In the ISO environment, the concept of change control is closely interwoven with conformance. ISO-certified manufacturers are expected to establish change control procedures as a way of improving overall product quality. ISO 9000 requires management to examine all changes that might affect the quality of the general manufacturing change control system. ISO 14000 requires correction of nonconformities, including modification of documents, and at the same time maintaining procedures to control documents.
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In a continuous effort to bring harmony to the general framework of processes, it is important to maintain communication between all the various departments and users within the system. Outdated legacy change control systems have proven that they lack the capability to bring users from several sources into a common platform. Such disconnects during the change control process eventually lead to confusion, communication gaps, and ultimately chaos. Management understands the criticality of following up on tasks, and notifying recipients about tasks not being completed within deadlines that helps users remain within the estimated time allotment for task completion.
This is where MasterControl general manufacturing change control software addresses the basic needs of manufacturing companies by providing an online platform shared between many types of users who only require login credentials to access the portal. Through this software, users across several departments can connect and share data and processes. This connectivity vastly improves efficiency through automatic task assignment, routing, scheduling, notification, and escalation of incomplete tasks.
The primary objective of the MasterControl general manufacturing change control software solution is to simplify the most tedious tasks such as approval of documents and allow them to be approved via forms. A link associates a document pending approval with a change submission form which leads to approval without needing to go through a repetitive approval cycle. To provide managers with better control over task management, a task's completion can be made dependent on another task. Apart from reducing the cycle time for prompting users to move to subsequent tasks, the software also provides an innovative dependency tree that outlines and illustrates the relationships between dependent processes.
General manufacturing companies realize the value of time and also the benefits of timely and effective system processes. Similarly, change control processes must also be efficient and produce favorable outcomes. However, most legacy-based change control systems lack the capability to generate the required data and route documents for an effective approval lifecycle. The earlier a change is implemented in a controlled manner, the easier it is to manufacture compliant products that are also cost-effective. MasterControl general manufacturing change control software systems are designed to streamline the entire change control procedure in accordance with the business requirements of any size organization.
The use of best-practice forms helps in collecting and tracking data at every stage of the change control process. MasterControl forms are divided in several sections, which makes it easier to store relevant information pertaining to a change (such as its description, justification, impact, etc.). Users can compare original and revised documents for evaluation. Since the initiator plays a pivotal role in the change control process, MasterControl general manufacturing change control software systems are designed to allow the automated forms to be used for many changes, depending on how many documents / items are affected by a change. For example, the form for a change in a component used in making 10 products can have 10 attachments, greatly streamlining the process. The system is also useful in qualifying the type of change by asking the initiator to evaluate the change in terms of training, validation, and regulatory requirements, which prompts an automatic risk assessment within the general manufacturing change control software. It also asks for classification of the change as low, medium, and high. Any high-level change implies great impact on the product and is likely to require regulatory filing. The priority of the change incorporated in the system can either be categorized as routine, temporary, or emergency. Additional forms can be customized within the general manufacturing change control software system based on the company's particular needs.
To integrate the change control process within the system, MasterControl general manufacturing change control software allows form-to-form launching. A change submission form can be launched directly from a Corrective/Preventive Action (CAPA) form, connecting one process to the next. Not only does MasterControl general manufacturing change control software streamline this process, but it also maintains the links so the user can review a completed process and easily see what triggered the change. The relevant information from the CAPA form is automatically entered into the change submission form, reducing data entry. The MasterControl general manufacturing change control system also shows the history of the entire process.
Once a change is properly implemented, the next step is to educate employees with the changes made in SOPs, policies, and other critical documentation. Training is a crucial component of the user education program. Instead of spending extensively on elaborate training programs, management can readily integrate the change control process with the training application. Any change to a document that warrants new training will automatically invoke training tasks. MasterControl can automate the process of distributing online exams with the training, and even includes automatic grading.
MasterControl general manufacturing change control software facilitates the conducting of elaborate searches for documents that require change. With the help of Organizers, users can search and retrieve documents effortlessly. All SOPs and other documents related to a particular change can be grouped together. A general manufacturing change control system allows user to create virtual folders within Organizers that will automatically retrieve documents based on pre-defined queries.
In order to analyze data and develop a profound insight into the state of the change control process within the system, management can use the MasterControl general manufacturing change control software system to generate different types of useful reports. The representation of data in summarized formats on various levels helps in dividing data as per business requirements. Data can be grouped together by a date interval and then charted over a date range. For example, the number of customer complaints that have led to a change can be totaled for each week and then charted for the last year.
To learn more about General Manufacturing Change Control Software Systems, please feel free to contact a MasterControl representative.