Other best practice
data trending examples



Reveal process behavior through disciplined data analysis.

Manufacturing data

    • Action limits based upon historical data to ensure:
      - batch to batch (inter) consistency
      - within batch (intra) consistency

    • Manufacture to Target

    • Release specification should not be used on in process charting

    • Suitable sample size and interval (to be considered a representative and an effective)

    • Continuous observation of process measurements in time order

    • Detect signals while production occurs to demonstrate control

    • Used by operators to maintain stable operation.

Change verification

    • Confirm whether a process modification produced a real shift

    • Used after equipment replacement, raw material changes,
      or site transfer

Problem solving and investigation

    • Identify step changes or unusual patterns

    • Where to target effort

    • Link signals to equipment changes, analysts, materials, or environment

    • Guide structured investigation combining process context with
      effective statistical understanding

Rare event monitoring

    • Track infrequent events such as complaints, adverse reactions, sterility failures, or environmental excursions

    • Time between events charts or count charts show changes in event frequency.

Supporting statistical analysis

    • Provide time context for regression, ANOVA, multivariate
      analysis modelling and AQL sampling

    • Prevent misinterpretation when models ignore process shifts

Knowledge capture and process understanding

    • Document how a process behaves through time

    • Build organizational knowledge of normal behavior

Reporting state of control

    • Demonstrate consistent & predictable behavior across time

    • Used in Continued Process Verification and Annual Product Reviews

    • Can be used to communicate with Regulatory Authorities

    • Support Process Validation (equipment & process)

    • Evidence for regulatory inspection and internal review

    • Governance (all management levels) use and
      communication tool

    • Regulatory submissions and supporting correspondence, including
      responses to authority observations, GMP deficiencies, and Warning
      Letters, as well as documentation prepared for regulatory meetings
      and filings.