Analytical Chemistry

Quality Control and Quality Assurance

Seven tools for quality control

Quality pros have many names for these seven basic tools of quality, first emphasized by Kaoru
Ishikawa, a professor of engineering at Tokyo University and the father of "quality circles." Start
your quality journey by mastering these tools, and you'll have a name for them too:
indispensable.

Cause-and-effect diagram (also called Ishikawa or fishbone diagrams): Identifies many

possible causes for an effect or problem and sorts ideas into useful categories.

Check sheet: A structured, prepared form for collecting and analyzing data; a generic tool that
can be adapted for a wide variety of purposes.

Control chart: Graph used to study how a process changes over time. Comparing current data to
historical control limits leads to conclusions about whether the process variation is consistent (in
control) or is unpredictable (out of control, affected by special causes of variation).

Histogram: The most commonly used graph for showing frequency distributions, or how often
each different value in a set of data occurs.

Pareto chart: A bar graph that shows which factors are more significant.

Scatter diagram: Graphs pairs of numerical data, one variable on each axis, to look for a
relationship.

Stratification: A technique that separates data gathered from a variety of sources so that patterns
can be seen (some lists replace stratification with flowchart or run chart). 

The concept of quality assurance,

 Quality assurance (QA) is any systematic process of determining whether a product or service
meets specified requirements.

QA establishes and maintains set requirements for developing or manufacturing reliable

products. A quality assurance system is meant to increase customer confidence and a company's
credibility, while also improving work processes and efficiency, and it enables a company to
better compete with others.

The ISO (International Organization for Standardization) is a driving force behind QA practices

and mapping the processes used to implement QA. QA is often paired with the ISO
9000 international standard. Many companies use ISO 9000 to ensure that their quality assurance
system is in place and effective.

The concept of QA as a formalized practice started in the manufacturing industry, and it has
since spread to most industries, including software development.

Quality assurance techniques,

Google ‘quality assurance methods’ and you will see that there are plenty of choices out there.
Here are just some of the most popular quality assurance methods and processes:
 Benchmarking
 Business process re-engineering
 Kaizen
 Operations analysis
 ISO accreditation
 Ishikawa diagrams
 Specifications
 Standard operating procedures
 Cost-benefit analysis
 Statistical sampling
 Quality management methodologies e.g. Six Sigma, Lean Manufacturing
The chances are your business is currently using at least one of these tools, even if you haven’t
formally labelled it as a quality assurance process. Some methodologies are more involved than
others; however, whichever one you select, the company intranet can simplify the processes
involved for a speedier and more effective outcome. Let’s find out how exactly.
Validation and Qualification...

There are a number of stages in performing a validation program which are widely accepted as
conforming to best validation practice, namely the stages of design qualification (DQ),
installation qualification (IQ), operational qualification (OQ) and performance qualification
(PQ).

DQ – Design Qualification.

The design qualification is focused on ensuring there is documented verification that the
proposed design is suitable for the intended purpose. The first element of A validation effort
should be the design qualification (DQ). Where applicable the compliance of the design with
Good Manufacturing Practice should be demonstrated and documented.

Validation Qualification

Product and Process Validation. IQ, OQ, PQ. Validation Gap Analysis. The Master Validation
Plan. … Information | Understanding | Best Practice.

IQ – Installation qualification.

The installation qualification is focused on ensuring that there is documented verification that an
item of equipment, as installed or modified, complies with the approved design and
manufacturer’s recommendations. This qualification covers the installation of equipment, any
related piping, services, instrumentation, which are checked to confirm adherence with current
engineering drawings and specifications. This stage includes the confirmation of the availability
of relevant supplier operating instructions and maintenance requirements, confirms adequacy of
calibration requirements and verification of materials of construction.

OQ – Operational qualification.
The operational qualification stage is focused on ensuring that there is documented verification
that the process, (or equipment, or facility) as installed or modified, performs as intended. The
OQ should follow IQ. This stage involves finalizing calibration SOPs, cleaning procedures,
confirmation of training, preventative maintenance requirements. The OQ results in the release
of the facilities, systems and equipment following validation report approval.

PQ – Performance qualification.

The performance qualification stage is focused on ensuring that there is documented verification
that the entire process, related equipment and supporting facilities as connected together can
perform effectively as required by the predetermined acceptance criteria. The PQ should follow
successful completion and sign-off of the IQ and OQ stages. The PQ stage consists of test runs
using production materials or qualified substitutes.

Calibrations

The word “calibration” may be used (and misused) in different contexts. Here, we are talking
about metrological calibration in the world of measurement technology.

Formally, calibration is the documented comparison of the measurement device to be calibrated

against a traceable reference device.

The reference standard may be also referred as a “calibrator.” Logically, the reference is more
accurate than the device to be calibrated. The reference device should be also calibrated
traceably, more on that later on.

With some quantities the reference is not always a device, but can also be for example a mass,
mechanical part, physical reference, reference liquid or gas.

Monitoring and quality reviews,

Monitoring, the ongoing evaluation of appropriateness of the design and operating effectiveness,
is a key element of a CPA firm’s quality control system. It serves to maintain the effectiveness of
the quality control system through keeping up to date on current changes in professional
standards and the nature of a firm’s practice. Monitoring also serves as an opportunity to
improve on the services the firm provides and the efficiency and effectiveness of those services.
Monitoring is a continuous process of evaluating a firm’s system of quality control that includes
Engagement Quality Control Reviews, post-issuance reviews, or periodic inspections of
completed engagements.

Quality Monitoring is when an individual or organisation takes the time to listen to and evaluate
the phone conversations taking place between staff and customers in order to improve call
handling, customer service, loyalty and revenue.  If an organisation has a call recording system
in place these interactions can be reviewed by playing back the recorded calls. Where there is no
call recording in an organisation, calls can be listened to and evaluated manually through live
side-by-side monitoring.

Periodicaltrainings,

ISO standards

ISO (International Organization for Standardization) is an independent, non-governmental,

international organization that develops standards to ensure the quality, safety, and efficiency of
products, services, and systems. ... ISO standards are in place to ensure consistency.