Nonconformances should be treated as "water off a duck's back"

Nonconformance Management System

Evahan assisted HDPE stormwater manufacturer, Stromen, with the design and implementation of its nonconformance system which forms part of its Quality Management System (QMS).

Nonconformances are a good thing, not a bad thing
At Evahan we frequently see our clients who are new to QMS, react negatively to the idea of tracking nonconformances. I guess their concern has its origins in that as young people at school we are taught that "mistakes a bad". But mistakes (nonconformances) are not bad at all, they are in fact a very positive thing. It is from nonconformances that organisations can study the root cause of that nonconformance  and then develop process and activity revisions to correct the nonconformance at and develop preventive actions, activities, processes, checks, balances and quality gates to prevent that nonconformance from happening again or at least mitigate and reduce the frequency of the nonconformance.

Nine Critical Elements to Stromen's Nonconformance System
 Evahan assisted Stromen design, develop and implement a robust Nonconformance Management System. The Nonconformance Management System has nine elements.

1. Start to change the culture of staff - noncomformances (NCs) a good thing, not a bad thing. You learn about root causes from NCs. You learn to develop solutions to overcome, eliminate or mitigate reoccurrence from NCs
    
2. Develop and produce NC Cards to capture NCs and post them on a Quality Board which is central tool in a Quality Communication & Collaboration System 
    
3. Develop a Root Cause Analysis System, consisting of a "How to Undertake Root Cause Analysis (RCA) Guide" and a collaboration platform for those impacted by the NC to collaborate, brainstorm and workshop the solution(s). The medium is usually the Quality Board.
    
4. Establish Quarantine Areas. In many organisation's there are three quarantine areas:
   1. Inwards Goods - for NCs identified when receipting Inwards Goods
   2. In-Process - for NCs identified In-Processing or at some point within the manufacturing workflow line
   3. Finished Goods - for  NCs related to finished products about to be shipped, or for defective goods returned by the customer
       
5. Develop a Procedure or Work Instruction that deals with the system to quarantine and contain the nonconforming input or output and contain any similar nonconforming inputs or outputs that are in-process or have been dispatched. The procedures must set out how the nonconforming inputs or outputs are to be identified and labelled, giving due consideration to the stability of the label or identification tag in the physical storage environments (eg outside, or inside) and is the information sufficient on the tag that it will pass the KISS Test. In this case the KISS Test is that a person with knowledge of the business should be able to read the nonconformance label or tag and gain a quick understanding of who put the input/output in the quarantine area, why they put it in the quarantine area and what is they are going to do about it, ie what's the next step.
    
6. Develop a Procedure, Work instruction or Guideline on factors to consider when making the decision to rework or scrap the nonconforming input or output
    
7. A process(s) to document and manage the Work In Progress and Completed NCs, usually involving the assignment of specific owners of the NC, the setting of target completion dates and entry into a centralised register, buy a person like a "Quality Manager" such as the Nonconformance NC and Continuous Improvement CI Register
    
8. The inclusion of monthly new, WIP and completed nonconformance metrics into the Quality Objectives, Targets and Actuals Register so this may be monitored by the relevant people (eg the Board the Senior Management Team, the Quality Team) as part of the ISO 9001 required Management Review Process.
    
9. Develop an internal audit methodology for the review of the nonconformance system and enter an internal audit(s) into the Internal Audit Schedule once or twice per year