Streamlining Quality Management Processes for ISO 16949

Documentation requirements
Executive dashboards, analytics and reports are critical for proactively managing compliance and quality programs. MetricStream Enterprise Compliance Platform has a built-in reporting engine that provides powerful data analytics and business intelligence. Role-based dashboards, control diagrams, and scorecards provide visibility into the ongoing compliance efforts and bring high-risk areas into focus.

MetricStream solutions have the ability to track issues, task ownership, assessment plans, remediation status, etc. on graphical charts with real-time information that can be accessed globally. Ability to drill-down to deeper levels of information with a single click provides an easy way to access the data at finer levels of detail.

Human resources
The MetricStream solution ensures that the training requirements are fully met and recorded from a compliance standpoint as well as provides employees easy access to a variety of training programs delivered by expert trainers and compliance specialists from around the world.

General
Effective training management drives quality control by ensuring all personnel are trained to adequately perform their jobs. For companies whose operations require compliance with federal regulation such as FDA and OSHA or are following quality standards such as ISO 9000, 16949, 14000, streamlined training procedures and ability to monitor the effectiveness of training are also essential to reducing the risk of noncompliance.

Competence, awareness and training
MetricStream Training Management solution provides the ability to maintain training offerings and descriptions for easy review. It records feedback on instructors and course material effectiveness, and conducting evaluations. Graphical executive dashboards and flexible reports with drill-down capability provide training data by a variety of parameters such as by department, skill, experience, location, and individual employees.and ability to monitor the effectiveness of training are also essential to reducing the risk of noncompliance.

Training
MetricStream Training Management solution provides the ability to maintain training offerings and descriptions for easy review. It records feedback on instructors and course material effectiveness, and conducting evaluations. Graphical executive dashboards and flexible reports with drill-down capability provide training data by a variety of parameters such as by department, skill, experience, location, and individual employees.and ability to monitor the effectiveness of training are also essential to reducing the risk of noncompliance.

Purchasing

Regulatory conformity: MetricStream Inspection Management and Nonconformance Management solutions ensure that the incoming material and finished products meet the established specifications.and ability to monitor the effectiveness of training are also essential to reducing the risk of noncompliance.

Supplier quality management system development training: The Inspection Management solution enables companies to maintain a consistent and systematic process for collecting, analyzing and plotting key inspection data to detect variances and identify nonconformance in incoming components and finished products. It provides a flexible means to define sampling plans and inspections criteria.

Incoming product quality: The solution provides an easy to use interface for inspectors to enter inspections data based on pre-defined sampling plan and inspection criteria. It allows creating sampling plans with part numbers for suppliers and setting up of qualitative inspection criteria as pass/fail or quantities measurement of an attribute with lower and upper specification limit values. The solution provides easy access to suppliers to input data related to products. This data can be analyzed and meets the goal of supplier conformity with in Technical Specification provided for the products.

Production and Service Provision

Preventive and predictive: MetricStream Equipment Management solution enables scheduling of general preventive maintenance, cleaning and calibration based on type and frequency of use to ensure that manufacturing equipment operates within the parameters necessary to produce products that meet established specifications. It automatically generates work orders for appropriate personnel and notifies production managers of the schedule in advance. Users can track and escalate due work orders to avoid delays and initiate evaluation of impact of out-of-tolerance measurements on in-process or finished products. Reporting provides complete visibility into the equipment inventory, maintenance/repair costs and performance metrics across the enterprise with easy status tracking of schedules and activities

Feedback of information from service: All records from the preventive and remedial maintenance which are caused by exceptions are kept and can be analyzed.

Validation of processes for production and service provision: The system routes maintenance requests to unit head for review and approval. It automatically assign maintenance task to appropriate personnel and generate work orders with email notifications. Users can initiate equipment recalibration or repair based on a corrective/preventive action or a change request and trigger SOP change or training request if appropriate. Reports can be generated on usage history, warranty and cost of maintenance.

Monitoring and measurement

Internal audit: MetricStream Audit Management solution is a comprehensive system that enables companies to manage all audits within an organization as well as audits of external entities, such as suppliers and contractors. It provides capabilities to efficiently plan, schedule and conduct audits, allows audit findings to be reviewed and analyzed by a team,enables initiation of follow-up activities such as corrective/preventive actions when needed, and provides the ability to monitor the entire process. The system allows creating an audit package with a defined objective and scope, organize audit in a logical structure and hierarchy with detailed checklists, evaluation and pass/fail criteria and tasks that need to be performed for executing the audit. Audit frequency and methods can be defined in the planning stage.

Quality management system auditmaintenance: Audits can be planned to verify compliance with technical specifications and other quality requirements.

Manufacturing process audit: The solution provides capability to schedule audits of each product, part or manufacturing process. It records all audit trails and results can be analyzed using strong reporting capability provided in system. Graphical dashboards help in analyzing and finding out effectiveness of manufacturing process.

Product audit: Audits can be planned for several stages in manufacturing process to ensure that all specified requirements related to product are met as per guidelines. Any variance or deviation raises alerts. These audits can be set on regular intervals and provides real-time visibility.

Auditing plans: The solution provides capabilities to efficiently plan, schedule and conduct audit for all quality related processes, and activities. The solution allows users to define an audit universe and create a risk-based annual audit plan to perform compliance audit. The system provides audit plan, audit programs, project schedule and various resources plan which can be dispatched to the auditors for conducting internal audit. Audit Engagement letter can be produced for issuing to the auditors and respective departments under audit. The solution provides various tools, utilities and reports for manpower planning.

Staff profiles information

Audit assignments and schedules for each auditor

Time budgeting and tracking information

Master audit calendar

Audit calendar – auditor wise

Auditor calendar and availability

Monitoring and measurement of processes: MetricStream solution provides capability to ensure that the incoming material and finished products meet the established specifications. The Inspection Management solution is a comprehensive system that enables companies to maintain a consistent and systematic process for collecting, analyzing and plotting key inspection data to detect variances and identify nonconformance in incoming components and finished products. It provides a flexible means to define sampling plans and inspections criteria. The powerful analytics and reporting capability with graphical dashboards give managers complete real-time visibility into the quality system and provide critical information for investigating nonconformance and executing corrective/preventive actions.

Monitoring and measurement of product: The solution provides an easy to use interface for inspectors to enter inspections data based on pre-defined sampling plan and inspection criteria. Incomplete inspection tasks show up on the To Do list of the assignee; reminders are sent to ensure timely action and failure to complete inspection by due date triggers escalations. Initiate internal or supplier corrective action (CAPA or SCAR) when nonconformance is detected to ensure follow up investigation and root cause analysis. It routes inspection data for review and approval. Complete inspection records for components inspected along with details of activities performed, dates, results, authorizations and equipment used are maintained as a part of the batch/lot record.

Control of nonconforming product: MetricStream Nonconformance Management solution is a comprehensive system that enables companies to establish and follow consistent procedures for material or processes that does not conform to desired specifications. The module supports identification, evaluation, segregation and disposition of nonconforming material as well as case investigation and tracking, possibly leading to a corrective action (CAPA).

Control of nonconforming product - Supplemental: When a product nonconformance occurs, the system allows initiating a nonconformance record and assigns a unique case number that can be used to track the incident as it goes through various stages. It provides detailed information about the issue. Users can categorize the issue type based on pre-defined criteria and select severity level as well as identify the responsible department or supplier and send notifications.

Control of reworked product: Procedure for rework, retesting and reevaluation can be initiated after determining quantities for return to vendor, use as is, rework and scrap. The data is applied to defects PPM metrics to enable constant monitoring of supplier performance. Enables triggering automatic alerts and notifications to appropriate personnel for initiating immediate remedial action to contain the impact of the nonconformance and conduct failure investigation to identify root cause.

Analysis of data

Analysis and use of data: MetricStream solutions provide complete real-time visibility into the audit, inspection, equipments and nonconformance data with analytics for trend analysis. Graphical executive dashboards and flexible reports, with drill-down capability, provide statistics and data by a variety of parameters. These reports help in analyzing conformity of product based on requirements, audits, nonconformance, supplier charge backs and corrective actions.

Improvement

Continual improvement: Corrective Action/Preventive Action (CAPA) is the core of a sound quality management system and is central to a closed loop, continuous improvement process. It provides end-to-end exception and change management capabilities to help companies capture problem data from anywhere in their operation, conduct investigation to determine the root cause, manage the entire preventive and corrective process, implement changes, and ensure that the problem is resolved effectively.

Manufacturing process improvement: MetricStream CAPA Management solution allows initiating of CAPAs based on exceptions and nonconformance during manufacturing process and provides a detail description of problem. User can also relate this to prior CAPA for trend analysis and getting to root cause. This helps in continuous improvement of manufacturing process.

Corrective action: Organization can define and set up workflow-driven procedures for corrective actions. The system assigns corrective action owner with the investigation task based on the responsible department and event type; a cross-functional team of investigators may also be assigned the task depending on the severity. Users can conduct the root cause analysis to identify the source of the problem and categorize the type of issue such as a process issue, human error or equipment problem. The system can be used to chalk out the detailed action plan with an estimated completion date and assign responsibility to carry out the action plan. It enables root-cause analysis and records action plan details to be reviewed and evaluated by quality managers who can approve the plan or send it back to the corrective action owner if the plan is not satisfactory seeking more information on the analysis.

Approval trigger automatic email notifications and the case appears in the To Do list of the person responsible to carry out the action plan with the assigned due date; failure to act in time triggers escalations. The system communicates required changes to all affected areas such as documents, equipment or training. Users can track the completion status of the action plan based on pre-defined milestones and trigger alerts when delays occur.

Corrective actions with high severity can be marked for follow up activity after a specific time period to confirm effectiveness of the action; the result of the follow up task is routed back to the quality unit for approval and final closure of the corrective action.

Problem solving: The solution allows user to analyze and get to the root cause identification and set up corrective actions.

Error-proofing: Checks and balances are created throughout the system to avoid errors. System requires root cause analysis and action plan details to be reviewed and evaluated by quality manager who can approve the plan or send it back to the CAPA owner if the plan is not satisfactory seeking more information on the analysis. Approval sends automatic email notifications and the case appears in the To Do list of the person responsible to carry out the action plan with the assigned due date; failure to act in time triggers escalation. The system communicates required changes to all affected areas such as documents, equipment or training. Users can track the completion status of the action plan based on pre-defined milestones and trigger alerts when delays occur.

Corrective action impact: Corrective action is a closed loop process and all actions are tracked and reported back to the team. Corrective actions can be marked for follow up activity after a specific time period to confirm effectiveness of the action; the result of the follow up task is routed back to the quality unit for approval and final closure of the Corrective action.

Preventive action: The solution provides distinct workflows form preventive actions. Each step in the preventive action process is documented and the system provides complete visibility into the progress with easy status tracking. A transparent system with each case traceable from any desktop in the organization makes preventive action management and execution a predictable and efficient process. Graphical executive dashboards and flexible reports, with drill-down capability, provide statistics and data by a variety of parameters such as preventive action counts by status, category, priority and action type. This analysis ensures prevention of nonconformities throughout the system.