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Statistical Process Control Course & Certification
Intermediate
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4.0
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3 hours
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About
Statistical Process Control (SPC) training helps organizations and individuals understand, monitor, and improve process performance through the use of statistical techniques and quality control methods. It provides practical guidance on identifying process variation, distinguishing common and special causes, applying control charts, and using data analysis to support consistent and reliable operations.
This Statistical Process Control (SPC) Training Course & Certification provides essential knowledge on SPC principles, variation analysis, control charts, process stability, capability studies, Cp, Cpk, Pp, Ppk, statistical limits, sampling methods, trend identification, root cause investigation, and continuous improvement practices. Upon successful completion, learners receive a certification demonstrating their understanding of statistical process monitoring and quality improvement techniques.
Who Should Enrol?
- Quality Assurance and Quality Control Professionals
- Manufacturing and Production Personnel
- Process Engineers and Continuous Improvement Teams
- Operations Managers and Supervisors
- Data Analysts and Process Improvement Specialists
- Regulatory and Compliance Professionals
- Auditors and Quality Management System Professionals
- Anyone involved in monitoring, controlling, and improving process performance
What you will learn
Understand the fundamental principles of Statistical Process Control (SPC), including process variation, common causes, special causes, and the role of statistical methods in quality improvement.
Learn how to use control charts, data analysis techniques, sampling methods, and process monitoring tools to identify trends, shifts, and process instability.
Develop knowledge of process capability analysis, including Cp, Cpk, Pp, Ppk, specification limits, control limits, and interpreting process performance results.
Gain understanding of SPC implementation practices, root cause analysis, variation reduction, continuous improvement approaches, and data-driven decision-making.
Course Syllabus
- A process as inputs, activities, outputs and controls
- Mapping the Meridian manufacturing chain
- Why every process varies — the six sources of variation
- Common cause versus special cause
- Tampering — why reacting to noise makes things worse
- Deming's funnel experiment
- SPC within ICH Q8, Q9 and Q10 and the validation lifecycle
- What a control chart supports, and what it does not replace
- Classify data as variable, attribute or count
- Distinguish a population from a sample
- Calculate a mean, median, range, variance and standard deviation
- Describe a distribution by shape, centre and spread
- Explain the empirical rule and the three-sigma convention
- Assess resolution, bias and repeatability in a measurement system
- Apply consistent rounding, units and significant figures
- What a control chart is and what its limits mean
- Control limits versus specification limits — the headline
- Rational subgrouping
- Choosing the right chart for your data
- Phase I baselining versus Phase II monitoring
- Run rules and the detection of non-random patterns
- False alarms, missed signals and average run length
- Writing a control-chart response procedure
- When to use the X-bar and Range pair
- Subgroup means, ranges, X-double-bar and R-bar
- The constants A2, D3, D4 and d2
- Constructing the limits from a Phase I baseline
- Worked example — Meridian tablet weight, 30 subgroups
- Reading the Range chart first
- Interpreting the signals: a mean shift and a variance inflation
- Investigating a signal without tampering
- Attribute data and the binomial model
- Defect versus defective
- Calculating p and p-bar correctly
- p-chart limits for constant and for varying sample size
- The staircase — why smaller samples give wider limits
- Worked example — Meridian packaging nonconformance
- Interpreting a signal and acting on it
- p-charts and np-charts compared
- Defects versus defectives — the distinction that decides the chart
- What a c-chart is · where it is used
- c-bar the limits, c-bar ± 3√c-bar
- Plotting · interpretation
- Interpret a c-chart, including a truncated lower limit
- Choose between a c-chart and a u-chart
- Recognise a measurement-system signal before blaming the process
- Stability first — why capability on an unstable process is a fiction
- Cp, Cpu, Cpl and Cpk
- Pp and Ppk, and what the gap between them tells you
- The prerequisites: stability, normality, resolution, data volume
- Non-normal and one-sided data, handled honestly
- Four capability scenarios compared
- Building an SPC monitoring plan
- Continued Process Verification and the quality system
- Data integrity and the records a chart generates
- Recap of all seven modules
- The ten habits of a good SPC practitioner
- The decision path: what chart, when
- The mistakes to avoid · the rule to remember
- Monday morning · where to go next
- 📘 Bonus: Statistical Process Control eBook (Free with purchase)
Course Benefits
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with developments in ICH Q8, Q9 and Q10, the FDA's process-validation lifecycle guidance and its Stage 3 Continued Process Verification expectations, EU GMP Annex 15, and the ISO 7870 (control charts) and ISO 22514 (process capability and performance) series, as our training courses are constantly monitored, reviewed and updated. Requirements vary by jurisdiction, and the course points you to the authority applicable to your own site rather than asserting a single global rule.
Learn from Industry Experts
The course content is Whitehall Training editorial material, developed to reflect established statistical process control practice in regulated pharmaceutical and medical-device manufacturing — the Shewhart and Deming tradition as it is applied in a modern pharmaceutical quality system. It is built around a single fictional manufacturing case study with four fully worked teaching datasets, so that every control limit and every capability index in the course is one the learner can reproduce for themselves.
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