The ISO 13485 Standard demands the organization establish and maintain a systematic identification of its business activities and process results throughout the material flow. The identification shall be according to specifications: medical device specifications and safety and regulatory requirements. The objective of the identification is to ensure products at all levels and stages of the realization process will be identified regarding their production, change, and quality status. The identification shall also eliminate the risk of mixing products, parts, or materials from different origins or with different statuses.
Identification of the medical device, its products, materials, components, and related activities
Identification refers to the establishment of a method or an activity with means for identifying an object and providing evidence of its identification and status. For example, the identification of a raw material shall indicate its expiry date, material safety data sheet (MSDS), date of manufacture and of arrival, storage conditions, and COC. Another example is that a manufactured part (process result) shall be identified with the catalog number, marking date of production, edition, model, lot or batch numbers, and relevant quality protocols. The conclusion of these types of data shall indicate the usability status of this material; it is allowed to be used in the realization or not. Data that may serve for identification and status determination include the following (but not limited):
- Product ID numbers—Information regarding the nature and character of the element
- Serial number, batch or lot number—Information regarding the history and origin of the element
- Dates like validity dates or manufacturing date—Indication regarding the status of the element
Developing methods for product identification
The identification of a product is regarded as the collection of related information throughout the supply chain management that indicates the identity of the process result in organizational terms and its status. Thus, it is necessary to define and develop a system, method, and structure for implementing and integrating identification methods in the processes of the QMS, respectively, for the process outputs. The principle of the identification is very clear—I could take a medical device and dismantle it to its smallest constituents and be able to tell the story of each one of them: where it came from, when it was assembled in the medical device or used in its realization, and when and what its status was as it was introduced to the medical device. In my book I review all the elements that are to be identified. Through the assignment of activities, means, methods, and identifiers throughout the material flow such as codes, tags, or product serial numbers, products will be correctly integrated in the realization processes The organization shall define activities for identifying the different process results in the different stages of the realization until finalizing the medical device and integrate those activities in the realization of the medical device.
Documented procedures for product identification
The organization is required to establish and maintain documented procedures with the main objective of describing the activities and techniques and how product identification shall be integrated in the realization processes of the QMS. In the book all issues that the procedure must refer to are specified.
Suitable means for product identification
The implementation of identification must be suitable to the type of the process result; in other words, the means of identification and the techniques that will be used must be proper for the type of element they will be identifying.
Unique device identification
Not to be confused with national or local unique identification numbers required by regulatory bodies, the organization will apply a unique device identification (UDI) to each released medical device when required by regulatory requirements. The UDI is an effective method (but not required by the ISO 13485 Standard) for ensuring exclusive identification for medical devices. The UDI system is intended to provide a single, unique device identification of the medical device, and every medical device shall be uniquely identified. I review in the book all the objectives of the UDI and specify which issues shall be considered.
Determining the status of products
The status of products shall be integrated in the management of materials, parts, components, and finished goods. When it comes to services, the status shall indicate whether the service was completed and the target object of the service is usable. The objective of status identification is to ensure that only products that have passed the required inspections and tests or been released under an authorized concession are released, used for the realization, or installed in the medical device. In other words, the status enables and manages the transition of goods in the workflow of the realization.
The status refers to the relative position or a state of product in a particular point in the process stage and the certain characteristics it bears at that point. Applying status management ensures that the product or the service, components, parts, and materials are being controlled and introduced to the necessary activities, tests, inspections, or concessions before they are released to the next stage (i.e., introduced to a process, packed, delivered, or installed). The syllogism is that a status of the product indicates its history. Allow me to explain. When I pick a product with a certain status, it means that the product went through different realization stages through which it earned its status. Objectives of status management include:
- Eliminating the possibility of mixing materials, parts, components, or products with different statuses
- Indicating in which process stage the product is situated
- Situating a product in its life-cycle
- Providing information regarding the fulfillment of the product’s requirements
In my book I review methods for implementing status management in the QMS.
Reference to the quality plan
The determination of the identification and status may be integrated with the quality plan and may cover the entire life-cycle of the product: material, development, production, storage, installation, and servicing. The status can indicate where the product is situated regarding the plan. Another way to put it is that the progress of a product in the life-cycle determines and indicates its status.
Integration of identification and traceability in risk management
When risk analysis indicates that there are some critical characteristics that must be identified, identification, traceability, and management of status will assist you in controlling these characteristics. Basically, the level and extent of identification will be determined according to the type and class of the medical device. The necessary controls of the detected risks may be identifiers like validity date or labeling that indicate how the product may be used. In the book many examples are reviewed and presented.
Nonconforming medical devices
Nonconforming products, raw materials and products that have been rejected, recalled, or found not to meet their specifications, should be exclusively identified in the organization. The objectives of identifying nonconforming products are to
- Notify the users of the QMS of the defective products
- Avert the use or installation of such products by distinguishing them from conforming ones
- Change the status of the product
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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