Where Does it Say THAT?! – Frequently Overlooked IATF 16949® Requirements
Where does it say THAT?! That’s a phrase that many auditors have probably heard. As most organizations in the automotive supply chain are aware, IATF 16949® is a demanding standard. With many requirements (comprising the entirety of ISO 9001, the IATF 16949® components, Sanctioned Interpretations, Core Tools, CSRs, etc.) the organization can feel a bit overwhelmed. It is not uncommon for an organization’s QMS (quality management system) to miss some of the more nuanced areas of the standard. While most IATF 16949® organizations are keenly aware of the requirements of control plans, FMEAs, management review inputs and outputs, internal audits, and so on, there are many more lesser-known requirements that may be overlooked or just plain forgotten.
With that in mind, the goal of this article is to bring some of those lesser-known requirements to light and help with the organization’s awareness. So, when an auditor asked for something that seems a bit obscure, you may not need to ask: “Where does it say THAT!?”
So, for your organization’s consideration, here are some of those overlooked requirements:
4.3.1 – Include supporting functions (onsite and remote) into the QMS. Does a parent company provide any support? Do you own any remote warehouses?
188.8.131.52 – Conformance of ALL products and processes (including outsourced) to ALL applicable customer, statutory and regulatory requirements.
184.108.40.206 – Top management reviews the product realization processes AND support processes to evaluate AND improve their EFFECTIVENESS (i.e.: did we meet desired results) AND EFFICIENCY (i.e.: did we produce with expected resources). This information is also input into management review.
220.127.116.11 – IATF® adders for Risk (including lessons learned from recalls, product audits, field returns and repairs, complaints, scrap, and rework).
18.104.22.168 – Quality objectives established annually (including TARGETS).
22.214.171.124.1 – Defined lab scope for INSPECTION, TEST or CALIBRATION services…if all three are done at the site, all three need to be addressed in lab scope. This includes inspections and tests performed on the production line.
126.96.36.199.2 – External lab used for INSPECTION, TEST OR CALIBRATION services 17025 certification must include the mark of the national accreditation body and the scope of the certification must include the service being provided. An ISO 17025 lab scope includes a certificate, plus a scope showing the calibrations or tests that fall under the ISO 17025 scope. Labs may perform services that are not on their ISO 17025 scope.
7.2.4 – 2nd party auditor competencies must meet CSR requirements for auditor qualifications. 2nd party auditors are those you hire to perform your internal audits or supplier audits. Keeping internal auditors competent per 7.2.3, 7.2.4, and CSR requirements is why many companies have simpleQuE perform their internal audits.
188.8.131.52c – Outsourced processes must be included on the processes sequence and interaction document (i.e.: process map or process flow diagram). These may be color coded or shaded to differentiate which processes are partially or fully outsourced (e.g., internal audits, etc.)
184.108.40.206.2 – Engineering standards/specification changes review should be completed within 10 working days of receipt. Not completed, but incoming changes must be reviewed to start the change process.
8.1.2 – ENSURE confidentiality of customer-contracted products and projects under DEVELOPMENT.
220.127.116.11 – Determining requirements of products shall include recycling and environmental impact.
18.104.22.168.2 – Special Characteristics shall conform to customer requirements for designation (see CSRs).
22.214.171.124.3 – Feasibility analysis required for any manufacturing or product technology new to the organization AND for any changed manufacturing process or product design.
Knowledge. Expertise. Experience.
Outsource Your Internal Audits
126.96.36.199 – Documented supplier selection process shall include an assessment of the selected supplier’s RISK to PRODUCT CONFORMITY and UNINTERRRUPED SUPPLY of the organization’s product to the customer.
188.8.131.52 – Direct Buy suppliers (customer dictated suppliers) still have to be controlled to section 8.4 (except selection) unless otherwise defined by the customer.
184.108.40.206 (Sanctioned Interpretation SI#7) – Where characteristics or components “pass through” the organization’s quality management system without validation or controls, the organization shall ensure that the appropriate controls are in place at the point of manufacture.
220.127.116.11 (Sanctioned Interpretation SI#8) – The organization shall require their suppliers of automotive products and services to develop, implement, and improve a quality management system (QMS) with the ultimate objective of eligible organizations becoming certified to this Automotive QMS Standard. AND using a risk-based model, the organization shall define a minimum acceptable level of QMS development and a target QMS development level for each supplier. (See what automotive supplier options may be available through MAQMSR.)
18.104.22.168c – Standardized work instructions must be in the language understood by the personnel responsible to follow them AND include rules for operator safety.
22.214.171.124 – Production tooling management shall include tool identification (asset number, status (production, repair, disposal) ownership and location.
126.96.36.199 – Preservation requirements Includes stock assessments, FIFO, obsolete control.
188.8.131.52 – Applies to any change (internal, customer, or supplier) that impacts product realization. Don’t forget to document the risk analysis.
8.6.4 – Received products and service (including outsourced processes like heat treating, plating, coatings, welding etc.) need to have some sort of verification…c) when the supplier has 2nd or 3rd party audits, they must have records of acceptable quality otherwise a method of receiving inspection is required.
184.108.40.206 – If a non-conforming product is scrapped, the scrapped product must be verified as “rendered unusable” PRIOR to disposal.
220.127.116.11 d – For monitoring and measurement of the manufacturing process, if variable data, records must be the actual measurement values.
18.104.22.168 – Process audits must include periodic sampling of shift handover.
10.2.3 f – Problem solving includes the review/updating of PFMEAs and control plans.
So, there you have it. This list is not meant to be fully comprehensive, nor is the information verbatim from the standard. The intention is to provide a little food for thought. Maybe at the company’s next internal audit, this list can be utilized to see if there is compliance to some of the lesser known requirements.
This is the first of a four part series of IATF 16949® articles written by simpleQuE consultant and auditor, Bob Dornhecker. With over 30 years of combined experience in auditing, manufacturing and certification, Bob has an extensive quality background. Additionally, he has taught and facilitated many quality related training classes for clients and has provided support to companies securing their own ISO/Quality Management Systems certifications. He also conducts ISO 9001 and IATF 16949® 2nd and 3rd party audits.
SimpleQuE offers a full line-up of IATF 16949® training courses which includes AIAG and VDA Core Tools, Root Cause Analysis and Problem Solving, Requirements and Implementation. With IATF® also putting a major focus on internal auditor competency, it is essential to have IATF 16949® Internal Auditor Training. Our IATF 16949 auditor training utilizes the process audit approach. Contact us to learn more about the customized services offered to match your certification and training needs.
SimpleQuE is not associated with the IATF®, IAOB, ANAB®, IAQG®, and is not a certification body. SimpleQuE is an independent consulting, training, and second-party auditing service provider that assists a company on a path for the company to obtain and maintain certification through accredited certification bodies.
Learn More About The simpleQuE Advantage