“Reduce, Reuse and Recycle” has been an environmental mantra for over 50 years.  It makes sense, so let’s apply it to your work.  You are already probably doing some of these steps, but let’s get into some details and see if these tips will help your company perform better overall.

Reduce

In order to reduce information, you need to do less work by only creating information that is needed.   But how can you do that, if the work is assigned to you?

First, let’s understand what is being asked of you.  When writing a protocol, report, change request or a corrective action plan, what are the requirements you are supposed to meet?  Are they clearly defined?  When was the last time you read the procedure that describes what you must do?  Are templates available, or have they changed recently?  Have you had specific Quality System training to understand the requirements in the Laws, Regulation, Guidance and Standards (LRGS) that are applicable to your work?  Have any LRGS changed recently? 

I have documented over 3200 LRGS objects that are applicable to the medical device industry, including all the FDA Consensus Standards.  Subscribe to the Consiliso Agile PLM environment to see these objects along with detailed metadata to determine what is applicable to your work.  (Note that standards themselves are not included but includes Consiliso metadata and where to find and purchase them).  Remember, as long as you document a rational case for using (or not) a consensus standard or claiming exemption from a regulatory requirement, regulatory bodies are more apt to agree with you than issue an audit finding.

Do you understand the requirements unique to the product you are working on?  When designing a product or solving a problem, the scope of the product and the issue must be clearly defined, otherwise you may be solving a problem that does not exist.  For example, back in the 1990’s, I visited a catheter manufacturer and saw they were putting on ESD (Electrostatic Discharge) wrist straps when using a computer.  They had an FDA inspector ask them why they were not using ESD wrist straps (he must have only previously visited electronic device makers) and they said the product was not electric, he then pointed to a computer, so they changed their procedure to require using wrist straps when entering data.  Too bad know one told them that the fully assembled computers are not ESD sensitive.

Reuse

Reusing information makes so much sense, why reinvent the wheel?  But most people have documentation systems with limited metadata and inadequate description fields.  These systems work for the person creating and releasing the document, but for everyone else, it is often a struggle to find the document again.  Engineers spend hours doing searches to try and see if the work was previously done.  Why can’t it be as easy as a Google search?

To do reuse right, the company needs to create their documentation systems with the correct numbering schemes, classes, product lines, statuses, and the ability to create links.  You don’t even have to spend months figuring that part out; I did it for you based on my 35 years of experience in the industry, across many kinds of device companies.  In the Consiliso methodology (which you can easily implement in any documentation or Product Lifecycle Management [PLM] system), there are defined master datasets including:

  • Document Classes
  • Part Classes
  • Equipment Classes
  • Change Classes
  • Event Classes
  • Manufacturer/Supplier Classes
  • Customer Classes
  • Standardized Part/Document/Workflow Statuses
  • Standardized Product Lines
  • Standardized Risk Codes (Cause, Defect, Hazard, Harm)
  • Standard Risk Levels

Just like in Microsoft Word, where there are multiple ways to save a document, you need to have multiple ways to find a document.  The ability to search by numbering, description, class, owner, product line, linked changes, linked events, predefined searches, ad-hoc searches and full text searches allow users to easily find work previously completed.  

But what if I need to have some disparate information (without any common metadata) linked together?  This is where most documentation systems fail.  The solution is to use a PLM system.  In a PLM you can use the Bill of Materials (BOM) functionality to link together parts, documents and equipment onto a single Grouping object.  I have created Grouping objects for managing Design History Files (DHF), regulatory submissions, and manufacturing process requirements.

If you want to see a system set up the correct way, contact me and I will give you a demo of our Agile Consiliso environment that can be used as a pre-set configuration if you use Oracle’s Agile PLM, or it can be replicated in other systems.

Recycle

If you need to create a new process validation, has a similar one been done in your company?  Hopefully you can find it and then check it against the latest template.  Note: the best practice is to have your templates revision controlled and identified the template/revision on the released document (or in the document object metadata).  If your company does not have a repository of templates or templates for documents people often create, you can download ours from the Consiliso Agile PLM environment (available via subscription).  We will give you access to an entire Quality System of cross-linked process documents, procedures and templates to use for almost any activity in any medical device company.  

When writing a procedure, protocol or report, call out (i.e. reference) separate released test method documents (internal or external standards), affected assemblies, work instructions, Quality System procedures, and equipment numbers in tables.  By having this information in a table, it become easier to see if there are gaps.  Also, you can create metadata links from your document to these references, thus creating your own little Wiki.  This makes your document easier to reuse!

Similarly, with parts and assemblies, your system should allow you to create a new configuration of parts by doing a “save as” or duplicating a template part.  You can change the dash number or create a new number based on rules of interchangeability.  I have had this functionally available in PLM and ERP systems, so we could create part class-specific templates if there was no existing part to build upon.

Now with AI, you can save time by taking an existing document, and ask your AI program to update it to the current template.  You focus your work only on what needs to be added to the document.  For validation test protocols, this capability saves hours of tedious copy/paste work. 

Summary

Reduce by never assuming you have all the requirements nailed down before you begin.  Make sure you are not duplicating work previously done.

Reuse information through systems with standardized metadata, and the ability to link or group applicable objects together.

Recycle by finding something that is close and build on what is already available.