Quality Control brings organizational focus on customer satisfaction and continuous improvement and provides the backbone for meeting regulatory requirements such as ISO 9001, ISO 13485, 21 CFR Part 11, and 21 CFR Part 820
Quality Management Modules
Document Management Software
Nothing is more fundamental than a good document management system, and it applies to every aspect of your business, so it is listed under every category. This module Provides both single and multiple document release capability and links between your documents and other areas of your business systems. It provides users with easy access to the latest procedures, and document authors with a multitude of conveniences and features for managing documents and controlling change to procedures.
Over 30 pre written procedures including a comprehensive 50 page quality manual are available to licensed users of The Lean Machine. Once you have the software, and load in the procedures, you are a long way towards implementation.
Corrective and Preventive Actions
The Corrective Action module can be used to capture a problem, investigate the cause, propose and approve a solution, and then follow up on that solution to ensure it worked.
When a non-conformance involves what you make or your raw material, this module can be used to initially capture the details of this event, approve the disposition, and provide trend analysis and reporting.
This module allows you to record inspections on multiple levels of detail. You can sign off on the receipt of material by simply indicating the amount of material received, or you can create a checklist of 100 inspection steps using GD&T Fonts to define measurement specifications. Inspections can also be linked into the list of operations on a work order, or to a non-conforming material record.
Equipment Calibration & Maintenance
The Equipment Module allows you to manage equipment that needs calibration, maintenance, or some other type of activity. These activities can be defined, scheduled and recorded. Reporting tools allow trends to be analyzed that support taking actions that will result in less waste associated with your equipment, whether it is down time, errors, or scrap.