If your organization is certified to ISO 9001 or a standard that is aligned with it, like AS9100 or IATF 16949, and you perform audits internally, then you should know this:
This means that Certification Bodies are scrutinizing internal auditors and their competency, especially when it involves IATF. That’s why many companies are choosing to outsource their internal audits to a 2nd party like simpleQuE whose auditors are qualified, certified, competent and are experts on the standards and customer specific requirements. In addition, many are current or former 3rd party auditors and bring valuable insight because of that knowledge gained from auditing for certification bodies.
Here are more reasons to outsource internal audits from our very own team of auditors (who have seen it all):
Why audits should not be done internally:
- Without proper training and experience, internal auditors don’t fulfil the competency requirements
- Lack of time to perform the audits and write reports
- Reports with limited or no findings or objective evidence
- No demonstration of the process approach or risk based thinking
- Timeliness of management in responding to findings/report
- Internal turnover resulting in too much variation in reporting/focus and overall quality of audits
Advantages to outsourcing internal audits
- Fresh set of eyes from outside the organization that are objective and unbiased
- Reduces company’s investment in continual training on changing requirements
- Professional and timely reports
- More cost and time effective, freeing up internal resources
- Management gives greater attention to an outside expert, especially when there are sensitive issues that an inside auditor may be hesitant to address
- Better internal response and acceptance of findings and opportunities for improvement
- More content, findings, comments, opportunities for improvement and observations for added value
- Our auditors have:
- In depth knowledge of the standard’s requirements,
- Experience in the field and can share best practices,
- An understanding of the process approach and risk based thinking
- The ability to provide consulting while auditing
- Compliance to ISO 19011 on auditing management systems
All solid reasons for turning your audits over to the experts. Contact us at 740-305-0868 or [email protected] for more information.
The International Automotive Task Force just released Revision 5 of the IATF 16949 Transition Strategy and Requirements. This revision of the Transition Strategy document incorporates a new FAQ no. 20 that clarifies questions for those situations where a previously certified IATF 16949 organization has to start over with an initial certification audit to IATF 16949.
Download the IATF 16949 Transition Strategy and Requirements document
For the last 12 years simpleQuE has attended the Toyota Opportunity Exchange (TOE) to network with Tier I suppliers like Dana Incorporated. Dana has 100+ facilities and 29,000 employees in 34 countries making it one of the world’s most influential automotive suppliers. Through the TOE, a relationship was developed with Dana and in 2013 simpleQuE won the opportunity to perform IATF 16949:2009 internal audits for the Dana site in Auburn Hills, MI. That opportunity has expanded to now include internal audits and/or IATF 16949:2016 transition consulting at five more Dana facilities in PA, IN, TN and KY. SimpleQuE consultants worked with the dedicated Quality team at Dana – Gordonsville, TN which recently successfully transitioned to IATF 16949. The first of our clients to do so!
Providing a forum for suppliers and minority business enterprises to connect is just one of the many ways that Toyota ensures its supplier base continues to reflect the diversity of its customers, partners and team members.
The automotive quality standard has come a long way since its first inception in 1994. With the new standard and more than 200 changes, simpleQuE recognized the need for an IATF Gap Audit Checklist to assist companies with the transition. The checklist includes the new automotive requirements (IATF 16949:2016 and ISO 9001:2015) and is intended to be used as a tool to identify both compliance with the new requirements and the differences between IATF 16949:2009 and the new requirements.
The utilization of this checklist, when populated with objective evidence of compliance and non-compliance, will satisfactorily demonstrate you have audited the differences between IATF 16949 standard and the new requirements. It should be used with your certification body as evidence of internal audits to the new IATF 16949 and ISO 9001:2015 requirements. It’s one of the methods simpleQuE auditors and consultants use with our own clients.
A free half hour of phone or email consulting with a simpleQuE expert is included with the checklist for the purchase price of $300.
The simpleQuE team wishes you a smooth and simple transition!
Did you know that the average STEM wage is $38k higher than the national average of all wages? This is one of the many reasons that STEM is here, and it’s here to stay. Take a look at our infographic below to learn more.
IATF 16949 is being adopted across the world and setting in place the quality management requirements for the design, development, production, installation, and service of automotive-related products. Take a look below at the world leaders in ISO/IATF16949 certification.
In October 2016 IATF 16949:2016 will be published by IATF and it will replace the current IATF 16949, defining the requirements of a quality management system for organizations in the automotive industry. It will be aligned with ISO 9001:2015 and its structure and requirements. IATF 16949:2016 will be implemented as a supplement to, and in conjunction with, ISO 9001:2015. www.iatfglobaloversight.org
IATF has also released a new transition strategy document for automotive suppliers and certification bodies to help with the transition. It includes information about timing and transition audit requirements. After October 1, 2017 no audits (initial, surveillance, recertification or transfer) will be conducted to IATF 16949:2009. IATF Transition Strategy IATF 16949 › IATF 16949
It is also important to note that IATF/IAOB will recognize TS certified companies that have upgraded to ISO 9001:2015 prior to IATF 16949 and allow reduced audit days when the company does eventually upgrade to the new IATF 16949 standard. Companies should coordinate with their registrar to determine the optimal audit approach and cost benefit. (Separate audits may be not be cost effective, but it will depend on each company’s situation.)
SimpleQuE consultants and instructors are ready to assist companies now with implementation, transitioning and training for ISO 9001:2015 and IATF 16949:2009. Consulting and training for IATF 16949 will be available after its release in October. Contact simpleQuE
Tight Transition Timelines
Important updates regarding the Aerospace and Automotive industries were shared with SimpleQuE representatives attending the Smithers Quality Assessment’s annual conference on July 14th. Speakers from the International Automotive Oversight Bureau (IAOB) and International Aerospace Quality Group (IAQG) provided insight into the upcoming changes to the IATF 16949 and AS9100 standards. All are targeted for release in the last 4 months of this year, with certification bodies ready to audit to the new standards in the first quarter of 2017 for AS and possibly later for TS. Transition timelines are going to be exceedingly tight. Here are a few key takeaways:
- The IAOB recommends TS certified companies upgrade to ISO 9001:2015 now, prior to upgrading to TS. The benefit will be less audit days when upgrading to 16949:2016
- The IATF is still working on how it can have more time beyond the September 15, 2018 expiration, before IATF 16949:2009 expires and the 16949:2016 standard has to be implemented.
- The IAOB was very careful not to say the new TS standard is based around ISO 9001:2015, but said it does follow the 10 clauses from Annex SL. They were also careful not to call the new standard IATF 16949:2016.
- There are only 4,353 active TS certificates in the US, down from a high of almost 6,000 prior to the recession.
- OEM’s are raising the bar with the new TS standard and performance is key for the automotive supply chain. (See our previous post – Shifting into High Gear for what we learned about the Rome, Italy meeting with TS stakeholders earlier this year. Many things are still changing from that meeting, so expect differences with the final release.)
- AS is accelerating requirements to upgrade. After June 15, 2017 no certification body can perform audits to the current AS standards. After 6/15/17 all scheduled surveillance and recertification audits must be to the new 2016 standard.
- This prevents companies from waiting until the last minute to upgrade because there are a limited number of AS certification body auditors and it would not be possible to get everyone upgraded near the deadline.
- There is concern regarding the extremely tight timelines. Companies have a shorter amount of time to retrain internal auditors, conduct audits, do a new management review, and get upgraded at the next scheduled audit after 6/15/17. Watch for simpleQuE’s aerospace training on the new standard.
- Here are two scenarios of the new timing requirements communicated by SQA:
- If your last registrar audit was June 1, 2016 then you could delay upgrading to your June 2018 annual audit.
- If your last registrar audit was June 21, 2016 then you must upgrade during your June 2017 annual audit, and have no choice to delay until 2018.
Keep up with simpleQuE’s blog posts and training courses for the latest information affecting the quality world.
SimpleQuE representatives were recently invited to attend the Eagle Certification Group auditor training, which included the latest information on anticipated changes to IATF 16949:2016, and they are significant! In May, Eagle participated in 4 days of meetings in Italy with all the stakeholders to provide feedback on the final draft TS standard to be released Q4 of this year. Get ready because the changes will greatly impact automotive suppliers and the industry!
Here are some of the significant changes we learned are in the TS final draft, which is still subject to change. But due to this late date, we anticipate many of the revisions are realistically coming, along with some unexpected new requirements.
- A new layout to 10 clauses to include all of ISO 9001:2015. Get a copy of this standard and begin compliance to the ISO changes, as they will be in the new TS standard.
- Harmonization of the Customer Specific Requirements within the TS standard, along with the core tools requirements.
- A new requirement for a documented process on Product Safety. It should include the identification of regulatory and customer requirements affecting safety, along with approvals for changes, customer notifications/reaction plans, special approval of control plans and PFMEA’s, specific training, and flow down of product safety requirements down the supplier chain.
- A new clause on Corporate Responsibility – in light of the problems with the VW emissions scandal and Takata airbags. There needs to be an escalation policy (which includes whistle-blowing) to improve integrity in social and environmental matters.
- A greater emphasis on process effectiveness and efficiency, with the need for management reviews to include process performance review. A rule that went into effect this year for certification bodies is that if processes are not performing effectively and efficiently and corrective actions taken by the company are not effective in a subsequent audit, the certification body is to write a major nonconformance.
- For plant, facility, and equipment design and layouts, a cross functional team is required, along with risk identification and risk mitigation techniques. This includes manufacturing feasibility prior to, and ongoing evaluations after start up, for maintaining process effectiveness and updating of documentation (control plans, job set-ups). This is also a new input to management reviews.
- A new requirement for customer-specific training as it may relate to customer portals and the communication of information to and from the customer (orders, releases, ASN, PPAP, corrective actions, etc.).
- A process must exist for determining and ensuring training needs for employees working with the customers during the quote, project development and production phases. As appropriate, these employees must be trained in APQP, Customer Specific Requirements, FMEA and Control Plans.
- A new focus and attention on embedded software as part of the design and development process (i.e. engine control modules, emission control systems, etc.). It also has its own clause outside of design, which requires a process for software quality assurance and the use of Automotive SPICE (Software Process Improvement and Capability Determination). A SPICE assessment or audit is also required prior to PPAP.
- Supply chain risk for quality and delivery is a new requirement for consideration in supplier selection. This may include financial stability, volume of automotive business, change management process, business continuity planning, and more.
- Total Productive Maintenance is a new clause requiring documented maintenance goals that include at least OEE (Overall Equipment Effectiveness), MTBF (Mean Time Between Failure) and MTTR (Mean Time To Repair). These also are now inputs to Management Reviews. When objectives are not met, there must be a documented action plan to address corrective actions.
- Companies need to identify manufacturing processes and error-proofing devices that can be bypassed. Based on risk and FMEA severity, bypass procedures must be developed, and may require customer approval. Bypasses must be reviewed daily with focused audits, with daily leadership meetings to reduce or eliminate bypass operations. Restart verification is required when no longer bypassing.
- Non-conforming product that is scraped must now be physically rendered unusable prior to disposal.
- There are new flow-down requirements to suppliers and external providers of products and services, which include cascading down the supply chain for regulatory/statutory requirements and special product and process characteristics.
- Gauge calibration clearly includes monitoring and measuring equipment required to ensure effective control of manufacturing processes.
- Internal audit requirements are enhanced with clear annual plans for the QMS, manufacturing process, and product audits. The number of audits and audit days must be specified and planned. A risk based approach needs to be utilized to prioritize the audit program, based on customer issues, performance trends, and criticality of the processes. Software development capability audits are also required.
- A process must exist to ensure internal auditors can demonstrate competence to audit TS, manufacturing processes and products, core tools, relevant Customer Specific Requirements, and more. There are also trainer requirements that must be met. Approved auditors must be documented and competency monitored through conducting of a minimum number of audits per year (as defined by you).
- Management review inputs are expanded by ISO 9001:2015 and the new TS standard, and include new topics of warranty performance, maintenance action plans, etc. Clear action plans must exist when customer requirements are not met.
- Warranty management is a new clause, requiring a process that also includes warranty part analysis and “no trouble found”.
- All customer complaints and field failures (including returned parts) must initiate formal problem solving and corrective action.
- TS will add back the requirement for Preventive Action.
- A documented process for continual improvement is required.
SimpleQuE offers quality management system consulting, internal auditing and training for Automotive, Aerospace and other industry standards. Contact us to learn more about transitioning to ISO/IATF16949:2016.