Month: August 2012

ISO 9001: Product Development and Customer Satisfaction

Manufacturing, inspection, exclusions

Q: Does a company certified to ANSI/ISO/ASQ Q9001-2008 Quality management systems — Requirements that produces raw materials for a customer according to their written specification also, as a raw material supplier, have a responsibility under ISO 9001 to meet the customer’s needs for their design intent and intended and known use?

In simple language, I sell a raw material to a customer who takes my raw material and then designs a product and sells it to a customer who uses it in the field. I wonder where does the ISO standard application stop for the raw material supplier?  How can a raw material supplier under ISO 9001 meet the needs of a customer’s trade secret designs, or further down the intended use of the product where the raw material supplier has no control over how it will be used or maintained?

A: Your question is more a legal one than a quality one. You are offering a product to a customer. This is your finished product and their raw material. When both parties agree to the terms and conditions (payment, form, fit, function, shipping, etc.) a contract exists. We call this a purchase order (PO) and part of that PO is the specification for your product. If they place an order to your spec, you have done the design work under ISO 9001 and they are accepting your design. END OF YOUR RESPONSIBILITY for future application and use. If you accept an order to their spec, they have done the design work and you are obligated to make sure your product meets the stated (and often implied) form/fit/function requirements. We call this quality control and you do this by testing in the lab prior to shipment.

Most firms address the issue of application by stating quite clearly in the contract terms that you are selling your product as-is and you do not warrant the product as fit for ultimate use. This is the kind of thing the lawyers require.

Having said all this, there is a requirement in ISO 9001 for you to measure customer satisfaction. You must state in your manual the concept (strategies) for doing this and have some defined processes – usually called procedures – to carry it out. Of course, part of this is the regular management review. Quality, marketing, and sales all provide input on how well the customer needs are being met. Your registrar should be examining how you do this.

If there is a trend showing that customers are unhappy with how the stuff performs under end-use conditions, ISO says you should address those issues. (Ignoring them is an option, if it is deliberate). Mature firms will work on building customer-supplier partnerships, getting their engineers to talk to your engineers. Although this is technically outside of the quality function, it is still part of your overall quality management system.

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.

ISO 9001 7.6a Calibration and Traceability

Gage R&R, Torque Wrence

Q: ANSI/ISO/ASQ Q9001-2008 Quality management systems — Requirements, clause 7.6a states, in part:

“Where necessary to ensure valid results, measuring equipment shall

a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international standards or national measurement standards…”

Does this sub clause require that the calibration process be performed in accordance with international or national calibration procedures? Or does it require that the measurement standards (hardware) used for calibration be traceable to international or national measurement standards (hardware)?

A: The standard is clear that it is the traceability of the calibration standards they are looking for.

Note: By definition, the traceability needs to eventually lead to an accredited lab who will be following procedures such as those set forth in ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories.

 Your internal calibration processes can best be guided by acquiring a copy of ANSI/NCSL Z540.3.

I hope this helped answer your questions.

Bud Salsbury
ASQ Senior Member, CQT, CQI

Related Content:

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

Force Field Analysis

Force field analysis

Q: I am trying to get information on Force Field Analysis.  Can you please provide me more details on the subject?

A: Thank you for contacting ASQ.  I received your request for more information regarding force field analysis.

The Quality Improvement Glossary by Donald L. Siebels defines force field analysis as a “technique for analyzing the forces that aid or hinder an organization in reaching an objective.  An arrow pointing to an objective is drawn down the middle of a piece of paper.  The factors that will aid the objective’s achievement, called the driving forces, are listed on the left hand side of the arrow.  The factors that will hinder its achievement, called the restraining forces, are listed on the right side of the arrow.”

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

ISO 9001 Second-Party Audits and Confidential Information

Reviewing confidential files, training records, human resources files

Q: I am auditing contractors involved in a huge project of ours, and from time to time when I ask for information (risk register, management review meetings, etc.), they say it is confidential.

Where is the limit for confidentiality and how I should deal with it? Actually, it seems like the contractor is using it as a trick.

A: What is not clear from your question is the contractual arrangements you have with your suppliers.  If the contract has a confidentiality clause and calls for second party audits, there is no excuse for withholding information.   ISO 9001:2008 — Quality management systems –Requirements does not address confidentiality.  That is best addressed in the specific arrangements between supplier and customer.

George Hummel
Voting member of the U.S. TAG to ISO/TC 176 – Quality Management and Quality Assurance
Managing Partner
Global Certification-USA
www.globalcert-usa.com/
Dayton, OH

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

Six Sigma Case Studies

Suppliers, supplier management

Q: I would like to browse through detailed Six Sigma Case Studies. I do not mind making a payment for detailed case studies in the fields of manufacturing, services and software.
Kindly direct me to the requisite links please.

A: Thank you for contacting ASQ.  I received your request for case studies on Six Sigma in the fields of manufacturing, services, and software.

“Six Sigma is an organization-wide approach used to achieve breakthrough improvements tied to significant bottom-line results. Unlike previous TQM approaches, Six Sigma specifies exactly how the organization’s managers s hould set up and lead the effort. Key features are the use of data and statistical analysis, highly trained project leaders known as Black Belts and Green Belts, project selection based on estimated bottom-line results, and the dramatic goal of reducing errors to about three per million opportunities” (taken from The Quality Toolbox, 2nd ed. by Nancy R. Tague)

ASQ has around 300 Six Sigma case studies available online.

A host of additional Six Sigma content is also available.

Scope of ISO 19011:2011

ISO documentation practices, requirements

Q: During a quick review of a recently revised standard, ISO 19011:2011– Guidelines for auditing management systems, we noticed that it is shorter than ANSI/ISO/ASQ 19011S:2008.

Also, we are wondering why there are no references to auditing the requirements in ANSI/ISO/ASQ Q9001-2008 Quality management systems.

Could someone please address our concerns?

A: With the expansion in scope of ISO 19011:2011 to cover all management system audits, the intent of the ISO 19011 standard is to provide guidance that is applicable to every management system discipline – not just quality management system audits.

One of the problems with the more general scope of ISO 19011:2011 is that it less helpful for addressing specific issues – such as internal audits of an organization’s quality monitoring and measuring processes.  This is why the ASC Z1-auditing subcommittee has initiated the process of developing supplemental guidance documents for internal audits and supply chain audits.  If there are specific issues or questions that you are interested in, you can ask that it be included in this supplemental guidance document (email standards@asq.org).

As to the difference in length –  with the U.S. adoption of ISO 19011:2011, the 2008 U.S. Supplement was made obsolete. What the Z1-auditing subcommittee is planning to do is to capture whatever guidance in that document is still important in the new supplemental guidance documents being drafted.

Thea Dunmire, JD, CIH, CSP
Chair, ASC Z1-Audit Subcommittee
ENLAR Compliance Services, Inc.
http://www.enlar.com/
Largo, FL

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

ISO 9001:2008 and Reasons to Obtain Third-Party Certification

Reviewing confidential files, training records, human resources files

Q: I have a question regarding an excerpt about ISO 9001:2008 — Quality management systems –Requirements, from the ISO webpage, which is below:

“…Although certification is not a requirement of the standard, the quality management systems of about one million organizations have been audited and certified by independent certification bodies (also known in some countries as registration bodies)…”

Our ISO 9001 quality management system (QMS) has been registered through third-party audits since 1994. But according to this statement, we should be able to represent ourselves as an ISO 9001 organization by simply meeting the requirements of the standard. These requirements, of course, don’t require third-party certification.

Is this the case? If not, isn’t the statement on the website misleading, in as much as certification is an implicit requirement of the standard?

A: I am a U.S. Technical Expert for ISO 9001 and associated QMS standards, have been involved with QMS standards since 1975 and am a published Quality Press author.

You are correct when you state, “we should be able to represent ourselves as an ISO 9001 organization by simply meeting the requirements of the standard. These requirements, of course, don’t require third party certification.” Many organizations use ISO 9001 as the basis for their quality management system without engaging in third-party audits. If you want to claim certification, I guess you could claim that you are “self-certified,” but I am not sure this would mean anything to anybody.

There are a variety of reasons for incurring the cost associated with obtaining an ISO 9001 certification:

  • Internal use: Many do this based on a perception of market advantage and use the certificates in advertisements promoting their goods and services. Some organizations use third party audits and certification to verify for their own management the adequacy of their quality management system.
  • Supplier qualification: The historical use for a quality management system standard is as a basis for qualifying the quality management system of suppliers. Development of quality management system standards dates to the 1950s. One of the early standards of this type was MIL-Q-9858A used by the Department of Defense for use in qualifying some of their suppliers.

Today, ISO 9001 is widely used as a qualification requirement for suppliers in many different product and service sectors. The automotive, aerospace, telecommunications and other industries have sector specific versions of ISO 9001 that are used with suppliers. These all require third-party certification.

  • Regulatory requirement: The European Union, FDA, Japan, Australia, Canada and many other countries use ISO 9001 as the quality management system for meeting certain regulatory requirements. Some regulatory bodies require third-party certification, others conduct their own audits (second-party audits) to verify compliance.

Bottom line: you should determine for yourself if you have a need for certification to ISO 9001 and act accordingly.

Joseph Tsiakals
Voting member of the U.S. TAG to ISO/TC 176 on Quality Management and Quality Assurance (ASQ)
Voting member of the U.S. TAG to ISO/TC 210 Quality Management and Corresponding General Aspects for Medical Devices (AAMI)

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

Sampling Plan for Pharmaceuticals

Pharmaceutical sampling

Q: We are a U.S. dietary supplements manufacturer operating under c-GMP conditions set by the U.S. Food & Drug Administration (FDA).

As such, we perform analyses of incoming raw materials (finished product ingredients), intermediate products (during manufacturing), and finished products. Analyses include identity testing (incoming raw materials), and other types of analysis (e.g. microbiological, heavy metals, some quantitative assays on specific compounds). These tests would be the attributes we wish to assess.

Basically, we are refining our sampling procedures and need to ascertain an acceptable number of samples to be taken for the various testing purposes outlined above.

The World Health Organization’s (WHO) Technical Report Series No. 929,  Annex 4, “WHO Guidelines for sampling of pharmaceutical products and related materials” references ANSI/ISO/ASQ 2859-1:1999 Sampling procedures for inspection of attributes – Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection in reference to the selection of a statistically-valid number of samples for testing purposes.

I note from your website that there are a number of other sampling standards available. I am seeking some guidance as to the most appropriate standard(s) for our particular purposes.

Any assistance you can offer would be much appreciated.

A: Though many of the sampling plans are similar, many standards organizations have published different interpretations of sampling schemes.  Since WHO recommends using ISO 2859-1 as the guidance document, I suggest selecting that plan.

There are similar documents that could be used as an alternative, if necessary:

1. ANSI/ASQ Z1.4-2003 (R2018): Sampling Procedures and tables for inspection by attributes

2. BS 6001-1:1999/ISO 2859-1:1999+A1:2011 Sampling procedures for inspection by attributes. Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection

3. MIL-STD-105E – Sampling Procedures and Tables for Inspection by Attributes*

4. JIS Z9015-0-1999 Sampling procedures for inspection by attributes — Part 0 Introduction to the JIS Z 9015 attribute sampling system

A few points to consider:

  • Usually for FDA-regulated products, a c=0 sampling plan is appropriate. See H1331 Zero Acceptance Number Sampling Plans, Fifth Edition, by Nicholas L. Squeglia
  • Based on risk, an Acceptable Quality Level (AQL) should be selected
  • Your sample size is usually set to be proportional to lot size.  If you are doing testing on bulk raw materials, the sample size will be set based on the variability of the lot as well as the variability of the method.

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

Note:

 *Military standard, cancelled and superceded by MIL-STD-1916, “DoD Preferred Methods for Acceptance of Product”, or ANSI/ASQ Z1.4:2008, according to Notice of Cancellation

Explore more about this topic.

Sampling Employee Tasks

Employees, Training, Working, Learning, Duties, Tasks

Question

We are collecting data on what tasks our employees in various departments do each day. We hope to eventually get a representation of what each employee does all year long.  Randomly, throughout the day, employees record the tasks they are doing.  We are not sure how to calculate an appropriate sample size and we are not sure how many data points to collect.

Answer

I wish there was a simple answer.  We need to consider:

  • If it makes a difference on how long an employee has been performing a job?
  • Are the departments are equivalent in terms of what they are doing?
  • What is the difference that you  want to detect?

The simple rule is that the smaller the difference, then the larger the sample size. By smaller, it is less than 1 standard deviation from the data that has been detected.

Random records are O.K., but really, shouldn’t you want a record for everyone for at least a week? That would give you an idea of what is done across the board and, then, if you are trying to readjust the workloads, you have some basis for it based on the logs.  My concern with the current method is that you may have a lot of extra paperwork to account for everyone for a certain time.

Additional information provided by the questioner:

The goal of this project is to establish a baseline of activities that occur in the department and to answer the question “What does the department do all day?”

The amount of time an employee has been performing a job does not make a difference. The tasks performed in each department are considered equivalent.  We are not accounting for the amount of time it takes to complete a task — we are more interested in how frequently that task is required/requested.

The results will be used to identify enhancement opportunities to our database and identifying improvements to the current (and more frequent) processes.  The team will use a system (form in Metastorm) to capture activities throughout the day.  Frequency is approximately 5 entries an hour at random times of the hour.

I have worked with the department’s manager to capture content for the following fields using the form:

  1. Department (network management or dealer relation)
  2. Task (tier 1)
  3. Why (tier 2 – dependent on selection of task)
  4. Lessee/client name
  5. Application
  6. Country
  7. Source of request (department)

We are looking for a reasonable approach to calculate the sample size required for a 90 – 95% confidence level.  The frequency of hourly entries and length of period to capture the data can be adjusted to accommodate the resulting sample size.

Answer

The additional information helps.  Since you have no previous data and you are getting 5 samples an hour from each employee, (assuming a 7 hour workday, taking out lunch and two breaks), that will give you approximately 35 samples a day. Assuming a five-day week, that gives you approximately 175 data points per employee.  This should give you enough information to get an estimate of what is done for a week.

Now, you will probably want to extend this out another three weeks so that you have an idea of what happens over a month.  If you can assume that the data collected is representative of all months, then you should be O.K.  If you feel that some months are different, then you may want to look at taking another sample during the months where you anticipate different volumes from the one you have. You can use the sample size calculation for discrete data using the information that you have already collected and not look at all employees, but target your average performers.

Jim Bossert
SVP Process Design Manger, Process Optimization
Bank of America
ASQ Fellow, CQE, CQA, CMQ/OE, CSSBB, CMBB
Fort Worth, TX

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

QMS Documentation Management

About ASQ's Ask the Standards Expert program and blog

Q: I was wondering if ASQ has any good information on managing QMS documentation.  My company is working right now on finding a solution for a better way to manage QMS documentation.  We have previewed some QMS document management software but think we can do all of the programming in house with Microsoft SharePoint. If you have any suggestions I would love to hear them.

A: Thank you for contacting ASQ.  According to The Quality Improvement Glossary by Donald L. Siebels, a quality management system is “a formalized system that documents the structure, responsibilities, and procedures required to achieve effective customer satisfaction levels”.

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