Quality Management Systems Internal Auditing 
A monthly newsletter from Internal-Auditor.com
[www.internal-auditor.com]

Brought to you by Ruth Ellen Carey Communications...of course! 

March 2004


Advertisement:  


www.nsf-isr.org


This Month's Newsletter Contents:

Feature Article.................................................................
Featured Book.................................................................
Question and Answers....................................................
Notes from the Field.......................................................
Monthly Scenario Explained.......................................
Element Understanding.................................................
The Back Page.................................................................
The Small Print................................................................
Auditing Core Tools
SPC Simplified
Ford Requirements
ISO 9001:2000 'auditing kit'
May 2003
Ford Internal Auditing CSR
How Much Training
Copyright notice

Featured Book of the Month:

Title: SPC Simplified: Practical Steps to Quality

Author: Amsden, Butler and Amsden

Publisher: Productivity Inc

Notes: Teaches statistical process control to everyone who needs to understand how to perform SPC. Revised to reflect the changing role of operators & line workers. Paper. DLC: Quality control Statistical methods.


 


 

You can order this book from internal-auditor.com at: http://www.internal-auditor.com/books.htm


top of page


This Month's Feature Article

Auditing Core Tools

Ford created quite a stir when they placed a requirement for internal auditor to be trained on "core tools" in their ISO/TS 16949 Customer Specific Requirements. How dare they tell us something that we should have been doing all along. It is quite difficult for me, as an internal auditor to audit something I know nothing about. If neither the question, nor the answer makes sense to me, how can I drive improvement, let alone judge conformance? This is the point I think Ford was getting at, and I think it deserves some discussion.

The first thing we must do is to ask; What are "core tools"? 

Automotive Core Tools

There are five "tools" identified by the automotive industry (at least US manufacturers).  These tools are used during the product realization process to help ensure the customer receives a consistent, quality product on time, all of the time. We will look at each of them briefly, and explore some of the items that an auditor might look for during an audit. Bear in mind, that this newsletter will not give you enough information to perform a proper audit. For that you will need to have a much greater understanding of the tools than can be presented in the brief time we have together.  

APQP

APQP stands for Advanced Product Quality Planning. This planning is conducted prior to production (hence, Advanced), although the final phase is used throughout the process to include manufacture. Each phase has distinct inputs and outputs. Each phase needs to involve various people from various departments to ensure coordination and communication between functions and departments. The APQP process normally will include most of, if not all of the other core tools.

The first phase is planning and defining the program. The second phase is product design and development, followed by process design and development. Phase four is validating the product and the process. Phase five is feedback assessment and corrective action. 

What to look for: 

Here is a sample of the things that an internal auditor must find out about the APQP process. 

  • Are the inputs and outputs of each phase documented?

  • Are the inputs and outputs understood?

  • Is there a hand-off between phases?

  • Is this hand-off formal?

  • How are the outputs of one phase integrated into the subsequent phase?

  • What are the roles and responsibilities of each phase?

  • What records are generated by each phase?

PPAP

Before making production parts, a supplier to the automotive industry must first prove they can make quality  parts in quantity. The way they prove they can do this is through the Production Part Approval Process, or PPAP. This is part of the APQP process, and validates the ability of the organization to meet the production requirements for that particular product. There  specific requirements for PPAP, including specific forms to be used. 

The final result is called a PPAP Part Submission Warrant (PSW). It has different levels of submission, depending on circumstances (typically dictated by the customer). Each submission level also  determines what documents, and or samples must be submitted to the customer.

Here is a sample of the things that an internal auditor must find out about PPAP. 

  • Are there PPAP files?

  • Are responsibilities identified?

  • Who signs the PSW?

  • How does the organization know what level to submit?

  • How does the organization know which forms to include?

FMEA

The Failure Mode Effects Analysis (FMEA) is not unique to the automotive industry. It is used in many different industries, and there are different types of FMEAs. FMEAs are a powerful tool in identifying and preventing failures in product, process or the system. It uses a formula which provides what is called a Risk Priority Number, or RPN. Then it prompts the organization to take actions to lower that number. 

Here is a sample of the things that an internal auditor must find out about FMEA. 

  • Are FMEAs being performed?

  • How are the numbers obtained?

  • Is there reaction to the the RPNs?

  • Are responsibilities for the actions identified?

  • What follow-up is done to ensure the actions were completed?

  • Are FMEAs updated as changes are made?

SPC

The worst word in manufacturing is variation. By theory, once we make one good part, all of the rest should be equally good. However, as we manufacture certain factors alter the output. These factors are called variation and come from a variety of sources. Tracking the variation can assist us in maintaining control over our processes. We use statistics to track the variation, hence the term Statistical Process Control, or SPC. SPC typically includes charting sampling, and looking for patterns and other items that indicate either a loss of control, or non-random variation within a process.

Here is a sample of the things that an internal auditor must find out about SPC. 

  • Is the organization keeping SPC charts?

  • Who is responsible for compiling SPC data?

  • What is done with the SPC charts?

  • Who analyzes the SPC data?

  • Can the data on the charts be trusted?

MSA

An important part of our operations is making sure our process outputs meet requirements. This usually requires some form of measurement. That means we use some form of measuring device. To ensure accuracy, each measuring device must be accurate, and the entire measuring system must be capable of achieving desired results. Typically we conduct a Measurement System Analysis (MSA) to ensure our measuring system can do what we need it to do. MSA might include a variety of different tests and analysis to determine our ability to meet our measuring needs.

Here is a sample of the things that an internal auditor must find out about MSA. 

  • Does the organization perform MSA?

  • Who is responsible for determining which assessment (test procedure) will be used?

  • Who participates in the measurement system study?

  • What records are kept?

Summary: 

As internal auditors, we need to be able to understand any tools we audit. This applies to far more than just the core automotive tools listed above. In order to have efficient, effective, credible, and useful audits, we need to have an understanding of what the tool is, when it is used, how it is used, and what evidence would show it is being properly and effectively applied. It is our responsibility to ensure we have the knowledge and skills (read competence) to audit tools of our industry. 

As always...Good Auditing!

top of page

 
Advertisement:


www.mmtc.org 


Question and Answers:

Q – If I provide my internal auditors the required training on core tools, will that satisfy the Ford requirements ?

A – Although Ford is the first to require core tools training for internal auditors, there is much more to the Ford CSR than core tools. Just taking current internal auditors and teaching them the core tools would probably not be enough, based on their experience and other training. What you need to do, is to review the requirements from all of your customers, and compare those with the qualifications and competencies of your auditors. A matrix showing the requirements and auditors might help in accomplishing this, although a matrix is clearly not required.  

top of page


ISO offers free-of-charge ISO 9001:2000 'auditing kit'

Twenty guidance modules on specific aspects of auditing ISO 9001:2000 quality management systems (QMS) are available free of charge from ISO and another three are being developed.

Short, easy to read and understand, the guidance modules that make up the "auditing kit" adopt a practical, "how to" approach. They have been developed mainly for certification body personnel carrying out audits of quality systems for organizations seeking an ISO 9001:2000 certificate as independent confirmation of their implementation of ISO's well-known standard.

To download your copy go to: http://www.iso.org/iso/en/commcentre/pressreleases/2004/Ref905.html 

top of page


Element Understanding:

ISO/TS 16949 Ford Customer Specific Requirement

"Internal Auditor Qualifications Internal QMS auditors shall be qualified per 4.39.1 or 4.39.2 below.

4.39.1 Be trained and evaluated in the following areas;

  • The Technical Specification ISO/TS 16949:2002
  • Related core tools (e.g. APQP, SPC, MSA, FMEA, PPAP)
  • Applicable customer-specific requirements, and
  • The automotive process approach to auditing.

4.39.2 And as part of the training, participates in practice sessions equivalent to one audit day in:

  • Case study audits and/or
  • Auditing role plays/simulations, and/or
  • On-site audits.

Core Tools and customer specifics must be taught by company or industry recognized experts/specialists."

The Ford CSR for internal  auditor qualification is the most stringent of all of the Big 3. However, most of the things listed do make sense for internal auditors. One of the important points of this requirement is the core tools training. The reason for this is that, in Fords opinion, too many internal auditors know little or nothing about core tools, and therefore do not audit them properly (an opinion I share). If audits are to be meaningful, the auditor must be able to understand the audit criteria., maybe not be an expert, but have an understanding. Ford wants the auditor to have a certain level of "working knowledge" of the core tools, sufficient to ensure the auditors can spot nonconformances, and provide suggestions on making the core tool more effective. 

top of page

 
Monthly Scenario Explained:

May 2003’s question:

You are auditing the purchasing process. There is a documented procedure, an associated work instruction and a supplier survey form outlining the method used for evaluating suppliers. The work instruction details the process used to fill in the form. The form contains several questions relating to the supplier's QMS. It also contains a place to fill in key measurables of supplier performance such as; on-time delivery, quality measures and price. The procedure states that this information is used to determine if the supplier remains on the Approved Supplier List. While examining the supplier records, you notice that in many cases, not every field on the form in filled in. When asked about this, the Purchasing Manager states that for the most part suppliers maintain 100 % on-time delivery and zero defects. Only when this is not the case, will the information be entered. It is much easier to track the exceptions, rather than the rule.

The answer:

There are two separate issues here. The first, and simplest is whether all fields are required to be filled in. If so, then that needs to be addressed. If there is no requirement, then how does the Purchasing Manager know that a blank means that they have met the requirement, or if that particular field was overlooked? Part of this answer might be related to who is filling out the form. Listing only exceptions would make them stand out more clearly, however, we want to ensure that all information which needs to be recorded is, in fact, recorded. Leaving the field blank might not be a nonconformance, but the auditor might suggest instead of leaving a field blank, a particular mark be applied to show that the requirement has been met.

 top of page


The Back Page:  

How Much Training?

This issue was designed to give some basic information on auditing the "core tools" used in an effective ISO/TS 16949 Quality Management System. Ford requires training on the core tools, and internal auditors do need to have some knowledge of the core tools.  But the question is;  How much training is required? Or better still; What level of competence is necessary?

I mentioned in January's issue that I was required to attend training because I could not prove I was "trained" in core tools. Unfortunately, the class I attended spent only about 15 minutes on all of the core tools, combined! The reasoning is that spending even a day on each tool would not provide the auditor with sufficient knowledge to conduct a useful and credible audit. But because of Ford's requirement, they had to mention the tools. 

In order for me to successfully audit the core tools, I really need to have a working knowledge of those tools. I do not need to be experts on them, but know enough to be able to question the results and the methodology. I need to know enough so that the auditees cannot fool, or mislead me. The amount of training, and competence will vary from individual to individual, but it should be treated like any other skill. The training must be real, and the experience must be useful.

Dave

...Good auditing!

top of page


Copyright notice: internal-auditor.com is fully protected under US and International copyright laws. Copying, or re-transmitting all, or any part of internal-auditor.com is expressly forbidden without prior written consent from Ruth Ellen Carey Communications.
internal-auditor.com is a publication of Ruth Ellen Carey Communications

 

Comments suggestions, complements and complaints should be directed to:
David Bradley, Industrial Communicator
Ruth Ellen Carey Communications
3698 Heathwood, E.
White Lake, MI 48383 USA

brad at rec-communications.com