ISO 9001 Notes

Sprinkled throughout the ISO 9001 standard are notes. These are highlighted by the word ‘NOTE’ in capitals. Examples of ISO 9001 notes are:

• In segment 4.1 "NOTE 1 Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvement.”
• In segment 4.2.1 “NOTE 3 The documentation can be in any form or type of medium."

There has been discussion in some circles about whether or not the standard should contain notes at all, or whether the standard requires that all notes be complied with. In fact some external auditors believe (wrongly) that these notes must be complied with.

ISO 9001 segment clarifies the use of notes. It states “Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement."

When reading the standard, the key word that identifies a requirement which must be complied with is the word ‘shall’. In the standard, the word shall can be interpreted to mean the word ‘must’.

For example, in segment 4.2.3 Control of documents, the sentence “Documents required by the quality management system shall be controlled” can be interpreted to mean Documents required by the quality management system MUST be controlled in order to conform to the standard.

When reading through the standard, keep in mind the words shall and NOTE. Be sure to meet the requirements found to contain the word shall and use those sentences identified by the word NOTE for guidance and clarification only.

For questions or assistance with your ISO 9001 implementation visit www.rosehillsystems.com

The Management Representative

ISO 9001 section 5.5.2 states: "Top management shall appoint a member of the organization's management" [to oversee the quality management system(QMS)].  The responsibilities of the 'management representative' are:

• Assuring that the QMS is developed and the processes of the QMS are maintained
• Reporting to management on the performance of the QMS
• Promotion of awareness of customer requirements

In moderate and large sized organizations, this person is typically the individual responsible for the quality function, but this is not necessarily the case.  In smaller organizations , there may be no formal quality organization.  In this case any member of management who is prepared to take on the  responsibilities above can assume the position.  It is common for the selected individual to interface with customers and suppliers on quality matters.

For the management representative to be successful, he or she must have the support of top management, and must understand the ISO 9001 standard.  There are instances where decisions must be made about the acceptability of product.   Sometimes the correct decision is unpopular for cost or other reasons.  The management representative must be supported when difficult issues arise, and must be willing to make the right decision.

To implement the standard, it is common for the management representative to form a team.  A quality team should include one or more members of the following groups:

• Manufacturing
• Purchasing
• Engineering
• Sales

Other groups such as accounting, inventory management, and warehousing may also be possible contributors.

If the management representative is not a quality professional, he or she should receive training in ISO 9001, and have access to a quality assurance consultant.  The elements of the standard only cover 14 or so pages, but the wording is pithy.  An experienced quality professional will understand the wording and its interpretation in the context of business practice, but the representative inexperienced in quality will likely gloss over key points in the standard.

For assistance or more information visit www.rosehillsystems.com.

Training Presentations

ISO 9001 Implementation requires that employees be trained in the standard.  Over the years I have done many training sessions in the standard.  These sessions typically take one to two days to conduct.  After a few hours going through the standard,  I find students eyes glossing over.   Either I or the material tends to put people to sleep.  In short I don't believe that a one or two day training session is particularly effective.

To address this training effectiveness issue, I have been developing PowerPoint presentations on specific elements of the standard.  The idea is that a segment can be covered completely in an hour or less, and can keep people's attention long enough to retain the material.  It also makes sense to train in an element as implementation of that element is about to start.

At www.rosehillsystems.com, in the Tools section, you will find a link these presentations.  They cover various elements of the standard with some added insight into implementation.  At this point there are a dozen or so presentations.  I will be adding to these presentations over time, so check back periodically.

Product Realization Planning

Product realization is the ISO 9001 term for product and / or service provision.  ISO 9001 section 7.1 states that: “The organization shall plan and develop the processes needed for product realization.”  A quality plan involves the following:

• Quality objectives
• Product requirements
• Documented processes
• Resources needed to produce, monitor and test the product
• Required verification, inspection, monitoring and measurement procedures
• Records needed to show that the processes and the resulting product meet requirements

Quality objectives should be consistent with the organization’s quality objectives.  Product requirements must be consistent with the outputs of the design process.

Documented production processes are not required, but it is a good idea to document how the processes that produce the product interact. A flow chart is a good way to show how the manufacturing of the product will occur and where the inspection points will be.  Documented inspection procedures which describe the product requirements, the inspection methods and tooling to be used, and the frequency of inspection assure a consistent inspection process.

Once the production processes are determined, it should be easy to determine the resources needed to create the product including:

• Manufacturing equipment
• Tooling
• Personnel needed to perform the work and do the inspection
• Inspection equipment and procedures
• Records needed

Inspection records are required.  The organization must be able to show that the product meets requirements, and the way to do this is to record inspection results.  Records should show the features inspected, the specification for each feature, the values obtained, the gauge / tool number used to perform the inspection, the inspector, and the date / time of inspection.  Inspection records can be a critical input to corrective actions, and analysis of data necessary for continual improvement.

For more information visit www.rosehillsystems.com

On-site Supplier Audits

In my recent post in March on Supplier Evaluations, I addressed supplier self-assessment questionnaires.  Questionnaires are good, but sometimes it is good to visit the customer.  What should one do when on-site at the supplier?

A client recently asked me how to conduct an on-site process audit of a supplier.  He was visiting the supplier anyway, so it made sense to him to conduct a process audit while there.

When doing such an audit, I like to start with known purchase orders (open and closed) and follow those orders from the point where the PO is received by the supplier to the point where the product ships.  Asking the supplier to retrieve records about a closed order also helps to assess the supplier’s record keeping.

To assist the client, I came up with 10 areas of questioning.   The questions follow a customer purchase order through the sales order, design, procurement, production and inspection processes.  They offer a pretty good idea about the supplier’s processes and how well aligned with the standard they are.  Such an audit can be conducted in a couple of hours and give a pretty good idea of the supplier’s compliance with ISO 9001 requirements.

You can find the questions here , in the advice section of my web site.  For questions, or additional information, visit www.rosehillsystems.com.

Training Requirements

ISO 9001 Section 6.2.2 Competence, training and awareness identifies five requirements:

1. Determine necessary competence
2. Provide training
3. Evaluate training given for effectiveness
4. Assure that personnel are aware of the relevance of their work
5. Maintain training records

1. Consider creating job descriptions. Job descriptions identify the skill set a qualified employee must possess to perform the functions of the job. Larger companies have them because they are used as a mechanism for determining the value of, and hence the wages paid for each job, but they also identify the training requirements for the employee.


2. With a job description in place, it is easy to do a gap analysis for an employee to determine what additional training he or she should be offered. Some training must be provided to all employees, and some training must be repeated periodically. Safety training is an example of training that in many cases is required to be given periodically. Most employees are not skilled in the requirements of ISO 9001, or quality in general, so some form of general quality training is normally required for all employees.


3. There are many ways to evaluate the effectiveness of training. One way is a periodic performance review. These are usually attached to pay increases, and, done properly; they also identify skills weaknesses that can be corrected by additional training. Perhaps the most effective method of determining training effectiveness is testing.


4. Employees want to do a good job. They know how to perform the tasks of the job and usually do it consistently well. But many manufacturing employees have no idea how what they are making or how the product they are making will be used. Explain to employees how the work they perform affects the quality of the products and services the organization supplies, and what the product does for the customer.
   
   Not explaining how the organization’s products are used can have unintended consequences. The Space Shuttle booster rockets were stored in a dry nitrogen environment prior to use. A component we produced helped circulate nitrogen in the storage container. We all watched the launch of the Challenger. When the Challenger space shuttle exploded on takeoff, the employee who assembled this component started crying because she believed that the product she produced had failed and caused the explosion. Of course this was not the case.


5. Each employee should have a training plan. A training plan outlines the training that a person is required to have. The training plan should be in alignment with the job description, and any other company or regulatory requirements for training. ISO 9001 requires that records of training performed be maintained. Training records can be compared to the required training and used to identify any required training which needs to be performed.

Finally, for those senior managers who believe that training is unnecessary, or a wasteful expense, I offer this question: How many incompetent people do you want working for you?

For more information visit www.rosehillsystems.com.  In the tools section you will find some PowerPoint presentations that can be used as a basis for ISO 9001 training.  Steal shamelessly.

Nonconforming Product

ISO 9001 section 8.3 Control of nonconforming product states: “The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.”  The standard requires that a specific procedure be written that describes how nonconforming product is controlled.

Simply put, the standard is saying: Don’t mix the good stuff with the bad stuff.  Defective material should be placed in an area specifically designated for nonconforming product.  That area should be segregated from good product and specifically labeled as nonconforming product.

The product placed in that area must be labeled, and its nonconformances identified.  It is common for organizations to generate a report that identifies and describes the defective product.  These reports go by many names such as Discrepant Material Report (DMR), Nonconformance Report (NCR), etc.  They typically identify the product, the discrepancy or discrepancies, and the number of pieces involved.  The form is also used to identify the actions taken, who authorized the actions, and what the final disposition of the material was.  The standard allows the following actions:

• Rework the product to specification
• Use as is (“authorizing its use, release or acceptance under concession”)
• Scrap
• Re-grade for some other purpose

My personal opinion is that ‘Use as is’ should be avoided if at all possible.  It has the following problems:

• An inferior product is gets shipped to customers
• A message is sent to employees that defects are acceptable

When product is reworked, it must be inspected for the defect originally identified. 

The discrepancy report, indicating the actions taken and the final disposition is a record which must be maintained.  Periodically records of nonconforming product should be analyzed.  Analysis might identify possible preventive actions that could reduce nonconformances in the future.

For more information visit www.rosehillsystems.com .

Supplier Evaluations

ISO 9001 section 7.4.1 states: “The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements.  Criteria for selection, evaluation and re-evaluation shall be established.  Records of the results of evaluations … shall be maintained.”

Some customers use site visits to assess the capabilities of the supplier, but ISO 9001 does not specifically require this practice.  Most customers send potential suppliers a self-assessment questionnaire.  Self-assessment questionnaires can be simple or complicated to complete.  Be aware that the likelihood of receiving a response to a questionnaire is inversely proportional to the questionnaire’s complexity.

I’m not in favor of complicated multi-page questionnaires in most cases.  If the organization intends to place a small order with a supplier it is not likely to use often, it is unlikely that a complex questionnaire will be returned in a timely manner, if it is returned at all.  A simple, short questionnaire is more likely to be completed and returned.

If the supplier is to be a key supplier with a significant business opportunity, and a likely long term business arrangement, it may be better to visit the supplier and complete a complex questionnaire yourself in an on-site audit.  Meeting the players creates a better, more lasting relationship with the individuals involved.  These relationships make problem solving over the phone or by e-mail more likely to be successful.   As to what questions to ask, Govind Ramu presents an interesting perspective, in the Expert Answers section of   Quality Progress March, 2013 where he addresses questions to ask and not to ask a supplier.

Consider establishing (and documenting) multiple criteria any of which will qualify the supplier.  Examples might be:

·         ISO 9001 certified

·         Over one year experience with the supplier with few product rejections

·         Franchised supplier (for distributors)

As you collect supplier qualification data, consider storing the responses in a database.  The database facilitates contacting suppliers when quality problems arise and provides a tool for re-evaluating the supplier.  I recommend contacting the supplier near the time when his certification expires, and if it is not certified, annually.  A database can facilitate and automate this work.

Key suppliers, those suppliers who get most of your business, should be rated by some rating system routinely.  The ratings should be fed back to the supplier.  Examples of such ratings might be:

·         On time delivery percentage

·         Number of lots rejected divided by the number of lots received.

·         A multiple of the two above.

For an example of a simple questionnaire visit www.rosehillsystems.com and click on Tools.

Preventive Action

Preventive Action

Many get confused with corrective and preventive actions.  While corrective action deals with existing nonconformances (defects), preventive actions deal with nonconformities that haven’t occurred, but might occur in the future. 

In section 8.5.3 Preventive Action, ISO 9001 states “The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence.”  Potential problems are usually identified from the analysis of metrics, or from audits.

For example, an organization has a metric for on time delivery, and will take corrective action when delivery falls below 95% on time.  The metric is above the limit, but examination of the metric chart shows that on time delivery has decreased each month for the past 5 months.  A corrective action is inappropriate because the metric hasn’t fallen below the requirement (95%).  In this case, preventive action is more appropriate.

Whereas corrective action requires that action be taken, preventive action does not.  Consider a control chart for a machine tool.  The chart indicates that the tool is wearing and may need to be replaced soon.  Do we change the tool now or wait until the control limit is exceeded?  An economic analysis might suggest that we wait for the control limit to be exceeded because the cost of the tool is high or the cost of lost production is high.   The customer may be in critical need of the product and we can’t afford to shut down the machine now.  A decision to continue production would close the preventive action.

 A decision to take action would allow the machine tool to continue operation while a plan is developed for implementing a replacement.  In contrast, if this were a corrective action, the tool would be shut down until a replacement is available.

Once the decision to take preventive action has been made, the process becomes very similar to corrective action.  An action is selected, usually by a team.  A plan is developed to implement the preventive action selected, and the implemented action is monitored for effectiveness.

Some organizations use one form for both preventive and corrective actions.  In the case of a preventive action, there is no evidence of nonconformance, and there is no containment plan, since a nonconformance has not occurred.  Root cause analysis still occurs because there may be many choices of actions to take.

When the action(s) have been identified, a plan for implementation is developed.

My steps of preventive action look like this:

1.       Problem statement

a.       State the requirement

b.      State the evidence of potential nonconformance

2.       Root cause analysis

3.       Preventive action plan

a.       What action(s) will be taken?  NOTE: The plan might be to do nothing.

b.      When will they be implemented?

4.       Follow Up

a.       Were the actions taken effective?

In contrast, my 5 steps of corrective (See my August 2012 blog) are

1.       Problem Statement

a.       State the requirement

b.      State the nonconformance

c.       State the objective evidence of the nonconformance

2.       Containment Plan

a.       When did the problem start?

b.      What are we doing to control the bleeding while we are looking for a solution ( short term fix)

3.       Root Cause Analysis

4.       Corrective Action Plan

a.       What will be done to eliminate the root cause(s)?

b.      When will they be implemented?

5.       Follow Up

a.       Was the implemented corrective action effective?

b.      Was the short term fix removed?

 

For more information visit www.rosehillsystems.com

Production Control

ISO 9001 section 7.5.1 states:  “The organization shall plan and carry out production and service provision under controlled conditions.”  It goes on to state that controlled conditions means availability of product specifications, work instructions, equipment, and test equipment etc.

In an audit I was conducting recently, I came across a work instruction that instructed the technician to ‘use the custom jig.’  This raises the question:  Does ‘controlled conditions’ mean that jigs and fixtures should be identified and controlled?  It’s an important question from the auditor’s point of view.  If the fixtures are not controlled, should I write a corrective action?

To me, control means the same thing for a tool that it means for a document or  inspection equipment.   It should be identified, it should have a revision, changes to it should be approved prior to issue, and it should be inspected periodically to assure it is viable for use.

I raised the question of controlled tools with other quality professionals, and they all seemed to think the standard is moot on this point.  They all agreed that it makes prudent sense though.  Other standards such as AS9100 (the aerospace equivalent of ISO 9001) clearly state the requirement for tool and jig control.

Consider the potential problems:

·         A fixture used in production wears out over time and must be replaced.  Without a drawing, how do we make a new one that works the same as the last one?

·       The fabricator of the fixture leaves the company, or worse, we need to use the tribal knowledge of the person who made it to make another (assuming he or she remembers how).

·         A technician trainee doesn’t know what ‘use the custom jig’ means and doesn’t use the one we’ve fabricated for the purpose.

The standard leaves many things to interpretation by the external auditor.  Regardless of what the standard says, or how it is interpreted, be sure to document all production tooling with a tool number or other identifier, revision level, and a controlled drawing.  Inspect the tooling periodically to assure it has not worn to the point where it should be replaced.  It may make your ISO 9001 implementation a little easier.

For more information go to www.rosehillsystems.com

On Inspection

ISO 9001 section 8.2.4 states “The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met.”   The standard goes on to say “Evidence of conformity with the acceptance criteria shall be maintained.”  It fails to point out though that quality cannot be inspected into the product.

Many organizations fail to achieve high quality, because they rely on inspection in the belief that they can inspect quality into the product.  Point 3 of Edward Deming’s 14 points states “Cease dependence on inspection to achieve quality.  Eliminate the need for inspection on a mass basis by building quality into the product in the first place.”  Phillip Crosby’s second absolute of quality says it differently: “The way to cause quality is through prevention not appraisal [inspection]”.

For a good example of what can happen when inspection is used as the only means of assuring quality read Austin, A L (2013) “Failure of Inspection The consequences of layering on quality checks” Quality Progress, January 2013.

In an audit I performed recently, the customer was inspecting welds using dye penetrant testing.  I issued a corrective action because no evidence that the tests had been performed was available.  The test reports didn’t include a place for the technician to indicate that the testing had been performed.  When inspection is performed assure that the results of inspection are recorded. 

Keep in mind that even 100% inspection is not 100% effective.  Inspectors make mistakes too.  Focus on mistake proofing production processes and designing quality into the product, not inspecting quality into the product.  Inspect when you must.  Select inspection points to occur just before high cost processes occur.  This assures that the product conforms to requirements before high cost is added to the product.  When you inspect assure that the results of inspection are recorded.

For more information go to www.rosehillsystems.com

The Case for Quality

ISO 9001 section 0.1 states: “The adoption of a quality management system should be a strategic decision of an organization.”  While ISO 9001 is the most widely adopted quality management system (QMS) standard in the world, many companies attach little or no importance to a well-designed QMS.

A recent article: Stauffer, R, Owens, D. “Lasting Impression: Quality management’s positive impact on the economy” Quality Progress, November 2012 makes the economic case for a QMS implementation, asking the question: “Does quality have a payoff?”

The authors reference the study “The Contribution of Quality Management to the UK Economy”, jointly commissioned by the Chartered Management Institute (CMI) and the Chartered Quality Institute (CQI). 

The study, researched and written by the Center for Economic and Business Research (CEBR), conducted a review of relevant business and economic literature, developed 18 case studies from various business and public service sectors, and surveyed 120 organizations.  From the literature research it concluded that an effective QMS resulted in:

·         Upward pressure on stock prices while unsuccessful quality management systems had the opposite effect.

·         Enhanced customer and employee satisfaction and retention.

·         Reduced costs.

·         Improvement in key financial performance metrics.

·         Greater focus on customer satisfaction.

From the organizations surveyed the CEBR found:

·         On average costs were reduced by 4.8%.

·         More than 93% agreed that the QMS was a significant contributor to success.

·         95% agreed that the QMS contributes to customer retention and satisfaction.

·         83% thought that the QMS provides consistent improvement and therefore higher productivity

·         83% agreed that without an effective QMS they could not justify pricing to customers.

The study examined key economic indicators in the UK for 2011.  The study determined that an effective QMS:

·         Contributed ₤86 billion ($135 billion) to GDP.

·         Contributed ₤8.4 billion ($13.1 billion) in corporate tax receipts.

·         Caused employment to be 1.43 million higher (4.94%) than it would otherwise have been.

The article makes a strong case for a well-designed QMS.  The results are likely transferrable to the US economy with similar results.

The benefits of an effective QMS take time to appear.  They do not happen overnight.  Commitment, involvement, and leadership from senior management are keys to success.

For assistance with ISO 9001 implementation see www.rosehillsystems.com

 

Acceptance Sampling

ISO 9001 section 8.2.4 says that the organization must monitor and measure the characteristics of the product in order to verify that the product meets requirements, but is silent on the methods to be applied to monitor and measure product characteristics.  The choice of inspection methods is left to the organization. 

Acceptance sampling is one such method.  Since it is not practical to inspect every item in a large batch, acceptance sampling allows you to infer batch quality by examining a random sample from the batch.  Statistically designed acceptance sampling plans, as a method of measuring product conformity, have been around since at least World War II.  Sampling plans like MIL-STD-105, authored by Harold F Dodge and others, have been in use for over 60 years.

Because not all items in the batch are examined, there are risks associated with statistical acceptance sampling.  Two risks are typically calculated:

·         The Acceptable Quality Level (AQL), also known as producer’s risk, is the percent defective that is likely to be accepted 95 % of the time.  There is a 5% chance that product of higher quality than the AQL will be rejected by the sampling plan.

·         The Lot Tolerance Percent Defective (LTPD), also known as consumer’s risk, is the percent defective that is likely to be accepted 10% of the time.  There is a 10% chance product as defective as the LTPD will be accepted by the sampling plan.

Each sampling plan has an associated operating characteristic curve (OC) which describes the probability of lot acceptance as a function of the lot’s percent defective.  The AQL and LTPD represent two points on the OC curve.  As the lot percent defective increases, the probability of accepting the lot based on the sampling plan that the OC curve represents decreases. 
In addition to the risks associated with acceptance sampling plans, there are some practical disadvantages:

·         While acceptance sampling greatly reduces the number of items inspected, other sampling methods such as statistical process control reduce inspection even further and provide process control feedback.

·         When a lot is rejected, we will know why the lot is rejected, but we will not know the root cause of the defect.  We will only know that the product is defective.  There is no control mechanism that will help us control the process the product comes from.

·         Acceptance sampling assumes random sampling, but in most cases the sample is stratified because the product is normally stored in boxes.  As such, it is possible that some product will never have a chance of being sampled and the sample will not be random.

·         Sampling plans based on AQL, LTPD, or AOQL (Average Outgoing Quality Limit) assume that a certain amount of defective material is acceptable.  This sends a message to employees and suppliers that some level of defectiveness is acceptable.  This is not the best message to send if the organization is trying to be a best in class producer.

Sampling plans can be designed by users, or selected from standards such as MIL-STD-105, now obsolete, or ANSI Z1.4 which implements the same plans.  A common pitfall suffered by users not familiar with sampling plan design is to design constant percentage sampling plans.  Avoid constant percentage sampling plans (a fixed percentage of the lot is sampled regardless of lot size).  For small lots, constant percentage sampling plans may not afford enough protection.  For large lots, an excessive amount of inspection will usually result, and the sampling plan will be over critical.

Consider a sampling plan that samples 10% of a lot.  For a 50 piece lot, a 5 piece sample will result in approximately a 1% AQL, but a 46% LTPD (a very weak sampling plan).  For a 5000 piece lot, a 500 piece sample will result in an AQL of .001% and the LTPD will be .46% - a plan unlikely to accept any lot.

While there are better ways to control production processes than acceptance sampling, acceptance sampling can be an effective method for a customer to protect itself from accepting defective purchased product.  Since the customer has no control over the manufacturing process, it is not important for it to understand what process variable caused defective material.  It need only know that the product is defective.  The customer is susceptible to stratified sampling, but accepts this disadvantage in favor of inspecting a small percentage of the entire batch.

For more information see www.rosehillsystems.com

 

Process Control using Shewhart Control Charts

ISO 9001 section 7.5.2 talks about controlling processes.  Some processes are controlled because the quality of the resulting product cannot be determined once the process is complete as 7.5.2 indicates, but there are many other good reasons to perform process control.  Collecting data on a process for the sake of collecting data is of little value.  It is best to collect and analyze process data. 

There are many tools for controlling processes.  The one I’ll talk about today is statistical process control using Shewhart Control Charts.  Walter Shewhart developed control charts around the turn of the last century.  They are tried and true, and I have used them to control a number of processes.

Control charts are based on the theory that the mean of a sample from a normal distribution is normally distributed, with the mean equal to the distribution mean and a standard deviation equal to the distribution standard deviation divided by the square root of the sample size.  In fact, for distributions that are non-normally distributed, the mean tends to be normally distributed.  So the technique is robust.

Shewhart control charts control the process mean by controlling the sample mean.  They control the process standard deviation by controlling the sample range.   Control is applied by calculating control limits for the sample mean and sample range and plotting the sample mean and range on mean (XBAR) and range (R) charts respectively. 

When a mean or range exceeds its control limit, we say that the process has gone out of control.  A data point that exceeds a control limit causes us to stop the process to understand the root cause of the out of control condition, or, more likely we make a process adjustment and note the adjustment on the chart.  For example, it is common for a machine tool to go out of control due to tool wear.  A simple machine adjustment brings the machine tool back into control.

One complaint about Shewhart Control Charts is that they are complicated to set up.  Some also complain that they require the machine operator to stop and make calculations.  In the old days, calculators and computers were not available, and it was more work for the machine operator to calculate the mean and range.  In the digital age though, these complaints are unfounded.  Software to create control charts is easy and inexpensive to come by, and some inspection tools actually do the work of calculating and plotting the control charts.

I put together a simple Excel spreadsheet that will do all the work for you.  You can download it here.  The spreadsheet has some fictitious data placed there so you can see the charts in action.  You can easily overwrite it with actual data.  Instructions for creating a control chart using the spreadsheet can be found here.  Instructions for using the control chart spreadsheet are also provided, and you can download them here.

For questions or help go to www.rosehillsystems.com

Process Control and the Process FMEA

ISO 9001 section 7.5.2 addresses the control of production processes where the resulting output cannot be verified by subsequent monitoring or measurement.   In these cases, defects only become apparent during the use of the product.  Examples of processes that fall within this section are:

• Welding
• Brazing
• Wave Soldering

There are many others.

Control of processes like these is accomplished by developing a well-defined process, validating that the process is effective, and controlling process variables using techniques such as statistical process control.

One tool for validating that the process is effective is the process FMEA (pFMEA).   Process FMEAs are interesting because they have wide applicability to a broad range of processes beyond those covered by 7.5.2.

FMEA stands for Failure Modes and Effects Analysis.  The technique has been around for a long time, having been first developed by the US Military (MIL-P-1629).  Many industries, such as automotive and aerospace have embraced the FMEA approach to both design and process validation.

In performing a process FMEA, the various steps in the process are presented in a spreadsheet.  Each process step has some likely failure mode(s).  Each failure mode has one or more root cause(s). 

For each root cause there is some effect on the product.  This is known as a failure effect.  To each failure effect is assigned a value for Severity (1-10).  The root causes of the failure effect are assigned frequency of occurrence (1-10), and a likelihood of detection (10-1). These three values are multiplied together to come up with a single Risk Priority Number (RPN).

The RPN is used to prioritize actions to improve the process.  As action is taken and process steps are modified, the RPN of the modified process is calculated to show the relative improvement.

There are 10 steps to conducting a pFMEA:

1. Review the process.  Create a process flow chart.  Liest each process step in a pFMEA spreadsheet.
2. Brainstorm the potential failure modes of each process step.
3. List the potential failure effects of each failure mode.
4. To each failure effect assign Severity (S) rankings (1 means not very severe, 10 means very severe).  Record the highest value among the failure effects identified as the severity ranking for the process step.
5. Identify the potential root causes of each failure mode.  To each root cause assign Occurence rankings (1 means occurence s are rare, 10 means the root cause occurs frequently).  When there is more than one root cause, reaord the highest value among the root causes.
6. To each root cause assign a Detection (D) ranking (10 means the root cause is unlikely to be dteected, 1 means it is very likely to be detected).  When there is more than one root cause, record the highest value among the root causes.
7. Calculate the RPN = S x O x D
8. Develop an action plan to improve the process, prioritizing on the highest RPNs.
9. Take the actions in the plan.
10. Recalculate the resulting RPNs after the actions are taken.

The FMEA method is not perfect.   The values assigned for Severity, Occurrence and Detection are somewhat arbitrary.  Moreover the values assigned are ordinal numbers or rankings, meaning a number assigned to a level.  They could as easily represent descriptions such as very low, low, medium, etc.  A higher value for a factor is more important than a lower value. 

Multiplication of ordinal numbers is not defined (We can’t come up with a numeric value for ”Low” x “High”).  A value of “4” is not necessarily four times as important as “1”.  The value “4” is just more important than “1”.  Still, the RPN has value, and when used properly the FMEA can direct a team towards process improvements.   In addition, the completed pFMEA provides evidence of how the process was developed.

A spreadsheet that can be used to perform a pFMEA can be downloaded here.  It is based on the process FMEA promoted by the Automotive Information Action Group (AIAG).  An example of a simple FMEA can be found here.   

For questions or assistance with FMEAs go to www.rosehillsystems.com

Customer Satisfaction

ISO 9001 section 8.2.1 states:
"As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements.  The mehtods for obtaining and using this information shall be determined."

Measuring customer satisfaction means understanding what your customers think.  There are many ways to glean this information including:

• Customer data such as quality and on time delivery reports
• Customer compliments or complaints
• Warranty claims
• Customer satisfaction surveys

The problem with the first method is that most customers don’t provide them, so you’ll only hear from a few customers and at most monthly.  It’s hard to generalize from just a few customer reports.

Customer compliments are rarer still.  It’s more common to hear from a customer when something goes wrong than when you’ve done something right.  Complaints tell what’s going wrong, but do not reflect the good the organization is doing.

Warranty claims are a good way to tell what goes wrong and how much it’s costing.   With this type of data, preventive actions can be focused and feedback on the effectiveness of actions taken will show up in a short time.

Perhaps the best way to monitor customer satisfaction is to ask your customers what they think.  Toward this end, customer satisfaction surveys are a preferred method of listening to customers.  There are many ways to implement these:

• Bingo cards - A bingo card is a small post card on which you ask a few questions and allow the customer to rate each question on a scale like 1 – 5. The other side has your address.They are typically placed in packaging are perhaps the least effective survey method. Few customers complete and return them.The card usually goes to the wrong department.A receiving department will probably just throw them out. It’s unlikely that they will get to the end user, and when they do, the end user is unlikely to return them. I tried these for several years and got less than a 1% return.
•  On line surveys from web sites like SurveyMonkey.com can be helpful, but again, the customer must be motivated to go to the site and complete the survey. Some companies run contests and award prizes as an enticement. Some retailers even offer discounts on future purchases for completing the survey. They get the data they want, and possibly produce another sale.    
• Salesmen’s feedback – One approach is to require the sales force to contact their customers periodically and ask a few well designed questions. The salesman completes a survey form and turns it in for analysis. This can be a good source of data, but the customer will be reluctant to indicate that the salesman is not meeting their expectations.
• The best method I’ve seen is the telemarketing survey. Telemarketers, properly trained, can get to the end user, ask a short list of well-designed questions, and get good feedback which can be analyzed and studied. At the same time, the telemarketer will probe the customer for other potential business. While costly, a well designed and implemented telemarketing survey will reward the company with excellent data, and additional sales that may exceed the cost of the survey.

Whatever method you choose, keep in mind that you should be able to analyze  the data and draw conclusions.  For help with this topic go to www.rosehillsystems.com