QA Interview Questions for Fresher and Experienced

Q.1 Define Quality assurance?

Ans: Quality Assurance is a broad range of concepts that contains all the
matters that individually or collectively affect the Quality of a product.
QA mainly concentrated on planning and documenting the procedures to
assure Quality.

Q.2 What is Documentation?

Ans: Documentation is all types of written procedures, records, and
instructions, Quality control test records with procedures involved in all
manufacturing activities of drug products.

Q.3 What are In process checks?

Ans: In-process checks are checks carried out during an activity to
monitor and, where necessary, to adapt the process to ensure that the
product conforms to its specification.

Q.4 During In-process Checks, what will need to be

checked/Recorded?
Ans: Recording of various parameters like; 1) Environmental Monitoring
2) Measured values obtained from the process equipment (ex:
temperature, RPM.) 3) Measured values obtained from persons (ex:
timings, entries.) 4) Process attributes (Ex: weight, hardness, stability.

Q.5 What precautions shall be taken while collecting in-process

samples?
Ans: While collecting in-process samples, protect the sample from
contamination while sampling (Do not collect samples with bare hands).
Use gloves while sampling.
Q.6 What are the factors which influence tablet hardness?
Ans: 1. force applied for compression
2. Binder quantity (More binder quantity, more hardness)
3. Presence of moisture in granules.

Q.7 If the leak test falls during In-process checks, what needs to be
done?
Ans: Immediately stop the packing process and check for:
1. Sealing temperature
2. Check knurling quality and change in printed foil.
3. Check & quarantine the isolated quantity of packed goods from the last
leak test passed during in-process.
4. Collect random samples & do a retest.
5. Blisters from the leak test passed containers shall allow going further,
and the rest must be de-blistered/ Defoil accordingly.

Q.8 What needs to be checked during AHU validation?

Ans: During AHU validation, the following tests shall be carried out:
1) Air velocity & number of air changes
2) Airflow pattern (visualization)
3) Differential pressure, temperature, and RH
4) Static condition area qualification
5) Dynamic condition qualification
6) Non-viable count
7) Microbial monitoring
8) Area recovery and power failure study

Quality Assurance Interview Questions Related to Documentation

Q.9 What Is a Change Control?
Ans: Change Control is a general term describing the process of
managing how changes are introduced into a controlled System. Into
validation, implies how changes to the validated system are made.
Change control is needed to demonstrate to regulatory authorities that
after system modifications, validated systems remain under Control after
system changes.

Q.10 What Is SOP?

Ans: A Standard Operating Procedure (SOP) is a specific type of
document that describes how to perform a particular task or operation in
a step-by-step outline. To ensure that tasks are conducted consistently
and appropriately, everybody in an organization must follow the same
procedures.

Many organizations have a broad range of SOPs that illustrate how to

execute various tasks. In many companies, technicians, and operators are
trained in how to follow individual SOPs and their training record
specifies the SOPs they are trained on and are authorized to use.

Q.11 Tell about the content of the SOP

Ans: 1. Objective or Purpose/Aim
2. Scope
3. Responsibility
4. Procedure
5. Precautions
6. Annexure
7. Abbreviations
8. Reference
9. Revisions History

Q.12 How do stability studies?

Ans: These are necessary for developing pharmaceutical products. The
influence of environmental factors (e.g., light, humidity, temperature.) on
active pharmaceutical ingredients (API) or pharmaceutical ingredients
(API) may be evaluated.

Q.13 Expand BMR and BPR

Ans: BMR – Batch Manufacturing Record, prepared as a written file
during the Manufacturing of a product by writing, and Recording Step by
the step manufacturing process, and details about batch recorded here.
For every BMR, BPR is to be held for further packing records. BPR
depends on packaging operation.

Related: Difference between BMR/eBMR/eBPR

Q.14 Difference between validation and calibration?

Ans: Validation provides written evidence to ensure that a particular
method or operation continuously develops a product with predetermined
requirements and quality credits. It is performed according to the
validation protocol.

Calibration denotes that Equipment produces the values in specified

limits by comparing the values produced by a standard. It Is done
according to the calibration SOP.

Q.15 What is a Change Request?

Ans: Change Control is a general term that describes the process of
managing the implementation of changes in a controlled system that is
controlled by the change request. control system into validation means
how changes are made to the validated system. Change Control is made
to demonstrate to the Regulatory authority, the reason that the validated
system remains under Control after the system change. Change Control
systems are a favorite target of regulatory auditors because they vividly
demonstrate an organization’s capability to Control systems.

Q.16 What is 21 CFR part 11?

Ans: Title 21 CFR Part 11 of the Code of Federal Regulations deals with
the Food and Drug Administration (FDA) guidelines on electronic
records and electronic signatures in the United States.

Q.17 Tell any five countries with their regulatory authorities.

Ans: India Central Drugs Standard Control Organization (CDSCO) USA
– United States Food and Drug Administration (USFDA) UK Medicines
and Healthcare Products Regulatory Agency (MHRA) Japan- Ministry of
Health Labour and Welfare (MHLW) Australia- Therapeutic Goods
Administration (TGA).

Common IPQA Interview Questions

Q.18 What position of the oblong tablet to be placed in the hardness

tester to know the hardness
Ans: It should be lengthwise because its breakage probability is more in
this position.

Q.19 Why do we calibrate an instrument at a particular interval?

Ans: because it can be possible for instruments to drift out of accuracy
after qualification. So it needs to requalify the instrument at a specific
time interval.

Q.20 What checks shall be carried out during the calibration of the
Disintegration Test apparatus?
Ans: 1. Strokes number per minute. It shall be a 29-32 cycle per minute.
2. Temperature by using probes and a standard thermometer. It shall be
37±1°C
3. Traveling distance by the basket. It shall be 53-57 mm.

Q.21 Why is positive pressure kept in the corridor, not in the process
area?
Ans: The different pressure gradient is essential at different locations to
avoid cross-contamination of a product through the air.

Q.22 Recommended storage condition for empty hard gelatin capsule

Ans: It should be 15-25°C and 35-5/% RH.

Q.23 What shall be the DT Temperature recommendation for

dispersible tablet
Ans) 25±1°C (IP) and 15-25°C (BP)

Q.24 Difference between validation and calibration?

Ans: Validation provides written evidence to ensure that a particular
method or operation reliably develops a product with predetermined
requirements and quality credits. It is performed according to the
validation protocol.
Calibration denotes that Equipment produces the values in specified
limits by comparing the values produced by a standard. It Is done
according to the calibration standard operating procedure.

Q.25 Tell the time required for long-term and accelerated stability
testing.
Ans: long term study 12 months
Accelerated stability for six months.

Q.26 What is SISPQ?

Ans: Safety, integrity, strength, purity, and Quality.

Q.27 Which Fluorescence material is used in BIN Washing while PQ?

Ans: Riboflavin

Q.28 Which class of Area is Required for Tablets and Capsule

Manufacturing?
Ans: Class D

Q.29 What is positive pressure?

Ans: The atmospheric pressure is higher than the immediate surrounding
areas, usually measured in inches of water or Pascal.

Q.30 What is the schedule- M?

Ans: schedule- M is the Good Manufacturing Practices and its
Requirements of premises of the plant, waste disposal, and Equipment.
GMP is divided into two separate parts:
GMP I for Factory premises
GMP II For plant and Equipment.
Q.31 What is the Deviation?
Ans: A deviation is an unexpected event that accrues during the ongoing
operation/activity/Documentation/entries at any stage of receipt, storage
and Manufacturing, analysis and distribution of drugs
products/Intermediate/Raw materials/ packing materials. The deviation is
to be reported as and when events occur and to be investigated for impact
analysis.

Q.32 What is VMP?

Ans: VMP Means Validation master plant. It is about brief information
about the Qualification, Validation, and calibration of Equipment,
instruments, and system. VMP types documents providing information on
the company’s Validation work program. Responsibility related to VMP
should be stated.

Related: Technical pharmaceutical interview questions/answers

Q33. What is Market Complains?

Ans: A complaint is any expression of dissatisfaction with a product or
service marketed. Any written/ genuine verbal communication received
directly from any customer, retailer, distributor, healthcare professional,
regulatory agency, patient (Consumer), or field staff regarding the safety,
identity, strength, purity, Quality, shortages, or any other such complaint
shall be treated as a market complaint.

Q.34 What is a Product recall?:

Ans: Removal or correction of marketed products for reasons relating to
deficiencies in Quality, safety, or efficacy, including labeling considered
to violate the laws.
Q.35 Vendor Qualification?
Ans: New Vendor: Manufacturer identified by Formulation Development
or purchase department as a manufacturer supplying a specific material
from a specific manufacturing site.

Approved Vendor: Manufacturer of raw material, primal, and printed

packaging material, approved by QA to supply specific material from a
specific site, based on the cGMP.

Q.36 Cleaning Validations?

Ans: DEFINITION: Cleaning Validation is the documented evidence that
an approved cleaning procedure will provide Equipment suitable for
processing medicinal products.

Q.37 Annual product quality review (APQR):

Ans: Documented regular periodic or rolling quality reviews of all
licensed medicinal products to verify the consistency of the existing
manufacturing process to highlight any trends and to identify product and
process improvements or weaknesses for licensed medicinal products the
appropriateness of current specifications for both starting materials and
finished products.

Q.38 What is the limit for “individual unknown Impurity” in API as

per ICH Q2A?
Ans: The limit of the “Any individual unknown Impurity” is not more
than 0.1%

Q.39 What are the class-1 solvents as per ICH Q3C?

Ans: Benzene – 2
Carbon tetrachloride -4ppm
1, 2 Dichloroethane – 5ppm
1, 1 Dichloroethene – 8ppm
1, 1, 1 -Trichloroethane-1500 ppm

Q.40 Different ICH guidelines

Ans:

Q.41 What is the specific gravity of Methylene chloride?

Ans: The specific gravity of Methylene chloride is 1.308 gm/ml

Q.42 Suppose the Area is class 100000, then what are the maximum
light and sound levels as per guidelines?
Ans: light level: not less than 300 lux.
Sound level: it should not be more than 80 decibels.

Related: Lux/Light intensity requirements

Q.43 What is the instrument name, which is used for measuring

vacuum during high vacuum distillation?
Ans: Macleod gauge
Q.44 Is the cGMP requirement only for personnel in Manufacturing?
Ans: No, this requirement is for every employee of the organization who
must know relevant cGMP requirements in his/her Area.

Q.45 Why do we conduct the training?

Ans: It brings awareness and helps employees to become competent.

Q.46 India belongs to which Climate Zone?

Ans: India comes under Climate Zone III (Known as the Hot, dry Zone)
and Zone IVb (known as Hot/Higher humidity)

Q.47 What is force degradation or stress testing:

Ans: Force degradation is also known as stress testing, and a drug is
degraded Forcefully by applying artificial methods.

It helps to know about Impurities that develop during the storage of drug
products in various environmental conditions. Forced degradation study
depends upon the product and the type of dosage form. Solid, liquid, and
injection have different procedures for the stress study.

Q.48 Explain Qualifications and their flow

Ans: Design Qualifications, installation Qualifications, Operational
Qualifications, and Performance Qualifications.
Flow=URS>> FAT>>SAT>>DQ>>IQ>>OQ>>PQ.

Q.49 What is a Critical Quality Attribute?

Ans: it is chemical, physical, biological, and microbiological
characteristics that should be under limits and range to ensure the Quality
of the products.
Q.50 What is OOS (Out of Specification)?
Ans: A result that falls outside established acceptance criteria established
in official compendia and by company documentation.
OR
Out of specification is the comparison of one result versus predetermined
specification criteria.

Example of OOS (Out of Specification):

The specification limit for the assay is 90.0-110.0 % w/w of the label
claim.
For a selected batch, the result obtained is 85.2 % w/w – This result is
out of the specification limit, which is often called OOS.

Q.51 What is OOT (Out of TREND)?

Ans: Results of a drug substance of a selected batch, which is within the
specification limit but a similar result compared to other batches of a
similar drug substance, falling outside the typical results of all compared
batches.
Or
specification results may be within limits but show a significant change
from the historical results.

Example of OOT (Out of TREND):

The result obtained 95.8 % w/w. Although the results are well within the
specifications, we should always compare the result with the previous
batch’s trend. If we found the typical value of the trend as 99.0 % w/w,
then this batch result (95.8 % w/w) is named out of trend.

Quality Assurance Interview Questions related to the processing Area?

Q.52 What is relative humidity?
Ans: it is the ratio between the amount of water vapor in a particular air
volume and at provided temperature. The maximum amount of water
vapor that the air can possess.

Q.53 If the temperature or RH of the Area goes out of the limit, what
action is to be taken?
Ans: immediately stop the line, and inform the responsible department to
raise the maintenance requisition slip. Ensure that all the intermediate
materials are correctly covered.

Q.54 How to stop cross-contamination in an area?

Ans: By ensuring to follow proper gowning procedure and material
transfer procedure and controlled staffing movement in the Area,
maintaining Differential pressure is also essential to controlled cross-
contamination.

IPQA Pharma Interview Question:

Q.55 What is process validation?

Ans: As per EMA Definition process validation is “documented evidence
that of a method, operated within established parameters, that can be
performed effectively and reproducibly to provide a medicinal product
meeting as per its predetermined specifications and quality attributes.”

USFDA Definition Process validation is “The evaluation of data and

collection, from the process design stage throughout the production stage,
to consistently delivering a quality product” based on established
scientific evidence.
Q.56 Consistent with regulatory guidelines (USFDA), what are the
stages of process validation?
Ans: Process validation involves a series of activities happening over the
lifecycle of Drug products and processes. There are three stages for
process validation activities.

Stage 1 — Process Design: The commercial manufacturing process is

defined based on knowledge gained through development and scale-up
activities.
Stage 2 — Process Qualification: During this stage, the method design is
evaluated to determine if the method is capable of reproducible
commercial manufacturing.
Stage 3 — Continued Process Verification: Ongoing assurance is gained
during routine production that the method remains in a state of Control.

Q.57 Tell How many batches took for the process validation?
Ans: The EMA draft guideline states “a minimum of three consecutive
batches,” with justification to be provided (there are some exceptions to
the current statement).

The USFDA guidance states that the number or quantity of batches must
be sufficient to supply statistical confidence in the method. It is a subtle
but essential distinction in the approaches.

Q.58 Explain the strategy for process validation of solid dosage

forms.
Ans: The use of different lots of raw materials should be included. i.e.,
active drug substance and major excipients.
 • Batches should be run serial and on different days and shifts
(the latter condition, if appropriate). Batches should be
manufactured within the Equipment and facilities designated
for eventual commercial production.
• Critical process variables should be set within their operating
ranges and will not exceed their upper and lower control
limits during process operation. Output responses should be
within the finished product specifications.
• Failure to satisfy the wants of the Validation protocol
regarding process input and output control should be
subjected to process requalification.
Q.59 What is Validation Protocol?
Ans: A written plan of action stating how process validation will be
conducted; it will specify who will conduct the various tasks and define
testing parameters; sampling plans, testing methods, and specifications;
will specify the product and its characteristics And Equipment to be used.

It must specify the number of batches and acceptance criteria to be used

for validation studies; and who will sign/approve or Disapprove the
conclusions derived from such a scientific study.

Q.60 What should be processed validation protocol content?

• General information
• Objective
• Background/Pr- validation Activities, Summary of
development and tech transfer (from R&D or another Site)
activities to justify in-process testing and controls; any
Previous validations.
 • List of Equipment and their qualification status
• Facilities qualification
• Process flow charts
• Manufacturing procedure narrative
• List of critical processing parameters and necessary
excipients
• Sampling, tests, and specifications
• Acceptance criteria
Q.61 What should be the blend sample size in In-process validation
studies?
Ans: It is a 1x – 3x dosage unit range on a case-to-case basis. As per
USFDA guidance, sampling sizes are often increased from lx -10x with
adequate scientific justification.

Q.62 How many sampling points should be considered for collecting

blend samples According to USFDA guidance?
Ans: According to USFDA guidance, At least 10 sampling locations are
to be considered.

In the case of connective blenders, At least 20 locations are

recommended to validate adequately (ex: ribbon blender)

Q.63 What will be the reason for the inside location variance of blend
data?
Ans: Inadequacy of blend mix, sampling error, or agglomeration

Q.64 What is the difference between EMA & US guidelines on

process validation?
Ans: EMA US Definition “documented evidence that the process,
operated within established parameters, can perform effectively and
reproducibly to produce a medicinal product meeting its predetermined
specifications and quality attributes.”

Definition It is “The evaluation of data and collection, from the process

design stage throughout the production stage, to consistently delivering a
quality product based on established scientific evidence.” The EMA draft
guideline states “a minimum of three consecutive batches,” with
justification to be provided (there are some exceptions to the present
statement).

The US FDA guidance states that the number of batches must be

sufficient to supply statistical confidence in the method. The EMA draft
encourages the use of product development activities but is less
sanctioned on requirements. The USFDA guidance emphasizes
documenting the event phase as a part of PV. The EMA guideline
explicitly allows the utilization of CPV to exchange traditional validation
efforts.

The US FDA approach does not place a high emphasis on CPV. It

requires all three stages of process validation to be fully addressed,
regardless of whether contemporary or traditional methods are utilized.
The US FDA guidance considers Equipment and process design and
equipment qualification as part of the overall process validation effort.
The EMA guideline sees the process as independent from Equipment and
facility. Currently, the EMA still relies on Annex-15 of the GMP guide
for instruction on equipment qualification.

Q.65 During process validation, Why the hopper challenge study is

performing?
Ans: Hopper challenge study was performed to evaluate the effect of
vibrations during compression on blend uniformity, a hopper study shall
be carried out.

Q.66 What are the critical process variables in the coating?

Ans: Pan RPM, inlet & exhaust temperature, spray rate, gun distance, and
air pressure.

Q.67 Why may blend be a critical parameter in tablet

manufacturing?
Ans: Less blending will result in non-uniform distribution of drugs and
poor flow, whereas more blending will result in de-mixing leading to
non-uniform distribution of drugs and an increase in disintegration time

Q.68 What is the mess size of the DT apparatus?

Ans: 1.8 to 2.2mm (#10)

Q.69 DT Apparatus Limits/ Tolerance Limits

Ans: Disintegration test apparatus Limits/ Tolerance Limits are as
follows:

1. Temp. of water bath/Actual observation / Tolerance limit 37-

39°C
2. Temp. in the beaker/ Actual observation L&R/ Tolerance
limit 37±2°C
3. No. of strokes/min./4times Actual observation L&R/
Limit 29-32
cycle./min.
4. Stroke heights/ Actual observation L&R/ Tolerance limit 55
±2mm.
 5. Baskets lowermost position/ Actual observation L&R/ 25
mm.
6. Sieve Integrity/ Actual observation L&R/ 2.0mm ±0.2mm
Q.70 What is recommended temperature for checking DT for
dispersible tablets?
Ans: 25±1°C as per (IP) and 15 to 25°C as per (BP).

Q.71 Tell pass and fail criteria for DT?

Ans: Repeat the test on 12 additional tablets or units if 1 or 2 units failed
to disintegrate. The goal is achieved if 16 out of 18 tablets/capsules
disintegrate entirely.

Q.72 Weight variation limits for Tablets?

Ans:

Q.73 Weight Variation Limits for Capsules?

Ans:
Q.74 Metal detector test and Principle with test piece size for Tablets
and Capsules
Ans: Principle- Electromagnetic induction principle
Test piece- Tablets – Ferrous (0.3mm), Non-Ferrous (0.3mm), Stainless
steel (0.5mm), Plain
Capsule – Ferrous (0.1mm), Non-Ferrous (0.15mm), Stainless steel
(0.20mm), Plain

Q.75 Define Clean hold time

Ans: The clean hold time is defined as the time between the completion
of cleaning and the initiation of the subsequent manufacturing operation.

Q.76 Define Dirty hold time

Ans: The dirty hold time is defined as the time between the end of the
manufacturing operation and the beginning of the cleaning process.

Q.77 Define Campaign Cleaning:

Ans: Campaign Cleaning: Campaign cleaning shall be performed after a
series of the same product batches manufacturing with the batch-to-batch
cleaning procedure. Campaign cleaning shall be performed if 8 batches of
the same product have been processed or 3 days have passed, whichever
is earlier

Q.78 Define Batch to Batch Cleaning:

Ans: Cleaning shall be performed, between batches and subsequent batch,
where the previous and next product is the same.

Q.79 Maximum Allowable Residue (MAR):

Ans: Maximum Allowable Residue is An acceptable transferred amount
of residue from the previous product to the next product.
Q.80 What are ALCOA and ALCOA++ ?
Ans: Read Full details about ALCOA and ALCOA ++ with examples here

Q.81 Define CAPA with an Example.

Ans: Read about CAPA and its Example here

Q.82 Tells me about Different Quality Risk Management

Methodology
Ans: Basic risk management facilitation methods (flowcharts, check
sheets, etc.)
Failure Mode Effects Analysis (FMEA)
Failure Mode, Effects, and Criticality Analysis (FMECA)
Fault Tree Analysis (FTA)
Hazard Analysis and Critical Control Points (HACCP)
Hazard Operability Analysis (HAZOP)
Preliminary Hazard Analysis (PHA)
Risk ranking and filtering
Supporting statistical tools

Q.83 Define the Black area

Ans: Non-manufacturing areas, such as warehouse, administration, and
workshop comprises the black area. Temperature and R.H. should be
controlled as per material specifications in a warehouse storage area.

Q.84 Define Dark gray area

Ans: Areas where primary packaged products are handled, such as visual
inspection of ampoules,
vials, blisters, and final packaging operations comprise the dark gray
area. Depending on the product temperature and relative humidity should
be controlled.
Q.85 Define Gray Area
Ans: Areas where operations like sampling, dispensing, compounding,
and producing solids, semisolids, and liquids for oral use comprise gray
areas. These are areas where personnel could come into direct contact
with open materials (starting materials, intermediate products, and open
primary packaging material).

Q.86 Define Blue Area

Ans: Parenteral bulk preparation takes place in the blue area.

Q.87 Define Green Area

Ans: Parenteral filling operation takes place in green areas.

Q.88 Tell me the types of Sampling

Ans: Random Sampling, Systematic Sampling, and Representative
Sampling.

Q.89 Define Random Sampling

Ans: Random Sampling is the Samples taken at random from the whole
population of the material.
The only requirement of such a random sampling process is that all parts
of the population have the same chance of being sampled. e.g. Inactive
R.M.

Q90. Define Systematic Sampling

Ans: Systematic Sampling is the Samples collected on the basis of a
given geometric or time pattern i.e at regular intervals. e.g. Sampling of
water
Q91. Define Representative Sampling
Ans: Representative Sampling is the sampling from the various layers &
a composite sample is prepared eg. composite samples from the container
are sampled.

Q.92 What are the types of different training programs?

Ans: 1. Induction training
Job oriented training
cGMP training
On-going training

Q.93 What are the classifications of residual solvents?

Ans: Residual solvents are classified into three classes based on the
possible risk to human
health:
Class-I (Solvents to be avoided)
Class-II (Solvents to be limited)
Class-III (Solvents with low toxic potential)

Q.94 What is the difference between Responsibility and

Accountability?
Ans: A. Responsibility: Personnel directly associated with the
implementation of the procedure
Accountability: Person directly associated with the implementation of the
system under
which the procedure falls.

Q.95 Why is nitrogen gas used in the manufacturing area at room

temperature and why not other gas?
Ans: Because nitrogen is chemically less reactive and does not react with
other elements at
ordinary temperatures. It is due to strong bonding in its molecules.

Q.96 What are the different types of cleanings?

Ans: There are three types of cleanings:
● Batch to Batch cleaning
● periodically cleaning
● Product change over cleaning

Q.97 What is the expiry date & re-test date?

Ans: Expiry date: The date placed on the container/labels of an API
designated the time during which the API is expected to remain within
established shelf life specifications if stored under pre-defined conditions
and after that, it should not be recommended to use.
Re-test date: The date when a material should be re-examined/Resampled
to ensure that it is still used for product manufacturing. The time period
during which the drug substance/molecules are expected to remain within
its specifications as per COA and thereafter, can be used in the
manufacturing, provided that the drug substance has been stored under
the defined conditions.

Q.98 What are contamination and cross-contamination?

Ans: Read complete details about contamination and cross-
contamination here

Q.99 What is the Batch number and batch?

Ans: Batch Number: A unique combination of numbers, letters, and/or
symbols that identifies a batch (or lot) and from which the production and
distribution history can be determined
Batch: A specific lot of material produced in a process or series of
processes in an area, so that it is expected to remain in homogeneous
form within given limits.

Q.100 What is quarantine?

Ans: The status of materials isolated physically or by other effective
means pending a decision on their subsequent approval or rejection.

Q.101 What is the definition of critical process parameters?

Ans: A process parameter whose variability has an impact on a critical
quality attribute and therefore should be monitored or controlled to
ensure the process produces the desired quality.