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.
By Jim Lee, President of simpleQuE
With the deadline for ISO 9001:2015, ISO 14001:2015, AS9100:2016 and IATF 16949:2016 approaching on September 14, 2018, companies have been slow to transition. The statistics are sobering, although not unexpected. The new ISO standards have been in effect for 2 years but only 6-20% have made the leap. (The number varies among registrars and the ANAB.) The final draft for the AS 9100 series followed a year later, but with the same deadline, and only 3% have upgraded. Even fewer IATF companies have transitioned – and all have only 1 year left to get the upgrade completed.
What should you be doing if you’re one of these companies that has pushed out the inevitable?
- Know that your next scheduled annual audits are the dates when you must transition to the new standards. If your next audit is a recertification and upgrade, you will need to perform the audit at least 2 months prior to your certificate expiring to give you enough time to address any potential nonconformances.
- Review the new standard and do a gap analysis to see where there are differences in your quality (and/or environmental) management system and the changes to the standard. Generic basic checklists are available from your certification body, or detailed gap checklists with tips and explanations can be purchased from simpleQuE. Learn more about simpleQuE’s Gap Checklist for: ISO 9001:2015, ISO 14001:2015, or IATF 16949:2016. Note that IAQG offers a free AS9100D Gap Assessment Workbook.
- Establish an action plan that will have you ready for your audits. Assign responsibilities and due dates to ensure you’re ready on time.
- Train your internal auditors and perform a full system audit to make sure your system is on track and in compliance. You must have evidence of a full internal audit and subsequent management review prior to upgrading with your certification body. If you can’t get your audits done in time you’ll need to outsource them. (SimpleQuE can conduct an internal audit to the new standard after the implementation effort to prepare you for the external audit.)
- Don’t expect to wing it and do nothing in preparation for these changed standards, or you will fail your next audit and lose your certification. Worst case if you aren’t ready in time, you may have to let your certification lapse and then become recertified at a later time when you’re ready. No one wants to hear that, but it is a reality for some who haven’t started.
- If you still aren’t sure how to proceed, work with a consulting firm (like simpleQuE) with certified experts who can provide consulting, training and customized plan to guide you through the transition.
Overall, what is at the forefront of a Quality Manager’s mind is the responsibility for performance improvement – improving the quality and the systems and processes that deliver them and all the resources that support these processes. That’s a very far-reaching responsibility that encompasses a variety of other factors like risk, corporate culture, employee impact, customer requirements and suppliers. In every organization, there are times when there are glitches in the system. We’ve identified some of the top issues that may concern a QM enough to keep him/her up at night, or even cause a headache or two.
- Recurring issues and product defects even total production shutdown (now that’s a nightmare!)
- Convincing top management to integrate the QMS as a Business Management System and make the QMS part of the business’ strategic direction
- Ensuring that customer specific requirements and expectations have been identified – that the company is meeting or exceeding customer expectations
- Keeping up with ever changing customer requirements as well as local, state and federal regulations
- Establishing and maintaining a customer-focused culture – from leadership down to temporary workers
- Transitioning to a new quality standard – where to even start?
- How to reduce waste and increase efficiency? Making sure the company is working as effectively as possible to keep up with competitors
- Have risk and preventative actions been adequately addressed from beginning to end?
- No accountability – processes defined by department managers and staff and then not following them
- Not ready or prepared for the certification audit (and what happens if there are findings or nonconformances?)
If any of these are keeping you up at night, remember, you’re not alone and there are consulting companies, like simpleQuE that can help. We listen, observe and assess to provide simple and effective solutions…and hopefully, a more restful night’s sleep.
Guest post by Larry Vance
As a professional auditor and consultant, I have had the opportunity to visit hundreds of different companies that have a certified Quality Management System and have opted to have their staff and employees perform the required internal audits. I have encountered internal auditors that have the proper training, knowledge, and experience and that want to complete the audits to the best of their ability and for the betterment of the company they work for. Unfortunately, I have also experienced internal auditors that, based upon their audit reports and my interviews, are only going through the motions and do not do any more than provide some evidence that they did an audit. They and their companies are really missing out on the true reason that all of the Quality Management System standards require a certified company to do internal audits. Continue reading “The Value of Outsourcing Internal Audits”