VV_7.0_Product (Service) Realization

7.0  Product (Service) Realization

7.1  Planning of Product Realization

Product realization at Supply Direct is defined as purchasing dental supplies, warehousing it, and then creating and delivering a Customer Order which meets the customer’s requirements. Product realization is a planned process at Supply Direct. Product realization records are maintained in the Supply Direct Business System and Inventory Control System.
When further planning is needed, such as a corrective or preventive action, or process improvements, managers will plan accordingly and include:

• The need for Quality **objectives for the process to ensure effectiveness of the process. Quality Objectives will be measureable.
• The need for **requirements for the product. This includes the individual components and the customer order.
• The need for a process. Processes will be developed to support product realization where necessary. These processes will be documented as needed to ensure consistent product realization.
• The need for **resources specific to the product. This includes the order and parts.
• The need for **Inspection specific to the product. This includes the order and parts.
• The need for Records. Such as records of order processing and inspection.
• Documentation of the analysis, plan and implementation.
• The need for Risk Management.

Applicable Procedures/Instructions:
Procedure-Purchasing
Procedure-Handling, storage, packaging and delivery
Procedure-Managing Non-Conformances
Procedure-Risk Management

7.1.1  Project Management

When required Supply Direct will plan and manage product realization in a structured and controlled manner to meet requirements at acceptable risk, within resource and schedule constraints.
 

7.1.2  Risk Management

Supply Direct has established, implemented and maintains processes for managing risk to the achievement of applicable requirements that includes as appropriate to the organization and the product.

• assignment of responsibilities for risk management,
• definition of risk criteria,
• identification, assessment and communication of risks throughout product realization,
• identification, implementation and management of actions to mitigate risks that exceed the defined risk acceptance criteria, and
• acceptance of risks remaining after implementation of mitigating actions.

7.1.3  Configuration Management

Configuration management consists mostly of unique Part Numbers assigned to product by both the manufacturer and Supply Direct. If a part materially changes the manufacturer will sell the product to Supply Direct with another unique part number assigned by the manufacturer. Customer assigned part numbers are verified and assigned at time of the order for recording on documents to the customer. Customer part numbers are not part of Configuration Management.
 

7.1.4  Control of Work Transfers

Supply Direct performs limited work transfers through sub-contracted suppliers.
 

7.2  Customer-Related Processes

7.2.1  Determination of Requirements Related to the Product

Basic customer requirements, specific manufacturer and part number, quantity, and delivery service are selected by the customer at the time the order is requested. Post-delivery activity consists of product returns and customer-initiated Corrective Actions.
Product specific requirements such as ESD, Packaging, etc. are met through process control even when not stated by the customer.
All applicable statutory and regulatory requirements, such as hazardous material, will be met.
Any additional requirements considered necessary will be addressed at the time the order is placed by the customer. Customer requirements arising after order placement will be handled on a case-by-case basis.
 

Applicable Procedures/Instructions:
Procedure-Design and Development

7.2.2  Review of Requirements Related to the Product

The process of the determination and review of requirements related to the products is accomplished through the sales ordering and marketing processes

Prior to the acceptance of a contract, the bid or order is reviewed to ensure that: 

• The requirements from the customer are adequately defined and documented; 
• Orders received by verbal means must be documented and agreed in writing before final acceptance;
• Any requirements differing from those in the accepted order and those in the bid are resolved;
• The facility has the capability to meet the accepted sales order requirements.

Applicable Procedures/Instructions:
Instruction-PMS
Instruction-Field Safety Corrective Action (FSCA) and Field Safety Notice

7.2.3  Customer Communication

The Organization has implemented arrangements for communicating with customers in relation to:

• Product information – via instruction manuals, quick reference guides and product-specific materials
• Enquiries, order handling, including amendments – primarily via e-mail or telephone
• Customer feedback, including customer complaints.
• Advisory notices and communication with regulatory authorities with respect to relevant requirements.

Applicable Procedures/Instructions:
Instruction-Complaints Handling
Instruction-Field Safety Corrective Action (FSCA) and Field Safety Notice
Instruction-PMS

7.3  Design and Development

Not Applicable. As an Authorized Representative, Importer, and Distributor, Supply Direct does not design or manufacture any products.
 

7.4  Purchasing

7.4.1  Purchasing Process

The organization performs purchasing of products, materials and services. Purchasing of such is conducted in accordance with established specifications for products, materials and services, including assessment of whether supply is critical or not.

Suppliers conducting The organizations specific processes are handled according to the supplier selection and evaluation procedures.

Selection of suppliers are based on;

• Suppliers ability to meet The organization’ requirements and possible certifications
• Performance of suppliers
• The purchased material’s effect on product quality
• Risk associated with the product.

Suppliers are monitored and evaluated periodically, and non-fulfilment are addressed with the suppliers proportionate with the risk and regulatory requirements.

The extent of the control of the suppliers is dependent on the type of product provided and the importance of the deliverables on the quality of the final product. The assessment of suppliers can include:

• On-site auditing of the supplier QMS
• Accepting certification of the supplier’s quality system by supplier’s Notified Body
• Accepting product certificates by supplier’s Notified body
• Review of product specific technical documentation when available from supplier
• Accepting product certificates issued by supplier
• Evaluation of samples
• Records of past performances
• Purchasing Information 

Applicable Procedures/Instructions:
Procedure-Contract Review

7.4.2  Purchasing Information

Purchasing information that clearly describes the product ordered are established, including where appropriate: 

• Material specifications
• Requirements for acceptance
• Requirements for qualification of supplier personnel – where appropriate
• QMS requirements at the supplier

Suppliers of The organizations’ specific materials are supplied with a contract which defines the requirements for the supplied materials.
 

7.4.3  Verification of Purchased Product

The organization controls the release of purchased products to assure that they meet the specifications and any applicable regulatory requirements in accordance with product specific instructions, defined by The organization.

The purchasing function carry parts of the responsibility to purchase, retrieve and verify materials purchased for the production and test of The organizations’ products. 

Applicable Procedures/Instructions:
Procedure-Receiving control
Procedure-Purchasing
Procedure-Managing Non-Conformances
Instruction-Product Release

7.5  Product and Service Provision

7.5.1  Control of Production and Service Provision

The organization secures that the manufacturing procedures are planned and carried out as outlined in Work instructions for the manufacturing processes. This includes the following;

• The availability of information that describes the characteristics of the product,
• The availability of work instructions,
• The presence of suitable equipment and clean rooms,
• The availability and use of monitoring and measuring devices,
• The implementation of process monitoring,
• The implementation of release and delivery activities, and
• The implementation of defined operations for labelling and packaging

The production is planned and carried out under controlled conditions, in accordance with the work instructions as maintained and approved by The organization.

Applicable Procedures/Instructions:
Procedure-Inspection and Testing
Procedure-Inspection- and test status
Procedure-Purchasing
Procedure-Handling, Storage, Packaging and Delivery
Procedure-Calibration and Inspection-, measuring- and test equipment
Procedure-Process and Software Control
Procedure-Managing Non-Conformances
Instruction-Product Release

7.5.2  Cleanliness of product and contamination control

Not Applicable.

7.5.3  Installation activities

An employee or representative from The organization must install the Device with the users and trains the users in the operation of the Device according to the user manuals. 
Records of such installation carried out is documented and maintained. 

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7.5.4  Services activities

The organization conducts service of The Device when there is a need for service, repair or maintenance. Such activities may be conducted on-site or in-house as convenient. 
Records of service are maintained with the original device history record per serial number and service records are analysed to determine if the information shall be treated as a repair and if improvements are needed.

7.5.5  Particular requirements for sterile medical devices / products with limited shelf time

Records of sterilization for Devices are supplied from our sub-contractors and evidence of the defined parameters applied in the sterilization process is checked for each sterilization batch which are also traceable to the product lot numbers.

7.5.6  Validation of Other Processes

Not applicable. (This area has intentionally been left blank)

7.5.7  Particular requirements for validation of processes for sterilization and sterile barrier systems.

Not applicable. (This area has intentionally been left blank)
 

7.5.8  Identification

The organization secures that product identification, traceability and status identification will be maintained throughout the product realization processes in accordance with receiving, production and delivery related procedures from The organization.

Barcodes are implemented on labels, but The organization does not yet utilize UDI for maintaining traceability as implementation of the UDI system is not mandated for use until transitioning to the new European Medical Device Regulation (MDR).  

Product inspection and test status indicates the conformance or non-conformance of the product with regard to the inspections and tests performed. 

The product status is maintained throughout the production cycle to ensure that only product that has passed the required inspections and tests and with the status “approved” are delivered to the customer.

Returned medical devices are identified and distinguished from conforming products.

Applicable Procedures/Instructions:
Procedure-Product Identification and Traceability

7.5.9  Traceability

7.5.9.1. General

Procedures for the traceability of medical devices has been established to define the extend of traceability towards products delivered and components/materials used.

Applicable Procedures/Instructions:
Procedure-Product Identification and Traceability

7.5.9.2. Particular requirements for implantable medical devices

Not applicable as The organization do not provide implantable medical devices.

7.5.10. Customer property

Customer property is identified, protected and safeguarded through the individual serial number or the batch number while the device is in The organization’s possession. 

If customer property is lost, damaged or other Instructions found unsuitable for use, the customer is notified via the complaint system.

7.5.11. Preservation of Product

Preservation of product is established and maintained during identification, handling, packaging, storage, and delivery of the product.
Products with limited shelf-life are controlled by the expiry date through the warehouse system.

Applicable Procedures/Instructions:
Procedure-Handling, Storage, Packaging and Delivery

7.6. Control of monitoring and measuring equipment

Not Applicable.