Quality Management - Quality Management Software - The Lean Machine

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

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 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 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

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

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

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)