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In this file, you can ref useful information about quality management system processes such as
quality management system processesforms, tools for quality management system processes,
quality management system processesstrategies If you need more assistant for quality
management system processes, please leave your comment at the end of file.
Other useful material for quality management system processes:
qualitymanagement123.com/23-free-ebooks-for-quality-management
qualitymanagement123.com/185-free-quality-management-forms
qualitymanagement123.com/free-98-ISO-9001-templates-and-forms
qualitymanagement123.com/top-84-quality-management-KPIs
qualitymanagement123.com/top-18-quality-management-job-descriptions
qualitymanagement123.com/86-quality-management-interview-questions-and-answers
quality management system. A range of workshops, seminars, and training courses are also
available.
2.
Where to Look
The FDAs Quality System Manual Provides the final rule on 21 CFR Parts 808,
812, and 820 effective 08/17/2009. [link updated 10/5/09]
does the person have a recipe approach (i.e. one size fits all) or does s/he consider the
unique circumstances of the company and the team?
2.
What to Cover Responsibility for a quality system begins with executive management.
Therefore, it is vital that executive management is involved from the beginning of the
process. Meet with executives to ensure their understanding of the management
responsibility sections of QSR and/or ISO. Then, initiate the quality system design and
implementation process by developing an organizational strategy with top management to
engage key players across the organization. Assemble a cross-functional team to define the
companys overarching quality policy. The quality policy should set forth the overall
intentions and direction of an organization with respect to quality, as established by
management with executive responsibility. Validate and reinforce the policy with
appropriate employees at all levels within the organization.
2.
Where to Look Refer to the documentation for the standard being implemented to
understand executive management responsibilities. Network with individuals in the field
and visit other companies to observe their operations and ask about their approach to
quality. Leverage the experience of the companys quality professional(s).
Build a Shell of the Quality System and Develop Elements as the Product Progresses
1.
What to Cover Map out the high level requirements and processes of the quality
system from end to end (i.e., from design through manufacturing, distribution,
postmarketing surveillance). Then, depending on the stage of the company and its
product(s), determine which processes and procedures need to be developed further, at a
greater level of detail. Design control is usually one of the first elements to be developed at
the tactical level. Change/document control often comes next, followed by
corrective/preventive action processes (to guide continuous improvement), and then
production/process controls. These elements should be built-out (following the guidelines
provided in the quality policy and working within the construct of the quality system
shell) as they are needed, based on the progress of the company.
2.
The FDA and Worldwide Quality System Requirements Guidebook for Medical
Devices (purchase site) A helpful reference complied by Kimberly A. Trautman, a
GMP/quality systems expert.
Marie Teixera and Richard Bradley, Design Controls for the Medical
Devices Industry (CRC Press, 2002).
Basem El-Haik and Khalid S. Mekki, Medical Device Design for Six
Sigma: A Road Map for Safety and Effectiveness (John Wiley & Sons, 2008).
What to Cover While it can be tempting to implement a quality system and then let it
run on auto pilot, a company must proactively monitor and maintain its quality system to
ensure ongoing compliance. Quality systems are meant to be dynamic, changing and
improving with the organization as new information, issues, and opportunities are
identified. By naming functional champions to oversee the entire quality system, as well as
the specific sections most relevant to their individual expertise, the company is more likely
to anticipate and prevent challenges and improvements. For this reason, a team approach is
typically preferable to assigning a single quality executive to maintain end-to-end oversight
of the quality system.
2.
Where to Look Work with executive managers to identify and empower the
appropriate quality champions. The companys quality professional(s) can help structure
these roles, responsibilities, and oversight processes.
What to Cover Train employees and executives on good audit techniques (discussed in
Quality Enforcement section). This training should be ongoing, not simply performed in
advance of a scheduled audit. Provide representative of the company with the opportunity to
practice their audit processes by performing internal audits on a periodic basis.
2.
Where to Look Many external training courses are provided that can be useful to
helping employees and professionals prepare for audits (e.g., offered through ASQ). The
companys quality professional(s) can also develop and lead such trainings internally. For
more information about the FDAs audit process, refer to the FDAs Quality Systems
Manual. ISO training is available through the many ISO-accredited third-party
organizations authorized to award ISO certification.
What to Cover Once the companys quality system is under development, look for
other work streams where the company will potentially benefit from increased rigor,
discipline, and accountability. Apply the same general principles to articulate goals, define
processes, developing metrics, and establish monitoring and correction mechanisms.
2.
Where to Look Based on its learnings from implementing a quality system, the team
may be able to tackle this step itself (ideally, through cross-functional collaboration).
1. Check sheet
The check sheet is a form (document) used to collect data
in real time at the location where the data is generated.
The data it captures can be quantitative or qualitative.
When the information is quantitative, the check sheet is
sometimes called a tally sheet.
The defining characteristic of a check sheet is that data
are recorded by making marks ("checks") on it. A typical
check sheet is divided into regions, and marks made in
different regions have different significance. Data are
read by observing the location and number of marks on
the sheet.
Check sheets typically employ a heading that answers the
Five Ws:
2. Control chart
Control charts, also known as Shewhart charts
(after Walter A. Shewhart) or process-behavior
charts, in statistical process control are tools used
to determine if a manufacturing or business
process is in a state of statistical control.
If analysis of the control chart indicates that the
process is currently under control (i.e., is stable,
with variation only coming from sources common
3. Pareto chart
5.Ishikawa diagram
Ishikawa diagrams (also called fishbone diagrams,
herringbone diagrams, cause-and-effect diagrams, or
Fishikawa) are causal diagrams created by Kaoru
Ishikawa (1968) that show the causes of a specific event.
[1][2] Common uses of the Ishikawa diagram are product
design and quality defect prevention, to identify potential
factors causing an overall effect. Each cause or reason for
imperfection is a source of variation. Causes are usually
grouped into major categories to identify these sources of
variation. The categories typically include
People: Anyone involved with the process
Methods: How the process is performed and the
specific requirements for doing it, such as policies,
procedures, rules, regulations and laws
Machines: Any equipment, computers, tools, etc.
required to accomplish the job
Materials: Raw materials, parts, pens, paper, etc.
used to produce the final product
Measurements: Data generated from the process
that are used to evaluate its quality
Environment: The conditions, such as location,
time, temperature, and culture in which the process
operates
6. Histogram method