Statistical control chart

Statistical control chart in quality management system

1. Presented by- Ashish R a j e n d r a Chaudhari M. Pharm 1st Sem. Statistical Control Chart 17-10-2019 1

2. CONTENT 17-10-2019 2

3. Statistical process control are tools used to determine whether a manufacturing of dosage form in pharmaceutical industry is in a state of statistical control or not The charts are used to provide a visual graphic representation of instances when a process is beginning to go out of control . Monitors, controls, and improves processes through statistical techniques. INTRODUCTION 17-10-2019 3

4. Pareto Diagram m ControlCharts Process Flow Diagram Histogram Scatter Diagram Check Sheets Cause & Effect Diagram 17-10-2019 4

5. What is Control Chart Statistical chart controlling mfg. processes Every process exhibits some normal levels of variation, but a control chart is designed to separate this common cause variation from special cause variations. When the control chart indicates the process is out of control, an operator should take action to make adjustments to bring the process back under control . 17-10-2019 5

6. Control Charts Statistical quality control can be implemented through control charts that are used to monitor the output of the process and indicate the presence of problems requiring further action. Control charts can be used to monitor processes where output is measured as either variables or attributes . 17-10-2019 6

7. Objective To secure information to be used in changing specifications or in determining whether the process can meet specifications or not. To secure information to be used on establishing or changing production procedures. To secure information to be used on changing inspection procedures or acceptance procedures or both. To provide a basis for current decision during production. To provide a basis for current decisions on acceptance for rejection of manufacturing or purchased product. To familiarize personnel with the use of control chart. 17-10-2019 7

8. Principle A process that is operating with only chance causes of variation present is said to be in statistical control. A process that is operating in the presence of assignable causes is said to be out of control. The 0goal of spc is the elimination of variability in the process 17-10-2019 8

9. Types 17-10-2019 9

10. Variable charts Charts for variable data requires measurements on continuous scale such as lengths, weight, P H or resistance Variable data include more information than attribute data , thus are preferred for SPC and essential for diagnosis Types of variable charts : 1) x-bar 2) r-bar 17-10-2019 10

11. Attribute charts Attribute data requires only a count of discrete measurements such as good or bad. The charts for attributes will be useful provided the defective rate is high enough to show on the chart with a reasonable subgroup size . Current competitive quality requirement in many industries are so high that attribute charts are not useful . 17-10-2019 11

12. Characteristics A control chart is a time-ordered diagram to monitor a quality characteristic, consisting of: 1. A nominal value, or center line, the average of several past samples. 2. Two control limits used to judge whether action is required, an upper control limit (UCL) and a lower control limit (LCL). 3. Data points, each consisting of the average measurement calculated from a sample taken from the process, ordered overtime. By the central limit theorem, regardless of the distribution of the underlying individual measurements, the distribution of the sample means will follow a normal distribution. The control limits are set based on the sampling distribution of the quality measurement . 17-10-2019 12

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14. Benefits A control chart indicates when something may be wrong, so that corrective action can be taken. The patterns of the plot on a control chart diagnosis possible cause and hence indicate possible remedial actions. It can estimate the process capability of process. It provides useful information regarding actions to take for quality improvement 17-10-2019 14

15. Importance Improving product quality Improving productivity Reducing waste Reducing defects and improving customer value 17-10-2019 15

16. Comparing the control chart information with the tolerance specification tells you about the process capability. Process capability is the long-term performance level of the process after it has been brought under statistical control Process capability is also the ability of the combination of people, machine, methods, material, and measurements to produce a product that will consistently meet the predefined specifications. PROCESS CAPABILITIES 17-10-2019 16

17. 17-10-2019 17 The capability index is defined as: Cp = (allowable range)/6s = (USL - LSL)/6s USL (Upper Specification Limit) LSL LCL UCL (Upper Control Limit)

18. Conclusion Several drawbacks in the conventional approach of drug formulation development can be solved by using control charts as tools in statistical process control to determine whether a manufacturing of dosage form in pharmaceutical industry is in a state of statistical control or not . The control charts serve to illustrate the current operational condition of a process by providing a visual display that clearly indicates whether a process is within limits, out of control, or headed for an out of control condition, offering management time to take corrective action and avoid waste . 17-10-2019 18

19. References Joseph M. Juran , A.Blanton Godfrey . Jurann’s Handbook 5 th edition, McGraw-Hill , New York Washington, D.C. pp. 45.1. Shah, S., Shridhar, P. And Gohil, D., 2014. Control chart: A statistical process control tool in pharmacy.  Asian journal of pharmaceutics (AJP): free full text articles from Asian J pharm ,  4 (3). Rami Hikmat Found, Adman Mukattash , Statistical Process Control Tools: A Practical for Jordanian Industrial Organization ,JJMIE, Volume 4 , No 6, December 2010, pp- 693-700 www.Slideshare.Com /control charts/Dr.Vijendar Palsingh 17-10-2019 19

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