8.1 Operational planning and control. JAKMAN supports planned and controlled product-service provision through its Product Specification template and Design Process. The template records customer and regulatory requirements; functional, performance, safety and environmental design inputs; production specifications; equipment and tooling needs; and documented quality-control and acceptance criteria for incoming, in-process and final inspection. It also provides for verification, validation, traceability, risk/change management, revision history and approval.
The Design Process applies these requirements through defined design stages, responsibilities, resources and controls. It requires documented inputs, output specifications, cross-functional review, verification and validation, controlled design changes, and translation of validated outputs into manufacturing procedures, tooling/equipment needs, environmental controls and work instructions. Its quality-assurance stage establishes inspection, testing and acceptance controls, supporting conformity to product and service requirements.
8.2 Requirements for products and services. JAKMAN provides a structured basis for customer communication through the Customer Contract template, which requires documented customer requirements, product/service specifications, written order acknowledgement, confirmed changes or deviations, and communication of delivery terms, lead times and late deliveries. It also requires customer approval before changes affecting the contract, product design, process or location are implemented, and requires notification and corrective action where a product or service is nonconforming.
The Quotation Approval Register records the customer, quotation, requirement-understanding decision, risks, opportunities, reviewer, approval status and related actions. The reviewed records demonstrate requirement confirmation and controlled follow-up for customer quotations.
Customer feedback, including complaints, is captured in the Customer Feedback Register and processed through receipt, review and follow-up. The Customer Feedback Process requires complaints, very low ratings, repeated issues and service-failure comments to be linked to proportionate actions in the Action Tracker, while all feedback supports trend analysis, management review and improvement.
The Communications Process provides a controlled method to define what is communicated, to whom, how, when and by whom, including external communications with customers.
8.3 Design and development of products and services. JAKMAN’s Design Process defines design planning stages, responsibilities, resources and controls; requires documented design inputs and outputs; and provides planned verification, validation and controlled design-change activities. Verified design outputs are translated into production specifications, manufacturing procedures, tooling and equipment needs, environmental controls and work instructions, supporting subsequent product provision.
The Product Specification template provides documented information for customer and regulatory requirements, functional, performance, safety and environmental design inputs, technical outputs, verification plans and results, validation plans and user/field-test results, production requirements, inspection and acceptance criteria, traceability, change records, revision history and formal approvals.
Design reviews are controlled through preliminary, critical and final stages. The Design Review Process requires the relevant product and reference documents, appropriate internal participants and external attendees, scheduled reviews, retained agendas, decisions, actions, notes and supporting evidence. This provides control of design interfaces, relevant interested-party involvement and evidence of review and follow-up. 2 The reviewed Design Review Register records demonstrate use of these stages and linked product documentation, participants, review dates and related actions.
The Product Approval Process links approval requests to the product, design-review record, reference documents, risks, opportunities, responsible requestor, reviewers, sign-off status and follow-up actions. This establishes an approval and traceability mechanism for controlling progression through design and development. The reviewed approval records show design-review linkage and approved sign-off status for product approvals.
JAKMAN provides a defined structure for establishing and retaining design inputs. The Design Process requires functional, performance, safety, compliance, customer, regulatory and environmental requirements to be documented as design inputs, with clarity and traceability maintained.
The Product Specification template captures customer and regulatory requirements together with functional, performance, safety/compliance, interface and environmental conditions. It also requires risk analysis, change records, revision history and approval, supporting documented, reviewable input information and consideration of potential failure consequences.
The Regulation Register retains applicable legislative requirements, compliance status, assigned people, review dates and linked actions. It provides a controlled source for considering relevant statutory and regulatory requirements during design and development.
Design-review records link product documentation, participants, external attendees and follow-up actions, providing a mechanism to review input-related issues.
JAKMAN’s Design Process defines expected design results through documented design inputs and outputs, including technical drawings, bills of materials, software architecture and design documentation. It requires verification plans, tests and inspections to confirm outputs meet inputs, and validation through user testing, field trials or simulated conditions to demonstrate that products meet their intended use.
The Product Specification template provides controlled documented information for design outputs, verification plans, test procedures and results, validation plans and results, production specifications, quality-control and acceptance criteria, risk/change management, revision history and approval. This structure supports retention of evidence that design and development activities have been completed.
The Design Review Process requires reviews at preliminary, critical and final stages, with relevant product documentation, participants, agendas, decisions, actions, notes and supporting evidence retained in the Design Review Register. Review outcomes can require progression, changes or further review, and resulting actions are tracked to completion. The Product Approval Process links the product, design review, risks, opportunities, sign-off and related corrective or improvement actions, providing further control over design decisions and follow-up.
JAKMAN’s Design Process defines design outputs as technical drawings, bills of materials, software architecture and design documentation that meet design-input requirements. Validated outputs are translated into production specifications, manufacturing procedures, tooling and equipment needs, environmental controls and work instructions. The process also requires incoming, in-process and final inspection/testing protocols and acceptance criteria, with packaging, labelling and traceability controls.
The Product Specification template retains these outputs as documented information, including design outputs, production specifications, inspection and acceptance criteria, packaging/labelling, traceability, revision history and approvals. It provides for verification and validation records, supporting evidence that the outputs meet requirements and are adequate for subsequent production and service provision. The Production Process applies approved specifications, work instructions, monitoring and measuring devices, in-process inspection, final inspection/testing and traceability before product release.
Design and development changes are controlled through the Change Approval Process. Changes that may affect product or service conformity, process capability, suppliers, regulatory compliance or management-system integrity are formally recorded, risk-assessed, reviewed and authorised before implementation. Approved changes are implemented under defined controls, verified for effectiveness and closed, while related actions address risks and mitigate adverse effects. The Change Approval Register retains the change description, reason, risk controls, reviewer, authorisation outcome, actions, notes and supporting attachments as evidence.
8.4 Control of externally provided processes, products and services. JAKMAN controls external providers through the Business Partner Register, Purchase Order Approval Register, Inward Goods Register and Supplier Contract. Supplier records identify provider role, QMS applicability, approval status, responsible reviewers, review dates, next review dates and related actions. This supports supplier evaluation, approval, monitoring, re-evaluation and retention of associated evidence.
The Supplier Contract establishes controls for externally supplied materials, components, finished goods and services that affect delivered product or service quality. It requires suppliers to operate a suitable QMS, meet specified drawings, standards and purchase-order requirements, use competent personnel, control sub-tier suppliers, provide traceability and conduct inspection, testing and verification. The contract requires notification and approval of changes, management of nonconforming outputs and corrective action.
Supplier performance is monitored for on-time delivery, conformity, responsiveness and corrective-action effectiveness. The agreement enables preferred, probationary or removal decisions, and permits customer, customer and regulator access to supplier premises, records and relevant processes, supporting supplier-site verification where required. It also requires supplier continuity planning for operational disruptions.
Purchase-order approval records require confirmation that requirements are understood, identify provider, risks, reviewer, approval status and follow-up actions before external supply is accepted. The Inward Goods Process ensures incoming external products are verified against the order through quantity, item identity, visual and performance checks, traceability and a conformant/nonconformant decision; nonconforming receipts are linked to actions.
8.5 Production and service provision. JAKMAN supports production and service under controlled conditions through the Production Process, which defines planning, material preparation, set-up, production, in-process inspection, packaging, final inspection, release and delivery. It assigns responsibilities to production management, supervisors, operators and the quality team, and identifies approved specifications, work instructions, SOPs, equipment, infrastructure, trained personnel and monitoring resources as required controls.
The Product Specification provides the documented framework for product and customer/regulatory requirements, manufacturing procedures, tooling, environmental controls, work instructions, inspection and acceptance criteria, packaging, labelling, traceability, risk controls and change approval.
The Infrastructure and Equipment Process records the identity, location, purpose, resources, type and operational status of facilities, equipment and tools used to support conforming product and service provision. It links assets needing maintenance, calibration, verification or planned servicing to the Maintenance and Calibration Register, retaining evidence of their ongoing suitability and effective operation.
Completed goods are inspected and tested before release, with the process retaining the serial or batch number, product, work order, operator, tester, inspection result and location. Passing items can be released to storage, delivery or another approved location, while failed items must enter nonconforming control. The Nonconforming Goods Process records containment, analysis, root cause, disposition, tagging, location and related actions, supporting error prevention and prevention of unintended release.
The Position Resource Process supports controlled production by determining the people required for effective operation, defining responsibilities and competence expectations through Position Results Descriptions, and reviewing whether staffing levels and competence meet operational needs. It links competence and training gaps to the Action Tracker and schedules ongoing resource reviews, supporting the appointment and maintenance of competent personnel for production and service provision.
Audit planning, checklists, evidence, findings, conformance status, corrective actions and scheduled follow-up provide independent review that production controls remain implemented and effective.
JAKMAN supports identification and traceability through the Product Process and Completed Goods Process. The Product Register establishes each product’s name, unique identifier, description, active or inactive status, reference documents, related actions and versioned notes. This provides a controlled product-level identity and supporting documented information for production and service activities.
The Completed Goods Process extends this identification to individual outputs by recording the unique serial or batch number, linked product, production date, work order, operator, tester and final location. It therefore provides traceability from the completed item to its approved product definition and production activity.
Monitoring and measurement status is controlled through the recorded inspection/test result. Outputs that pass inspection may be released to finished-goods storage, customer delivery or another approved location; outputs that fail are not released and are directed to nonconforming control for segregation, review and further action. Related actions are linked through the Action Tracker, retaining traceability of corrective or improvement follow-up.
JAKMAN supports control of customer or external-provider property through the Infrastructure and Equipment Process and its associated register. The process provides a Customer Equipment asset category and records each item’s identifier, description, location, operational status, required resources, related actions and supporting evidence. This enables property under the organisation’s control to be identified, located, monitored and retained within documented information.
Where maintenance, calibration, verification or planned servicing is needed, the process links the asset record to the Maintenance and Calibration Register, supporting protection and continuing suitability of customer equipment used in operations. Timestamped, versioned notes, related actions and attachments provide retained evidence of changes, issues and supporting records.
The reviewed process establishes identification, status and evidence controls for customer equipment. It doesn't explicitly describe notification to the customer or external provider when their property is lost, damaged or unsuitable; that communication would need to be evidenced in the relevant property record or associated action.
JAKMAN supports preservation of outputs through the Infrastructure and Equipment Register by identifying and controlling the facilities, utilities, security arrangements, environmental controls and equipment needed for conforming production and service provision. Records retain each asset’s unique identifier, status, location, purpose, required resources and related actions.
JAKMAN controls changes that may affect product or service conformity through the Change Approval Process. Changes to processes, materials, suppliers, designs, equipment, packaging and inspection methods are formally raised, reviewed, risk-assessed and authorised before implementation. This supports continuing conformity with customer, regulatory and management-system requirements.
The Change Approval Register retains documented information for each change, including a unique identifier, description, reason, request date, required-by date, risks, opportunities, assigned reviewer, sign-off status and related actions. The defined lifecycle requires approved changes to be implemented under controls, verified for effectiveness and closed; rejected or aborted changes are also recorded.
Authorisation is evidenced through the reviewer and formal sign-off outcome—Pending, Approved, Rejected or Aborted—while required implementation and risk-treatment tasks are linked to the Action Tracker for accountability and closure. Timestamped, versioned notes and supporting attachments preserve an auditable history of the review, approval and follow-up actions.
8.6 Release of products and services. JAKMAN supports planned verification before product release through the Production Process, which requires final inspection and testing to confirm conformance before release and delivery. Product Specifications define customer and regulatory requirements, quality-control acceptance criteria, final-product inspection, acceptance thresholds, and serial/lot traceability.
The Completed Goods Process records each finished item’s serial or batch number, linked product, work order, operator, tester, inspection/test outcome, and location. Only a Pass result is eligible for release to finished-goods storage, customer delivery, or another approved location; a Fail result is directed to nonconforming control. The reviewed Completed Goods records demonstrate this control, including passed items released to Finished Goods Store and failed items held in the Nonconforming Goods Area, with the tester identified.
The Audit Process provides independent review of whether these planned arrangements are implemented, retaining audit criteria, sampled evidence, conformance outcomes, findings, and follow-up actions in the Audit Register and linked checklist.
8.7 Control of nonconforming outputs. JAKMAN supports identification and control of nonconforming outputs through the Nonconforming Goods Process and Return Material Process. The Nonconforming Goods Register records the serial/batch number, product, work order, description of nonconformance, control, consequences, analysis, root cause, location, tagging status, responsible check-in person, related actions, and disposition. Permitted dispositions include segregation, correction, concession, containment, return, and suspension of provision.
JAKMAN also provides for nonconformities identified after delivery through the Return Material Register. It captures the customer, product, return reason, warranty status, completed RMA-form status, tagging, check-in person, disposition, controlled location, attachments, and related action.
