The Lean Machine

Quality Management

Quality Management

Quality management software brings organizational focus on customer satisfaction and continuous improvement and provides the backbone for meeting ISO certification, FDA and other regulatory requirements.

Implementation is easy and highly customizable, so you are can plan, track and improve every aspect of your company’s policies and procedures.

Seven of the twenty-six modules included in The Lean Machine are focused on quality; these modules create a strong foundation on which to build a lean and mean company

Document Management
Document Management

Our robust document management module, one of 26 modules included in our software, will help you get control of the paper floating around your office and quickly conform to ISO 9001, 13485, FDA, or other regulatory requirements.

Integrated with our inventory management, quality, internal audit, and corrective action (CAPA) modules, you will also better manage supplier quality.

Key Features of the Document Management Module
Requirement Sign Off
Require users to sign off on a training record after the document is released. The Document control module will record how long the user has the document open during the initial training review of the document and displays this time next to their training signature.
Linking To Material Management
Link a document to a part in the material management module and use the review and approval of the document to control the release of its corresponding part for production in the Material Management Module.
Open Multiple Documents
Open multiple documents at the same time and keep track of which ones are open with the dynamic hyper-linked open screen list on the Main Menu.
Documents Needs
Documents needing review, approval, editing, and more will show up on the appropriate user’s dashboard with a link to the applicable area of the Document Management Software.
Automatically E-mails
Automatically e-mails the Review Authority list when the document is ready for review, and also when the final draft is ready for approval.
Document Releasement
Release any document with “Template” in the title and automatically import it when beginning a new document of that type.
Reviewers Access
Give reviewers access to edit the final draft with a first-come-first-serve check-in/check-out document review mechanism.
Importing Documents
Import your existing documents without renumbering, reformatting, or renaming them.
Tracking Printed Copies
Will also help you track the printed copies of your controlled documents.
Release Multiple Documents
Release multiple documents under a single DCO/ECR form.
Linked Document
Link or embed documents in their original file format.
Create useful relationships to your documents to include
Other Documents Quality Records Created
FMEA Projects Work Centers/Departments
Iso Clauses Addressed User List
Parts From The Bill Of Materials
Metrics Events/Tasks
Document Templates
Document Templates

The quality of the documents you put into your document management system is as important as ensuring employees are looking at the correct revision.

Which ever way you decide to start a procedure, the Document Templates system in The Lean Machine™ will start you off on the right foot.

  • Quality Manual
  • Preparing Work Instructions
  • Document Template
  • Human Resources
  • Management Responsibility
  • Order Processing – Custom Products
  • Product Handling and Preservation
  • Purchasing
  • Statistical Process Control
  • Verification of Purchased Product
  • Document Control
  • Control of Non-Conforming Product
  • Customer Satisfaction, Feedback and Complaints
  • Document Training
  • Equipment Calibration and Maintenance
  • Packaging, Labeling, and Shipping
  • Product Identification and Traceability
  • Quality Audits
  • Storage Areas
  • Request More Information
  • Working with Controlled documents
  • Design Control
  • Employee Training
  • Final Inspections
  • Order Processing – Catalog Products
  • Preservation and Protection of Company Data
  • Production Work Orders
  • Quality Records
  • Supplier Evaluations
Deviations Module
Deviations Module

Deviations from the approved procedures in your document management system can potentially affect quality, and therefore, regulatory compliance. Also called out-of-specification (OOS) results, deviations can occur during raw material and finished product acceptance, sampling and testing, manufacturing, or product distribution.

While it is impossible to completely avoid deviations, FDA-regulated companies, especially pharmaceutical companies, must have the ability to manage both planned and unplanned deviations.

Features of the Deviation Module
Link to a location in the Contact Manager module to support supplier quality tracking
Automatic linking to 12 other modules in The Lean Machine
Deviation tasks are rolled up to the user dashboard
Multiple date ordered investigation notes
E-mail reviewer list via MS Outlook
Multiple person approval list
Six customizable text fields
Trend reporting and analysis tools
Corrective Action Preventive Action
Corrective Action Preventive Action

Corrective and preventative actions require a flexible tool that will help you determine the root cause of non-conformities or other undesirable situations and prevent their recurrence.

Features of the CAPA Module
Supports a teamwork approach to corrective actions
With assignments of specific activities, to include a CAPA Manager, Investigators, Action Plan Implementer, Action Plan Reviewers, and Reviewers after the action plan is complete to ensure the follow-up results justify the completion of the corrective or preventive action.
Action plan management
tools
To both describe and manage the action plan, including attachments, and the ability to automatically create a new event record specifically designed as a CAPA action plan, which supports assignments, due status, completion status.
Links to other records within The Lean Machine
These can include documents, audits, nonconforming material reports, metrics, parts, customer complaints, customers, vendors, equipment, and management review meetings.
Accountability support
Through dashboard links to all CAPA records based on their stage and assignment so that all users involved with the CAPA have direct links to their CAPA responsibility as soon as they log into the software.
Fields for the key information
Needed to describe the initial problem, the Nonconformity, the Requirement, the Evidence, and the Risk or Concern that justifies why the CAPA is needed.
Triage system
To encourage CAPA input from everyone without bogging down CAPA system with improvements that don’t need to be managed in the CAPA system.
Multiple root cause analysis tools
Such as the 5-Why process as well as the A3 format used at Toyota.
The CAPA module also includes useful features such as
Chronology tracking to have The Lean Machine automatically log the significant user actions as the CAPA record is completed
MS Outlook integration to export due dates and the description of actions needed your MS Outlook calendar
Linking the Corrective Action module to your own released procedure on corrective actions
The ability to E-mail the corrective action to a vendor or a customer
Extensive reporting and trend analysis capabilities
Non-Conforming Material
Non-Conforming Material

Identifying and controlling non-conforming material is critical to prevent unintended use or delivery.

However, non-conformance, from a Lean point of view, is an opportunity to improve other processes that are affected by a non-conformance event.

What you can do with Non-Conforming Material Module
Customize the name of this module
Customize the name of this module and various fields to suit your business environment. Call it Rejected Materials, NCRs, RMAs, Bug Reports, or whatever makes the most sense to your employees.
Print out a RMA form
Print out a RMA form for a customer that authorizes them to return a product. Scan the bar code on this form when it is returned with the product to quickly identify and process it when it arrives with the returned item.
Track root causes
Track root causes and link events to individual vendors, employees, work centers, or stage of production as applicable.
Include additional reviewers
Include additional reviewers as part of a Material Review Board using the electronic signature feature.
Link each rejected component
Link each rejected component with its own disposition review / MRB record.
Tracks reject codes
Tracks reject codes for multiple components of a given item.
Quality Inspection
Quality Inspection

The Quality Inspection Software module allows you to record inspections with as much or as little detail as suits your needs.

Integration with the other modules in The Lean Machine make quick work of getting the inspection set up with all the needed checklist information automatically.

With Quality Inspection Software you can
Record the results of inspection activities for any type of inspection such as:
Receiving – add material to inventory
First Article
In-Process
Final
  • Create a checklist of inspection points for a particular part as part of that parts quality plan based on any type of inspection needed.
  • Designate someone in system settings to perform or assign receiving inspections and have POs imported from your ERP system trigger the needed inspection automatically and appear on that users dashboard.
  • Or receive purchase orders in TLM and have parts designated for receiving inspection automatically generate inspections with the quality plan checklist loaded and ready to go.
Equipment Calibration
Equipment Calibration

The Calibration Software module allows you to manage equipment and calibration resources and activities.

With Calibration Software you can
Equipment events are pulled into and displayed on the Employee Dashboard for users assigned to equipment related tasks.
Indicate availability and tracks “up time” based on when equipment is taken in and out of service.
Manage Company Assets such as:
Calibration equipment, Production equipment, Computer Resources, etc.
Schedule and perform reoccurring events such as:
Calibration, Maintenance and Safety Inspections.
Scan bar codes to check equipment in or out to employees.
Print bar codes to label equipment. (Code 3 of 9 format)
QMS Software
Most quality management software (QMS Software) platforms consist of document control, audit management, non-conformance tracking, corrective action, and employee training, however, our QMS Software is expanding to more areas of the business, depending on the QMS needs of your company.
Let's Build Your Solution
Our QMS Software is backed by a 100% success rate for ISO Certification On The First Try!
If you have any questions or want more detailed information, do not hesitate to call us.