.1.1 c Periodically review external provider performance
Non-conformances, OTD
8.4.1.1 d Define the necessary actions to take when dealing with external providers that do not meet requirements
See 8.7, 10.2
8.4.1.1 e Define the requirements for controlling documented information created or retained by external providers
See 7.5
8.4.2 Type and extent of control
Triad ensures that externally provided processes, products and services do not adversely impact our ability to deliver conforming products and services to our Customers.
8.4.2 Ensure the level of control of external providers on meeting the requirements
8.4.2 a Ensure that the processes of external providers are controlled
8.4.2 b Define how to control the external provider and its process outputs
The level of control will vary
8.4.2 c1 Account for potential impact of the outputs of the external provider
8.4.2 c2 Account for control of the external provider
Monitor effectiveness
8.4.2 c3 Account for results of the periodic review of external provider performance
See 8.4.1.1 c
8.4.2 d Define how to control the outputs of externally provided processes
Ensure conformity of products and services to customers
8.4.2 Perform verification activities of externally provided processes, products and services according to the risks identified
See 8.1.1 Audits may be performed, but limited to site visit, review of required documentation, review of part approval process, product inspection and service verification upon receipt
8.4.2 Include inspection or periodic testing, as applicable, when there are high risk of nonconformities
8.4.2 Identify and record in order to allow recall and replacement later if it is found product does not meet requirements
When product released but pending all required verification activities
8.4.2 Define the scope and requirements for delegation for verification to the external provider
See 7.5
8.4.2 Periodically monitor the external provider's delegated verification activities
Record any results
8.4.2 Implement a process to evaluate the data in the test or validation reports
If applicable
8.4.2 Implement a process to validate the accuracy of test reports
When raw material is identified as critical
8.4.3 Information for external providers
Triad ensures the adequacy of requirements prior to communicating with an external provider. Triad shall provide all details relevant to the external provider such as technical data, approval method, identification, controls required, etc. A process to qualify external suppliers exists to establish approved supply chain controls. Triad initiated purchase order terms and conditions restate all required external supplier criteria.
8.4.3 Check the adequacy of the requirements
8.4.3 a Communicate to external providers the requirements
Processes, products and services to provide
8.4.3 b1 Communicate to external providers the requirements
The acceptance criteria/approval of products and services
8.4.3 b2 Communicate to external providers the requirements
The approval of methods, process and equipment
8.4.3 b3 Communicate to external providers the requirements
The approval to release products and services
8.4.3 c Communicate to external providers the requirements
Regarding the competence (any required qualifications)
8.4.3 d Communicate to external providers the requirements
The relations between Triad and the external provider
8.4.3 e Communicate to external providers the requirements
The control and monitoring of the external provider's performance
8.4.3 f Communicate to external providers the requirements
The verification or validation that Triad or the customer intends to conduct at the external provider's premises (if applicable)
8.4.3 g Communicate to external providers the requirements
Design and development control
8.4.3 h Communicate to external providers the requirements
Special requirements, critical items, key characteristics
8.4.3 i Communicate to external providers the requirements
Test, inspection, verification including production process verification
8.4.3 j Communicate to external providers the requirements
The use of statistical techniques for product acceptance and any instructions for acceptance
8.4.3 k Communicate to external providers the requirements
The need to implement a QMS or provide comparable evidence of compliance to specific requirements
The need to use customer designated or approved external providers, including process sources
Notification of non-conformances, approval required and/or disposition
Prevention of counterfeit parts
Notification of changes to the process, products, facility location
Flow down of applicable requirements
Provision of test specimens, FAI approval
Required documentation
8.4.3 l Communicate to external providers the requirements
Access rights by Triad, end customer and/or regulatory authorities
8.4.3 m Communicate to external providers the requirements
The assurance that persons are made aware of their contribution to product or service conformity
The assurance that persons are made aware of their contribution to product safety
The assurance that persons are made aware of the importance of ethical behavior
8.5.1 Control of production and service provision
Triad has production and service provision under controlled conditions. This is accomplished by:
8.5.1 Apply controlled conditions of production and service provision
Including delivery and post-delivery activities
8.5.1 a1 Save documented information of specifications of products and services and the expected activities
See 7.5
8.5.1 a2 Save the documented information of results to be achieved
See 7.5
8.5.1 b Include in the controlled conditions the inspection resources
See 7.1.5
8.5.1 c Include in the controlled conditions the inspection activities
Verify the appropriate stages of processes outputs meet criteria
8.5.1 c1 Ensure that documented information for monitoring and measurement activity includes criteria for acceptance or rejection
See 7.5
8.5.1 c1 Ensure that documented information for monitoring and measurement activity includes stages where the verification operations are to be performed
See 7.5
8.5.1 c1 Ensure that documented information for monitoring and measurement activity includes measurement results are to be obtained
A minimum an indication of acceptance or rejection
8.5.1 c1 Ensure that documented information for monitoring and measurement activity includes any specific monitoring and measurement equipment required
And instruction associated with their use
8.5.1 c2 Ensure that when sampling is used for product acceptance, there is a justified sampling plan based on statistic principles
The sampling plan should match the criticality of the product
8.5.1 d Include in the controlled conditions adequate infrastructure and environment
See 7.1.3, 7.1.4
8.5.1 e Include in the controlled conditions the staff competence
Include any necessary qualification, see 7.2
8.5.1 f Include in the controlled conditions the validation of the ability of a process to achieve the expected results
If outputs cannot be verified
8.5.1 g Include in the controlled conditions the actions to prevent human error
Tools, guides, etc.
8.5.1 h Include in the controlled conditions the activities of release, delivery and post-delivery
See 8.6, 8.5.5
8.5.1 i Include in the controlled conditions the establishment of criteria for workmanship
Written standards, samples and/or illustrations
8.5.1 j Include in the controlled conditions the accountability for all products during production
Part quantity, scheduled orders, definition of nonconforming product
8.5.1 k Include in the controlled conditions the control and monitoring of identified critical items in accordance with established processes
Include key characteristics
8.5.1 l Include in the controlled conditions the determination of methods to measure variable data
Tooling, machine probing, inspection equipment
8.5.1 m Include in the controlled conditions the identification of in-process inspection/verification points
If verification cannot be performed at later stages
8.5.1 n Include in the controlled conditions the availability of evidence that all production and ispection/verification operations have been completed as planned
8.5.1 o Include in the controlled conditions the provision for the prevention, detection and removal of foreign objects (FOD)
See 8.1.3
8.5.1 p Include in the controlled conditions the control and monitoring of utilities and supplies to the extent they affect conformity of product requirements
Such as water, compressed air, eletricity, chemical products
8.5.1 q Include in the controlled conditions the identification and recording of products released for subsequent production use to allow recall and replacement if it is later found the product does not requirements
Pending completion of all required measuring and monitoring activities
8.5.1.1 Control of equipment, tools and software programs
8.5.1.1 Validate and maintain equipment, tools and software programs used to automate, control, monitor or measure production processes
8.5.1.1 Define storage requirements for production equipment and tooling
When applicable, periodic condition checks
8.5.1.2 Validation and control of special processes
8.5.1.2 a Establish, as applicable, arrangements for definition of criteria for the review and approval of the processes.
When processes cannot be verified by subsequent monitoring or measurement
8.5.1.2 b Establish, as applicable, arrangements for determination of conditions to maintain the approval
When resulting output cannot be verified by monitoring
8.5.1.2 c Establish, as applicable, arrangements for approval of facilities and equipment
When processes cannot be verified by subsequent monitoring or measurement
8.5.1.2 d Establish, as applicable, arrangements for qualifications of persons
When processes cannot be verified by subsequent monitoring or measurement
8.5.1.2 e Establish, as applicable, arrangements for use of specific methods and procedures for implementation and monitoring the processes
When processes cannot be verified by subsequent monitoring or measurement
8.5.1.2 f Establish, as applicable, arrangements for requirements for documented information to be retained
When processes cannot be verified by subsequent monitoring or measurement, see 7.5
8.5.1.3 Production process verification
8.5.1.3 Implement production process verification activites to ensure the production process is able to produce products that meet requirements
First article inspection (FAI)
8.5.1.3 Use a representative item from the first production run of a new part or assembly
FAI processing
8.5.1.3 Repeat this activity when changes occur that invalidate the original results
ECO, process change, tooling change shall result in repeated FAIs
8.5.1.3 Retain documented information of the results of production process verification
See 7.5
8.5.2 Identification and traceability
Triad uses suitable means to identify outputs when it is necessary to ensure the conformity of products and services.
8.5.2 Use appropriate means to control the unique identification of process outputs
8.5.2 Maintain the identification of the configuration of the products and services
Identify differences between the actual and required configuration
8.5.2 Inspect processes throughout the production and service provision
In order to identify the status of process outputs
8.5.2 Establish controls for the media when acceptance authority media is used
Stamps, electronic signatures, passwords, employee ID in ERP
8.5.2 Control the traceability of process outputs
When traceability is a requirement, the unique identification is used
8.5.2 Retain the documented information on traceability
See 7.5
8.5.3 Property belonging to customers or external providers
8.5.3 Exercise care with property owned by customer or external provider
During use or storage
8.5.3 Identify, check, protect, monitor and safeguard customer or external provider property
When in use, labeled
8.5.3 Notify the customer or external provider when their property has been damaged, lost and maintain documentation of the issue
Following improper or incorrect use only; does not apply to expected degradation from use, see 7.5
8.5.4 Preservation
Triad exercises care with property belonging to the customer or external provider while it is under our control and use. Consumable materials used int he production process are controlled by identification, which may include lot number and expiration (when applicable).
8.5.4 Preserve the process outputs throughout production and service provision activities
Identification, packaging, handling, storage, transport, protection
8.5.4 a Include in preservation of outputs provisions for cleaning
8.5.4 b Include in preservation of outputs provisions for prevention, detection and removal of foreign objects (FOD)
8.5.4 c Include in preservation of outputs provisions for special handling and storage for sensitive products
8.5.4 d Include in preservation of outputs provisions for marking and labeling, including safety warnings and cautions
8.5.4 e Include in preservation of outputs provisions for shelf life control and stock rotation
8.5.4 f Include in preservation of outputs provisions for special handling and storage for hazardous materials
8.5.5 Post delivery activities
Triad will meet requirements for post-delivery activities as agreed upon in the contract. The following are considered:
8.5.5 Meet the requirements for post-delivery activities
8.5.5 a Account for statutory and regulatory requirements
See 4.2
8.5.5 b Account for negative impacts related to products and services
Consequences of potential risks
8.5.5 c Account for the nature, use and lifetime of products and services
Based on IPC class and to the extent of post-delivery activities as agreed upon
8.5.5 d Account for the requirements of interested parties
Especially customers
8.5.5 e Account for customer feedback
8.5.5 f Account for the collection and analysis of in-service data
Performance, reliability, lessons learned
8.5.5 g Account for the control of technical documentation
Product use, maintenance, repair
8.5.5 h Account for controls required for work undertaken external to the organization
Such as off-site work
8.5.5 i Account for customer product support
When applicable; warranties shall apply to IPC workmanship
8.5.5 Take action when problems are detected after delivery
Including investigation and reporting
8.5.6 Control of changes
Triad will review and control changes for production and service provision, to the extent necessary to ensure conformity. Persons authorized to approve production or service provision changes are identified.
8.5.6 Review and control unplanned changes
See 6.3
8.5.6 Identify persons authorized to approve production and service provision changes
Changes affecting processes, production equipment, tools or software programs
8.5.6 Retain the documented information on unplanned changes
See 7.5; include the review process, authorization of changes and actions implemented
Triad has implemented planned 'points' at appropriate stages to verify that the product and service requirements have been met. The release of products and services occurs when all stages of work are completed and the assigned authority - typically QA and/or test - has verified completion. Electronic data of release is maintained.
8.6 Check products and services with activities at appropriate stages
8.6 Release products and services after verification of conformity
Unless written approval of deviation is received
8.6 Retain the documented information on the release of products and services
See 7.5
8.6 a Include in the documented information evidence of conformity
Results of acceptance compared to he acceptance criteria
8.6 b Include in the documented information the traceability of products and services
Including the employee having authorized the release
8.6 Ensure that retained documented information provides evidence that the products and services meet the defined requirements
When required to demonstrate product qualification
8.6 Ensure that all documented information required to accompany the products and services are present at delivery
See 7.5
8.7 Control of non-conforming output
Triad ensures outputs that are NONCONFORMING are controlled and prevented from use or delivery. Based on the type of nonconformity, Triad will take appropriate actions to assign responsibilities, mitigate further nonconformance and determine if OTD is impacted.
8.7.1 Identify and treat nonconforming process, products and services outputs
Isolate, prevent unintended mixture with conforming product
8.7.1 Conduct corrective actions based on impacts
See 10.2
8.7.1 Conduct corrective actions based on post-delivery activities
See 8.5.5
8.7.1 Maintain documented information on the nonconformity control process including the provisions for defining the responsibility and authority for the review and disposition of nonconforming outputs
Indicate persons approved to make decisions
8.7.1 Maintain documented information on the nonconformity control process including the provisions for taking necessary actions
To mitigate impact on other processes, products or services
8.7.1 Maintain documented information on the nonconformity control process including the provisions for timely reporting of nonconformities affecting delivered products and services
To the customer, interested parties as necessary
8.7.1 Maintain documented information on the nonconformity control process including the provisions for defining corrective actions for nonconforming products and services detected after delivery
CAR based on impact, see 10.2
8.7.1 a Handle nonconforming outputs with corrections
Rework
8.7.1 b Handling nonconforming outputs by segregation
Customer returns or WIP
8.7.1 c Inform the customer
See 7.4
8.7.1 d Handle nonconforming outputs by asking authorization
Only when customer approval/acceptance is required
8.7.1 Implement dispositions of use-as-is or repair for the acceptance of nonconforming productions only after approval by authorized representative
QA
8.7.1 Implement dispositions of use-as-is or repair for the acceptance of nonconforming productions only after approval by the customer
Only when customer approval/acceptance is required
8.7.1 Conspicuously and permanently mark product dispositioned for scrap unti phyically rendered unusable
OR isolate in safe space
8.7.1 Inspect counterfeit or SUSPECTED or risk identified as counterfeit parts
Prevent use and/or reentry into the supply chain
8.7.1 Check conformity after any correction
Resume workflow
8.7.2 a Retain the documented information on the description of nonconformities
Electronically, see 7.5
8.7.2 b Retain the documented information on implemented actions
See 7.5
8.7.2 c Retain the documented information on approved concessions
See 7.5
8.7.2 d Retain the documented information on the person having decided the handling of the nonconformities
See 7.5