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13 September 2013

Statistical Services

To obtain the best possible performance, production processes have to be optimized. Optimization, anyway, has to be maintained over time.

PSC, process statistical check, QC, quality control and determination of AQL (Acceptance Quality Level) are a set of statistical means able to guarantee a stable process, a high performance and to prevent cases of product non-compliance.

 

At the same time, it is fundamental to work on error analysis techniques according to FMEA (Failure Modes and Effects Analysis) and FTA (Fault Analysis Tree) methods

 

Returned goods, waste and performances in general are improved annulling reprocessing due to OOS (out of specifications – analytical results out of specifications).

 

Our Consulting Services

  • Accurate study of the process an of its faculty
  • Planning of experiments according to DOE (Design of Experiments) method and of the production processes through PAT (Process Analytical Technology) to assess the influence of every single variable on the result and the characteristics of the final product so as to reduce vain attempts and costs, increase detailed information and make industrial processes – both chemical and mechanic – stronger, allowing to meet specifications without fail
  • Assessment of total of past data
  • Construction and implementation of control charts
  • Analysis of mistakes and of malfunction effects, resulting in risk analysis and their managing
  • Identification of corrective and preventive actions to eliminate non-compliances according to GMP (CAPA-Corrective Action and Preventive Action)
  • Business Process Modeling (BPM) of business processes: map of real processes (“as-is”) and progressing processes (“to-be”) to identify necessary improvements to move from processes detected in as-is to those executed in to-be. Interventions may be incremental and included in the BPM, or radical, thus opening the issue concerning business process reengineering (Business Process Reengineering or BPR). Interventions may concern both technology and organization and normally imply also training on the new processes
  • Formulation of final reports at the end of the studies, resulting in the assessment of the obtained results

 

Our consulting services in the Statistical Services field are ideal to accelerate production processes ensuring at the same time a consistent quality of the product, reducing waste and reprocessing costs, thus achieving remarkable system economies.

 

Use Cases

  • At the end of the trial
  • Before production start-up
  • Before marketing
  • If package leaflet is produced

 

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