QUESTIONS & ANSWERS Quality Digest Hosted IATF 16949:2016 Transition Experiences Webinar 3.21.17
Q:
IS THERE A TIME REQUIREMENT REQUIREMENT WHERE WHERE DOCUMENTATION REVIEW MUST BE
DONE PRIOR TO ACT ACTUAL UAL TRANSITION TRANSITION AUDIT AUDIT?
A: It needs to be done as soon as possible. The document review is to make sure that you are ready ready for the audit. If we do not get the documentation ahead of time and we go out to your site and realize that you’re not ready ready for the transition, this can have some unwanted consequences. First, we may not be able to proceed with the actual audit on a back to back situation. This This may push us out of your window of being able to perform the audit and then you must start over at that point. Our advice is, get the information to your CB as early as possible.
Q:
FOR THE TRANSITION TRANSITION AUDIT AUDIT, WILL IT BE ABLE TO BE PERFORMED BY THE
EXISTING AUDITO EXISTING AUDITOR R(S), OR WILL IT NEED TO BE PERFORMED BY NEW AUDITO AUDITOR R(S) FOR THE NEXT 3- YEAR CYCLE?
A: IATF is making an exception this go around for the transition; you are able to keep the same auditors for the next three years.
Q: WHA WHAT T ARE YOU
REFERRING TO WHEN YOU SAY “TRANSFER” IN THAT WE
CANNOT TRANSFER TRANSFER AND AND TRANSITION TRANSITION A AT T THE SAME TIME?
A: The rule states that you cannot do a Transfer and a Transition audit both at the same time. “Organizations “Organiza tions certified to ISO/TS 16949:2009 cannot transition to IATF 16949: • at a transfer audit to a new IATF-recognized certicatio certication n body, • at a special audit.” IATF - International Automotive Task Force, Force, TRANSITION STRATEGY STRATEGY ISO/TS 16949 › IATF 16949 — REVISION 2
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Q:
I DO NOT UNDERSTAND THE DIFFERENCE BETWEEN TRANSFER AND
TRANSITION ? WHAT IS THE DIFFERENCE ?
A: A transfer is transferring from one certification body to another. A transition is when you are going from one version of a standard to the next. In this case, you are transitioning from ISO/TS 16949 to IATF 16949.
Q:
GIVEN THE NUMBER OF AUDITORS IN THE REGISTRAR SYSTEM VS. THE
NUMBER OF COMPANIES THAT REQUIRE A TRANSITION AUDIT, WHAT ARE THE PENALTIES IF YOU’RE LEFT BEHIND, MEANING NOT ENOUGH AUDITORS AVAILABLE TO MEET DEMAND?
A: What the IATF has decreed is that all transition audits must be completed by September 15, 2018. What that means, if you don’t make it by that timeframe then you must start over with an initial audit. There is some talk about having a little more leeway, but at this time, they are holding a hardline on the September 15th date. It is a real dilemma in the industry, that is why DNV GL is bringing on some additional auditors and getting them qualified because we see that it will be an issue. IATF has lessened some of the requirements for qualifying auditors, but it is still a cumbersome method for auditor qualification.
Q: WHAT ARE
THE KEY DIFFERENCES BETWEEN THE IATF16949
/ TS 16949 STANDARD? VERSUS THE OLD ISO
A: It is basically what was in the Webinar presentation. Please check out the slides as there are quite a few changes in everything from software to risk management. In the past, it was always about customer requirements and satisfying the customer. Now they have thrown in the interested parties so there is recognition that it goes beyond just what the customer requires. That is a significant change. IATF has addressed this even more with some of the sustainability requirements. So, you’re looking at more of the total company not just what they output to the customer.
Q:
MANAGEMENT OF CHANGE --- DOES APQP COVER THIS REQUIREMENT?
A: It depends on how far you’ve taken it, but probably not. Most of the time it is just product related documentation. However, it is much more than just the product that must follow the management of change.
DNV GL Business Assurance USA, Inc.
1400 Ravello Drive Katy, Texas
1 (877) 368-3530
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Q:
TAKING INTO ACCOUNT WHAT WAS PRESENTED, MOST OF THE GOOD
COMPANIES THAT I KNOW FOLLOW THE METHODS / SLIDES PRESENTED IF THEY ARE IMPLEMENTING ISO 9001:2015. WHAT IS AFTER ALL THE KEY DIFFERENCE ISO 9001:2015 VERSUS IATF 16949?
A: IATF does not contain the ISO 9001:2015 text like some other industry standards. IATF 16949:2016 only contains the automotive specific additional requirements; however, the organization is still required to comply with ISO 9001:2015. See the Webinar slides for more details regarding the changes.
Q: WHAT WOULD BE A ASSESSMENT?
RECOMMENDED RISK METHODOLOGY FOR SUPPLIER
A: A couple different methods could be used. One method would be to do it in an excel spreadsheet, but what makes it a little more complex is you want to incorporate those additional suggested items in that section of the standard to evaluate risk. An example of one that I recommend is a two tier of purchase. Take your purchase categories and evaluate risk. Focus in on the higher risk categories and then go to specific vendors on risk.
Q:
IS IT SUGGESTED THAT WE UTILIZE TURTLE MAPS SHOWING OUR INPUTS AND
OUTPUTS OF OUR PROCESSES?
A: It is one of the preferred methods we like to see when we’re auditing, however it is up to you how you would like to approach it. Wendy - Visually it is nice to see but it is difcult for companies to maintain. There is another way to depict the inputs, outputs, controls and so on. You can do it in what I call a “at turtle” which is just a matrix in a table where you would have all the categories. If you already have turtles and you like to use that format, then by all means continue. But if you don’t have turtles or you don’t like that format, you can go to a little different format, but you need to address your inputs and outputs and processes, your methodologies and controls as this is very helpful for every organization to identify for each process.
Q:
CAN YOU PLEASE POINT TO SOME USEFUL RESOURCES FOR UNDERSTAND-
ING THE EMBEDDED SOFTWARE ADDITIONS?
A: The standard now requires that a “software development assessment methodology” be used . Some resources: http://resources.sei.cmu.edu/asset_files/TechnicalReport/1988_005_001_15638.pdf
DNV GL Business Assurance USA, Inc.
1400 Ravello Drive Katy, Texas
1 (877) 368-3530
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Q: WHAT
IS NTF - NO TROUBLE FOUND, WHICH IS NEW IN THIS STANDARD.
HOW DO WE ADDRESS IT?
A: You’re talking about Warranty Management. “When an organization is required to provide warranty for their product(s), the warranty management process must address and integrate all applicable customer-specic requirements and warranty party analysis procedures to validate No Trouble Found (NTF). Decisions should be agreed upon by the customer, when applicable.” Plexus/AIAG TRANSITIONING from ISO/TS 16949:2009 to IATF 16949:2016 PPT
Q: THIS
DOES NOT RELATE TO THE CONTENT PRESENTED, HOWEVER, COULD
YOU ELABORATE ON WHETHER TOTAL PRODUCTIVE MAINTENANCE WOULD APPLY TO INTERNAL LABORATORY EQUIPMENT?
A: It depends upon the type of equipment it is. Is it something that is used daily or is it something that is used occasionally that you do maintenance on as needed. Or is it a critical piece of equipment and then do you need to make sure that it is available everyday so you have to do total productive maintenance on it.
Q: WILL ALL
OUR SUPPLIERS BE REQUIRED TO BE IATF 16949?
A: This is different from the previous standard that just made reference to ISO/TS 16949 as a basis that suppliers had to comply with, being ISO 9001 as a minimum. It was always implied but now IATF 16949 has strengthened this. All the tier 1’s have been required for some period now. I believe that there is an impetus now to push this down further to the tier 2’s and tier 3’s and it just depends on how it will be interpreted. I believe that the idea is to have everybody in the supply chain IATF 16949 certified. We still don’t know how quickly the flow down will be.
Q:
CAN YOU EMAIL A COPY OF THE “FLAT TURTLE” TO US?
I’M NOT SURE I
FOLLOW HER COMPLETELY.
A: Contact Wendy at 847-542-2128 or go to her website www.isoparr.com where she has posted an example you can download.
DNV GL Business Assurance USA, Inc.
1400 Ravello Drive Katy, Texas
1 (877) 368-3530
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Q: WHAT ARE THE CRITICAL ITEMS TO INCLUDE AUDIT? ARE THEY IN THE PRESENTATION?
IN THE DOCUMENTATION
A: Per the IATF Transition Policy: The off-site documentation review shall include, as a minimum, a review of the client’s quality management system documentation (i.e. quality manual and procedures), including the evidences about conformity to IATF 16949 requirements.
Q:
HOW USEFUL IS AN INTEGRATED PLATFORM FOR MANAGING ALL TS2
DOCUMENTATION? DO YOU SEE A TREND TOWARD MANAGING EVERYTHING IN SUCH A SYSTEM AS OPPOSED TO A FRAGMENTED SILOED APPROACHED USING MICROSOFT EXCEL?
A: Obviously, the larger companies have the resources for sophisticated document control systems, SharePoint sites even. Your smaller organizations don’t have those resources so they do it the old-fashioned way. I don’t believe that there is any requirement, one way or another, in the standard that address that issue. It is up to how the company prefers to manage their documentation. 99% of the companies that we audit are using the oldfashioned way. Each document is isolated; it’s updated and then you must figure out where that change impacts other documents, Then you have to train everyone to these changes.
Q:
PLEASE DEFINE RSL, WHAT KINDS OF EXTRA EFFORT RESULT FROM
HAVING RSLS, AND WHAT IS NEEDED TO BE ABLE TO DEFINE A POTENTIAL RSL AS SOMETHING THAT ISN’T AS BURDENSOME?
A: The remote support location (RSL) is any offsite location that offers any support to the manufacturing location. This could include everything from a corporate headquarters that provides HR support, the sales office, warehouse, to even design centers that support the site. All these are different support locations and the way IATF looks at it, all these together make up the organization; the entire organization must be certified not just the manufacturing location. When IATF looks at you, they look at you completely, whether you’re the manufacturing location or an off-site location. It is somewhat burdensome for larger organizations because things change all the time but it is part of the rules, and that is the way IATF has defined it.
DNV GL Business Assurance USA, Inc.
1400 Ravello Drive Katy, Texas
1 (877) 368-3530
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Q: WHAT WAYS ARE
THERE TO PROVE 2ND PARTY AUDITOR COMPETENCY ? DO
WE NEED TO GET CERTIFIED TRAINING FOR 2ND PARTY AUDITOR’S FOR THEM TO AUDIT SUPPLIERS ?
A: There is no definition for that. It is what the organization has defined. You must define that for yourselves. You need to make sure that the auditors are competent and that the system is effective, the organization can define that from their experiences. What we will be looking to see from the CB’s standpoint: is the system effective, including the competency of the auditor.
Q:
IF YOUR TS CERTIFICATE EXPIRES IN JANUARY 2018, DO YOU HAVE TO BE
FULLY CERTIFIED TO THE IATF BEFORE THE EXPIRATION DATE?
A: The timing of the recertification audit must be done prior to your last recertification audit, whenever that needs to be. If your certificate expires in January, your audit will possibly occur a few months before then and that audit must be to the new standard. Of course, you must address all the non-conformances. The timing remains the same, in that the certification decision, where all the NCs have been closed out and the person that does the tech nical review issues the brand-new certicate, must be done prior to when your certicate expires. All the rules that existed prior are still in existence and you must compile to them in the new standard. “Organizations certified to ISO/TS 16949:2009 shall transition to the new IATF 16949, through a transition audit in line with the current audit cycle for ISO/TS 16949:2009 (i.e. at a regularly scheduled recertification audit or surveil lance audit), according to the allowable timing requirements dened in the IATF Rules, section 5.1.1.” IATF - International Automotive Task Force, TRANSITION STRATEGY ISO/TS 16949 › IATF 16949 — REVISION 2
Q: ANY
SPECIFIC TIME FRAME IDENTIFIED FOR RELEASE OF REVISION OF FMEA
MANUAL? HEARD IT WAS THIS YEAR SOMETIME...
A: We have heard the same thing, and when it gets issued there will be a big publication from AIAG; but all we know is that it will be issued later this year, and we don’t have a definitive time frame.
DNV GL Business Assurance USA, Inc.
1400 Ravello Drive Katy, Texas
1 (877) 368-3530
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Q:
ISMAEL MENTIONED DOC REVIEW ON REMOTES –
“CORP.
OFFICE IS
REMOTE FOR SEVERAL PLANTS AND DIFFERING REGISTRARS” WE FIND IATF ‘DEFINITIONS’ OF THESE
- WHERE FUNCTIONS E.G. “SALES”?
CAN
A: In the IATF Rules 5. It defines what is a remote support location. It is “any support given to a manufacturing location”.
Q:
IS UPPER MANAGEMENT HELD TO MORE ACCOUNTABILITY IN IATF VERSUS
/ TS MANAGEMENT TS REP BEING THE GO TO PERSON THE OLD ISO DURING AN AUDIT?
IATF 16949 follows the ISO 9001:2015 standard in that regard. Top management is now responsible for the management system.
Q: WHAT
IS CSR?
Customer Specific Requirement.
Q:
IS THERE ANY BENEFIT TO MAINTAINING A CORPORATE QMS IN LIGHT OF THE
NEW REQUIREMENTS ? FOR EXAMPLE, MATRICES OF CSR’S - NOT ALL CSR’S APPLY TO ALL OUR MANUFACTURING LOCATION. SAME WITH INTERESTED PARTIES. IS IT BETTER TO CHANGE TO SINGLE SITE?
It is up to each organization to determine the best approach for its structure. You need to determine if a Corporate QMS or individual manufacturing site QMS is more effective or efficient.
DNV GL Business Assurance USA, Inc.
1400 Ravello Drive Katy, Texas
1 (877) 368-3530
dnvglcert.com
