Karomi Technology: Karomi Document Management Workflow Automation BPM Solutions

Karomi

Solutions

Quality

Document Control	Corrective and Preventive Action (CAPA)
Customer Complaint Process	Audit Management
Calibration and Preventive Maintenance	8D
Kaizen

Karomi's Quality Management System provides organizations 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.

• 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

• 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




• 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




• 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




• 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.




• 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



• Kaizen

  Kaizen means continuous improvement. Using the Kaizen process, workers are seen as valuable assets within the organisation and are encouraged to continually try to improve the quality of work. There is no supervisor looming large and waiting for a chance to attack each worker when they find an inefficiency to fix. Rather, all are held accountable by their peers for quality. This continual cycle of small improvement leads to continuous small profit increases, as costs are cut in multiple areas of the production cycle.

  The Kaizen Process works as follows:
  

  • The employee identifies a problem, waste, or an opportunity for improvement and writes it down.
  • The employee develops an improvement idea and discusses it with his or her supervisor.
  • The supervisor reviews the idea within 24 hours and encourages immediate action.
  • The employee implements the idea. If a larger improvement idea is approved, the employee should take leadership to implement the idea.
  • The idea is written up on a simple form in less than three minutes.
  • Supervisor posts the form to share with and stimulate others and recognizes the accomplishment.

  Kaizen implementation in Karomi
  

  • Users can identify a problem and enter the details in a structured eForm
  • Once submitted, the eForm is routed through a workflow to the supervisor
  • Supervisor and originator can iterate through the process until there is agreement
  • The idea is implemented and an online Kaizen template is filled in
  • Once approved the Kaizen repository is updated and information shared with others
  • The Kaizen repository can be searched based on type of Kaizen and type of improvement (Cost Saving, Safety, House Keeping, Quality, Productivity or Accuracy of Data)