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Cost Of Poor Quality (COPQ)

Cost of Poor Quality (COPQ) in Quality Control
Every product has a cost of production, which may include:
 Raw material cost
 Formulation or process cost
 Man power cost
 Utility cost
 Packaging cost
 Transportation cost
 Marketing cost
Thus all the money spent to procure, produce and finally deliver the product in totality make up the product cost. Apart from all the routine costs one more cost which adds to the product cost is Cost of Poor Quality (COPQ). COPQ as a concept was first published by James Harrington in his 1987 book “Poor Quality Costs”.
In Pharmaceutical industry the cost of product like any other product depends on all the above listed parameters. But as drugs / medicines are intended to be administered mostly to the patients for curing the disease except sometimes when they are given for prophylactic purpose to healthy individuals, the quality of these drugs has to be assured not only to produce the intended effect but also to avoid any unwanted effects like-toxic effects, adverse effect, interaction, non-compatibility, allergic reactions, teratogenecity, anaphylaxis, only to name a few. Hence the regulatory bodies always consider quality as the heart of these articles and monitor it for its best before being delivered to the end users.
The quality of pharmaceuticals is ensured by- Quality Control Department, which is responsible for sampling, testing and controlling the quality critical attributes of final product. The overall quality is assured by the Quality Assurance Department which ensures by the effective implementation of QMS that the product is manufactured as per the authorized procedure using suitable and appropriately tested materials, packed and supplied in the correct manner as per the requirement. The QA Department by effective management of OOS, Change management, Deviations, In process checks, Corrective and Preventive Actions, Good Documentation Practices monitors and controls the overall quality of the product.
COPQ in Quality Control Department can be mainly assigned to the following parameters:
 Measurement System Variations
 Instrument breakdowns
 Lack of training
 Improper standardization
 Calibration failures
 Lack of precision
 Improper reagent quality
 Utility failure
 Sampling error
 Testing error
 Improper storage
 Visual error
 Glassware breakdown
 Washing problems
 Carryovers
 Improper Column maintenance
 Power failures
 Software related problems
 Sterility failures
 Documentation errors
Measurement System involves both the analyst and instrument which are responsible for measuring the quality of product. Due to improper results obtained there may be frequent repetitions which may lead to increase in COPQ.
Instruments generally used in the analytical laboratory may range from a small magnetic stirrer with no measurement capability to a highly sophisticated UPLC which may require skill and expertise to handle. Improper handling or wear and tear due to lack of preventive maintenance may lead to frequent instrument breakdowns which adds to COPQ.
Half-knowledge is worse than ignorance. - Thomas B. Macaulay Training is the most important aspect in QC like any other critical department. Only trained and qualified personnel should be carrying out various activities as per the requirement in QC.A newly joined chemist should not be assigned any work independently unless he is properly trained and qualified. Untrained people may commit mistakes which may not be noticed immediately and may lead to rework.
Standardization of volumetric solutions and working standards is a routine practice in QC. Volumetric solutions are used to determine the titre of the sample for quantification in various titrimetric analysis like Acid base, complexometric, potentiometric / redox etc. If the molarity is not determined with accuracy and precision may lead to faulty results.
Analytical instruments used in QC should be qualified and calibrated prior to use. Calibration frequency of the instrument may vary depending upon the manufacturer recommendation, criticality and complexity of the instrument and the intended use of the instrument. It may be daily like ph meters and balance, monthly like FTIR, UV, melting point apparatus, six monthly like dissolution apparatus, HPLC, GC etc. Instrument calibration is one of the critical parameter which assures the correctness of measurement system. Calibration failure may lead to faulty results of analysis. Hence any such failures should be investigated with sound scientific judgment.
Lack of precision may be instrument precision or analyst precision. Both the variations may be dangerous as they may lead to faulty results. Instrument precision is generally a part of System Suitability Checks whereas analyst precision should be ensured by proper training and monitoring the analysts for any errors.
The quality of reagents plays a vital role in analysis. Unless until mentioned categorically A R grade (Analytical Reagent) reagents should be used which are certified by the manufacturers. Wherever the reagent quality is mentioned in the Method of Analysis viz. spectroscopy grade KBr, HPLC grade methanol, USPRS, specially dried methanol for KFR appropriate quality reagent should be used as using a different grade reagent may affect the test results.
Many utilities are used in QC which may aid for testing in the laboratory. Compressed gases like Zero air, Nitrogen, Oxygen, Helium, Argon, Carbon dioxide are routinely used in the laboratory for various purpose. Some may be required by the instruments like GC, AAS, TOC, FTIR etc. while some are required in the process. Electricity of course is required by almost all the instruments. HVAC, vacuum are few more utilities. Failure of the utilities may lead to rework, reanalysis which will finally lead to increase in COPQ.
Sampling is an important step in QC activities as the result of analysis totally depends on the sample under analysis. Sampling should be carried out in such a manner that the sample is representative of the whole lot. Appropriate precautions should be taken during sampling like the temperature, humidity, differential pressure should be maintained in sampling booth. Equipments used should be clean and dry cleanliness should be ensured to avoid cross contamination. Visual observation for any abnormality or damage to container is also an important step. In case of packing materials where the quantity received may be huge suitable sampling quantity can be chosen based on the ISO / military standards to take a representative sample. If sampling is not done properly as per the procedure it may lead to OOS results. The sampling quantity should be calculated properly to avoid excess sampling of very costly material.
Testing error may be due to lack of training to the chemist, failure to follow the Method of Analysis, wrong interpretation of observations, lack of precision, instrument breakdown etc.
Proper Storage of sample, reagents, standards, accessories is very important to achieve reliable results. Some items may be required to store under refrigerated conditions, some in desiccators to avoid moisture ingression, some should be protected from light. If the sample or standard or reagent is not stored properly it may lead to decomposition or degradation which may give faulty results.
Although most of the tests in modern laboratory are carried out by instruments (instrumental analysis) still there are may which require meticulous observation by human eye. Some tests like end point determination in volumetric analysis, particulate matter, appearance and description etc are still carried out by visual examination. Hence chemists should be properly trained to observe, differentiate and identify various organoleptic attributes.
Glassware is used for carrying out the various tests. Most of the glassware are calibrated and certified A class category. This glassware is required in large quantities and may add substantially to COPQ if frequent breakdown is there.
Washing of glassware is very important in QC. Improper washing may lead to cross contamination and impurities which may warrant reanalysis adding to COPQ. Cleaning validations are done to ensure the effective cleaning.
Carryover of the impurities may be due to improper cleaning of glassware or insufficient washings given to the chromatographic systems. Cleaning is very important to avoid carryovers.
Chromatographic columns are the heart for HPLC and GC analysis, but column maintenance is very important to avoid any damage to the columns which may give ghost peaks, improper peaks, back pressure etc.
Most of the sophisticated instruments in the analytical laboratory continue the analysis (run) around the clock. Continuous power supply is required to complete the analysis in time. Frequent power cuts may lead to damage of some components of the instrument and loss of analysis time. Hence such instruments should be connected to continuous power supply.
The instruments which use software and mostly the GxP instruments should be validated for the software usage and should be strictly controlled to avoid any loss in data, corruption due to virus or data acquisition and analysis errors.
Sterility testing of sterile products is a critical test. Any reason which leads to false sterility test results may lead to reanalysis and investigation which is a lengthy procedure and may add to COPQ.
Documentation is the most important step of any process. “We believe only in God, everyone else should bring documents” is the best guideline to maintain and follow Good Documentation Practices. Loss of data, improper documentation, improper storage and retrieval of documents may add to COPQ.
Thus COPQ may be minimized by controlling the various parameters as discussed and product costs can be cut to compete in the market.

“A penny saved is a penny earned”. - Benjamin Franklin

Comments

  1. I read your post . it was amazing.Your thought process is wonderful.
    The way you tell about things is awesome. They are inspiring and helpful.Thanks for sharing your information and stories.
    iso 9000

    ReplyDelete
  2. I read your post . it was amazing.Your thought process is wonderful.
    The way you tell about things is awesome. They are inspiring and helpful.Thanks for sharing your information and stories.
    iso 9000

    ReplyDelete

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