STATISTICAL PROCESS

CONTROL CHARTS
© Shivang Chaudhary
FOR IMPLEMENTATION OF CONTROL STRATEGY & CONTINUAL IMPROVEMENT in QbD
© Created & Copyrighted by Shivang Chaudhary
Which Control Chart
should be selected?

Continuous Data Continuous Discrete Data

Data or
Discrete One Defect per unit Multiple Defects per unit
Data? i.e. Classify Defective or Not i.e. Count Defects / unit
Defects?
What is the
Sample Size
(n)? Is Sample Size Is Sample Size
Constant? Constant?
Individual Rational Rational Equal Sample size in Unequal Sample size Equal Sample size in Unequal Sample size
Measurements Subgroups Subgroups every subgroup in every subgroup every subgroup in every subgroup
n=1 2 < n < 10 n > = 10 Yes No Yes No

X-MR / I-MR X bar – R Chart X bar – S Chart np -chart p - chart C-chart u - chart

No. of Defects / unit (c)

Fraction Defectives(P)

No. of Defects / unit

Values of Range

No of Defectives(d)
UCL
Values of SD
Values of 𝑋

CL

LCL
Sample No. Subgroup No. Subgroup No. Subgroup No. Subgroup No. Subgroup No. Subgroup No.
In X-MR Chart In X bar - R Chart In X bar - S Chart p 1−p UCL = u + 3 u/n
UCL = np + 3 np(1 − p ) UCL = p + 3 UCL = C + 3 C
UCL = X + 2.66R UCL = X + A2R UCL = X + A3S 𝑛
CL =np =n(Σd/mn)= Σd/m CL = p = Σd/mn CL = C = ΣCi / m CL = u = ΣCi / Σ n
CL = X = ΣXi / n CL = X = ΣXi / m CL = X = ΣXi / m
p 1−p
LCL = np - 3 np(1 − p ) LCL = p - 3 LCL = C - 3 C LCL = u - 3 u/n
LCL = X - 2.66R LCL = X - A2R LCL = X - A3S 𝑛

In I-MR Chart In R Chart Where, Where,

In S Chart
LCL = D3 R p= Σd/mn m = No of Subgroups
LCL = 0 LCL = B3S
CL = R = Σ MRi/ n-1 CL = R = Σ Ri/ m p= d/n=fraction Defective n = No of inspection units in subgroups
CL = S = ΣS / m
UCL = 3.27 R UCL = D4 R m = No of Subgroups c = Number of defects found in the subgroup
UCL = B4S
R = Σ MRi/ n-1 R = Xmax – Xmin n = No of Samples in each subgroup (Sample Size) u = Number of defects per inspection unit = c/n
2
Σ Xi−X
MR = R – Rn-1 m =No of Subgroups S= d= Nos. of Defectives in each subgroups
n−1
n= No. of Samples mn = Total Nos. of items inspected in m subgroups

VARIABLE CHARTS ATTRIBUTE CHARTS

Assay, Weight Variation, Content Uniformity, Diffusion, Dissolution, Permeation Physical Appearance, Compliance Rates, Sterility, Endotoxins / Pyrogens, Extractable, Leachable , %Defectives, %Yield

Water by LOD, Water by KF, Impurities, Hardness, Friability, Disintegration, DO, pH, Physical Defects (Particulate Matter, Clarity, Transparency, Creaming, Sedimentation, Caking,
Viscosity, Rheology, Specific Gravity, Density Phase Separation, Capping, Lamination, Sticking, Picking, Mottling)