ISO 9001 7.1 Product Realization

Suppliers, supplier management

Q: Our company, certified to ISO 9001:2008 Quality management systems–Requirements, is experiencing quite a bit of supplier non-conformance.

An option we are interested in is to have a set of manufacturing drawings for our suppliers and a set of inspection drawings. Either the manufacturing set would require tighter tolerance than the inspection set, or the inspection set would have looser tolerances than the manufacturing set.

What would the criteria be to introduce this theory into our procedures?

A: I suggest that you consider the point of ISO 9001:2008 Quality management systems–Requirements, clause 7.1, regarding the development of product objectives. Your planned approach is similar to what is intended by this clause.

The organization should set its product requirements during the product planning stage. Product requirements should be based upon design inputs, outputs, verifications and validations. This provides the essential measurements (tolerances) required for the product to function as designed or intended.

The requirements sent to suppliers, or to the shop floor, should be within the design tolerances or criteria, but not necessarily the same. However, in the event that inspection or a supplier identifies/provides a product that is outside the drawing requirements, it would be up to the engineer or the designer to decide if the product still meets the design criteria. If so, the product would be disposition “accept as is” and would still function as planned.

If repetitious non-conformance is encountered and the product is still within the design criteria, then changes to the supplier and inspection criteria should be considered to prevent continued non-conformance. If the non-conformance does not meet the product requirement or the design criteria, corrective action should be taken with the supplier.

Bill Aston
ASQ Senior Member
Managing Director of Aston Technical Consulting Services
Kingwood, TX
www.astontechconsult.com

For more on this topic, please visit ASQ’s website.

Qualifications for QMS Staff Training Position

Training, learning, conference, certification, recertification

Question

I work at an environmental testing laboratory company with facilities in California.  We are certified to ANSI/ISO/ASQ Q9001-2008: Quality management systems – Requirements & ISO/IEC 17025-2005: General requirements for the competence of testing and calibration laboratories and are pursuing certification to  ANSI/ISO/ASQ E14001-2004: Environmental management systems – Requirements with guidance for use.

We are attempting to hire an assistant quality manager (AQM) whose primary function will be staff training on the quality management system.

We have identified an excellent candidate in Ireland and are attempting to secure a work visa for her in order to come to the United States and join us. The folks at the Immigration and Naturalization Service are demanding that we write a job description so that they can somehow justify bringing her into the country.  One of their requirements appears to be related to having a bachelor’s degree in education in order to fulfill the training function. In addition, they are demanding that we prove that this is an “industry standard,” namely, having an education degree in order to become a training manager.

My question for you is: is a bachelor’s degree in education a normal requirement for a quality training position? If so, can you offer any guidelines in terms of companies or types of firms that may have this requirement? If not, what can you tell me about normal background or education requirements necessary for the AQM – the training position that I am considering?

Answer

The short answer is no — a degree in education is not a normal industry requirement. I believe the Immigration folks are confusing this position with a school teacher who is required by most states to have a teaching certificate. One of the requirements for most teaching certificates is an education degree from an accredited college or university – the so-called “normal” schools.

An education degree is not normally required and usually not desired in industry.

It would be much better to emphasize the quality knowledge aspects. It is quite common for candidates to have one of the ASQ certifications, such as ASQ Certified Quality Improvement Associate certification (easier) or the ASQ Certified Quality Engineer certification (very hard).

Dennis Arter
ASQ Fellow
The Audit Guy
Columbia Audit Resources
Kennewick, WA
http://auditguy.net

Random Sampling

Inventory, Inspection, Review, Suppliers, Supplies

Q: When inspecting components on tape and reel, pulling parts at random can present a problem in a pick and place operation.  Also once removed, the samples would have to be put back on tape for use.

Is there a practical or common sense procedure to follow?

A: This is not an uncommon problem and I know that I’ve been in a similar situation. What we did was to inspect at the beginning and the end of each tape. That way we were not causing disruption to the process.  It worked pretty well with the suppliers we had. But prior to doing that, we certified our suppliers by going to their facility and performing a process audit to make sure that the process was meeting our requirements.

Jim Bossert
ASQ Fellow

For more on this topic, please visit ASQ’s website.

Coordinate Measuring Machines (CMMs) and Digital Bore Gages

Gage R&R, Torque Wrence

Q: When inspecting diameters with tolerances of .0005 and below, are there any studies relating to the accuracy of different inspection methods, such as a coordinate measuring machine (CMM) versus a digital bore gage with setting ring combination?

A: The answer to this question can often be one of opinion and/or personal preference.  What I will present are my opinions, along with some known facts.

Non-contact measurement systems such as optical and laser equipment are bulky, expensive and impractical.  With these systems, the part must be taken to the system. This is not much good in a production environment.

While a CMM is without a doubt very accurate, they are also slow.  Like the optical or laser equipment, the parts must be taken to the system.  In many production situations it is more practical to check the part in the machine.  Also, even though CMMs come with reticulated heads, measuring at abstract angles or various depths is not always an option.  It is also wise to keep in mind that deeper bores would require longer stylus probes.  This is a situation that can introduce concerns of error and rapid movement can generate false contact readings with longer styli simply due to the motion.

A final thing to keep in mind is the high initial price of a CMM, as well as the maintenance costs.

Two and three point contact measurement is readily available.  Popular digital bore gages are calibrated to a master ring.  The rings themselves can be verified with a CMM or sent out for certification traceable to national standards. Most digital bore gages can be set up to interface with a statistical process control system. This is important when process control is vital.

Cylinder bore gages (generally two point contact) can sometimes have problems with linear accuracy. Analog versions can be more prone to operator error.

While two point systems will more readily detect ovality, where this is not a major concern, three point digital systems are, in this quality technician’s opinion, the best all-around option.

When I am inspecting parts in which ovality could be an issue, if the parts are readily portable, I will check a percentage with a CMM to verify their roundness.  However, for speed, accuracy, practicality, and price, a three point digital bore gage would be the way I would go to verify product with tight tolerances.

A final note: If parts are relatively small and can be in contact with other materials, robotics is often used with air gage instruments.  This is another expense but can be introduced in high volume manufacturing.

I hope this will help.

Bud Salsbury
ASQ Senior Member, CQT,CQI

For more on this topic, please visit ASQ’s website.

Standard Vs. Specification and Guidance Documents

ISO documentation practices, requirements, records

Question

What is the difference between a standard and a specification?

Answer

There is no single or simple answer to your question. The answer depends upon the context of the question. Relative to the ANSI/ISO/ASQ Q9000 Series: Quality management standards, I direct you to ANSI/ISO/ASQ Q9000:2005 Quality management systems – Fundamentals and vocabulary.

ISO 9000:2005 defines specification as a document that states requirements. A specification can be related to activities (e.g. procedure document, process specification and test specification), or products (e.g. product specification, performance specification and drawing).

ISO 9000:2005 does not define “standard”. The first part of the ISO 9000:2005 introduction reads:

“The ISO 9000 family of standards listed below has been developed to assist organizations, of all types and sizes, to implement and operate effective quality management systems.

— ISO 9000 describes fundamentals of quality management systems and specifies the terminology for quality management systems.

— ISO 9001 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide products that fulfill customer and applicable regulatory requirements and aims to enhance customer satisfaction.

— ISO 9004 provides guidelines that consider both the effectiveness and efficiency of the quality management system. The aim of this standard is improvement of the performance of the organization and satisfaction of customers and other interested parties.

— ISO 19011 provides guidance on auditing quality and environmental management systems.

Together they form a coherent set of quality management system standards facilitating mutual understanding in national and international trade.”

In other words…

ISO 9000 is a standard that describes fundamentals and specifies the terminology.

ISO 9001 is a standard that specifies requirements.

ISO 9004 is a standard that provides guidelines.

ISO 19011 is a standard that provides guidance.

This implies that a standard is a formal document that establishes uniform criteria, methods, processes and practices — which may or may not be requirements.

ISO 9000:2005 also makes a distinction between quality management system requirements and requirements for products using the terms “specifications” and “standards.” It states:

“The ISO 9000 family distinguishes between requirements for quality management systems and requirements for products.

Requirements for quality management systems are specified in ISO 9001. Requirements for quality management systems are generic and applicable to organizations in any industry or economic sector regardless of the offered product category. ISO 9001 itself does not establish requirements for products.

Requirements for products can be specified by customers or by the organization in anticipation of customer requirements, or by regulation. The requirements for products and in some cases associated processes can be contained in, for example, technical specifications, product standards, process standards, contractual agreements and regulatory requirements.”

Joe Tsiakals
Voting member of the U.S. TAG to ISO/TC 176 (ASQ)
Voting member of the U.S. TAG to ISO/TC 210 (AAMI)

TS 16949 Calibration Management

Automotive inspection, TS 16949, IATF 16949

Q: Under the standard ISO/TS 16949:2009 Quality management systems – Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations — is it acceptable to allow an instrument user to request a calibration extension under certain circumstances?

Here are just a couple of examples:

The user is in the middle of a test that they don’t want to disrupt until completed.
Equipment is installed on a test vehicle that is at a remote location and is not readily available.

I should note we are an automotive supplier engineering facility doing advanced product development.

A: Here is my usual advice about calibrations:

1. The calibration frequency is both a matter of use and criticality of measures. Instrument companies err on the side of frequent recalibrations.

2. As with most standards based on ISO 9001:2008, the calibration frequency is an internal company decision as the requirement is:

•    Process for calibration management
— Records need to show (7.6.2):
> Equipment identification, including the measurement standard against which the equipment is calibrated
> Revisions following engineering changes
> Any out-of-specification readings as received for calibration/verification
> An assessment of the impact of out-of-specification condition
> Statements of conformance to specification after calibration/verification
>  Notification to the customer if suspect product or material has   been shipped

Therefore, it is the supplier who determines the frequency of the calibration, as well as the standard to which they are using. If the supplier sets a frequency schedule they should follow it unless they get a concession from their customer.

I have done a large calibration study where an engine plant did the statistical analysis, which saved them millions of dollars to set optimal gauging schedules for an engine plant. I recommend that such a study be conducted by this company as soon as possible.

Ron Berglund
Voting member of the U.S. TAG to ISO/TC 176
ASQ Fellow
Canton, MI

For more on this topic, please visit ASQ’s website.

Z1.4:2008, Using Acceptance Quality Limit (AQL)

Pharmaceutical sampling

Q: I have a question about how to use ANSI/ASQ Z1.4-2008 Sampling Procedures and Tables for Inspection by Attributes.

I am looking to achieve a 99.5% production yield.  How do I calculate that using the Acceptance Quality Limit (AQL) in this standard?  Is it as simple as taking (100-AQL) to calculate the expected yield?

A: The ANSI Z1.4-2008 standard is not intended for calculating production yield or expected production yield.  The AQL is the maximum percent non-conforming that can be considered acceptable as a process average.  Typically we set this as the percent defective that would be accepted at a 95% confidence.  If you want to sample such that you have 95% confidence that the average production yield is 99.5%, you can find a sampling plan with an AQL of 0.5%.  Also, please understand that the tables in the standard are not exact value for AQL.  Using the binomial distribution (or hypergeometric for sampling with no replacement) you can calculate the exact probability.

Steven Walfish
Secretary, U.S. TAG to ISO/TC 69
ASQ CQE
Statistician, GE Healthcare
http://statisticaloutsourcingservices.com/

For more on this topic, please visit ASQ’s website.

ISO 9001 SOPs for HR and IT Departments

Mr. Pareto Head and IT

Q: My company wants to become certified to ISO 9001:2008 Quality management systems–Requirements by the end of this year. We have nearly all of our common standard operating procedures (SOPs) identified and written. But some of our departments—HR and IT in particular—are proving to be a little more difficult as far as identifying activities we might need to document.

Could you provide a few examples of procedures that might be available for  an IT and HR department? More specifically, I’m looking for examples of what others may have done with ISO 9001:2008 in conjunction with corresponding SOPs.

A: ISO 9001:2008 specifically requires the organization to have documented procedures for the following six activities:

4.2.3 Control of documents.
4.2.4 Control of records.
8.2.2 Internal audit.
8.3 Control of nonconforming product.
8.5.2 Corrective action.
8.5.3 Preventive action.

From an ISO 9001:2008 perspective, there are no mandatory procedures required for HR or IT departments as supporting functions for an organization. It is recommended, however, that you have your processes documented to ensure accountability for actions, consistency and standardization.

When there are many employees involved in various organizational functions, the hand-offs between the functions and employees can blur, with little to no accountability for the final outcome. In addition, having processes undocumented is not scalable, repeatable and reproducible as the organization grows larger.

The ISO 9001 website guideline further clarifies that the extent of the quality management system’s documentation can differ from one organization to another based on:

The size of organization and type of activities.
The complexity of processes and their interactions.
The competence of personnel.

While this may not be the right forum to share examples of SOPs, I can provide a typical list of ISO 9001:2008 procedures that may be applicable to HR and IT functions.

A better way to develop procedures for the listed processes is to bring the stakeholders and experts together, map the process in its current state, brainstorm, identify and remove nonvalue-added activities, and then reissue a new value-added procedure.

Typical SOPs in HR

  •     HR planning process.
  •     New employee orientation process, including mandatory training and certifications.
  •     Training needs analysis.
  •     Employee training and development process, which also includes training, skill competency assessments, periodic evaluations and certifications.

Typical SOPs in IT

  •     IT resource planning process.
  •     Data archival, retention, backup and disaster recovery process.
  •     IT hardware and software maintenance and information security management process.
  •     Quality information systems, including infrastructure planning, implementation and improvement.

Govind Ramu
Senior manager, quality systems
SunPower Corp.
San Jose, CA

ISO 9001 Clause 7.5.1 Work Instructions

Mr. Pareto Head and standard work

Q: Within my organization there has been much debate on what a work instruction is. The term work instruction is not defined in the ISO 9001-2008 Quality management systems—Requirements standard (appears in clause 7.5.1).

Our question is that if the organization is providing services such as maintenance and repair of the customer’s equipment, and the customer provides maintenance and repair manuals and publications for this equipment to the organization, would this literature satisfy the requirements of ISO 9001:2008 as work instructions? Any assistance provided would be greatly appreciated.

A: You are correct when you state that “work instructions” is not defined in ISO 9001:2008, nor is it in ISO 9000:2005 Quality management systems–Fundamentals and vocabulary.

Terms are not defined by the Technical Advisory Group (the standard developers)  when it is felt that the general accepted usage is clear and unambiguous. Such is the case with this term. A work instruction is simply what the name implies, instructions to do work. Written instructions might not be necessary and so the phrase “as necessary” is in the text of the standard. It depends on your specific situation.

The challenge to comply with the requirements of clause 7.5.1 is not in the definition (or lack of definition) of work instructions. It is planning and carrying out production and service work under controlled conditions.

Are your work processes controlled? This clause identifies six elements that need to be considered. Work instructions are one of the six elements. Do your operators know what to do? Are they trained? Do they need written instructions? In general, you must make this call, not an auditor. If you are challenged by an auditor, you need to be able to defend you position. But there is no hard and fast rule here.

Let me note that telltale signs of lack of control are frequent errors, defects and rejects. This indicates to an auditor that you don’t have a controlled process. You need to tighten things down including addressing those of the six elements that are at the root cause of your process failures. You might need work instructions or improved work instructions based on process performance.

You mention that your organization maintains customer equipment and that the customer provides manuals. These manuals might be adequate. They might not. Let’s say that part of your maintenance is changing the oil on a gasoline engine. The manual, hopefully, states when this needs to occur. It might not. You probably need to establish a maintenance schedule for changing the oil and lubricating the machine, recording when this is done. Do you need a detailed work instruction on how to change the oil? Probably not. However, the machine might be complicated and have many lubrication points, a number of them not at all obvious. In such a case, a simple work instruction might be useful.

The key is to control your process and use whatever is needed to do so.

Joe Tsiakals
Voting member of the U.S. TAG to ISO/TC 176 (ASQ)
Voting member of the U.S. TAG to ISO/TC 210 (AAMI)

For more on this topic, visit ASQ’s website.

ISO 9001 Clause 8.2.3 and 8.4

Checklist, Conformity, Go/No Go, Inspection, ISO 9001

Question

Our quality management department, of which I am the lead internal auditor, has a question that we have been debating for some time:

How do we apply ISO 9001:2008 Quality Management systems-Requirements, clause 8.2.3 Monitoring and measurement of processes and 8.4 Analysis of data, in a non manufacturing organization?

Our organization is primarily software, software modification of COTS that is implemented into our products, and applications modified for our business unit’s use.

My specific questions are:

1. How is the effectiveness of process improvements measured?

2. What methods of measurement do we use to capture the effectiveness?

3. Is there a check sheet or report form available that would guide us on how to apply these two requirements?

Thank you for your assistance in this matter. We want to implement a methodology for capturing measurement and effectiveness of process improvement data, but are at a loss as to how and where to start.

Answer

You posed several questions about ISO 9001 compliance.

1. How is the effectiveness of process improvements measured?

In a service environment there are typically many process characteristics that can be monitored or measured to assess whether the process has been planned and is being carried out under controlled conditions. Without knowing details of your service offering, it is difficult to comment explicitly.

Possible examples of metrics that may be appropriate include on time completion of a project, after-release detected “bugs,” time required to maintain “released” software modules, and etc.

Also, such metrics can be graphed and cost can be tied to each metric so that when process improvements are made, the benefits can be presented to management in management review in terms of the financial benefits of aggressive measuring and monitoring initiatives.

2. What methods of measurement do we use to capture the effectiveness?

See #1 above.

3. Is there a check sheet or report form available that would guide us on how to apply these two requirements?

Any check sheet or form would have to be developed by you to suit your processes.

Charlie Cianfrani
Consulting Engineer
Green Lane Quality Management Services
Green Lane, PA
ASQ Fellow; ASQ CQE, CRE, CQA, RABQSA Certified QMS-Auditor (Q3558)
ASQ Quality Press Author

For more on this topic, please visit ASQ’s website.