The Nine Elements of Lean Configuration

The Nine Elements of Lean Configuration
Nine elements comprise the Theory of Lean Documents
The allure of finally terminating your paper quality management system (QMS) feels very liberating. You can see the excitement in everyone's eyes during the new QMS software presentation.  Gone will be the days of paper engineering change notice---everything will be circulated and approved electronically and finally everyone will have time to do their jobs. They can hardly wait to tell their cubicle buddies about the new world they will soon live in.
Nine months later into the three-month project ...

"I thought all of these SOPs were going to be revised for the new system.  What do you mean they're not?  Did someone think they would revise themselves?"
"Who entered this client information?  It is all wrong!  That's an old address!"
"I used to have a place on the form to enter my inspection code.  Why isn't it in the new system?"
Configuration is sometimes the last thing on anyone's mind when it comes to a new ERP or QMS software implementation project.  All too often, an incorrect assumption exists that simply uploading or entering paper-based information into the new system is all it takes and the system will self-correct any discrepancies.
All these favorite numbering schemes and paper-based policies come at a price.  A very high price.  As in hundreds of hours at $200+ per hour high.   In fact, there may be more money in configuring the system than in the module installation itself.
Configuration is hard, lengthy, and tedious work.  So is testing and software validation.   
Taking poor paper habits and automating them in a new system is a great way to automate major cost overruns and schedule delays, not to mention bringing a company to its knees.
Lean configuration - a logical extension of our Theory of Lean Documents - offers a way to step back and challenge your assumptions concerning the content of your new electronic QMS.
This theory boils everything down to nine elements:
1 - Document
2 - Serial Number
3 - Model Number
4 - Information Unit
5 - Location
6 - Work Unit
7 - Account
8 - File Location
9 - Part
These may not be obvious and seem overly simplistic.   But everything one encounters in terms of configuration, information, and documents is one of those nine elements. 
Here are some examples:
Description or Definition
1 - Document
A piece of written, printed, or electronic matter that provides information or evidence or that serves as an official record.
-   Drawings
-   Design History File (DHF)
-   Bills of Material (BOM)
-   Job Description
-   Material Specification
-   Meeting Agenda
2 - Serial Number
        A number showing the position of an item in a series, especially one printed on paper currency or on a manufactured article for the purposes of identification.
-   Batch Number
-   Equipment (specific unit)
-   Gauge (specific unit)
-   Instrument (specific unit)
-   Lab Notebook
-   Lot Number
-   Production Log Book
-   Serialized Product Unit
3 - Model Number
A number assigned by a manufacturer to identify different products offered
-     Catalog number
-     Equipment
-     Gauge
-     Instrument
-     Product
-     SKU
4 - Information Unit*
A unique label, record, statement, or other static piece of information identified by a specific number for purposes of future search and retrieval that is not subject to revision, except to correct the original information source.
-     Audit Observation/Response
-     Chart Recorder Printout
-     Complaint Record
-     Data Entry
-     Device History Record (DHR)
-     Dimension ID number
-     Email (used for reference)
-     Log Entry
-     Material Review Record
-     Meeting Minutes
-     Non-Conforming Material Report
-     Material Review Record
-     Reference Standard
5 – Location
A particular place or position
-      Company Facility Address
-      Clean Room (specific room)
-      Customer’s Address
-      Electrical Grid Sector
-      Equipment Location
-      Fire Protection Section
-      Supplier’s Address
-      Room in Office Area
-      Section of Building
-      Shop Floor Area
6 – Work Unit**
An assignment identified by a unique retrievable reference number where one or more tasks are to be performed by one account for the benefit of another account to deliver a specific benefit, product, or service.
-      Action Item or Task
-      Corrective Action Assignment
-      Preventive Action Assignment
-      Program (product launch)
-      Project
-      Project Phase
-      Purchase Order
-      Service Request
-      Work Order
7 - Account
A company, department, person, or entity which either provide or receive services, usually in exchange for money or financial compensation.
-      Contractor
-      Customer
-      Department
-      Employee
-      Service Provider
-      Supplier
8 – File Location
The electronic or physical location where the original of a document or record is kept.
-      Database (controlled)
-      Directory
-      File Cabinet
-      File Folder
9 - Part
Inventory unit of materials, components, or consumables used to build a product, as part of a process, or to provide a service
-      Custodial Consumable
-      Inventory
-      Label (stock)
-      Office Supply Consumable
-      Packaging Supply Item
-      Product Component
-      Raw Material
*Although similar to Units of Information in information theory, in the above usage is in the narrower context of a retrievable legible static information record used by a human for future reference.

**Used in the context of projects, tasks, etc.
If one steps back and considers every job in a life science design and manufacturing operation, these elements are the building blocks of information, processes, products, and services that comprise ERP and QMS systems.
The work is just beginning.  A different way of thinking requires new concepts and even new tools.
The time is long overdue to challenge the traditional approach to controlled information in the life sciences and the myths surrounding its foundations.
Jose Mora is a principal consultant specializing in manufacturing engineering and quality systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, Jose served as director of manufacturing engineering at Boston Scientific and as quality systems manager at Stryker Orthopedics.

His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles.

Mora has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches. Mora can be reached at (917)566-0965 or