The document discusses quality management system audit checklists. It provides examples of advantages and disadvantages of using audit checklists. Some key advantages are that checklists promote planning, ensure consistency, and act as memory aids. Some disadvantages are that checklists can be seen as intimidating and focus too narrowly. The document also describes several quality management tools, including check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, and histograms. It provides examples of how each tool is used.
QMS SOP [QUALITY MANAGEMENT SYSTEM - STANDARD OPERATING PROCEDURE]Nabeela Moosakutty
Standard Operating Procedure (SOP)
A Standard Operating Procedure (SOP) is a set of written
instructions that documents routine or repetitive activity followed by
an organization.
The development and use of SOPs are an integral part of a
successful quality system as it provides individuals with the information
to perform a job properly, and facilitates consistency in the quality and
integrity of a product or end-result. To ensure quality control, all
procedures are standardized, So SOPs are integral part of Quality
assurance process.
Purpose
SOPs detail the regularly recurring work processes that are to be
conducted or followed within an organization. They document the way
activities are to be performed to facilitate consistent conformance to
technical and quality system requirements and to support data quality.
They may describe, for example, fundamental programmatic actions and
technical actions such as analytical processes, and processes for
maintaining, calibrating, and using equipment. SOPs are intended to be
specific to the organization or facility whose activities are described and
assist that organization to maintain their quality control and quality
assurance processes and ensure compliance with governmental
regulations.
If not written correctly, SOPs are of limited value. In addition, the
best written SOPs will fail if they are not followed. Therefore, the use of
SOPs needs to be reviewed and re-enforced by management, preferably the
direct supervisor. Current copies of the SOPs also need to be readily
accessible for reference in the work areas of those individuals actually
performing the activity, either in hard copy or electronic format, otherwise
SOPs serve little purpose.
SOP-Benefits
a) The development and use of SOPs minimizes variation and promotes
quality.
b) SOPs can indicate compliance with organizational and governmental
requirements through detailed work instructions and can be used as
apart of a personnel training program.
c) It minimizes opportunities form is communication and can address
safety concerns. SOP-Writing Styles
SOPs should be written in a concise, step-by-step, easy-to-read format.
Information should not be overly complicated.
SOP Process
a) Preparation
The organization should have a procedure in place for
determining what procedures or processes need to be documented. Those
SOPs should then be written by individuals knowledgeable with the
activity and the organization's internal structure. These individuals
are essentially subject-matter experts who actually perform the work
or use the process.
SOPs should be written with sufficient detail so that someone with
limited experience with or knowledge of the procedure, but with a basic
understanding, can successfully reproduce the procedure when
unsupervised
b) Review and Approval
SOPs should be reviewed (that is, validated) by one or more
individuals with appropriate training and experience with the process.
QMS SOP [QUALITY MANAGEMENT SYSTEM - STANDARD OPERATING PROCEDURE]Nabeela Moosakutty
Standard Operating Procedure (SOP)
A Standard Operating Procedure (SOP) is a set of written
instructions that documents routine or repetitive activity followed by
an organization.
The development and use of SOPs are an integral part of a
successful quality system as it provides individuals with the information
to perform a job properly, and facilitates consistency in the quality and
integrity of a product or end-result. To ensure quality control, all
procedures are standardized, So SOPs are integral part of Quality
assurance process.
Purpose
SOPs detail the regularly recurring work processes that are to be
conducted or followed within an organization. They document the way
activities are to be performed to facilitate consistent conformance to
technical and quality system requirements and to support data quality.
They may describe, for example, fundamental programmatic actions and
technical actions such as analytical processes, and processes for
maintaining, calibrating, and using equipment. SOPs are intended to be
specific to the organization or facility whose activities are described and
assist that organization to maintain their quality control and quality
assurance processes and ensure compliance with governmental
regulations.
If not written correctly, SOPs are of limited value. In addition, the
best written SOPs will fail if they are not followed. Therefore, the use of
SOPs needs to be reviewed and re-enforced by management, preferably the
direct supervisor. Current copies of the SOPs also need to be readily
accessible for reference in the work areas of those individuals actually
performing the activity, either in hard copy or electronic format, otherwise
SOPs serve little purpose.
SOP-Benefits
a) The development and use of SOPs minimizes variation and promotes
quality.
b) SOPs can indicate compliance with organizational and governmental
requirements through detailed work instructions and can be used as
apart of a personnel training program.
c) It minimizes opportunities form is communication and can address
safety concerns. SOP-Writing Styles
SOPs should be written in a concise, step-by-step, easy-to-read format.
Information should not be overly complicated.
SOP Process
a) Preparation
The organization should have a procedure in place for
determining what procedures or processes need to be documented. Those
SOPs should then be written by individuals knowledgeable with the
activity and the organization's internal structure. These individuals
are essentially subject-matter experts who actually perform the work
or use the process.
SOPs should be written with sufficient detail so that someone with
limited experience with or knowledge of the procedure, but with a basic
understanding, can successfully reproduce the procedure when
unsupervised
b) Review and Approval
SOPs should be reviewed (that is, validated) by one or more
individuals with appropriate training and experience with the process.
Good manufacturing practices for complementary medicinesTGA Australia
This presentation provides an overview of GMP clearance application process, the TGA compliance risk framework, major deficiencies and manufacturing quality challenges.
Previously certain classes of active substances were required to be manufactured in dedicated or segregated self-contained facilities Certain antibiotics, Certain hormones, Certain cytotoxic ,Certain highly active drugs .This was due to the perceived risk of these active substances.
Pharmaceuticals not covered under these criteria were addressed by a cleaning validation process This involved reduction of the concentration of residual active substance to a level where the maximum carryover from the total equipment train would result in no greater than 1/1000th of the lowest clinical dose of the contaminating substance in the maximum daily dosage of the next product to be manufactured.
This criterion was applied concurrently with a maximum permitted contamination of 10 ppm of the previous active substance in the next product manufactured. Whichever of these criteria resulted in the lowest carryover, constituted the limit applied for cleaning validation. However, these limits did not take account of the available pharmacological and toxicological data They may have been too restrictive or not restrictive enough. EMA therefore felt for a more scientific case by case approach for all classes of pharmaceutical substances.
The subject of cleaning validation in active pharmaceutical ingredient manufacturing plants has continued to receive a large amount of attention from regulators, companies and customers alike.
The integration of Cleaning Validation within an effective Quality System supported by Quality Risk Management Processes should give assurance that API Manufacturing Operations are performed in such a way that Risks to patients related to cleaning validation are understood, assessed for impact and are mitigated as necessary.
It is important that the requirements for the finished manufacturing companies are not transferred back in the process to active pharmaceutical ingredient manufacturers without consideration for the different processes that take place at this stage.
This presentation covers the requirements of Cleaning Validation for a Multipurpose API Manufactuirng Plant
Management review is the routine evaluation of whether management systems are performing as intended and producing the desired results as efficiently as possible. It is the ongoing “due diligence” review by management that fills the gap between day-to-day work activities and periodic formal audits.
In this presentation from IVT's 4th Annual Validation Week EU, Paul Pluta, discussed the differences between the traditional approach to cleaning validation and the lifecycle approach, applicable regulatory guidance, current industry trends, the necessary phases of the lifecycle approach (design and definition, cycle development, validation, and implementation), how to continously monitor the process, change control, and common obstacles to compliance.
This presentation correlates the requirements of Annex 11 guidelines to other official regulations and guidance documents.
The correlation is organized in a tabular format.
In the row lists the contents of Annex 11 together with the paragraph numbers.
Rest of the rows correlate the section numbers of
Annex 11 Versions 1993
US FDA 21 CFR Part 211
US FDA Part 820 and
US FDA 21 CFR Part 11
The Checklist contains explanations and recommendations that:
- Facilitate the audit;
- May serve as a guide in the transition to the new version of ISO 9001: 2015 using 'fill the gap' methodology;
- Allow for QMS self-assessment for compliance with ISO 9001: 2015;
- Facilitate learning and understanding of the new version of ISO 9001:2015 requirements
- User-friendly format and professional layout - reviewed and approved by experienced ISO 9001 quality auditors.
- 72 pages
Good manufacturing practices for complementary medicinesTGA Australia
This presentation provides an overview of GMP clearance application process, the TGA compliance risk framework, major deficiencies and manufacturing quality challenges.
Previously certain classes of active substances were required to be manufactured in dedicated or segregated self-contained facilities Certain antibiotics, Certain hormones, Certain cytotoxic ,Certain highly active drugs .This was due to the perceived risk of these active substances.
Pharmaceuticals not covered under these criteria were addressed by a cleaning validation process This involved reduction of the concentration of residual active substance to a level where the maximum carryover from the total equipment train would result in no greater than 1/1000th of the lowest clinical dose of the contaminating substance in the maximum daily dosage of the next product to be manufactured.
This criterion was applied concurrently with a maximum permitted contamination of 10 ppm of the previous active substance in the next product manufactured. Whichever of these criteria resulted in the lowest carryover, constituted the limit applied for cleaning validation. However, these limits did not take account of the available pharmacological and toxicological data They may have been too restrictive or not restrictive enough. EMA therefore felt for a more scientific case by case approach for all classes of pharmaceutical substances.
The subject of cleaning validation in active pharmaceutical ingredient manufacturing plants has continued to receive a large amount of attention from regulators, companies and customers alike.
The integration of Cleaning Validation within an effective Quality System supported by Quality Risk Management Processes should give assurance that API Manufacturing Operations are performed in such a way that Risks to patients related to cleaning validation are understood, assessed for impact and are mitigated as necessary.
It is important that the requirements for the finished manufacturing companies are not transferred back in the process to active pharmaceutical ingredient manufacturers without consideration for the different processes that take place at this stage.
This presentation covers the requirements of Cleaning Validation for a Multipurpose API Manufactuirng Plant
Management review is the routine evaluation of whether management systems are performing as intended and producing the desired results as efficiently as possible. It is the ongoing “due diligence” review by management that fills the gap between day-to-day work activities and periodic formal audits.
In this presentation from IVT's 4th Annual Validation Week EU, Paul Pluta, discussed the differences between the traditional approach to cleaning validation and the lifecycle approach, applicable regulatory guidance, current industry trends, the necessary phases of the lifecycle approach (design and definition, cycle development, validation, and implementation), how to continously monitor the process, change control, and common obstacles to compliance.
This presentation correlates the requirements of Annex 11 guidelines to other official regulations and guidance documents.
The correlation is organized in a tabular format.
In the row lists the contents of Annex 11 together with the paragraph numbers.
Rest of the rows correlate the section numbers of
Annex 11 Versions 1993
US FDA 21 CFR Part 211
US FDA Part 820 and
US FDA 21 CFR Part 11
The Checklist contains explanations and recommendations that:
- Facilitate the audit;
- May serve as a guide in the transition to the new version of ISO 9001: 2015 using 'fill the gap' methodology;
- Allow for QMS self-assessment for compliance with ISO 9001: 2015;
- Facilitate learning and understanding of the new version of ISO 9001:2015 requirements
- User-friendly format and professional layout - reviewed and approved by experienced ISO 9001 quality auditors.
- 72 pages
Used in the career talk for the college of Industrial Engineering to share with them the idea that being Innovative helps in having that competitive edge in the job market. Also, that the Industrial Engineering college is a rich source of future innovators since they have the skills such as process-thinking and eyes for what can be done better.
What is BPM Workflow Automation System?
Please read through my brief overview. The system used is a FREE Open-source Processmaker workflow from www.processmaker.com.
Easy Way to Automate Manual Processes with BPM Workflow Solution
Presented in the last Six Sigma and Process Excellence conference August 7 and 8, 2014 at Hotel Intercon Manila care of www.fmi.com.ph
Bonitasoft workflow solution was presented as one of the popular BPM workflow automation tools.
This keynote was presented in an event hosted and organized by both freelancer.ph and iAcademy last December 10, 2013 at iAcademy, Makati, Philippines.
Disaster proof your business and livelihood in easy simple steps using Project Management basics.
This is a whitepaper suggesting how Six Sigma DMAIC methodology can be applied to address a long time problem of banks regarding line queuing at the branches.
What is being discussed here is the thought process of arriving at results which matters or with impact rather than doing time-wasting trial and error.
Disclaimer: The insights and opinions expressed in the whitepaper are solely by the author and does not represent any bank. The data used were simulated to recreate the scenarios close to the clients' experience at the branch. Any resemblance is only a matter of coincidence.
The most comprehensive definition of internal audit is given by the IIA, USA. It is,
"Internal auditing is an independent, objective assurance and consulting activity designed to add value and improve an organization’s operations. It helps an organization accomplish its objectives by bringing a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control and governance processes."
The purpose of the presentation is to provide clarification for a better understanding of what internal audit definition, objectives, functions, stages and reporting are all about? What difference does it make in the presence of an external audit? How different is its scope from that of the external audit? How internal audit standards contribute to better performance of internal audit work and its reporting to the Board or Audit Committee?
1. Quality management system audit checklist
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• qualitymanagement123.com/23-free-ebooks-for-quality-management
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• 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
I. Contents of quality management system audit checklist
==================
In looking at current auditing standards, ISO 19011 makes reference to “Preparing work
documents” in Clause 6.4.3. The following is an extract from this clause:
“The audit team members should review information relevant to their audit assignment and
prepare work documents as necessary for reference and for recording audit proceedings. Such
documents may include
Checklists and audit sampling plans, and
Forms for recording information, such as supporting evidence, audit findings and records of
meetings.
The use of checklists and forms should not restrict the extent of audit activities, which can
change as a result of information collected during the audit”
The use of audit checklists:
Whilst not always required in management system standards, audit checklists are just one tool
available from the “auditors toolbox”. Many organizations will use them to ensure that the audit
at a minimum will address the requirements as defined by the scope of the audit.
There can be different approaches audit for ISO 9001:2000. For example:
Audit from the organization’s Quality Management System to the ISO 9001:2000 requirements.
Use of checklist to audit from the requirements to the organization’s management system.
However, it is beneficial to audit from the organization’s quality management system up to the
requirements. A checklist may be used to ensure that all relevant ISO 9001 requirements
addressed.
2. Advantages of using audit checklists:
1. Checklists if developed for a specific audit and used correctly:
Promote planning for the audit
Ensure a consistent audit approach.
Act as a sampling plan and time manager.
Serve as a memory aid. Provide a repository for notes collected during the audit process (audit
field notes).
2. Audit checklists need to be developed to provide assistance to the audit process.
3. Auditors need to be trained in the use of a particular checklist and be shown how to use it to
obtain maximum information by using good questioning techniques.
4. Checklists should assist an auditor to perform better during the audit process.
5. Checklists help to ensure that an audit is conducted in a systematic and comprehensive manner
and that adequate evidence is obtained.
6. Checklists can provide structure and continuity to an audit and can ensure that the audit scope
is being followed.
7. Checklists can provide a means of communication and a place to record data for use for future
reference.
8. A completed checklist provides objective evidence that the audit was performed.
9. A checklist can provide a record that the QMS was examined.
10. Checklists can be used as an information base for planning future audits.
11. Checklists can be provided to the auditee ahead of the on-site audit.
Disadvantages of using audit checklists:
1. The checklist can be seen as intimidating to the auditee.
2. The focus of the checklist may be too narrow in scope to identify specific problem areas.
3. Checklists are a tool to aid the auditor, but will be restrictive if used as the auditor’s only support
mechanism.
4. Checklists should not be a substitute for audit planning.
5. An inexperienced auditor may not be able to clearly communicate what he/she is looking for, if
they depend too heavily on a checklist to guide their questions.
6. Poorly prepared checklists can slow down an audit due to duplication and repetition.
7. Generic checklists, which do not reflect the specific organizational management system, may not
add any value and may interfere with the audit.
8. Narrow focused checklists minimize unique assessment questions / approach.
Conclusion: There are advantages and disadvantages in using audit checklists. It depends on
many factors, including customer needs, time and cost restraints, auditor experience and sector
scheme requirements. Auditors should assess the value of the checklist as an aid in audit process
and consider its use as a functional tool.
==================
3. III. Quality management tools
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:
Who filled out the check sheet
What was collected (what each check represents,
an identifying batch or lot number)
Where the collection took place (facility, room,
apparatus)
When the collection took place (hour, shift, day
of the week)
Why the data were collected
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
4. to the process), then no corrections or changes to
process control parameters are needed or desired.
In addition, data from the process can be used to
predict the future performance of the process. If
the chart indicates that the monitored process is
not in control, analysis of the chart can help
determine the sources of variation, as this will
result in degraded process performance.[1] A
process that is stable but operating outside of
desired (specification) limits (e.g., scrap rates
may be in statistical control but above desired
limits) needs to be improved through a deliberate
effort to understand the causes of current
performance and fundamentally improve the
process.
The control chart is one of the seven basic tools of
quality control.[3] Typically control charts are
used for time-series data, though they can be used
for data that have logical comparability (i.e. you
want to compare samples that were taken all at
the same time, or the performance of different
individuals), however the type of chart used to do
this requires consideration.
3. Pareto chart
A Pareto chart, named after Vilfredo Pareto, is a type
of chart that contains both bars and a line graph, where
individual values are represented in descending order
by bars, and the cumulative total is represented by the
line.
The left vertical axis is the frequency of occurrence,
but it can alternatively represent cost or another
important unit of measure. The right vertical axis is
the cumulative percentage of the total number of
occurrences, total cost, or total of the particular unit of
measure. Because the reasons are in decreasing order,
the cumulative function is a concave function. To take
the example above, in order to lower the amount of
late arrivals by 78%, it is sufficient to solve the first
three issues.
5. The purpose of the Pareto chart is to highlight the
most important among a (typically large) set of
factors. In quality control, it often represents the most
common sources of defects, the highest occurring type
of defect, or the most frequent reasons for customer
complaints, and so on. Wilkinson (2006) devised an
algorithm for producing statistically based acceptance
limits (similar to confidence intervals) for each bar in
the Pareto chart.
4. Scatter plot Method
A scatter plot, scatterplot, or scattergraph is a type of
mathematical diagram using Cartesian coordinates to
display values for two variables for a set of data.
The data is displayed as a collection of points, each
having the value of one variable determining the position
on the horizontal axis and the value of the other variable
determining the position on the vertical axis.[2] This kind
of plot is also called a scatter chart, scattergram, scatter
diagram,[3] or scatter graph.
A scatter plot is used when a variable exists that is under
the control of the experimenter. If a parameter exists that
is systematically incremented and/or decremented by the
other, it is called the control parameter or independent
variable and is customarily plotted along the horizontal
axis. The measured or dependent variable is customarily
plotted along the vertical axis. If no dependent variable
exists, either type of variable can be plotted on either axis
and a scatter plot will illustrate only the degree of
correlation (not causation) between two variables.
A scatter plot can suggest various kinds of correlations
between variables with a certain confidence interval. For
example, weight and height, weight would be on x axis
and height would be on the y axis. Correlations may be
positive (rising), negative (falling), or null (uncorrelated).
If the pattern of dots slopes from lower left to upper right,
it suggests a positive correlation between the variables
6. being studied. If the pattern of dots slopes from upper left
to lower right, it suggests a negative correlation. A line of
best fit (alternatively called 'trendline') can be drawn in
order to study the correlation between the variables. An
equation for the correlation between the variables can be
determined by established best-fit procedures. For a linear
correlation, the best-fit procedure is known as linear
regression and is guaranteed to generate a correct solution
in a finite time. No universal best-fit procedure is
guaranteed to generate a correct solution for arbitrary
relationships. A scatter plot is also very useful when we
wish to see how two comparable data sets agree with each
other. In this case, an identity line, i.e., a y=x line, or an
1:1 line, is often drawn as a reference. The more the two
data sets agree, the more the scatters tend to concentrate in
the vicinity of the identity line; if the two data sets are
numerically identical, the scatters fall on the identity line
exactly.
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
7. Environment: The conditions, such as location,
time, temperature, and culture in which the process
operates
6. Histogram method
A histogram is a graphical representation of the
distribution of data. It is an estimate of the probability
distribution of a continuous variable (quantitative
variable) and was first introduced by Karl Pearson.[1] To
construct a histogram, the first step is to "bin" the range of
values -- that is, divide the entire range of values into a
series of small intervals -- and then count how many
values fall into each interval. A rectangle is drawn with
height proportional to the count and width equal to the bin
size, so that rectangles abut each other. A histogram may
also be normalized displaying relative frequencies. It then
shows the proportion of cases that fall into each of several
categories, with the sum of the heights equaling 1. The
bins are usually specified as consecutive, non-overlapping
intervals of a variable. The bins (intervals) must be
adjacent, and usually equal size.[2] The rectangles of a
histogram are drawn so that they touch each other to
indicate that the original variable is continuous.[3]
III. Other topics related to Quality management system audit checklist (pdf
download)
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