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Overview

Quality Hub GINEZ uses statistical process control to evaluate batch conformity. This guide explains how to properly record measurements and understand the control chart logic.

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Measurement Equipment

Before recording measurements, ensure you have the proper equipment:

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Digital Refractometer (% Sólidos)

  • Used for measuring solid content (Brix)
  • Follow procedure IO-DOP-OP-002
  • Record temperature at time of measurement
  • Take two independent measurements for accuracy

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pH Reactive Strips

  • Used for measuring pH levels
  • Follow procedure IO-DOP-OP-001
  • Wait for color stabilization before reading
  • Compare against provided color chart
Calibrate equipment regularly according to your quality management procedures. Inaccurate equipment leads to false non-conformities.

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Control Chart Logic

Quality Hub GINEZ uses a three-level control chart system to classify batch conformity:

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Understanding the Limits

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Red Lines (Specification Limits)

These are the minimum and maximum acceptable values defined in product standards:
  • Lower Spec Limit: Minimum acceptable value
  • Upper Spec Limit: Maximum acceptable value
  • Values between red lines = CONFORME (Compliant)

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Yellow Lines (Tolerance Limits)

These represent a ±5% relative error tolerance around specification limits:
  • Lower Tolerance: Spec Min × 0.95
  • Upper Tolerance: Spec Max × 1.05
  • Values between red and yellow lines = SEMI-CONFORME (Within Tolerance)

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Outside Yellow Lines

  • Values outside tolerance = NO CONFORME (Non-Compliant)

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Example: Solids Measurement

Assume a product has these standards:
  • Spec Min: 10.0%
  • Spec Max: 12.0%
Calculated Limits:
  • Lower Tolerance (Yellow): 10.0 × 0.95 = 9.5%
  • Lower Spec (Red): 10.0%
  • Upper Spec (Red): 12.0%
  • Upper Tolerance (Yellow): 12.0 × 1.05 = 12.6%
Classification:
  • 11.0%: CONFORME (between 10.0 and 12.0)
  • 9.8%: SEMI-CONFORME (between 9.5 and 10.0)
  • 12.4%: SEMI-CONFORME (between 12.0 and 12.6)
  • 9.2%: NO CONFORME (below 9.5)
  • 13.0%: NO CONFORME (above 12.6)

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Recording Solids Measurements

1
Prepare the Sample
2
  • Ensure the product is well-mixed
  • Take a representative sample from the batch
  • Note the ambient temperature
    • 3
    Take First Measurement (M1)
    4
  • Place a drop of product on the refractometer prism
  • Close the cover and wait 5 seconds for temperature stabilization
  • Read the % Sólidos value from the display
  • Record the measurement temperature in °C
  • Enter both values in the form:
    • % Sólidos - M1: The Brix reading
    • Temp - M1: The temperature
    • 5
    Take Second Measurement (M2)
    6
  • Clean the refractometer prism thoroughly
  • Take a fresh sample
  • Repeat the measurement process
  • Record the second measurement:
    • % Sólidos - M2: The Brix reading
    • Temp - M2: The temperature
    • 7
    The system automatically calculates the average of M1 and M2. This average is used for conformity evaluation.
    8
    Clean Equipment
    9
    After recording, clean the refractometer according to maintenance procedures.

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    Recording pH Measurements

    1
    Prepare the Sample
    2
  • Ensure the product is well-mixed
  • Pour a small amount into a clean container
  • Use fresh reactive strips (not expired)
    • 3
    Measure pH
    4
  • Dip the reactive strip into the sample
  • Remove immediately and shake off excess liquid
  • Wait 10-15 seconds for color development
  • Compare the strip color against the reference chart
  • Determine the pH value
    • 5
    Enter pH Value
    6
  • In the Valor de pH field, enter the measured value
  • The system accepts values from 0 to 14
  • You can enter decimals (e.g., 7, 7.5, 8)
  • The field will reject invalid entries automatically
    • 7
    Common Error: Entering pH values outside 0-14 range. The system will not accept these values.

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    Recording Organoleptic Parameters

    Organoleptic parameters are evaluated visually and compared against product standards.

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    Apariencia (Appearance)

    1. Observe the product in good lighting
    2. Compare against the expected appearance for the product
    3. Select the observed characteristic from the dropdown:
      • CRISTALINO: Clear, transparent liquid
      • OPACO: Opaque, non-transparent
      • APERLADO: Pearl-like, lustrous appearance
      • TURBIO: Cloudy or hazy
      • PARTICULAS SUSPENDIDAS: Visible particles floating
      • SEPARACION DE COMPONENTES: Visible layer separation
    The system knows the expected appearance for each product. If you select a different appearance than expected, it will flag as non-conforming.

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    Color

    Compare the product color against reference standards:
    1. Use daylight or neutral lighting
    2. Compare against color reference (if available)
    3. Select:
      • CONFORME: Color matches specification
      • NO CONFORME: Color differs from specification

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    Aroma

    1. Smell the product (safely, without direct inhalation)
    2. Compare against the expected fragrance profile
    3. Select:
      • CONFORME: Aroma matches specification
      • NO CONFORME: Aroma is off or different

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    What Happens During Validation

    When you click “Finalizar y Generar Lote”, the system performs these checks:

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    1. Required Field Check

    • Verifies all mandatory fields are filled
    • Checks that solids measurements (if applicable) have all 4 values (M1, T1, M2, T2)
    • Checks that pH (if applicable) is filled

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    2. Solids Conformity Evaluation

    If solids apply: 
    Average = (M1 + M2) / 2

IF Average >= Spec_Min AND Average <= Spec_Max THEN
    Status = CONFORME
ELSE IF Average >= Tolerance_Min AND Average <= Tolerance_Max THEN
    Status = SEMI-CONFORME  
ELSE
    Status = NO CONFORME

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    3. pH Conformity Evaluation

    If pH applies: 
    IF pH >= pH_Min AND pH <= pH_Max THEN
    pH Status = CONFORME
ELSE
    pH Status = NO CONFORME

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    4. Appearance Conformity Evaluation

    IF Appearance == Expected_Appearance THEN
    Appearance Status = CONFORME
ELSE
    Appearance Status = NO CONFORME

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    5. Overall Status Determination

    IF ANY parameter is NO CONFORME THEN
    Overall Status = NO CONFORME
ELSE IF ANY parameter is SEMI-CONFORME THEN
    Overall Status = RETENER (Tolerance/Hold)
ELSE
    Overall Status = CONFORME
    The most severe non-conformity determines the overall batch status.

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    Understanding Notifications

    After submission, you’ll see one of these notifications:

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    ✅ Producto Conforme

    Meaning: All parameters passed specification limits Action: None required. Batch is approved for release. Duration: 4 seconds

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    ⚠️ Producto en Tolerancia (Retener)

    Meaning: All parameters passed, but some are within tolerance (yellow zone) Action: Releasable with caution. Document in batch record. Duration: 6 seconds

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    ⚠️ Producto No Conforme

    Meaning: One or more parameters failed tolerance limits Action: DO NOT release batch. Immediate review required. Click “Ver detalles” to navigate to Quality Control. Duration: 8 seconds
    Non-conforming batches must not be released for sale. Initiate your NCR (Non-Conformance Report) procedure immediately.

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    Best Practices

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    Accuracy Tips

    • Take measurements at stable temperatures
    • Clean equipment between measurements
    • Record values immediately - do not rely on memory
    • Use fresh, calibrated reagents and strips

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    Documentation

    • Record any unusual observations in the Observaciones field
    • Note environmental conditions if relevant (high humidity, temperature extremes)
    • Document equipment used if multiple devices available

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    Efficiency

    • Prepare all materials before starting measurements
    • Follow the same sequence every time to avoid missed steps
    • Record measurements as soon as taken
    • Keep standards and procedures accessible for quick reference

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    Troubleshooting

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    ”Faltan mediciones de Sólidos” Error

    This means you filled some but not all solids fields. Solution: Ensure all 4 fields are filled: M1, T1, M2, T2

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    ”Falta medición de pH” Error

    This means pH is required for this product but not filled. Solution: Enter the pH value in the Valor de pH field

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    pH Field Won’t Accept My Value

    The field validates pH range (0-14). Solution:
    • Check you’re entering a number, not text
    • Ensure value is between 0 and 14
    • Use decimal point, not comma (e.g., 7.5, not 7,5)

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    Measurements Keep Showing Non-Compliant

    If batches consistently fail:
    1. Verify equipment calibration
    2. Check measurement procedure compliance
    3. Review product formulation
    4. Contact Quality Manager

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    Next Steps

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