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Deviations (issues): The major impact of minor non-conformances on audit requirements

Deviations (issues): The major impact of minor non-conformances on audit requirements

In the relentless pursuit of quality, manufacturing thrives on consistency and adherence to specifications. However, even the most well-oiled production line can encounter hiccups. This is where the concept of non-conformances comes in.

This article delves specifically into minor non-conformances, often termed deviations or issues, in the manufacturing context. Read on to learn how to distinguish them, manage them, and stop them from becoming permanent bad habits in your supply chain.

Not all non-conformances are created equal

In the heat of production, a “hard” failure or non-conformance might be easy to spot. However, minor issues or deviations are subtler. Therefore, to regain control, you must first distinguish between a surprise and a request:

  • Planned deviations (permits/concessions): The supplier asks for permission before shipping. Perhaps they need to run a mold at a slightly higher temperature or use an alternative sub-component due to shortages. In other words, this is a request for a temporary change in the process you have to approve or deny.
  • Unplanned deviations (incidents/issues): You catch this at Incoming Inspection. The parts arrived, and the plating is slightly off-color, or there is a cosmetic scratch. It is a surprise, and now you have to decide: scrap it, or issue a concession?

The trap: If you approve too many planned deviations you aren’t managing quality, but slowly rewriting the specification to be looser without realizing it.

Cheat sheet: Non-conformance vs. Deviation

FeatureNon-conformanceDeviation
FocusProduct failureProcess variance
TimingDetected after it happenedCan be planned (permit) or unplanned (issue)
SQE roleContainmentRisk assessment and disposition
Kiuey moduleIncoming InspectionSCAR/CAPA Manager

The silent killer of strategic bandwidth

Why do we call this “minor” non-conformances? These issues are treated as less of an inconvenience because they often don’t stop the line immediately. But for SQEs, they are a major administrative burden. If you are tracking these approvals via scattered spreadsheets and email chains, you are exposing yourself to two critical risks:

  1. Lack of traceability: Six months from now, when a field failure occurs, will you be able to find the specific email where you approved that “minor” process change?
  2. Recurrence: A supplier asking for the same deviation three times isn’t a deviation anymore —it’s a capability issue. Without a centralized system, it is nearly impossible to spot this pattern and manage the associated risk.

The solution: Stop chasing, start engineering

Deviations shouldn’t be ignored. Your goal isn’t just to record them, but to ensure they don’t threaten the integrity of your supply chain. Effective management requires a move from manual spreadsheets to a centralized single source of truth.

Using a tool like PPAP Manager, you can control this chaos:

  • Create concerns in seconds: You can log a supplier concern in less than a minute, replacing the 20-minute email drafting process.
  • Track recurrence: The system automatically flags if a specific issue is repeating, allowing you to identify it promptly and demand a root cause analysis (RCA) like an 8D or 5 Whys instead of just issuing another waiver.
  • Link to performance: These deviations feed directly into the AVL Supplier Manager, automatically adjusting the supplier’s scorecard. This turns every concession into  data points that have an impact on future business.

Pro-Tip for SQEs: Always set an expiration 

When granting a deviation permit, never leave it open-ended. Define a specific quantity (e.g., “First 500 units”) or a specific time frame (“Valid until Oct 30th”). This forces the supplier to fix the root cause rather than relying on the waiver permanently.

Regain control of your process

Deviations are inevitable, but they shouldn’t consume your day or ruin your weekend. Don’t let minor issues bury you in major paperwork. Centralize your deviation requests and non-conformances in one platform and gain the visibility to say “no” when it matters and “yes” when it’s safe —without having to dig through your inbox.

Ready to stop the chaos? Discover how Kiuey’s SCAR/CAPA Manager helps you track, trend, and close issues faster, so you can focus on high-impact decisions.

Tags:

deviation process in manufacturingdeviation reportnon conformance vs deviationtypes of deviation

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