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
Quality Management Modules
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
Create useful relationships to your documents to include
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 (53 pages, linked for easy navigation)
- Preparing Work Instructions
- Document Template
- Human Resources
- Management Responsibility
- Order Processing – Custom Products
- Product Handling and Preservation
- 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 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
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
The CAPA module also includes useful features such as
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
The Quality Inspection Software 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.
With Quality Inspection Software you can
Record the results of inspection activities for any type of inspection such as:
Create a checklist of inspection points for a particular inspection, or attach the MS Word Inspection Template configured with a GD&T Font interface. (installed with The Lean Machine.) Re-use past inspection checklists. Using Quality Inspection Software you can develop inspection templates (Quality Plan) for Receiving, In-Process, or Final inspections for a given part and load them for each type of inspection.
The Calibration Software module allows you to manage equipment and calibration resources and activities.
With Calibration Software you can
Studies show that 60-80% of product cost is tied to administration. With this fact in mind, we build a quality management software product that could administer document, quality, and inventory management knowing that we wanted to be Lean about it and attack that 60-80% statistic.