Category Archives: Quality Matters
FREE E-Book for ISO 9001:2015 Requirements
Guidance for Implementation of Quality Management Systems for Certification to the ISO 9001:2015 Standard
Complete the form below to download the “eBook”
Supply Chain Management Tools Enhanced in QMSCAPA
Essential to most company Quality Management Systems are the effective management and over-sight of its supply chain. Supply chain management is often referred to as the streamlining of a business’ supply-side activities to maximize customer value and satisfaction. Effective evaluation and analysis of suppliers in the supply chain can lead to competitive advantages in the marketplace. Also, a well-managed continual process for surveying existing and potential suppliers can lead to improvements in the supply chain that are as efficient and economical as possible.
The QMSCAPA Supply Chain Management Tools consist of …
| ❑ | A database for Supplier Survey Questionnaires that may easily edited or copied to modify as an additional set of Supplier Survey Questionnaires. |
| ❑ | A Supplier/Vendor Table with relationships for …
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How do you Assess Quality Risk?
Managing Quality Risk
By Jack T. Bogle, Managing Partner | Click here to request the full article and FMEA examples as a Microsoft Excel and Word files.
In ISO 9001:2015, Preventive Actions appear to be giving way to Risk Assessment and Management, similar to what we have learned in AS9100, ISO 13485, ISO 14001, and 19001 among others.
I am exploring ways to us Failure Mode Effects Analysis methods to assess quality risks. Ultimately, I intend to add a working module for assessing risk into QMSCAPA, our quality management software (single-users may have a free license). The functional level of usability that I hope to achieve is to provide support for the evaluation of ISO 14001 Significant Environmental Aspects, and risk assessments associated with medical devices and aerospace components.
In FMEA, failures are prioritized according to how serious their consequences are, how frequently they occur and how easily they can be detected. An FMEA also documents current knowledge and actions about the risks of failures for use in continual improvement. FMEA is used during design, planning and production stages with an aim to avoid future failures and sometimes called preventive actions. Very often it is used for process control, before and during ongoing operation of the process. Ideally, FMEA begins during the earliest conceptual stages of design and continues throughout product or service realization.
The outcomes of an FMEA development are actions to prevent or reduce the severity or likelihood of failures, starting with the highest-priority ones. Also, it may be used to evaluate risk, develop priorities for risk management and mitigating known threat vulnerabilities. Lastly, FMEA helps determine the appropriate selection for remedial actions that reduce cumulative impacts of life-cycle consequences (risks) from a systems failure (fault).
Let me know your thoughts and ideas for assessing risk in quality management systems.
Advantages for Using FMEAs
- Improve the quality, reliability and safety of a product/process
- Improve company image and competitiveness
- Increase user satisfaction
- Reduce system development time and cost
- Collect information to reduce future failures, capture knowledge for lower risk
- Reduce the potential for rework, warranty and product return concerns
- Early identification and elimination of potential failure modes
- Emphasize problem or failure prevention
- Minimize late changes and associated cost
- Promotes collaboration for teamwork and idea exchange between functions
- Accentuates preventive action, which reduces the possibility of same kind of failure in future
- Reduce impact on company profit margin
- Improve production yield
The example Failure Mode Effects Analysis (FMEA) table shown below or on the following page is designed to multiply the ratings for DS * POF * CD, which equals the Priority Risk Number (RPN).
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Failure Mode Effects Analysis (FMEA) for Risk Assessments |
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Note: The Risk Priority Number (RPN) Column contains a formula to multiply P * S * D = RPN |
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Row # |
Activity or Factor |
(P)robability |
(S)everity |
(D)etection |
= RPN |
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1) |
What can happen if … |
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2) |
The wrong ingredients or components are used, or |
0 |
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3) |
The wrong package is used, or |
0 |
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4) |
The wrong size is made or shipped, or |
0 |
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5) |
The wrong color is shipped, or |
0 |
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6) |
The wrong label is on the product, or |
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7) |
The delivery is not on-time, or |
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8) |
The product is damaged in delivery, or |
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9) |
The product is lost during shipping, or |
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10) |
You know Murphy, what can go wrong will eventually go wrong in preventive measures are not designed into to your QMS |
0 |
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- Probability (P) of occurrence description and impact rating (1 lowest & 10 highest);
- Degree of Severity (S) description and impact rating (1 lowest & 10 highest);
- Certainty of Detection (D) description; ability to detect from inspection or use and impact rating (1 lowest & 10 highest);
- RPN = Risk Priority Number.
QMSCAPA v1.6.2 Available for Download
We recently added enhanced hyper-linked controls for Document Management in our QMSCAPA software, version 1.6.2 (single-user is license free). Essentially, you can now add unlimited attachments to the Document Control Index and CAPA log.
In addition, we now include:
- Supplier/vendor evaluation scoring module, with user-defined evaluation criteria.
- Monitoring and measuring device table.
- Enhancements to the Training Program and Scheduling modules.
- Additional search capabilities in the CAPA log.
For the full article please visit QMSCAPA on the web, which includes user guidance and download links. Once again, the single-user version of QMSCAPA is free to all to use.
What do AS/ISO auditors look for when conducting an audit for a certifying body?
It’s complex, but here’s a popular short answer in the form of “auditor questions”:
- Are the processes properly documented and operating within the requirements of the Standard?
- Are quality policies effectively communicated internally and externally to you suppliers and outsources?
- Do the records and objective evidence substantially demonstrate that the QMS is effective?
- Are the procedures for assessing process effectiveness validated?
- Are measuring and monitoring processes of your QMS indicate that Quality Objectives are being met?
- Are the procedures for Control of Documents, Control of Records, Control of Non-Conforming Products, Corrective Actions and Preventive Actions effective?
- Are the internal auditing and management review procedures effective and can you demonstrate continual improvement?
Access Business Communications, Inc.
International Management Systems
16835-236 Algonquin Street
Huntington Beach, CA 92649
Always insist on an ISO Certification issued by an ACCREDITED Registrar
PPAP – Pre Production Part Approval Process – What Is It And Why Do I Need To Do One?
A PPAP is simply a series of analyses of various aspects of a production manufacturing process. Prior to beginning production, the supplier needs to prove out his processes and procedures, on actual production tooling. The PPAP is simply a way of reporting the results of this process testing to the customer so they know the supplier has the ability to fulfil the production at the quality level required by the customer. It also demonstrates the recovery techniques to be used in the event non-complying materials are discovered during the production run. This allows the supplier to approach a zero defect quality level in his shipments. The author has created such robust manufacturing systems and procedures to produce assemblies used in critical automotive applications that have maintained a zero defect level at production levels of multi millions of assemblies per year over spans of several years.
The PPAP begins with the quality-planning phase of the production. This starts with a Process Flow Diagram that outlines each step in the process from the time the raw materials arrive, until the completed parts are shipped out to the customer. Any event in the plant from the storage and moving steps, to the processes applied, to the inspections performed are identified and listed in this simple, sequential diagram. Any quality procedures or specific work instructions, if required, are identified in the steps where they may be needed.
From the Process Flow Diagram, a Process Failure Mode and Effects Analysis (PFMEA) is derived. This simply takes each of the production tasks and looks at what can go wrong, how severe the results will be if it goes wrong, and what can be done to minimize those risks.
Using the Process Flow Diagram and PFMEA, a Control Plan can drawn up that encompasses each phase of the production, how it will be controlled, and probably most importantly, how you will react in the event any out-of-compliance parts are discovered. It also lists the production equipment and tooling, the inspection tools, and other facilities needed to produce a zero defect part.
The control plan is the heart of the PPAP, and should be a document used extensively in your own shop when performing the production processes. Everyone who handles the part and has anything to do with the production should be familiar with this document, able to read it, and to recognize that it is the governing document in how the product is produced. In the event the customer audits your manufacture of processing, they will undoubtedly ask for the control plan and then ask to see each of its steps being performed.
To ensure that the inspection methods as identified on the control plan are repeatable and reproducible, an analysis of the gauges is performed. This is called a Gauge Repeatability and Reproducibility Analysis, or Gauge R&R for short. It requires three inspectors performing inspections of the characteristics that gauge will be used to inspect, on 10 parts three separate times. These results are inserted into a straightforward statistical formula and a numerical evaluation of the capability of that gauge is determined. This is repeated for each of the gauges measuring each of the characteristics identified on the control plan.
The next phase of the PPAP requires the manufacture of a sample number of parts on actual production tooling, using the same procedures, personnel, production facility, and all other aspects of the expected production run. This sampling is of some finite number, usually something like 300 pieces. These are then analyzed in several ways to ensure the production run meets all of the requirements the customer requests.
The first of these analyses is the layout inspection. Generally at least two parts from each different tooling cavity (in the case of a plastic injection molded part) or each assembly machine, each production line, oven or other piece of production machinery, is fully inspected with each characteristic identified and inspected. This is referred to as a layout inspection, and is generally accompanied with an annotated drawing identifying which characteristics were inspected.
Next a process potential study is performed where major characteristics on a certain number of these production parts, usually 30 or 50 are chosen and inspected. These are usually important fit and function characteristics. It may be an interface dimension, for instance in a machined part, or something like a plating thickness or other characteristic deemed important by the customer. When these results are plugged into a statistical formula, a good reading of the process’ capability to produce consistent production is easily determined.
Doing a PPAP is not just a task in paperwork only useful for the customer, but rather a valuable tool usable by the supplier to help identify possible trouble spots in the production ahead. It gives the supplier a chance to formally think through how they can handle future problems that may arise in production. It gives supervisors and managers a simple road map to follow to perform their production tasks. It is also a valuable training tool for employees charged with making the production.
Jeff Spira is a senior partner with ABCI Consultants.
Measuring & Monitoring Quality
In previous articles posted I have written about ways to measure and monitor quality. In this article I will cover some fundamental methods for measuring and monitoring quality that covers the following business functions:
- Sales quoting, including proposals, and contracts through to fruition of an order from a customer.
- Purchasing, including the request for quotes, issuance of purchase orders, receiving and verification of products purchased and the inspection process.
- Manufacturing and/or production processes, including assembly and configuration.
- On-time delivery and/or shipping.
- Customer Satisfaction Surveys.
Of course, there are many ways that an organization can measure and monitor quality related processes, which may be effective. Therefore, I hope to provide you with an understanding of how to get started with an effective quality measurement and monitoring process that may be most applicable to your situation.
Download QMSCAPA software licensed free
Checklist
I am an advocate for the use of checklist, especially in Sales, Purchasing and Manufacturing/Production processes. For example, you might consider one or more checklists that are used during various phases or checkpoints in each process. For the purpose of this article the word product is used for products and services. Here’s fundamental list for the use of checklist.
Sales Process
• Compare RFQ to a Quote offered
• Compare Customer Purchase Orders to Quotes offered
• Check quantities, prices, extended prices, lead times and product options.
Purchasing Process
• Compare Quotes received to RFQs.
• Compare Purchase Orders to bill of materials received.
• Compare Purchase Orders to Invoice received.
• Check quantities, prices, extended prices, lead times and product options.
• Include a simple check list for the verification and inspection of received goods.
Manufacturing or Production Process
• Compare production planning, configuration and work instructions against orders received.
• Use a traveling checklist document or computerized program to monitor essential steps in complex production, configuration and assembly process.
Simple examples for Measuring and Monitor Quality
To effectively measure and monitor sales, purchasing, manufacturing and production quality you may be required to identify specific products (or services) and the customer or supplier. Therefore, your quality measuring and monitoring tool (journal, spreadsheet, database, or other computer program) may need an entry for specific part or components, plus the customer or suppliers name or identification.
Sales Quality Journal (view journal)
• Record the appropriate date of the recorded Sales data.
• Record the gross quantity of orders accepted.
• Record the quantity of orders cancelled prior to delivery.
• Record the quantity of returns.
• Record the quantity of replacement orders.
• Derive the net quantity of orders accepted from the information above.
• Compare the gross quantity of orders to the net quantity of orders accepted and report the comparative as a percentage.
• Communicate your Sales Quality score to your customers, personnel and affiliates.
Purchasing Quality Journal (view journal)
• Record the date of the recorded Purchasing data.
• Record the gross quantity of products ordered.
• Record the gross quantity of products received.
• Record the quantity of rejected and, or returned.
• Record the quantity of reworked after concession.
• Derive the net quantity of products accepted from the information above.
• Compare the gross quantity of products to the net quantity of products accepted and report the comparative as a percentage.
• Communicate your Purchasing Quality score to your vendors, personnel and affiliates.
Manufacturing and/or Production Journal (view journal)
• Record the appropriate date of the recorded Production data.
• Record the gross quantity of products made or produced.
• Record the gross quantity of products rejected.
• Record the quantity reworked.
• Record the quantity scrapped.
• Derive the net quantity of products put into inventory (or ready for customer use) from the information above.
• Compare the gross quantity of products produced to the net quantity of products available and report the comparative as a percentage.
• Communicate your Production Quality score to your personnel and affiliates.
On-time delivery and/or shipping (view journal)
(Two methods of record On-Time Delivery described below)
• Record the appropriate date of the recorded Delivery data.
• Record the quantity of orders delivered or shipped.
• Record the product and customer as needed.
• Record the ‘ship by date’ (SBD), which is typically identified in pre-sale negotiations or through order processing.
• Record the ‘actual ship date’ (ASD), which will allow you to compare the SBD the ASD to determine if the delivery is expected to be early, on-time or late.
• Record the ‘customer due date’ (CDD), which is typically identified in pre-sale negotiations or through order processing.
• Record the ‘actual received date’ (ARD) (must by verified in the shipping process to know the date the customer actually receives the product). Once you know the ARD, then compare the CDD to the ARD to determine if the delivery is was actually early, on-time or late.
• Option 1, use the SBD vs. ASD tallies: Measure on-time delivery by comparing the total shipments to the total on-time shipments (or early + on-time shipments) and report as a percentage on-time.
• Option 2, use the CDD vs. ARD tallies: Measure on-time delivery by comparing the total shipments to the total on-time shipments (or early + on-time shipments) and report as a percentage on-time.
• Communicate your On-time Quality score to your customers, personnel and affiliates.
Customer Satisfaction Surveys Journal (view journal)
• Record the appropriate date of the recorded Customer Satisfaction Survey data.
• Make the process of Customer Satisfaction Survey as a perpetual process as opposed to a periodical or occasional process.
• If possible, include a ‘Customer Satisfaction Survey’ with all communications with the customer, which includes correspondence, invoicing, and deliveries.
• Keeping the survey as simple as possible, include up to 10 customers satisfaction elements and ask your customer to rate the element on a scale of 1 to 10, with 1 being a poor rating and 10 being the best rating.
• Hone your survey questions so they can best add value to your quality process.
• Record the quantity of surveys received or recorded.
• Tally the score of each question and each survey, and derive the Customer Satisfaction as percentage.
• Setup a running or real-time journal for recording Customer Satisfaction.
• Communicate your Customer Satisfaction Quality score to your vendors, personnel and affiliates.
Over-all Quality Score (view quality dashboard example)
Assuming that you implement a quality measuring and monitoring process for the above described business functions and metrology, then you can derive an ‘Over-all Quality Score’ by summing the percentages of each function (filtered by an appropriate date range); divide the gross percentage amount by five (or by the quantity of quality measurements that you have elected to use). For example, during the past year a business scores its (1) Sales Quality at 95%, (2) Purchasing Quality at 92%, (3) Production Quality at 93%, (4) On-time delivery at 96%, and (5) Customer Satisfaction at 91%; the sum of these scores is a gross number of 467 divided by 5 equals 93.4% Over-all Quality Score.
Once again, there are many ways that you can measure and monitor quality. This article is to provide a method that may cover your essential business functions and is easy to implement with a spreadsheet, or database or computer application.
Over the years, I have developed all three of these tools and recently incorporated these metrology techniques into QMSCAPA software, which is currently available free of license fees. Also, to aid in the measuring and monitoring of an organization, I have developed what I am calling a ‘Quality Management System Dashboard‘ so at a glance one can visualize an organizaton’s over-all quality effectiveness.
Your feed-back is always invited and welcomed.
Jack Bogle, President Access Business Communications, Inc. International Management Systems 16835-236 Algonquin Street Huntington Beach, CA 92649Referenced Links:
ISO Certification and Registration Services
Quality Management Systems Software
How do you measure customer satisfaction & quality?
I have created a Windows software application, which I have named QMSCAPA, for internal auditing, corrective action requests, preventive action requests and other quality management system elements.
My objectives are to provide a low cost ISO software tool that is very robust, multi-user, easy to use and very easy to adapt for many types of businesses.
From a software point of view, I have learned that measuring quality and customer satisfaction can be infinite. How many times have you heard, “an X bar R chart can be used to measure anything”?
Of course, well written customer surveys can be an effective tool for collecting customer satisfaction feed-back and the summary of data can be very straight forward. Therefore, I have designed the QMSCAPA Customer Survey module to include:
Always insist on an ISO Certification issued by an ACCREDITED Registrar
- A database for client or customer data;
- A methodology to print or email surveys to individual client or customers’;
- User customizable survey forms;
- One to a hundred survey questions that can be user defined;
- Survey answers may scored on a scale of 1 to 10, or 1 to 100;
- A data collection and input program to record survey results;
- A variety of survey reports for results.
How do you survey and collect customer satisfaction information?
My next challenge is to incorporate a generic tool to identify quality metrics for many types of measurements, products and services, like:
- Quantity of achievements vs. quantity of failures;
- Due dates vs. actual dates;
- Variable A vs. Variable B;
- Other generic variables, etc.
How do you measure quality?
What tools do you use to record quality related data?
Why are our customers asking us if we are ISO Certified?
We only distribute products made by other manufacturers? Literally, we buy products in bulk, separate into individual packages and then ship them out.
Why are our customers asking us if we are ISO Certified?
Most people are referring to ISO 9001:2008 Certification when they ask, “are you ISO Certified?”
Here are some easy answers to the questions about ISO 9001:2008 Certification.
(1) We want our order done right the first time so we can provide our customer’s order right the first time.
(2) We want a third party (certification body) to confirm in writing that you are doing what you say you will do.
(3) We want our customers to get products with the highest level of quality assurance.
(4) We don’t want to have the expense of auditing our supplier’s quality system.
Always insist on an ISO Certification issued by an ACCREDITED Registrar
QMSCAPA™ stands for Quality Management System, Corrective Actions and Preventive Actions. QMSCAPA™ is a Microsoft Windows compatible computer application, which is designed to generate a CAPA log for a Quality Management System based upon the ISO Standards. 
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