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Free Stuff! We want to be the "LINUX" of QMS tools! Why not make ISO based Quality Management Systems easier and less expensive to implement and improve for everyone? Please enjoy free use of these working documents that we hope you will find useful in your pursuit of a better QMS. All that we ask in return is that if you make improvements that you feel would benefit others, then please send us a copy, so that we can continually improve these tools for everyone. New items or revisions are highlighted. NOTE: You can also find more information, tools, and templates through our Stuff for my auditor training courses Process Approach Tools Process Spider - Let's
face it, the process turtle is overrated and underused (for audits only)
without adequate input and use by top management. It's time for it to
evolve. The Six Sigma SIPOC model is better than the turtle but still
has its limitations. Why not merge and improve these two tools and
while we're at it start using Six Sigma and ISO 9001 together? If it's
not measurable, then why define it at a high level / management level view of
a process? Here is a MS Excel template for defining processes that I
feel is an improvement over the turtle. The goal is to define a process
in a way that can be used by top management to effectively manage processes
through measurements. This is still in development and any input / help
is appreciated. My Excel skills are limited so any formatting
improvements are appreciated also. You may want to check often for
updates. Eventually, this will be released within a full Quality Manual
template. Current improvements include a focus on more meaningful
information for top management such as process risk analysis. Why a
spider you ask? It's got 8 boxes / legs and just plain sounds cooler
than a turtle. All I want is credit for the name... - added SIPOC Quality Manual
- A MS Power Point based Quality Manual that seems to be the
"best" approach for ISO 9001 / TS 16949 based Quality
Manuals. The most important part of the ISO 9001 requirements for any
Quality Manual is to "define the interaction between the
processes". This clearly achieves this goal and can be actually
used within the organization as a tool for employee orientation
training. NOTE: You need to start the QM using the Power Point Presentation
file called "Quality Manual" in the QMS Manual sub-folder. -
revised ISO 9001 required
procedures - I have now given away Gemba
business process flow model - Kindly provided by Allan
Aanonson. Based on a quote from Taiichi Ohno - "Let flow manage
the processes, and not let management manage the flow." Slide 1
shows today's typical management method. Slide 2 shows how we might
ideally manage our business. Do your business objectives start with
profit targets and attempt to cascade these down throughout the
organization? This might make you rethink this concept as a backwards
approach to managing a business. - added Process Flow Model
- Kindly provided by Ted Schmitt. A MS Word based process diagram
that expands on the basic "turtle" and "SIPOC" models by
showing how PDCA works within the process and also includes environmental
aspects for your ISO 14001 needs. A great tool to "define the
interaction between the processes". - added SIPOC Process Detail - A MS Excel based process definition tool to help define the QMS processes and form the basis for your Quality Manual. Balanced
Scorecard - A MS Excel based balanced scorecard that can streamline
and improve your management review process. NOTE: This example was done
for a commercial printer. Your scorecard will be based on your
processes and metrics as defined in your SIPOC Quality Manual. Please
contact me directly for help customizing this for your business. - added Management Review
Worksheet- A MS Word based worksheet that can streamline and
improve your management review process. - added Process Turtle Diagram - A
simple tool to help define the basic information necessary to effectively
manage a process. - added Comprehensive
Measurement Systems - PDCA - A PowerPoint slide that can be used to
explain the concepts of an effective QMS based on PDCA. - added ISO 9001 Management Overview
Presentation -
A MS Power Point presentation for educating top management on their critical
leadership role on this journey. – REVISED Disciplined Problem Solving Tools Problem
Solver & Improvement Form - A corrective action form that can be used
for all types of problems as well as to track OFI's, preventive actions, and
continual improvement projects. Includes the use of form fields for analysis
purposes. Also includes the failure mode risk priority numbers (RPNs) before
and after action is taken so the quality/effectiveness of individual
corrective and preventive actions and ultimately the effectiveness of these
systems can be measured. - Help text was recently added for most fields (use F1
key or look in MS Word status bar) . revised
Problem
Solver & Improvement Form Ranking Criteria - To be used with the
Problem Solver Improvement Form. - revised FMEA Template - This is a
powerful tool to identify and prioritize problems in any company. FMEAs
are a great source for preventive actions! Used in the automotive and
aerospace industries for years. Also can and should be used with the Problem
Solver Improvement Form. To order a great FMEA instruction manual /
workbook go to www.aiag.org and look under
"products/training" then "quality" then "core
tools" then "FMEA-3". - revised FMEA Ranking Tables - A good
example of criteria for ranking FMEA severity, occurrence and detection
values - added 5-Why Root Cause Analysis and
Corrective Action Package- This includes a form used by Drill
Deep Root Cause Analysis Worksheet - This is a tool used by GM to get to
the root cause of a problem. - added Honda 5P corrective action workbook -
This is a tool used by Honda to get to the root cause of a problem. One
of my favorites... - added Audit Program Management Tools The following tools are meant to work together to more effectively manage an audit program. This list starts with some generic tools for all audit programs and then provides some tools modified specifically for ISO 9001 and TS 16949. Procedure for
Internal Audits - This procedure simply explains how to use the
various tools that follow and is required for ISO 9001, TS 16949 and other
management system standards. - added Internal
Auditor Competency Matrix - An audit program is only as effective as
the competence of its auditors. Hint: Is the audit manager using ISO 19011
for guidance? Auditors need to know more than ever in order to be
effective! An auditor training course is only the beginning of this
journey and most audit programs do not assess their auditors' knowledge beyond
this. This MS Excel matrix can be used to record and analyze auditor
competency levels and raise flags when there are shortages using conditional
formatting. This example was created for TS 16949 auditors - added Internal Audit Effectiveness Survey - A nice tool to evaluate, quantify and analyze the effectiveness of internal auditors and the internal audit program as reported by the auditees (the customers of the audit process) - revised 2/22/05 Audit
scheduling worksheet - Are you focusing your audits where they are needed
most and getting a good return on investment for your audits? This is a
simple and easy to use tool that clearly and logically demonstrates
scheduling of internal audits by status and importance of the QMS
processes. Based on FMEA concepts. - revised Process Audit Questions
- Some basic questions that should be covered during any process audit.
Works well with ISO 9001 and TS 16949 Audit Summary Reports. - added How to Audit Top
Management- Some helpful tips and audit trails for auditing top
management. - added Pre-Audit
Questionnaire for Top Management - A nice tool to prepare top management
for their involvement with the QMS and give auditors some specific questions
to ask. This is a work in progress. - added ISO 9001 specific audit tools ISO 9001 Audit summary report - A powerful form to focus auditors on the task at hand... To sample and record evidence of compliance & effectiveness. - revised 12/06 ISO
9001 element applicability matrix - First you need to know which ISO 9001
clauses and CSRs (Customer Specific Requirements) apply to each process so
you know what to audit. Process owners can and should use this matrix to
prepare for the audits as well.- revised ISO 9001 Audit
analysis and scoring matrix - - Next you need to record the results of
your audits and show that you covered the applicable ISO 9001 clauses and
CSRs in each process. Then you might want to analyze the audit program
results and present this analysis to top management. This MS Excel form
records, tracks and analyzes audit results. Note the conditional
formatting so management can easily see where they have issues that need
attention. - revised TS 16949 specific audit tools TS
16949 Audit summary report - A powerful form to focus auditors on
the task at hand... To sample and record evidence of compliance &
effectiveness. Also provides a measurement of management communication
and employee awareness as required by TS 16949 clause 6.2.2.4. - revised TS
16949 element applicability matrix First you need to know which ISO/TS
clauses and CSRs (Customer Specific Requirements) apply to each process so
you know what to audit. Process owners can and should use this matrix to
prepare for the audits as well. - revised TS 16949
Audit analysis and scoring matrix - Next you need to record the results
of your audits and show that you covered the applicable TS clauses and CSRs
in each process. Then you might want to analyze the audit program
results and present this analysis to top management. This MS Excel form
records, tracks and analyzes audit results. Note the conditional
formatting so management can easily see where they have issues that need
attention. - added TS 16949
Layered Process Audit Checklist and scoring matrix - TS 16949
additionally requires very focused manufacturing process audits. Some
customers require a specific methodology for these audits called
"Layered Process Audits". This MS Excel based process audit
checklist and scoring / analysis tool can be used for this purpose. -
added Training System Tools Employee
Competency Matrix - This MS Excel matrix can be used to record and
analyze employee competency levels and raise flags when there are shortages
using conditional formatting. - added Employee Competency
Matrix - This MS Word matrix can be used to define competency and
training requirements and track employee competencies. - added Training
Effectiveness Survey - A nice tool to evaluate, quantify and analyze
training effectiveness as reported by the trainees - added Training
Effectiveness Survey with form fields - An "on-line"
version of this tool. MS Word Form Fields can be used to automate data
collection and analysis. added HR & Training
Procedure - This procedure was created for a small company
using these tools but clearly addresses all of the key HR and training
processes - hiring, orientation, OJT, and ongoing improvement. It can
be included in your Quality Manual or can be controlled on its own but
obviously will need to be modified to explain your company's own
responsibilities and methods. - added "Why We Hate HR"
- The title of this article is a little harsh but it brings some
important points to the forefront. HR should be accountable for
employee and organizational competency and its impact on the bottom line
should be MEASURED! - added Laboratory QMS Tools In my experience as a
TS 16949 auditor I have found that clause 7.6.3.1 is almost never adequately
understood by most companies or auditors. What I look for is some
planned, executed, recorded, analyzed, and summarized laboratory
testing / calibration process validation methods. This is sometimes called
"lab proficiency testing". Each type of test or calibration
listed on your lab scope should have been initially validated as capable.
Examples would be round robins, R&Rs on test / calibration METHODS,
repeated checks using XbarR charts on retained samples / gages, etc.
The results of these studies should be reviewed and additional, ongoing
studies should be considered where the variation in the test / calibration
process is not fully understood and controlled. Laboratory Proficiency Report Template
- This report can be used to summarize your lab's proficiency testing results
for management review. - added ISO
17025 Audit analysis and scoring matrix - MS Excel based process /
element analysis & audit scoring tool automatically provides scoring
summary and conditional formatting. - added Other QMS Tools Generic PPAP - A MS Excel PPAP
tool. This is how suppliers / parts / materials should be approved! -
revised MSA Worksheet - A MS Excel
worksheet for completing full MSA studies, not just gage R&Rs! - added Supplier Approval
Worksheet - A nice tool to logically approve suppliers with. - Revised Fun Stuff The Demotivator series - Everyone needs to lighten up sometimes... A nice collection of these classic inspirations. Just download and unzip the file then point your screen saver towards it when you choose "my pictures slideshow" in the display/ screensaver menu. This file is almost 6MB so allow for some download time. Of course, you can always go directly to www.despair.com for these and other fun stuff.
For more information on these tools and many others that we offer please contact us.
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