Manufacturing
Business Drivers
The manufacturing industry faces many common challenges such as
- Meeting compliance
- Faster time to market
- Efficient and high quality production
- Effective customer service processes
- Tightening credit markets and rising commodity costs, and
- Mounting margin pressures and uncertainty in consumer spending patterns
Increasingly more complex products, globalization, and the need to operate faster and leaner are just some of the pressures driving organizations to implement standardized and processes in their organizations.
Karomi Solutions
Karomi Solutions for Manufacturing provide companies the opportunity to increase overall business efficiency and accountability by decreasing reliance on paper-based processes. Automating and tracking key quality, compliance and back office processes with Karomi Workflow and Document Management improves visibility, decreases errors and oversights and reduces labor and other costs.
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Document Control :
Karomi Document Control System provides the ability to store, edit, distribute, and manage documents online. It includes features ideal for ISO, TS, QS, and other standards.
Types of Documents Quality Manual SOP, Work Instructions FMEA, Control Plan, Process Charts Checklists PPAP Gage Studies Engineering Drawings Training Materials Part images Product related documents Marketing Plan Supplier Handbook Contracts Invoices, Vouchers Karomi Document Management offers the following capabilities for Document Control
- User-Defined Hierarchical Directory Structure
- View/Edit Security Role
- Check In/Out Edit control
- Revision Tracking System
- Controlled Viewing/Printing/Emailing/Downloading
- Full Electronic Distribution
- Detailed Audit Logs
- Automated Periodic Review
- Electronic Approval workflow System
- Distribution Log
- Document/Drawing Annotation
- Multi-format document viewer
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Corrective and Preventive Action (CAPA) :
Karomi's web-based Corrective Action and Preventive Action (CAPA) management software grants you commanding flexibility when you find a nonconformance, accidents, incidents, supplier issues and customer complaints with your products or production processes. The ability to collect, correlate, investigate, and make informed improvements can be automatically executed with Karomi CAPA solution.
The software provides you a configurable, comprehensive anytime, anywhere Corrective Action Preventive Action tool. The web forms help guide you in fully identify, define, investigate and correct any nonconformance you have found. The configurable workflow allows you to monitor your solution from draft through effective verification of your corrective action/preventative action. This will help meet your compliance objectives for ISO, cGxP, OSHA, and FDA 21 CFR Parts 11.
Trend Reporting
Companies that choose Karomi understand that benchmarking leads to results. Karomi's built-in reporting tools enable you to quickly compare locations, business units, action types, and any other parameter of interest.
Benefits of the Karomi CAPA application:
- Accelerate corrective action cycle time
- Quickly record new corrective and preventive actions
- Meet ISO guidelines for managing CAPA
- Improve communication across the enterprise
- Centralize CAPA action planning
- Effectively manage milestones and key dates
- Automate reminders and other alerts
- Identify and understand trends
- Continuously improve products and processes
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Customer Complaint
Customer complaints are a fact of life in any business, but tracking and managing those complaints effectively can give your organization a significant competitive advantage. Karomi provides an out-of-the-box solution that can be customized to suit your exact requirements.
Improve Collaboration
Karomi is a secure, web-based solution that enables you to share information across the entire organization. You decide who should have access to the Karomi system. After that, authorized employees can access the complaint-tracking system from anywhere, using only a standard web browser.Easily Record New Complaints
Regardless of how customers contact your organization, Karomi enables your staff to record new complaints quickly and accurately. Most manufacturers already use some kind of form to track complaints. Karomi lets you configure a fully customized web form to categorize and record complaint details. If desired, you can also include a web form on your website or intranet to enable customers to submit complaints directly to the Karomi system.Notify the Right People
With Karomi, you’re in control. If you wish, Karomi can send an email notification each time a new complaint is received – ensuring that the right people are kept in the loop. Email alerts can be used for:- Reminders
- Inactivity alerts
- Task assignments
- Review requests
- Closure requests
Within Karomi you can create and modify workflow rules to meet your evolving needs.
Root Cause Analysis and Continuous Improvement
World-class manufacturing companies analyze complaint trends to identify opportunities for improvement. Karomi makes it easy to identify emerging trends quickly, and even gives you the ability to manage improvement projects.
Graphical reports can be exported to Excel or downloaded as PDFs, enabling you to share up-to-the-minute information with your executive team. The ad-hoc reporting tool lets you create custom reports that highlight any area of interest.
Karomi reports can then be fed back into your organization to improve product design and manufacturing processes – helping you deliver superior quality every time.Benefits of Karomi Complaint Handling Software for Manufacturers:
- Quickly record new customer complaints
- Ensure acknowledgement of every complaint
- Meet ISO guidelines for complaint tracking
- Maintain a complete record of every complaint
- Centralize complaint details
- Share information across the enterprise
- Effectively manage milestones and key dates
- Report on trends
- Take advantage of customer feedback to continuously improve products and service
- Identify the root causes of complaints
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Supplier Portal
Enhance accountability, increase visibility and reduce defects
Karomi dramatically improves communication with your suppliers and ensures greater accountability. The Karomi Portal enables you to register suppliers and provide them with access to all or any part of your quality, corrective action and finance related software.Supplier Orders, Payments and Shipments
- Invoices received
- Payments sent
- Open delivery schedules
- Over due receipts and receipt history
- Supplier item summary
- Purchase order and history
- On-time delivery performance
- Returns
- Supplier shipping schedule and dispatch status
- Supplier rating (Quality rating, Delivery Rating)
- Supplier Audit information
Supplier Corrective Action Report (SCAR)
- Record New SCARs : Once a supplier is registered, simply complete a form to report defective shipments and other issues that require corrective or preventive action. Karomi’s customized intake form is designed to capture the information your suppliers need to take action. Depending on your requirements, this can include the ability to select the appropriate vendor, attach a photo of the efective shipment, report lot numbers, etc.
- Supplier Access : No IT resources are required to get your suppliers up and running – the entire system is accessible securely through a standard Internet browser. As new issues are reported, suppliers are notified automatically by email. Suppliers can also login to the Supplier Portal and view all their outstanding corrective actions.
- Collaborate on SCARs : Your suppliers can take advantage of Karomi in the same way your company uses Karomi internally. Users can develop action plans, assign tasks internally, set deadlines and attach documentation.
- Approve and Close : Once an investigation is complete, suppliers can submit the corrective action for approval. This approval request triggers an email to the appropriate party, who can then review the work and determine if the SCAR should be closed.
- Supplier Comparison Reporting : Karomi makes it easy to communicate performance targets and results to your suppliers. In seconds, you can compare the performance of each supplier over time and track improvements using up-to-the-minute data.
- Cost Recovery : Non-conforming product, late deliveries, and unresponsive service impose real costs on your business. Karomi ensures discipline and accountability by accurately recording and analyzing the cost of these errors. Karomi also enables a cost-recovery process that identifies amounts for recovery, seeks supplier approvals and notifies your finance team.
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8D
8D is a problem-solving methodology for product and process improvement. It is structured into eight disciplines, emphasizing team synergy. Each discipline is supported by a checklist of assessment questions, such as “what is wrong with what”, “what, when, where, how much”.
Karomi Quality and Corrective Action software can form an integral part of identifying problems and enabling your team to manage the process of resolution. The 8D process is mapped into a Karomi workflow and data capturing eforms allow team members to record their findings. 8D reports are available online for tracking and analysis at any time.
8D Facts:
- 1. Use Team Approach: Establish a small group of people with the knowledge, time, authority and skill to solve the problem and implement corrective actions. The group must select a team leader.
- 2. Describe the Problem: Describe the problem in measurable terms. Specify the internal or external customer problem by describing it in specific terms.
- 3. Implement and Verify Short-Term Corrective Actions: Define and implement those intermediate actions that will protect the customer from the problem until permanent corrective action is implemented. Verify with data the effectiveness of these actions.
- 4. Define end Verify Root Causes: Identify all potential causes which could explain why the problem occurred. Test each potential cause against the problem description and data. Identify alternative corrective actions to eliminate root cause.
- 5. Verify Corrective Actions: Confirm that the selected corrective actions will resolve the problem for the customer and will not cause undesirable side effects. Define other actions, if necessary, based on potential severity of problem.
- 6. Implement Permanent Corrective Actions: Define and implement the permanent corrective actions needed. Choose on-going controls to insure the root cause is eliminated. Once in production, monitor the long-term effects and implement additional controls as necessary.
- 7. Prevent Recurrence: Modify specifications, update training, review work flow, improve practices and procedures to prevent recurrence of this and all similar problems.
- 8. Congratulate Your Team: Recognize the collective efforts of your team. Publicize your achievement. Share your knowledge and learning.
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Audit Management
Audits are an essential element of any form ofher compliance system. Karomi greatly simplifies the process of constructing, scheduling and running an audit. Its flexibility and ease of use means that even the most unusual or complex audit can be set up logically and quickly.
Solution Overview
- Ability to setup audit checklists for any quality and regulatory standard
- Provides for a central master schedule of all audits.
- Tracks and alerts for upcoming and overdue audits.
- Integrates the audit findings with the corresponding corrective actions.
- Generates valuable audit and management feedback reports.
- Enhanced security and audit trail features that comply with the electronic signature and records requirements of the 21 CFR Part 11 regulation.
Karomi organizes auditing process in a series of phases as shown in the image below
Audit Management
- Allows you to schedule audits and track the upcoming and overdue audits.
- Ability to present the history of audit findings at a specific site or vendor.
- Tracks the current status of all audits initiated.
Reports and Trends
- Built-in audit templates and audit finding reports.
- Several built-in management reports on audit status and history.
- Built-in performance statistic report.
Corrective Actions
- Central corrective action module that can be used for all corrective actions, including the ones associated with audits.
- Integrated with Karomi CAPA module
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Calibration and Preventive Maintenance
The Calibration and PM solution can help you satisfy international quality specification requirements for process control (preventive maintenance) and control of inspection and test equipment (calibration). It is designed specifically to meet all the requirements for a fully functional calibration system as described by quality standards such as ISO 9001, ISO 13485, AS9100 and TS 16949.
It maintains a master list of equipment for calibration and preventive maintenance. With this solution you can document the basic equipment information along with detailed calibration and/or preventive maintenance instructions.
Solution Overview
- All types of equipments can be managed including Inspection Devices, Test Devices, Tooling, Machinery, Facilities and Laboratory Equipment.
- Create a master list (database) of all equipment (asset list).
- Identify the individual maintenance and calibration needs of each piece of equipment.
- Create instructions (work instructions) for each type of maintenance or calibration activity.
- Collect and record data into user friendly eforms
- Track equipment downtime.
- Track preventive maintenance labor.
- Record both routine (preventive) maintenance and non-routine maintenance (for example, repairs) performed.
- Record when calibration is performed.
- Run reports which list maintenance and calibration performed and as well as maintenance and calibration due.
- View all equipment with calibration overdue or calibration that will become due soon.
- View all equipment with preventive Maintenance (PM) overdue or PM that will become due soon.
- Integrated to the email system for alerts and escalations
- Vendor management and tracking for equipment sent outside for calibration
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Order-to-cash Process
The order-to-Cash process streamlines the workflow from customer order to the payment collection. It creates a transparent system which allows stakeholders to view the status of the order as it is executed and fulfilled. All documents related to the order e.g. client order, invoice, POD, I&C report, etc., are compiled and made available online for instant access.
Solution Overview
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Order Booking
- Customer orders are scanned and uploaded into the system for processing
- Order verification is done and any corrections notified immediately
- Orders can then be booked into any LOB application like an ERP
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Order Execution
- Orders are split into multiple internal work orders based on business rules
- Invoices raised are uploaded into the system
- Shipment details / Lorry receipts are captured into the system
- Once shipment reaches the client, the Proof-of-Delivery (POD) document is attached to the order
- Installation and Commissioning (I&C) of the product is done and a I&C report is added to the order.
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Payment collection
- With visibility across the branches, all sales executives now can keep the customer informed on delivery status and payment dues.
- Payment details are loaded onto the system by the sales executive and payment acknowledgement sent out automatically by the system.
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Search and Reporting
- Search and obtain documents based on order no., invoice no. and other reference numbers
- Search and retrieve documents related to order
- Search based on sales executive, customer, branch and location
- Reports based on any criteria filtering by location, branch, product type, etc.
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Engineering Change Control (ECR / ECN)
An Engineering Change Request (ECR) is the formal notice that an item within the system may require modification. The request can be triggered by a quality audit, customer compalint or an internal change request.
The ECR is routed through a workflow to all the stakeholders in various departments to get their feedback. Engineering, Quality, Material Management, Finance and Marketing are few of the departments who might have a say on whether the change is to be implemented or not.
An Engineering Change Proposal (ECP) secures the acceptance of document changes prior to altering the original documents. Once the concurrence of all the stakeholdes have been obtained, the actual changes to the product drawings and the BOM are done.
The Engineering Change Notice (ECN) documents the implementation milestone. That is, a signed-off ECN demonstrates that the documents listed on it have been updated and may be used in accordance with the effective dates listed. The ECN also provides information on the cost of the change: the expenses associated with scrapping or reworking old parts, and retooling and implementing new ones. Along with the ECN, updated drawings and BOM could also be released.
Karomi can be used to map the ECR to ECN process easily though the workflow system. All approvals and tracking can be done from within the Karomi system. Documents generated or released in the process can be manaegd through the Karomi document management system. The process is mapped on to the Karomi Workflow platform while the ECR and ECN forms are replicated as eForms. The ECN document is generated from the system based on the changes done.
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New Product Development (NPD / NPI)
The phase-gate process is an operational road map for moving a new-product project from idea to launch. It allows organizations to divide the New Product Development effort in several time phases separated by management decision gates. The team in charge of a given phase must successfully complete a pre-defined set of related activities in each phase prior to obtaining approval to proceed to the next stage. Evaluations and approval are carried out by a multi-disciplinary management team called Product Committee, Investment Review Board or other similar name.
Phase and gate processes are an effective way of controlling development expenses as they restrict the investment in next stage until management has evaluated the outcome of the current stage. When properly automated and when clearly integrated in a portfolio approach, they can also improve dramatically time-to-market by speeding up decisions and funding in priorities the project carrying the most value.
Karomi's workflow and document management system captures the entire NPD process and keeps everyone informed of the progress. Audit logs, Status tracking, single document repository, alerts/reminders/escalations and reporting, make NPD an ideal process to be automated using the Karomi product.
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Engineering Drawing Management
Karomi gives CAD users all the essential document and drawing management controls as part of the Karomi Drawing Management System, resulting in higher productivity and greater accuracy. With Karomi in place, CAD users and managers have better tools to manage engineering change processes and share engineering information with user groups and enterprise business systems.
Some of the features of the Karomi Engineering Drawing Management System are:
- Customizable Hierarchy: Drawings and related files can be stored in the hierarchy best suited for the organization. This hierarchy can be created and updated at any time.
- Comprehensive search: All drawing attributes and custom attributes are indexed and can be searched and retreived easily. Search results point to the relevant drawings and files for quick access.
- Manage any type of file: Store, control and track any and all file formats from CAD drawings, MS Office files, Scanned files, PDF files, Images, etc., in the same repository.
- Version Control: The system automatically manages different versions of the drawings and files with an audit log of who created/modified and when.
- Check out/Check in/Publish: Only one user can edit a document at a time. All interactions are logged. Comments can be entered while updating the drawing or file.
- Security: Drawings and files have multiple levels of security.
- Permit/Deny access to the entire Drawing repository
- Permit/Deny access to a specific drawing folder
- Permit/Deny access to a specific drawing or file
- Set permissions based on users, groups, roles, department-wise and location-wise
- Set permissions based on attributes
- Distribution list: Setup a distribution list who will be automatically notified everytime a drawing is updated or changed.
- Drawing Number Generation: The drawing management system provides a facility to issue new drawing numbers based on product category or any other criteria.
- Print Management: Control printing of drawings through a print request facility
- Audit Trails: All updates, version changes, views, prints and distributions are logged and can be queried.
- Customizable attribute list: Using a simple drag-n-drop interface, the list of attributes related to drawings and files can be set and updated at any time
- Synchronize block data: Changes to AutoCAD file block data automatically imported into corresponding attribute/metadata fields
- Built-in viewer with annotations and markup: The built-in viewer allows viewing of all CAD formats, PDF, MS Office, Images and Scanend documents. Annotations and Markups can be made on the files and shared with other users.
- Digital Rights Management (DRM): Option to permit/deny printing, cut-copy-paste and save on the desktop can be set
- Approval Workflows: Integrated approval workflows can be triggered automatically or by an user to send the drawings for review and approval. Approval workflows can be customized to suit the needs of the organization. Personalized inbox for approvers alert users of pending approvals. Reminders and escalations can also be configured.
- Integrate with other systems: The drawing management system can be integrated with the existing Email system to send out alerts and reminders. The system can also be integrated with an ERP system in real-time or by exporting required data into an excel file.
