Latest Mandatory procedures as per IATF 16949

There are some mandatory procedures as per IATF 16949.

Product Safety Procedure ( 4.4.1.2):

The organization shall have documented process for manufacturing of product safety related products and manufacturing processes. Check the detail about product safety procedure.

Calibration Procedure ( 7.1.5.2.1):

The organization shall have a documented process for managing calibration and verification records. So maintain calibration record of all measuring and test equipment and gauges in the organization ( own /customer provided / supplier provided ). For more detail about calibration procedure.

Competence Training ( 7.2.1):

The organization shall define and maintain a procedure for identifying training needs and acquiring competence of all personnel performing activities affecting conformity to product and process requirement. For more detail about competence training.

Internal Auditor Competency ( 7.2.3):

The organization shall have a procedure to verify the competence of all internal auditors with any customer specific requirements. All the QMS auditors, product & process auditor shall have knowledge as applicable:

  • All Core Tools ( APQP, PPAP, FMEA, SPC, MSA)
  • ISO 9001:2015 / IATF 16949 ( Certified Internal Auditor)
  • Customer specific requirements ( CSR)
  • Process approach
  • Risk base thinking
  • Knowledge about auditing.

Internal auditor competency can be added in the procedure of Internal Audit.

Employee Motivation ( 7.3.2):

The organization shall maintain a procedure to motivate employee to achieve quality objective, to do continual improvement and to make a good work environment. Employee motivation can be done such as establishing a suggestion policy, attendance reward or best employee of the month on the basis of some criteria. The detail about employee motivation can be added in the procedure of training.

Engineering Specification ( 7.5.3.2.2):

The organization shall have a procedure having the review, distribution and implementation of all customer engineering drawing or any ECN received. Any engineering drawing / specification change should be done within 10 working days. Check the detail about Engineering specification and Engineering change notice ( APQP Procedure)

Design and Development ( 8.3.1.1):

The organization shall establish, implement and maintain a procedure for design and development process and shall focus on error prevention instead of detection. Follow the procedure for APQP.

Special Characteristics ( 8.3.3.3):

The organization shall establish, document and implement its processes to identify special characteristics including customer specified by the CFT approach. All special characteristics should be cascaded in FMEA, Control Plan, Operation Standard & Work instruction through a special characteristics symbol. For more detail about special characteristics, follow procedure of APQP.

Supplier Selection ( 8.4.1.2):

The organization shall have a procedure for supplier selection. The selection process shall include:

  • Supplier quality management system
  • Supplier quality and delivery performance
  • Volume of automotive business
  • Adequacy of available resources
  • Manufacturing capability

Fore more detail about supplier selection process.

Outsource Process Control ( 8.4.2.1):

The organization shall have a procedure to identify outsource process and to select the control used to verify conformity of externally provided products, processes and services. For more detail about outsource process, follow the procedure of outsource process. Outsource activity can be added in the procedure of supplier control.

Statutory and Regulatory requirement ( 8.4.2.2 ):

The organization shall document prepare a procedure to ensure that purchased products, process and service conform to the applicable statutory and regulatory requirements such as end of life vehicle (ELV) testing etc.

Supplier Monitoring ( 8.4.2.4):

The organization shall have a procedure to evaluate supplier performance in order to ensure conformity of externally provided products, processes and services. Below points must be added in supplier monitoring ( Rating):

  • Quality rating of products supplied
  • Delivery rating
  • Customer disruption
  • Premium freight occurrence
  • Quality or delivery notification

For supplier monitoring follow the procedure of Supplier control.

Control of Changes ( 8.5.6.1):

The organization shall have a procedure to control and react to change that impact product realization. The effect of any change to customer or supplier shall be assessed. The organization shall:

  • Validate the change before implementation.
  • Define control plan to ensure compliance with customer requirement
  • Maintain verification and validation record
  • FMEA for risk analysis

The ECN activity can be added in the procedure of APQP.

Temporary Change of Process Control ( 8.5.6.1.1):

The organization shall identify, document and maintain a list of the process control including inspection, measuring, test and error proofing devices. It include the primary process control and approved alternate process control for contingency. For more detail about Temporary change process control procedure.

Control of Repair & Rework (8.7.1.4 & 8.7.1.5):

The organization shall have a documented process for rework & repair control and other relevant documented information to verify compliance to original specification. Also the organization shall do risk analysis of rework and repair process before rework decision. The organization shall retain record of the disposition of rework & repair product including quantity, disposition, disposition date and traceability information.

Non Conforming Product handling (8.7.1.7):

The organization shall have a procedure for disposition of non conforming product which can not be done rework or repair. The organization shall verify the product to be scraped before disposal. Follow the procedure of Non conforming product handling and red bin analysis.

Internal Audit ( 9.2.2.1):

The organization shall have a procedure for internal audit. It includes the internal audit program that covers the internal quality management system audit of all departments, manufacturing product and process audit. For more detail about internal audit procedure.

Corrective Action / Problem solving ( 10.2.3):

The organization shall have a procedure for corrective action. It includes:

  • Corrective action for in house complaints, customer complaints, breakdown or audit non conformity.
  • Containment action
  • Root cause analysis
  • Systematic corrective action
  • Verification of corrective action implementation
  • Standardization

For more detail about corrective action, Follow the procedure for complaint handling.

Poka Yoke / Error Proofing ( 10.2.4):

The organization shall have a documented process to determine the use of appropriate error proofing methodology. Prepare a list of all poka yoke used in the organization and a poka yoke verification check sheet. Add detail of poka yoke in FMEA and frequency of checking in control plan & operation standard. Keep challenge parts for verification of poka yoke.

Continual Improvement ( 10.3.1):

The organization shall have a documented process or procedure for continual improvement. Identify the methodology used, objectives, measurement, effectiveness and record in Kaizen format. Prepare a manufacturing process improvement action plan by focusing on reduction of process variation and waste. Continual improvement can be on productivity, quality, cost, defect reduction & safety (PQCDS).

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