QUALITY PLANNING

• A quality plan is a document, or several documents, that together

specify quality standards, practices, resources, specifications, and the
sequence of activities relevant to a particular product, service,
project, or contract.
• Quality plans should define :
1) Objectives to be attained (for example, characteristics or
specifications, uniformity, effectiveness, aesthetics, cycle time, cost,
natural resources, utilization, yield, dependability, and so on)
2) Steps in the processes that constitute the operating practice or procedures
of the organization
3) Allocation of responsibilities, authority, and resources during the different
phases of the process or project
4) Specific documented standards, practices, procedures, and instructions to
be applied
5) Suitable testing,inspection, examination, and audit programs at
appropriate stages
6) A documented procedure for changes and modifications to a quality plan as
a process is improved
7) A method for measuring the achievement of the quality objectives
HOW TO WRITE A QUALITY PLAN
• Quality Assurance or Quality Control plans evaluate and/or modify an
organization’s procedures to help ensure they provide the desired
results.
• Quality control plans are often viewed as a set of instructions that
should be followed.
• They document the planning, implementation, and assessment
procedures for a project, as well as any QA or QC activities.
• Some areas may be more detailed than others, based on the project,
process, or organization’s needs.
• It is important to note that each plan is unique based on the
organization’s needs and their Quality Management System (QMS).
• However, quality control plans should always have a structure that
permits improvements to the plan.
• This allows employees to offer input on how to improve efficiency and
quality.
• In addition, the plan should be reviewed by others periodically,
including stakeholders, to ensure the plan is comprehensive.
• Quality control plans generally include detailed information on:

1) An overview or introduction of the project or process detailing the background, need, scope,
activities, and important dates or deadlines
2) The organizational structure or org chart detailing necessary team members, including external
vendors
3) Each team member’s responsibilities and qualifications necessary to fulfill stated duties
4) Work verification (e.g., who is responsible for carrying out a task, as well as who is
responsible for checking the work)
5) Supplier standards (e.g., specify the standards the prospective suppliers must meet before they
can bid on a contract, such as ISO 9001:2015 series)
6) A list of qualified suppliers
7) Testing parameters
8) Performance standards and how performance will be documented
9) Acceptance criteria
10) Deliverables
11) A feedback mechanism for internal and/or external customer
feedback
12) Quality control procedures
13) Audits
14) Training (e.g., overview, job-specific, or refresher training)
15) Corrective action and preventive actions, including the person(s)
responsible for CAPA
Suggested corrective action
Required notifications
16) Any references or related materials, including performance ratings
or performance reports
QUALITY INFORMATION FEEDBACK
1) Customer Feedback:
Should be continually solicited and monitored: Customer Feedback
should be continuously solicited as customer preferences keep on
changing.
2) Customer complaints (feedback)
Customer feedback must be continuously solicited and monitored to
reduce the dissatisfied customers as much as possible.
Purpose of Feedback:
1) Discover Customer Dissatisfaction:
The feedback helps to know how satisfied or dissatisfied the customer is.
A customer who does not complain and switches to another brand is more
dangerous than a customer who complains.
Customer dissatisfaction can be a big eye opener and help discover what
more needs to be done for a product or service.
2) Discover Relative Priorities of Quality:
Certain parameters of quality are more important than others.
Whenever planning for a quality goal the organization should prioritize its
goals.
3) Compare Performance With Competition:
Watching competitor activity is a good learning tool for any organization.
This is a way of benchmarking us vis- à-vis others.
4) Identify Customer’s Needs:
There is a saying that salesman who discovers a customer need before everyone else
is more likely to get the sales.
The same logic holds for organizations as well.
You can always reap the benefits of first mover advantage.
5) Determine Opportunities for Improvement:
Customer feedback also helps an organization in determining about opportunities
for improvement.
TYPES OF CUSTOMERS
• Internal Customer:
The customer inside the company are called internal customers
• External Customers:
An external customer is the one who used the product or service or
who purchase the products or service or who influences the sale of the
product or service.
Tools of Customer Feedback:

1) Comment Card:
This can have simple open questions so that customer can answer it quickly.
2) Customer Questionnaire:
Design of questionnaire is of utmost importance to get timely and relevant information.
3) Focus Groups:
Focus groups are mostly used in B2B set up. Especially in pharmaceuticals industry, key opinion makers are made part of
the trial. Their opinion holds sway over doctors of hinterland. It helps them get a word to mouth publicity as well.
4) Toll Free Telephone Numbers
5) Customer Visits
6) Report Cards
7) Social Networking Sites: There are certain sites where visitors can share good or bad experience with a product or
service.
These sites give real insight into customer’s minds.
On other social networking sites, like Twitter and Facebook, people share their experiences and sometimes, unknowingly
may give opinion about a company.
Now certain companies are having devoted teams to analyse these data.
8) Employee Feedback:
9) Mass Customization:
Mass customization is another good tool to know about changed
preferences. Levi’s gives a facility on its website which enables a
potential customer to choose certain fabric, colour and design. Once
the customer places an order Levi’s gets the jeans stitched and
delivered at customer’s doorstep.
 Service Quality
• Organization Level
1) Identify Each Market Segment:
2) Write Down The Requirements:
3) Communicate The Requirements
4) Organize Processes
 TQM CULTURE
1) Modern quality management
• The traditional method of quality control made the holding of stocks essential.
• Pressures to reduce stock holding and their associated costs led to the
development of Quality Assurance and Total Quality Management (TQM) as
replacements for Classic QC.
• The emphasis now is to prevent the purchase or production of defective goods
in the first place, not to catch them after the event.
• It is now appreciated that quality depends on the people and the processes
used, not just the materials.
• Quality and efficiency has been widened, therefore, to cover the entire
firm, not just materials and products.
2) Quality Assurance - procedures as well as products are examined
and changed if necessary to ensure/assure customers that products are
fit for purpose.
3) Total Quality Management (TQM) - this is the system where the
responsibility for quality lies with ALL employees.
It commits the organisation to continuous improvement (Kaizen) of all
activities relating to the quality of the product and the satisfaction of
the customer.
TQM is really a culture, as to be effective it requires a change in
attitudes
4) Self-checking - the individual or group responsible for the product or
task checks quality all the time, ensuring that the next person in the
chain receives a quality product.
5) Team working. Firms work with their suppliers, sometimes even
investing money and/or buying shares in them, to ensure that the
product purchased is of the desired quality, so needing no checking on
delivery; in effect it is pre- checked at the supplier's factory.
The avoidance of faulty production requires that three aspects are
efficient:

• Methods - systems and procedures

• People - both line and staff functions
• Materials
• All these have to be efficient for a quality outcome.
 QUALITY AUDITS

• Quality audit is the process of systematic examination of a quality system

carried out by an internal or external quality auditor or an audit team.
• It is an important part of an organization's quality management system and is
a key element in the ISO quality system standard, ISO SERIES
• Auditing is defined as the on-site verification activity, such as inspection or
examination, of a process or quality system, to ensure compliance to
requirements.
• An audit can apply to an entire organization or might be specific to a function,
process, or production step.
• Some audits have special administrative purposes, such as auditing documents,
risk, or performance, or following up on completed corrective actions.
THE THREE DIFFERENT TYPES OF
AUDITS
• ISO 19011:2018 defines an audit as a "systematic, independent and
documented process for obtaining audit evidence [records,
statements of fact or other information which are relevant and
verifiable] and evaluating it objectively to determine the extent to
which the audit criteria [a set of policies, procedures or requirements]
are fulfilled."
• There are three main types of audits:

1) Process audit:
This type of audit verifies that processes are working within established limits.
It evaluates an operation or method against predetermined instructions or standards to measure conformance
to these standards and the effectiveness of the instructions.
A process audit may:
• 1) Check conformance to defined requirements such as time, accuracy, temperature, pressure, composition,
responsiveness, amperage, and component mixture.
•
• 2) Examine the resources (equipment, materials, people) applied to transform the inputs into outputs, the
environment, the methods (procedures, instructions) followed, and the measures collected to determine
process performance.
• 3) Check the adequacy and effectiveness of the process controls established by procedures, work instructions,
flowcharts, and training and process specifications.
2) Product audit:
This type of audit is an examination of a particular product or service,
such as hardware, processed material, or software, to evaluate whether
it conforms to requirements (i.e., specifications, performance
standards, and customer requirements).
3) System audit:
• An audit conducted on a management system.
• It can be described as a documented activity performed to verify, by examination
and evaluation of objective evidence, that applicable elements of the system are
appropriate and effective and have been developed, documented, and
implemented in accordance and in conjunction with specified requirements.
• A quality management system audit evaluates an existing quality management
program to determine its conformance to company policies, contract
commitments, and regulatory requirements.
• Similarly, an environmental system audit examines an environmental management
system, a food safety system audit examines a food safety management system,
and safety system audits examine the safety management system.