an organization is the collective body of processes, operating
procedures, objectives, responsibilities, resources and
infrastructure needed to implement effective management of quality.
The first step in setting up a quality management system within a company
is to generate a
This should be done even before any quality procedures or specifications
The quality manual is the company's quality
It is a document that states
in a concise and brief
format the high-level policies and objectives of the company required to
achieve its desired level of quality. It should also show how the
company's over-all documentation of specifications is structured.
is good practice for a company to choose an international quality
standard as basis of its quality management philosophy before it writes
up its quality manual. One such standard that semiconductor companies
have embraced over the years is the
9000 series of
standards. As such, most semiconductor companies base their quality
manual on the ISO 9000 standards. An ISO 9000-based quality manual must
address every ISO element or section of the ISO 9000 standard that the
company wants to be certified to.
ISO quality section or element addressed by the quality manual should be written
with at least three parts, i.e., Scope, Policy and Responsibilities. The Scope portion
should simply state the purpose of the covered area. The
Policy portion should state the company policy regarding the
applicable ISO clause. The
Responsibility portion should state who, in generic titles or
positions, is responsible for the policy.
Quality attainment and maintenance need money (referred to as the cost
of quality) so the quality system of the organization should not exceed
what's needed to meet the organization's quality objectives. It is
therefore essential for a company to clearly document its quality
objectives, and the processes by which it will achieve these objectives.
The embodiment of these quality objectives is the company's
standard, and it is up to the quality system to ensure that the
company's documented procedures, actual operation, and quality records
all conform to this standard.
system should encompass not only the quality of the finished product of
a company, but should cover the quality of operational processes as
well. In fact, it not only must cover the over-all in-process
quality of the company, but should also consider the quality systems of
its suppliers and subcontractors, as well as those of the customers.
semiconductor industry, the quality system of a company is the backbone
of how it does its business. A company that has a great product can fail
if the quality of its operations is inferior. Even the basic task of
getting customers relies greatly on the quality system of the company.
For instance, a semiconductor company needs
ISO certification before
it can attract customers, and ISO certification revolves around an
extensive audit of the quality system of the company.
Quality System Planning
Quality system planning is the
first stage in setting up a quality management system within the company.
This pertains to the identification and acquisition of resources,
logistics, and manpower needed to define and achieve the required quality
of the company. If the company is to be certified to ISO 9000, then
quality planning should ensure that the company's quality system will
eventually conform to all the requirements of the ISO9000
Quality planning should
include compatibility among the various aspects of the company's
operations from start to finish: product design, production, and product
inspection/testing. It should also include definition of product and
process specifications. Identification of the necessary monitors as well
as inspection/verification stations at suitable points along the
production process should also be addressed as early as quality planning.
Measurement capability requirements must likewise be defined during
Quality System Documentation
Once the quality system plan
of the company has been completed, the quality system must undergo full
documentation that comprehends the complexity of the production process,
the manpower skills required for production, and the training requirements
to achieve these manpower skills. At the minimum, quality system
documentation should include the company's quality manual and
specifications showing the company processes, work instructions in support
of these processes, and production/quality records required by these work
III. Quality System Implementation
The last stage of setting up a
quality system is, well, its implementation. By the time this stage is
reached, the over-all quality system should have been defined and
documented, and supported by product- or process-specific quality plans.
Implementation should involve everybody in the company - the management
for enforcing, reviewing, and continuously improving the quality system,
and the personnel to comply with the quality system to achieve the
company's quality objectives. Quality
must be conducted regularly to ensure that the actual implementation of
the quality system is in full conformance with the quality system
organization needs a mechanism by which it can check whether or not its
operations are complying with all standards defined to meet its charter
and objectives. This is the purpose of quality audits: to ensure
that the company has documented standards or specifications on how to do
things and that these standards are complied with at all times.
put, a quality audit consists of preparing a list of items
(procedures, equipment set-ups, quality records, measurements, etc.)
to check and going to the areas responsible for these items for an actual
check or audit of these items. The audit may be performed by a person (the
auditor) or a group of persons (the audit team).
Using the audit
plan or checklist as basis, the auditor proceeds by asking questions,
reviewing documents, checking records against specs, making measurements,
etc. to ensure that all the audit items have adequate documentation and
are implemented in accordance with the documentation. There are three
types of audits: 1)
audits; and 3)
also known as internal or self audits, pertain to audits wherein the auditors themselves
are employees of the company being audited. Some companies let
people directly audit the areas they are responsible for, while some
companies ask people to audit areas that are not under their jurisdiction.
Self-audit teams are usually composed of three or four people.
involve a direct customer of the company being audited as the auditor.
Needless to say, a second-party auditor has a direct interest in how well
the auditee adheres to the standard, even if he or she is not an
employee of the auditee.
pertain to audits wherein the auditor is an independent, third-party entity not
related in any way to the company and the company's customers. Third-party auditors
are usually hired by the company to conduct audits that will help the
company get certified to a certain quality standard, such as the
Gap Analysis and Corrective
The world is not perfect, so
there will always be room for improvement within the company.
is the comparison of what actually goes on within a company to what is
required of the company. At a high level, it pertains to the comparison of
the existing quality system and its current implementation to the
requirements of external standards. At a different albeit equally
important level, gap analysis is the comparison of the company's actual
practices with its quality system requirements. The objective of gap
analysis is to identify as many discrepancies as possible in order to
systematically address them through a
corrective action system.
Gap analysis and corrective
action pertaining to quality system conformance to external requirements
are often addressed by a special team composed of personnel who have the
expertise and authority on the element being analyzed. Simply put, this
team will review the company's quality system against the conformance
model it was or will be certified to, as well as applicable government
regulatory and statutory requirements. Any gaps will then be
addressed by instituting process changes and making the necessary
Just as there is a need to do
gap analysis at quality system level, there is a need to do gap analysis
at product/process conformance level. Thus, a company's quality
system must include a gap analysis (GA) mechanism and corrective action
(CA) system for product/process conformance discrepancies. No matter how
mature a company's operations are, there will be glitches along the way.
An effective corrective action system will minimize, if not preclude, the
recurrence of such glitches in the future.
At a minimum,
the GA/CA system of the company must have a standard procedure for: 1)
highlighting detected discrepancies and initiating a GA/CA request; 2)
documenting the gap analysis results; 3) identifying and documenting
containment and corrective actions; 4) proper disposition of affected
products, if any.
Corrective Action System;
Monitors and Controls;
The ISO9000 Standard;
Metrology and Calibration
All Rights Reserved.