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The organization is required to plan and perform production and service provision under controlled conditions. The control must be performed and achieved according to the planning requirements specified within clause 7.1 (Planning of Product Realization). The control would apply to all realization processes, and would include activities such as:
  • Production activities
  • Product release activities
  • Replication activities
  • Sterilization processes
  • Delivery activities
  • Transportation activities
  • Installation activities
  • Maintenance activities (support and services)
  • Operation activities
  • Labeling activities

For example, if the medical device is to be sold in a sterile condition, the sterilization method must be defined, documented, recorded, and validated. The planning and carrying out of controlled conditions for the production and service provision will refer to the next issues (as far as is applicable).
This chapter deals with the controls over the different elements and resources that combine the realization processes, and specifies the requirements for achieving controlled production conditions. Once again, the goal is ensuring conformance to the medical device specifications. The control shall be planned in accordance with the medical device requirements and specifications (i.e., those specified in clause 7.1). The customer, the manufacturer, and the local authority should have decided upon and documented the particular requirements and specifications required to realize the medical device. Now is the time to ensure—supported by objective evidence—that the medical device is realized and conforms to the specifications. A good way of doing this is via a well-controlled realization process.

Determination of Conditions

Before planning and submitting the controls, the manufacturer shall define and determine the required conditions necessary for the realization of the medical device:

  • Activities
  • Means and resources

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 included quality objectives, goals, product specifications, realization means, and resources. Now is the time to verify that the conditions to achieve the plan are applicable. The conditions will be determined in accordance with the medical device specifications.
The conditions are combined from the elements that influence the realization processes:

  • Environment
  • Machinery
  • Tools and equipment
  • Materials
  • Human resources
  • Knowledge
  • Regulations

If we take a few steps back in the process and return to the development labs, we can see that the issue of controlled conditions was to be accounted for there. During the development of the medical device you will have already designed the processes and activities that will transfer the specification to a product. The realization conditions were also to be considered. The output should have included the condition requirements.

Tools and Equipment

Tools and equipment used during product realization must be under control. It is required that you define the controls and maintenance activities that are to be implemented.
The functionality of tools and equipment is affected when they are not properly maintained and controlled. This also directly affects the medical device. The required maintenance activities of tools and equipment shall be defined, documented, and made available for the person who uses them and realizes the product with them.
The goal is to ensure that the information related to the tools and equipment includes adequate information, and is available at the workstations at the realization stage. It is necessary that you identify the departments or individuals that use these tools and equipment, and that you verify that they are trained, qualified, and have the appropriate skills to operate them. When determining the control on tools and equipment, one shall estimate the affect that the tools and equipment have on the medical device. The extent of the control shall be determined in accordance with their extent of their use, and their affect on characteristics of the medical device. In cases where the issue is critical, the manufacturer will develop processes and procedures in order to increase control. This is related to risk analysis.
For example, when an employee operates equipment during the sealing process, an improper operation will result in a defective medical device. Suppose that a required maintenance activity had not been performed; the outcome will likely be a far from desirable one. You are required to ensure that:

  • The worker is trained and qualified
  • The operation instructions are available to them
  • The equipment is maintained and controlled
  • In cases where there is a risk for the safety and intactness of the tools and equipment, a measure of precaution should be implemented in order to ensure their protection.
  • Under tools and equipment we may encounter:
  • Vessels
  • Mixers
  • Work tools
  • Molds
  • Production tools
  • Computer software
  • Test equipment
  • Maintenance equipment
  • Assembly tools
  • Electronic equipment

Infrastructure and Work Environment

The infrastructures related to the product realization must be under control. The requirements for the controls are specified in clauses 6.3 and 6.4. It is defined there how one must plan and implement controls and maintenance activities into the infrastructure and work environment of the realization process. The functionality of infrastructures and work environments is affected when they are not properly maintained and controlled. This directly affects the medical device too.
The control and maintenance activities of infrastructure and work environment shall be defined, documented, and made available; once for the person who uses it to realize the product, and twice for the person responsible for maintaining and servicing it. The goal is to ensure that the documentation related to the infrastructure and the work environment used to realize the product includes the adequate information, and is available to the appropriate parties. In order to maintain it effectively, you are required to define which parameters that can affect the medical device; thus, which are essential for control.
Process parameters that are influenced by the infrastructure and work environment include:

  • Cleanliness
  • Sterilization
  • Orderliness
  • Temperature
  • Humidity
  • Particle count
  • Electrical current
  • Speeds
  • Pressure
  • Accuracy
  • Tension
  • Geometrical measures
  • Machine cycles
  • Technical performances

 

Release Activities

The release activities are to be defined and controlled. The objective is to prove that the manufacturing phase has been completed successfully, and that the medical device is a finished good ready for the delivery. This will be done with the definition of final acceptance activities or tests (final release tests)—that is, activities that will ensure that the product was realized according to the requirements—and that all controls were implemented, and the product meets the acceptance criteria. The activities will be supported with records. This requirement refers to each lot production, series production, batch production, serial production, jobbing work, or piece production. It does not mean that the control is finished—only that:

  • The production of the medical device is completed
  • The product went through all the required realization processes and activities
  • Each process was validated and approved according to specified criteria by an authorized person
  • The required realization records are verified, completed, and available
  • All the required validation activities (for products, parts, and processes), during and after the processes, have been completed and the results are satisfying
  • The medical device is identified and labeled as specified
  • The medical device is packed as specified, and the packaging is controlled
  • The medical device is stored in the appropriate conditions
  • All the required records are complete
  • The traceability is maintained as specified
  • The risk management activities has been appropriately implemented
  • Release of the medical device (approval that the medical device is ready for delivery)

This webpage contains only a fragment of the chapter 7.5 Production and service Provision from the book: ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry published by:

CRC Press

 You may purchase the book through:

 

Amazon

Complete Guide to Quality Management in the Medical Device Industry

 

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