Introduction:

Statistical Process
Control
Webinar, May 06th 2021
Time Agenda Heru Purnomo
09.00 – 09.30 Introduction: Statistical Process Control Director PT Abifa Teknik
09.30 – 10.00 Type of Control Chart
Indonesia
10.00 – 10.30 Control Limit Determination

10.30 – 11.15 Real Time Evaluation For Monitoring Process

11.15 – 11.30 Q&A

11.30 – 13.00 ISHOMA Anwar Fitrianto, PhD

13.00 – 13.30 Introduction - Capability • Department of Statistics, IPB
13.30 – 14.00 Basic Concept – Cp, Cpk & Pp, PpK
University
• Minitab Certified Trainer
14.00 – 15.15 Capability Determination – Normal & Non Normal Data
• Statistician at PT Abifa Teknik
15.15 – 15.30 Q&A
Indonesia

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A Case Study
Example – Establish and Maintain State of Control

▪ Product X, change Aluminum tube supplier from A (International Vendor) to

B (local vendor)
▪ During validation, fill weight Product X is out of specification limit.
▪ Internal Limit : 5,10 – 5,30 gr (target filling 5,20 gr)
▪ Registered Specification : Not lower than 5 gr
▪ Tare based on average of 120 tube
▪ Potential root cause : variable of empty tube

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Data Collection
Fill Weight (gr) Min 5.15
5.23 5.23 5.23 5.35 5.22 5.22 5.20 5.22 5.21 5.21 Max 5.35
5.25 5.20 5.23 5.28 5.23 5.21 5.21 5.22 5.18 5.21
5.23 5.21 5.18 5.33 5.22 5.21 5.22 5.22 5.21 5.20 Average 5.22
5.18 5.21 5.22 5.15 5.22 5.21 5.20 5.21 5.21 5.23
5.22 5.23 5.23 5.26 5.19 5.20 5.20 5.20 5.20 5.19 RSD (%) 0.50
5.21 5.22 5.20 5.22 5.22 5.21 5.19 5.22 5.23 5.21
5.19 5.23 5.22 5.25 5.23 5.20 5.22 5.19 5.23 5.20
5.18 5.22 5.19 5.32 5.17 5.22 5.22 5.24 5.21 5.21
5.19 5.20 5.20 5.25 5.22 5.16 5.23 5.22 5.23 5.20
5.25 5.21 5.26 5.21 5.18 5.20 5.21 5.20 5.21 5.22
5.22 5.19 5.24 5.24 5.20 5.19 5.20 5.25 5.20 5.20
5.18 5.22 5.28 5.21 5.21 5.25 5.23 5.23 5.24 5.22
5.22 5.20 5.20 5.23 5.24 5.23 5.19 5.20 5.22 5.20
5.19 5.24 5.24 5.19 5.23 5.19 5.20 5.23 5.21 5.21
5.23 5.21 5.29 5.21 5.22 5.18 5.21 5.21 5.20 5.21
5.24 5.24 5.29 5.22 5.24 5.23 5.20 5.19 5.20 5.21
5.19 5.21 5.27 5.23 5.25 5.22 5.21 5.22 5.21 -
5.23 5.19 5.26 5.19 5.21 5.20 5.20 5.23 5.22 -
5.21 5.19 5.27 5.19 5.25 5.22 5.22 5.20 5.22 -
5.21 5.22 5.22 5.24 5.21 5.20 5.21 5.19 5.22 -

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A Case Study
Example – Establish and Maintain State of Control (Cont’d)

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A Case Study
Example – Establish and Maintain State of Control (Cont’d)

Fact Finding :
- Process run in 4 days (shift 1-2, shift 1, shift 1, shift 1)
- Standard deviation of empty tube SD is 0,001 → less variability

Data Verification :
- Split all data based on days

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A Case Study
Example – Establish and Maintain State of Control (Cont’d)

Key Question
▪ Why data on Day-1 more
variance than rest of days?
▪ What is the different
condition/situation between
day 1 with rest of days?
▪ Was it true this out of filling
weight limit due to variable
of empty tube from supplier
B?

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A Case Study
Example – Establish and Maintain State of Control (Cont’d)

Outcome from further investigation and interview to operator

- During shift-1 process running with 2 operators, while shift-2 only 1 operator
- Operator activities : run the process, perform in process weight check, batch
record documentation
- During day 1, on shift-2, the operator kept stopping the machine, juggling
between above activities → Increase special cause variation

Batch Decision :
Release with justification

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Lesson Learn

1. Try to provide the data using visualisation

2. To understand story behind the data
3. Evaluate data using the proper statistics method for decision making

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Process Validation Definition
Old
Concept
Establishing documented
evidence which provides a
high degree of assurance that
a specific process will
consistently produce a product
meeting its pre-determined
specifications and quality
characteristics
• Focus on document as evidence
• As long as meet specification and quality
characteristics
New
Concept
The collection and evaluation
of data, from the process
design stage throughout
production, which establishes
scientific evidence that a
process is capable of
consistently delivering quality
products
• Based data collection and evaluation
• Process design stage required before process
validation
• Established scientific evidence
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Validation Process – Overview
• PRELIMINARY • FINAL
R&D QUALITY RISK QUALITY RISK
PRODUCT ANALYSIS ANALYSIS
DEVELOPMENT
DOCUMENT
STAGE 1 STAGE 2
PROCESS PROCESS
DESIGN QUALIFICATION

STAGE 3
PRODUCT CONTINUED
DISCONTINUED PROCESS
VERIFICATION

• LAST • LIFE CYCLE

VERSION OF QUALITY RISK
DOCUMENT ANALYSIS

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Validation Process - Objective

Success validation program depends upon information and knowledge

from product and process development

1. Understand the source of variation

2. Detect and presence degree of variation
3. Understand the impact of variation on the process & ultimately on
product attributes
4. Control the variation in a manner commensurate with the risk it
represents to process & product

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STAGE 1 - PROCESS DESIGN
Stage Intent
Stage 1 • Build product knowledge
Process Design through development and scale
up activities
• Established design of process
for robust process for routine
manufacturing activities .
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Typical Activities
• Quality by Design
• Product development activities
• Experiments to determine process
parameters, variability and
necessary controls
• Risk assessments
• Design of Experiment testing
• Define CPP & CQA
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STAGE 2 - PROCESS QUALIFICATION

Stage Intent Typical Activities
Stage 2 To confirm the process design • Facility design
Process as capable of • Equipment & utilities qualification
Qualification reproducible commercial • Process Performance qualification
manufacturing • Strong emphasis on the use of
statistical analysis of process data
to understand process consistency
and performance
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STAGE 3 – PROCESS VERIFICATION

Stage Intent Typical Activities

Stage 3 Ongoing assurance that the • Proceduralised data collection from every
Continued process remains in a state of batch.
Process control during routine • Data trending and statistical analysis
Verification production • Product review
through quality procedures • Equipment and facility maintenance
and continuous improvement • Calibration
initiatives. • Management review and production staff
feedback
• Improvement initiatives through process
experience
• Integrated CAPA and Change Control
Management
 Definition

❑ Statistical control or process “stability” is a state in which

only common cause variation is evident.

❑ Common cause variation is the normal expected variation

in a process that is:
▪ Due to the process itself
▪ Produced by interactions of variables within that
process
▪ Present in all processes
▪ “In statistical control” (stable) provided it is the only
variation present
▪ Predictable
 What is Out of Control?

❑ A process that is out of statistical control or “unstable”

demonstrates evidence of special cause variation.

❑ Special Cause Variation is...

▪ Due to a specific cause
▪ Caused by special circumstances not inherent in the
process.
▪ Generally easier to detect than common causes.
▪ Not predictable
Common Cause Variation
Special Cause Variation