Expert ISO Assistance

Rob Kantner answers your questions:

Predictive maintenance? (1/04/09)

In the ISO/TS is recommended use of PREDICTIVE maintenance. What to do to introduce this system.

"Predictive maintenance" requires that you track the incidence of breakdown of essential parts, systems, components, etc., and use that information to develop maintenance methods timed to prevent that breakdown.

You don't do it for everything. Just for the essential things -- i.e. systems that, if they fail, can adversely affect the customer, the product for the customer, your ability to deliver on time to the customer, etc.

Example. I have a client who is a smelter. Their furnaces use pyrometers to manage / monitor the heat. The client determined over time that their pyrometers tend to fail after a year. When a pyrometer fails, it causes their production process to go longer than necessary, disrupting schedules etc. So they now routinely replace pyrometers at one year. This is a form of "predictive" maintenance - evidence-driven and applied only to something that is really important.

Does GM require sub-supplier ISO? (6/6/06)

Does GM require their suppliers to have sub-suppliers ISO approved? What is the ISO TS16949 rule? -- J. Jaquish

Check the FAQ published by International Automotive Oversight Board (IAOB). This explains the details better than I could. Briefly, suppliers in the 16949 food chain are expected to do "supplier development" with their suppliers, with the goal of eventually bringing them into the 16949 fold where appropriate. 16949 is not appropriate for all, so ISO 9001:2000 is an acceptable substitute.

How to write ISO/TS 16949 procedures? (5/16/06)

What books do you recommend for the novice in writing procedures pertaining to TS16949? I am in the process of converting our system from IS)9001-200 to TS16949 and am working hard to understand exactly what is needed in addition to the current ISO Standard.

You can use the same procedures you have for ISO 9001:2000, updating them to be sure that the ISO/TS requirements are addressed. You should also map out your processes using the automotive "turtle" diagram. This is not difficult to do. If you need an example, let me know.

can we get away without records? (1/2/06)

We are a QS9000 facility with plans to transition to TS 16949 soon. I have implemented TPM in a few areas with forms as the control. This also creates a record for QS. I recently thought of a new approach using a scheduling board and cards. I think that it would work well and be a visual management aid. The problem will be with the record side. None would be created. Do you think an auditor would have a problem with this approach even if it is more efficient and easy to use? -- P.B.

Under ISO/TS, just as with QS, specific records must be available and preserved in the areas specifically cited. Besides that, there must be sufficient records for audit evidentiary purposes. On that basis I believe an auditor would have serious problems with a system that generated no records for audit.

After QS: ISO/TS or ISO 9001:2000? (10/3/05)

We're a QS9000 certified company that does tin plating, next year our certificate expires. We can certify to either ISO 9001:2000 or TS16949. What would you recommend we certify to given that our company employs only 20 people and about 40-60% our plating ends up in automotive parts? Larry Cichelli

Interesting question. If you are supplying plating on parts that end up on cars, then you fall within the scope of ISO/TS 16949. The question is: Do your customers require you to certify to ISO/TS 16949? That's where the answer to your question lies. If they do not require it, then I would absolutely recommend going with ISO 9001:2000. Much simpler, less overhead.

Preventive maintenance (9/29/05)

hi. please give me some examples (or simple comments) of preventive maintenance in iso ts/16949. thanks advance

Preventive maintenance is simply a matter of checking a piece of equipment, per a set schedule, for a prescribed list of key issues, such as fluid levels, settings / adjustments, worn parts, etc. This is prescribed and documented on a checklist usually. That's the bare bones essence of it. There's also predictive maintenance, but that's a topic for another time.

Accreditation of calibration? (7/1/05)

If a company has a ISO/TS 16949 qualification, is it really needed that all instruments which can't be calibrate by themselves, always must be carried out with a EA certificate (RvA, UKAS, DKD, BKO Etc..) or is it enough that the third party has a accreditation by EN 17025. How strict are the regulations for the right scope of calibration (for example: accreditation covers pressure till 10 bar, calibration must be carried out till 20 bar) Are there any exceptions?

The issue of accreditation of calibration services tends to be customer-driven. Thus far in the ISO/TS environment we operate in, certification to 17025 has been sufficient.

As to the degree of rigor, this also tends to be customer-driven. Exceptions have been made on a case by case basis but it's awfully hard to get a customer to agree to them.

Process to motivate employees? (6/9/05)

Section states that we shall have a process to motivate employees to achieve quality objectives... Any ideas on how to motivate without using such things as paid incentives or an employee suggestion program. By the way-LOVE your website

One motivational method is to involve employees in the setting of performance objectives and evaluating results. Many of our clients have regular information meetings with employees to review the results of performance metrics and get suggestions. They also have team based incentives that don't necessarily involve money (i.e. comp time, etc.) Including training updates in these meetings can also add an incentive effect. (And thank you for the nice compliment on our web site!)

Does ISO/TS 16949 require preventive maintenance? (11/17/04)

Is preventative maintenance subject to ISO/TS where paperwork is concerned and would the paperwork require a control number?

Preventive maintenance is absolutely required by ISO/TS 16949. Forms used in preventive maintenance should be controlled either by number or by date.

What If Our ISO/TS 16949 Customer Does Not Require Special Characteristics Symbols?

With regard to special characteristics symbols, how should the ISO/Ts 16949 language be interpreted as the standard is applied further down the supply chain (Tier 2 and Tier 3 suppliers)? For example, the Big 3 require the usage of special symbols to denote various critical product characteristics in various documents. We are a Tier 3 supplier and our customers do not require anything like this and it is not anticipated that they will at any time in the future. How should we address this to an external auditor? What about other issues, such as PPAP compliance (the use of specific forms), and APQP (use of FMEA's and Ppk information)?

There are 2 steps to this. First, in your quality manual (which is policies only), you simply say that you use the special symbols as required by your customers. In the documents further down the chain (procedures, etc.), you say the same thing. When an auditor asks you to show an example, you simply tell him/her that your customers do not use such symbols and that, if they ever do, you are prepared to follow suit. Clearly, however, the special characteristics that YOU identify as part of the APQP process need to be identified as required by your customer.

On PPAP, even though you are not required to do it, you will need to write a brief procedure as to HOW you would do it if you were ever required to. I know this sounds ridiculous, but it's what is expected (I ran into this myself with a client in a similar situation as to yourself). APQP you will need to address, along with FMEAs and Ppks and so forth. The APQP process is generic enough that most companies can adopt it, and your registrar would expect to see the process in place.

ISO 9001, Then QS or 16949?

Hi. Does a firm have to get ISO 9000 sertificate before taking QS 9000 or ISO/TS 16949? Thanks for your help.

You can, if you wish, register to ISO 9001 (2000) and then "add on" ISO/TS 16949 as a second step. (You certainly do not want to bother with QS-9000 at this juncture, as it is being phased out.) ISO/TS 16949 includes all the ISO 9001 (2000) requirements in it. So you can take that two-step approach if you want, and it's not a bad idea to do so (if you're compelled to go ISO/TS 16949 in the first place, which is a whole other issue). Or you can implement a ISO/TS 16949 compliant system and get registered.

Have Your Credit Card Ready

where can I actually get a copy of ISO/TS 16949?

Call Automotive Industry Action Group 248-358-3003.

Keeping It Quiet

I understand that ISO/TS 16949 standards require or advise auto industry vendors and suppliers to work in a very close and cooperative manner. This may include the exchange of confidential processes or information. Does ISO/TS 16949 have any requirements or standards that speak to the duty of the other party to keep such secret information/processes confidential?

Yes, ISO/TS 16949 has a specific requirement pertaining to confidentiality. See 7.1.3.

How Long For Transition?

We are a rather small company (45 people) and we want to upgrade our quality system from ISO9001 (since december 1993) to ISO/TS 16949. What are the average mandays for this kind of upgrade?

Hard to say with any specificity because, like everything else, it depends on what you have now. We've done quite a few quality system upgrades / transitions of this type (and have implemented ISO/TS 16949, and its predecessor QS-9000, in several dozen organizations). The amount of work is not insignificant. Fortunately it's all add-on. You'll need to amend your existing Level 2 documents (and systems) to comply with the additional requirements (easy to identify in the ISO/TS 16949 Standard itself). You'll need to add perhaps a half dozen Level 2 procedures / systems to document processes not required by ISO 9001. If you don't have Level 3s covering all production related tasks, you'll need to develop those. You'll need to implement the revisions among the people whom they affect (which, in a business your size, is just about everyone).

So someone needs to edit just about all the documents you have (Level 1, 2, and 3); add some additional Level 2 and 3; train the affected parties, and add the additions to the internal audit schedule. In terms of "man days" for you -- if I were doing it personally, the document updating / editing part would probably take 6-10 man days (depending on the amount of process redefinition that would need doing); training probably 3-5 man-days (not including time spent by trainees); auditing an additional 5-12 man days depending on size of your audit team(s), etc.

Please regard these as experienced guesses.

How On Time is "On Time"?

What does "100% on time" mean in QS-9000 Can we define on time as a window of time (eg. 7 days), or does each order to a sub-contractor have to have a single delivery date?

"On time" means by the time specified by the customer. If the customer says March 25, then it's March 25. If the customer says March 25 plus or minus 7 days, then that's what "on time" means. This should be established at the contract review stage -- in fact, contract review is not complete without it. NOTE: ISO/TS 16949 does not have this requirement.

From ISO 9001 to ISO/TS 16949

Dear Rob,pardon my internet ignorance as this is my 2nd week on the net! I am in the 3rd(and final) year of the IQA (Institute of Quality Assurance UK) exams.My subject is the introduction of ISO/TS 16949 into LANGTEC LTD.UK.We are ISO 9001 Reg. Q? What are the logical first steps? Regards Ken.

I take it you are planning to migrate your quality system from ISO 9001 to ISO/TS 16949? You're already 2/3 of the way there, because 16949 includes ISO 9001. The place to start is to get hold of the requirements and analyze the "additional" requirements that have to be met (it's very easy to see; they are called out separately in the 16949 document).

Must We Have a Business Plan as Part of Our QS-9000 / ISO/TS 16949 System?

How important is having a Business Plan in place from the QS-9000 perspective? We have a team working on the QS-9000 implementation and the team is completely divided on this issue. Can we put it out to the end? Will it be ever looked at by the Registrars?

Actually, ISO/TS 16949, which is replacing QS-9000, has no specific requirement for a business plan. (The Standard refers to a business plan in two places and seems to presume that one exists, but nowhere does the Standard specifically require one.)

From a QS-9000 perspective, though, the business plan must exist and must be an active, living document. It must be covered by document control procedures and there must be a defined process for creating it, reviewing it, updating it, and using it. All of these matters are subject to audit and will most certainly be audited. However, the plan itself is not subject to third party audit. Most assessors merely want to assure themselves that it exists and will not tend to go to the trouble of actually reading it. Merely viewing it seems to be enough.

However, you must do all the rest of the things mentioned here, and I would not put it off to the very end.

Do Tier 2 Firms Have to be Registered to ISO/TS 16949?

Do 2nd tier suppliers have to be certified by a third party registrar by the end of the year? I work for (major manufacturer). Our customer told us that we have to be 3rd party certified by the end of the year. I was under the impression that we only have to show compliance.

This sort of thing is customer driven. If your customer wants third party certification and is adamant about it, that's pretty much the end of the discussion. You're not alone.

Does PPAP, etc., Apply to All Customers?

We are an ISO 9001 certified company that is considering the implementation of ISO/TS 16949 because of pressure from some of our automotive customers. These automotive customers make up a small percent of our total customer base. My question is, In order to be registered to ISO/TS 16949 do we need to apply such requirements as PPAP, control plans, MSA, etc. to all customers or would it be O.K. to apply them to only requesting customers?

PPAP is at the discretion of the customer. You would have to have a process for doing PPAP, but would only actually do them for customers requiring it. The other subsystems you mention would have to be implemented across your processes regardless because they address the scope of your process and are not customer specific.

I know this isn't the answer you want to hear, but I hope it helps.

Customer Satisfaction

Hi Rob: I am working on the Customer Satisfaction procedure - Is customer satisfaction the inverse of customer dissatisfaction - or a separate measure?

The standard states that we must assure objectivity and validitiy in our assessment. Do you have any suggestions as to how this can be accomplished - or references to customer satisfaction models we could use.

The inverse of customer dissatisfaction can be construed as customer satisfaction, but that is not the sense of the Standard. Most organizations establish more direct ways of gathering customer satisfaction indicators. In large part this involves trapping and reporting information that most employees are not accustomed to trapping and reporting. These could include:

  • Customer "positive mentions" (times a customer praises your organization's work, without being asked)
  • Customer referrals (every time a customer refers someone else to you, that's a sign of satisfaction)
  • Customer repeat purchases (another sign of satisfaction)d) Growth of total sales, revenues, profits (indicate more customers buying and/or customers buying more)
  • Growth of purchase frequency, or average purchase size

Gather this data, organize it, report it, and then trend it from period to period (say, quarterly). Be sure you keep evidence so that you can show the basis for the numbers. The toughest part is getting everyone involved -- everyone with customer contact responsibility -- to be aware of and to report this type of information.

Customer surveys are another method that just about everyone uses. Now you're not relying on spontaneous expressions of satisfaction, but instead more or less prompting them. Obvioiusly it's a 2-edged sword because you'll hear about dissatisfaction too -- but that's just as important. Many customers won't express dissatisfaction unless asked. But they still feel it and not only act on it (by going to competitors, etc.) but also communicate it to others, thereby hurting your most important and effectivemarketing initiative: word of mouth advertising. So you need to ask them and make it as easy as possible to respond. Unfortunately many firms don't do this because they dread the results.

None of these methods is wholly objective. But in this particular arena, true objectivity is virtually impossible. Customer satisfaction is not something tangible, that we can measure, like a part. It is nebulous. But since it's what we are all about, it's important information to help in planning and assessing how well we're doing. It's also the thing that most companies cut serious corners on because "we're too busy."