• Alma Brainy

Top 10 Major Findings

Updated: Aug 26, 2018

Since last year Alma Brainy has published a series of "IATF In One Page". It cover topic all topics related to developing an audit programme, through to full completion of an audit. These are suitable for both new and experienced management system auditors. The publication includes all techniques and approaches that can be applied to any management system audit (ISO14001, ISO9001 and ISO45001).

10.2.1 Nonconformity and corrective action and 10.2.3 Problem solving


Nearly 20 years after the first issue of ISO/TS16949, organisations still are

having a major problem in taking effective problem solving and applying the

relevant tools and techniques. While the pressure from customer somehow helped

in improving how organisation deal with external concern, these requirements

also cover dealing with internal concerns, internal and external audit findings.

The new IATF rules (5th edition) says that, if a minor nonconformity was not

addressed effectively from a previous third-party audit it is changed to a major

nonconformity. The other major nonconformity was related to corrective action

(10.2.1), this has helped contribute to the high number of nonconformities against

these requirements. Alma Brainy offers a one-day course on practical problem

solving including case studies and practical exercises. For more information

contact info@albrainy.com



8.5.1 Control of production and service provision, 8.5.1.1 Control plan, and 9.1.1.1 Monitoring and measuring of manufacturing processes


These are not new IATF requirements, thus it is very surprising. This is surprising, as these are not new IATF requirements. The new rules in IATF requires for the third-party auditors to spend a minimum of 1/3 of the audit time in the production process, with a focus on the effective implementation of the PFMEA and control plan, it is crucial for an organization to have a robust internal manufacturing process audit programme to identify any issues and ensure systemic corrective action is taken to address them effectively.



8.3.5.2 Manufacturing process design output

There are some additional requirements such as capacityanalysis and maintenance plans and work instructions for any newly introduced processes and equipment. An organization needs not only to ensure that all the part approval documentation is prepared and accepted by the customer, but all the required internal documentation required by production, needed to make the product at the required quality level at the required rate, is prepared, communicated, and the relevant people trained and/or verified as competent in the new product and/or process introduced.



6.1.2.3 Contingency plans


It is expected, not many organisation has a robust contingency plan. This can be clearly seen on the number of organisation that failed to meet "On-Time Delivery".

Often time the development of contingency plan was not done as a team. IATF 16949 emphasis on the process to develop and review the plan(s) with a multidisciplinary

team including top management. Those that has been listed in this clause including recurring natural disasters, interruption from externally provided products, key

equipment failures, processes and services, utility disruptions, fire, labour shortages or infrastructure disruptions. In certain cases, companies have also failed to provide evidence of testing the contingency plan for effectiveness.



8.3.5.2 Manufacturing process design output


There are some additional requirements such as capacity analysis and maintenance plans and work instructions for any newly introduced processes and equipment. An organization needs not only to ensure that all the part approval documentation is prepared and accepted by the customer, but all the required internal documentation required by production, needed to make the product at the required quality level at the required rate, is prepared,

communicated, and the relevant people trained and/or verified as competent in the new product and/or process introduced.



7.2.3 Internal auditor competency


This is a “low hanging fruit” for third party auditors to raise nonconformities. Now, the internal auditor needs to ensure auditors are competent and understand the ISO9001:2015 and IATF 16949: 2016 requirements, relevant customer specific requirements, the automotive core tools, process approach including risk-based thinking, and able to plan, undertake and report audits. Obviously this is stringent nonconformities are almost everywhere. Alma Brainy has uploaded in our website a series of notes and tips that are useful for the internal auditors.



8.5.1.5 Total Productive Maintenance


The requirement is tougher than in ITS16949. What has been added to the new standards includes providing sufficient maintenance resources, setting a clear maintenance objectives, and where maintenance objectives are not met, the process owner should be able to show a clear action plan to address any shortfall in performance.



7.1.5.1.1 Measurement System Analysis


MSA is still one of the requirements in IATF 16949 least understood by organisations. Many organizations have a Gauge R&R excel spreadsheet which the data was taken by not the normal people that run the process. Some common findings are the inability of the person in charge to explain and interpret the data, wrong and/or insufficient sample selection, corrupted formula which made the data to be meaningless. Third party auditors have been trained and well versed with all the MSA technical knowhow.