The organization is required to perform the realization of the product and the provision of the service under controlled conditions. The control must be performed and achieved according to the planning requirements specified within clause 7.1—Planning of product realization. Implementing production and service provision under controlled conditions refers to the assurance of variables that affect the performance of an element used in the realization of the product or service. Control is achieved by applying and enforcing a set of principles and conditions that will guide and accompany the realization processes. The control allows the organization to monitor the different variables during the realization that may affect the performance of the QMS and the quality of the product and to extract reliable data and information regarding the realization. These data will be used to verify the results.
Ensuring product conformity to specification
Clause 7.5.1 deals with the controls over the different elements and resources that combine the realization processes with the goal of ensuring conformance to medical device specifications. The control shall be planned in accordance with the medical device requirements and specifications (i.e., those specified in clauses 7.1, 7.2.1 and 7.2.2). During realization, the necessary controls shall be put in place and supported by objective evidence that will ensure that the medical device is realized and conforms to the specifications.
Ensuring availability of defined conditions
Before planning and submitting the controls, the manufacturer shall define and determine the required conditions necessary for the realization of the medical device by means of activities and resources. It will be done by organizing and ensuring a set of conditions, processes, and activities that will transform requirements into a product. The implementation of realization processes includes specification of process inputs, parameters, and conditions that will ensure conforming process outputs, for example, under which conditions the intended outputs may be achieved, or the requirements of the process and the operating environment that are needed for achieving the intended outputs. The activities, means, and resources were defined as part of the quality plan while implementing the requirements from clause 7.1—Planning of product realization. The planning was done with reference to quality objectives, goals, product specifications, realization means, and resources. Now is the time to verify that the conditions to achieve the plan are available. The following principles are clearly defined:
- The organization shall define the condition necessary for the realization.
- The organization shall define the controls over these conditions.
- The controls shall ensure and provide evidence that the conditions are maintained during the realization processes.
Availability of required records for demonstrating the expected results
The organization is required to ensure that records that define the evidence and results of realization controls will be available during the realization of processes. The goal of the records is to facilitate traceability and review of the manufactured of a device or batch. The evidence shall indicate:
- The conditions at the time of the realization and the inputs that were delivered to them:
- Availability of suitable inputs for the realization
- Condition and status of resources
- Availability of knowledge and competence
- Availability of required documentation for the realization
- The results of process tests and their extent of meeting their specifications:
- Results of product characteristics
- Results of process parameters
I suggest in the book a system in order to effectively plan a format that will gather all the necessary data and information regarding the progress of the realization.
Controlling qualification of infrastructure
The organization shall define what the controls are that will ensure the qualification of infrastructures. Qualification of infrastructures refers to a set of activities that will indicate whether infrastructures are validated, suitable, and adequate for use in the realization of the medical device. Developing these controls is widely discussed in Section 6.3. Please refer to this section for the development of these controls. Here in clause 7.5.1, you are required to implement these controls during the realization of the medical device and provide evidence with conclusions regarding the validation status of the infrastructure and the equipment that will indicate that the infrastructures were qualified during the realization. In this book, I support the method of IQ, OQ, and PQ.
Labeling activities
Labeling is used for the identification, technical description, and use of the medical device and refers to the written, printed, electronic, or graphic matter affixed to the medical device:
- Attached to the medical device
- Attached on its packaging system
- Accompanying the medical device
The label has an important role in the use and functionality of the product; it is a printed or a graphic element that provides information regarding the intended use, performance, and safety of the medical device. It may be integrated in the medical device itself or on the package. The ISO 13485 Standard specifically requires defining the labeling processes: activities with which the label is integrated with the medical device and the controls to ensure their execution. In my book I refer to the following issues related to the labeling:
- Identification of the product itself
- The traceability and unique identification of the product (with serial numbers or batch numbers)
- Identification of components in the product
- The status of the product regarding its readiness for use, that is, not released, ready for use, and disqualified
- The product’s safety, functionality, performance, and intended use
- Special requirements such as regulatory requirements or applicable standards
Packaging activities
The operation and activity of packaging the product may be a critical issue and affect the quality of the medical device, and the packaging processes are reviewed as any other realization process. The packaging operations of the medical device—as well as the materials used in its containers and package—are to be defined, documented, and controlled. The objective of the control of the packaging activities is to ensure its compliance with the medical device’s specifications—that is, the validation of sterilization; sealing of packages (where required); the use of appropriate materials for a package; performing the right packaging activities (which will not harm the medical device); ensuring the safety, functionality, and performance of the device; and the preservation of packages while handling or storing them. Another objective is to instill awareness of the importance of the issue among employees. The handling of packages and materials will be controlled in order to preserve them and their characteristics during storage, processing, handling, and delivery. The controls shall cover issues like sealing of packages (where required); the use of appropriate materials for a package; performing the right packaging activities (which will not damage the product); ensuring the safety, functionality, and performance of the product; and the preservation of packaging materials while handling or storing them. The control of the packaging activities shall also include validation of equipment, tools, and processes, as well as materials. In my book I refer to the following issues related to the packaging activities:
- The packaging operations and their controls
- The activities of handling and working with packages
- Environmental factors to be taken into account
- Material and package specifications
- Information and instructions regarding the handling of the package
- Regulatory requirements, standards, and technical specifications related to the product that describe packaging requirements.
Release activities
Release of the product or service refers to the required activities and their documented approval that products or services that are delivered to the next stage of realization or delivered and eventually used. Release indicates that the released process results fully meet their specifications and requirements. The objective of release activities is to ensure that the realization of the product or service has been successfully completed and that the product or the service meets all its requirements and is ready for delivery to the next stage.
The organization shall implement planned and documented arrangements for the release of the product or service at appropriate process stages and locations needed to verify that the product and service requirements have been met. During the realization processes, one must ensure that those requirements are implemented and practiced. The general idea claims that the realization of a product is combined from various elements. At some point of the overall process, before delivery to the customer, the organization must stop and review the realization and decide whether the product meets its requirements. In my book I suggest effective way and method for conducting effective release activities according to the ISO 13485:2016 standard requirements.
This webpage contains only a fragment of the chapter 7 – Product realization from the book:ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry, Second Edition published by:
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