|ISO / TS 16949 / QS 9000 Requirements||MasterControl Features|
|(ISO / TS 16949 Clause 4.2.3 Control of Documents)|
Documents required by the quality management system shall be controlled in terms of review/update, changes/revisions, distribution, approval, etc.
MasterControl Documents™ automates routing, escalation, approval, and delivery of SOPs, policies, and other documentation. Provides a centralized Web-based repository that's secure, but at the same time accessible to all authorized users which ensures implementation of quality standards like QS 9000. MasterControl provides automatic revision control to ensure compliance with ISO standards that only the current version of an SOP is available. When a user makes a change in the "InfoCard" (the MasterControl tool that provides basic information for every record), the user must enter a reason for the change. The system tracks these changes and makes them available through reports.
|(ISO / TS 16949 Clause 188.8.131.52 Training)|
The organization shall establish and maintain documented procedures for identifying training needs and achieving competence of all personnel performing activities affecting product quality.
MasterControl Training™ automates assignment and monitoring of training tasks and grading of online exams. Allows sequencing of training courses, so after a prerequisite is completed, the next course is automatically launched. Provides group sign-off feature for verifying training of large groups of employees.
|（ISO / TS 16949要求事項7.1.4変更管理）|
The organization shall have a process to control and react to changes that impact product realization according to ISO regulations.
MasterControl Change Control™ streamlines the entire change control procedure for faster turnaround. It offers a best-practice form to ensurance compliance with TS 16949 standards that incorporates priority level and prompts risk assessment according to quality standards and classification of the change as low, medium, or high. Any high-level change is likely to require regulatory filing. Customizable reports provide real-time status of change control tasks and the entire quality system.
|(ISO / TS 16949 Clause 7.2.3 Customer Communication)|
The organization shall determine and implement effective arrangements for communicating with customers in relation to product information-customer feedback, including customer complaints which will lead to quality processes implementation.
MasterControl Customer Complaints™ streamlines the complaint-handling process and reduces the lifecycle from submission to resolution. A simple, three-step process is incorporated in a pre-configured, multi-page form that starts with processing of a complaint, moving to internal investigation, and culminating with issue resolution which ensures quality standard like QS 9000.
|(ISO / TS 16949 Clause 8.2.2 Internal Audit)|
The organization shall conduct internal audits at planned intervals to determine whether the quality management system conforms to the planned arrangement-and is effectively implemented and maintained.
MasterControl Audit™ automates, streamlines, and effectively manages the audit process. Provides advanced tracking capability, from scheduling and planning to execution and completion. Offers best practice forms for tracking basic audit information and audit findings. Automates scheduling of all recurring audit-related activities and provides analytics and reporting capability for Increased Management Visability.
|(ISO / TS 16949 Clause 184.108.40.206 Problem Solving)|
The organization shall have a defined process for problem solving leading to root case identification and elimination.(ISO / TS 16949 Clause 8.5.3 Preventive Action)
The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence.
MasterControl CAPA™ integrates the corrective and preventive action process with other quality processes of ISO. Provides best-practice "8D" process that guides the quality team through every step of CAPA. A CAPA form can be launched directly from another form (i.e., a nonconformance report). Automatically enters relevant data into a CAPA form, reducing data entry and eliminating errors from manual transfer of information. Provides customizable reporting capabilities to help managers monitor entire quality management life cycle according to QS 9000.