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Form analysis
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AUDITING WHAT MATTERS: WHY VARIATION IS KEY

Layered Process Audits

By EASE
January 18, 2023

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Imagine you’re conducting layered process audits and you see the following two
questions on your checklist: 

 1. Is the poka-yoke device bolted to the machine?
 2. Does the operator clear the extra plastic from the part before removing it
    from the mold? 

While both questions address process inputs important to reducing defects, only
the second question addresses an input that’s likely to vary over time.
Variation is key when selecting elements to verify with layered process audits,
helping you get the most valuable information in a short amount of time. 

Today we’re looking at why it’s so important to focus on variation when writing
layered process audit (LPA) questions. We also explore some practical examples,
the role of the 6Ms and how LPA software can help you check inputs at the
desired frequency.  

 * Download your free Ultimate Guide to Layered Process Audits for more LPA
   question best practices, examples and tips


WHY VARIATION MATTERS

When it comes to choosing an input to verify with an LPA question, there are
several aspects to consider: 

 * Is it high value? Checking paperwork or forms is a waste of time when you
   only have ten minutes to complete an audit. 
 * Can you design a yes or no question around the input with clear evidence of
   conformance? Auditors need to be able to easily check whether the process is
   in or out of conformance. 
 * Is the process element something that can vary over time? An input may be
   high value and easy to check, but if it never changes you don’t need an LPA
   question to check it. 

Asking questions about process elements that don’t vary over time tends to
frustrate auditors and operators, hurting buy-in for your LPA program. If people
don’t think the questions have value, they’re more likely to check out and
simply pencil whip the audit.  

Just as important, LPAs are designed to be frequent, and to achieve that you
must be able to complete them quickly. That means only having about ten
questions on each checklist. With so few questions included on each audit, each
one needs to have maximum impact. Verifying elements that don’t vary is a waste
of time and a lost opportunity to catch another problem that could lead to
product defects.  

So how do you know whether an element varies over time? One simple way to find
out is by asking the operator. Soliciting operator feedback can provide valuable
insight into which questions are likely to hit home, and which ones are likely
to provide little value. 


USING THE 6MS TO DRIVE VARIATION TO ZERO

A great place to start when building your LPA question library is the 6Ms of
process control. Based on an Ishikawa or fishbone diagram, the 6Ms are used to
categorize process inputs that, where variation exists, can lead to quality
problems. The 6Ms are: 

 1. Man (People): Variation in how an individual employee does their job, or
    variation among how different workers perform an operation, can lead to
    problems. 
 2. Machine: Changes in equipment operation such as those due to normal wear and
    tear can lead to defects. 
 3. Method: Variation in methods should only occur if you are using separate
    sets of work instructions to produce similar parts for different customers.
    Most LPA questions won’t focus on Method because there shouldn’t be
    variation in documented methods.  
 4. Mother Nature (Environment): Environmental conditions such as high humidity
    or high temperatures are a crucial source of variation, since they can
    impact equipment performance as well as stability of materials.  
 5. Material: Examples of material-related variation would be if a raw material
    was labeled incorrectly, the wrong parts were brought to the work area or if
    there’s an issue with supplier quality.  


GETTING THE FREQUENCY RIGHT

There are certain situations where asking a question daily on an LPA would be
too much, yet not asking it at all also represents a risk. The above instance of
the poka-yoke device being bolted to the machine is one such example.  

Asking this daily or even weekly is likely too frequent, especially if you’ve
never had a problem with it in the past. However, let’s say you installed the
device as part of a corrective action to prevent upside-down assembly. As such,
this might be something you want to check periodically to make sure it’s still
working. 

Instead of including it on a daily checklist, however, you might add it to a
pool of low frequency questions, so that it’s checked once every 45 days. The
way you do this is by creating a custom tag in your question library,
randomizing checklists to rotate in just one low frequency question per audit.
LPA software like EASE makes this simple, also allowing you to create tags for
each of the 6Ms to ensure broad coverage of known risks.  

While it may be tempting to throw anything and everything into your LPA question
library, discretion is critical. By focusing on elements likely to vary—and
dialing down the frequency of questions that don’t—you can ensure you’re getting
the most value from these fast, frequent audits.  

 * Download a free case study to learn how a leading global tire manufacturer
   uses custom tags in EASE to eliminate systemic quality problems



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Ease, Inc. is a leading provider of process performance solutions, enabling
manufacturers and service providers to meet the increasingly complex demands of
the connected world, while also lowering their cost of quality.

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