How to perform an internal audit in an automotive industry

 Purpose of internal audit:

To establish a Procedure for Internal Audit of Quality Management System and to ensure whether the Quality Management System confirms all type of internal audits.

Type of Audit in automotive industry:

Quality System Audit:

The organization’s Processes and their related results comply with planned arrangements and to ensure effective implementation.

Process Audit:

Determination of the effectiveness of the manufacturing process.

Product Audit:

To ensure conformity to product requirements at appropriate stages of production and delivery to verify the conformity to all specified requirements such as dimensions, packaging, functionality and labeling.

Scope of Internal Audit:

Applicable for below:

• Organization Quality Management System.
• Manufacturing Process Audit 
• Product Audit.

Responsibility:

MR / Qualified auditors

Procedure Steps:

Quality System Audit :

Sl No	Activity	Reference	Responsibility
1	Prepare a List of Internal Auditors based on their Qualification (Min. Graduate or Diploma) for the Audit of QMS, Knowledge & Experience. (Minimum 2 years) with an internal audit certificate.	List of Internal Quality System Auditors	MR
2	Prepare Internal Audit Plan (frequency twice in a year), considering all QMS related processes & activities as well as the results of previous audits.	Annual Quality System Audit Plan	MR
3	Prepare an Audit Schedule considering the status & importance of processes & activities and the number of shifts of operation. Ensure the qualified and Approved auditors are used for carrying out the Audit.	Audit Schedule	MR
4	The audit Schedule is communicated to all the auditors and auditee at least 7 days in advance.   Audit Check List is prepared for each Process ensuring that the Audit Check List is updated as per QMS Standard and Customer Specific Requirements.	Audit Schedule  & Audit Check. List & Observation Sheet	MR
5	Communicate the non-conformance to concerned auditee for taking appropriate actions on the same. The corrective action on the identified Non-conformance is initiated. For non- conformance, the following action is initiated :   (a)  Correction done immediately. (b)  The root cause is analyzed within one week & corrective action is implemented according to the type of root cause. The target date for implementation is as follows:- (a)  Close all observations within one month	Internal Quality System Audit Non-Conformance Report.	MR & Certified Auditors
6	Summarize all Department Audit Finding Results.	Audit Summary Report	MR
7	After Completed of each Audit Cycle:-   a) Audit Result Summary is prepared and audit results are reviewed. b) Audit Plan will be reviewed and revised based on audit results (if required.) c) When internal / External Non conformity or Customer Complaints occur, the audit frequency shall be appropriately increased or decreased.	Revised Annual Audit Plan	MR

 Manufacturing Product & Process Audit:

Sl. No	Activity	Reference	Responsibilty
8.	Prepare a List of Internal Process and Product Auditors based on their Qualifications, Knowledge and experience for the product and process audit. ( Criteria: Qualification Min Diploma & Min 2 year experience )   .	List of Process and Product Auditors	MR
9	Prepare Process and Product Audit Schedule considering the status & importance of processes and production activities and the number of shifts of operation. Ensure the qualified and approved auditors are used for carrying out the Process and Product Audit.	Annual Process and Product Audit Plan	MR
10	Prepare an Annual Process and Product Audit Plan, considering all processes and products. Special Focus to be given on NG Areas of the previous audit, customer-compliant action taken history, and action taken on customer visit observations.   Process & product audit frequency once in a year	Process  and Product Audit Schedule	Carrying out audit by the auditors as per the audit schedule & Refer audit checklist or observations and non-conformance are recorded.   Verify the countermeasure and effectiveness for Customer Complaint / Internal Problems & Previous Audit finding, Customer visit observation).
11	Process and product Audit Schedule & Process and Product Audit Check List.	Process and Product Audit Schedule is communicated to all the auditors and auditee at least 7 days in advance.   Process and Product Audit Check List is prepared. Ensure that the Process and Product Audit Check List is updated as per Product and Process requirements if any.	MR
12	Communicate the non-conformance to the concerned auditee for taking appropriate actions on the same. The corrective action on the identified Non-conformance is initiated as per the following Action.   a) Correction done immediately. b) Root cause is analyzed within 4 days c) Corrective action is implemented according to the type of root cause. Corrective Action:- The target date for implementation are as following:- (1)  Action related to documents revision & preparation within –one week. (2)Action related to imparting in-house/on job Training within fifteen days. (3)Action related to outside support within two weeks Action Related to system Amendment within fifteen days.	Audit Check List &  Observation Sheet	MR
13	After Completed of each Manufacturing Process and Product Audit Cycle:-   a) Process and product audit result summary is prepared and audit results are reviewed. b) Process  and product audit plan will be reviewed based on result findings if applicable	Internal Process and Product Audit Non – Conformance Report	MR
14	Summarize all Department Audit Finding Results.	Audit Summary Report	MR
15	After Completed of each Manufacturing Process and Product Audit Cycle:-   a) Process and product  audit result summary is prepared and audit results are reviewed. b) Process  and product audit plan will be reviewed based on result findings if applicable	Revised Annual Process/Product  Audit Plan	MR
16	After Completed of each Manufacturing Process and Product Audit Cycle:-   a) Process and product audit result summary is prepared and audit results are reviewed. b) Process  and product audit plan will be reviewed based on result findings if applicable	Audit Summary Report	MR, Respective Department Heads.

Audit Frequency:

1	Quality Management System	Once in a year if more than 5 NC in an audit, then again re-audit in next 2 months	Management Representative
2	Process Quality Audit	Once in a year if more than 5 NC in an audit, then again re-audit in next 2 months	Management Representative
3	Product Quality Audit	Once in a year if more than 5 NC in an audit, then again re-audit in next 2 month	Management Representative

Internal Audit Checklist as per IATF 16949:

Internal Audit Checklist for Top Management:

• Are the Quality Policy & Quality objectives established for the quality management system & are compatible with the strategic direction of the organization?
• Are the Quality Policy & Quality objectives reviewed at a defined frequency & is there a plan where the targets are not met?
• Are the Quality Management System requirements integrated with the Business plan?
• Are the Business plan available & risk is identified & integrated with a business plan?
• Are there any risks and opportunities identified? Any Mitigation actions for risks identified?
• Contingency plan when abnormal conditions / unexpected changes to satisfy customer requirements in the event of an emergency such as labor shortage, utility interruptions, or key equipment failure.
• Is the Contingency Plan tested for suitability and reviewed annually with CFT including top management?
• Is the relevant document amended and communicated to the relevant department in case of an amendment to the order?
• Customer satisfaction survey form & action plan on customer dissatisfaction factor.
• Are the roles & responsibilities & authorities are defined for each designation & are communicated & understood within the organization?
• Status of previous internal audit NC closure.

Internal Audit Checklist for QA department:

• Availability of latest procedure e.g Handling customer complaints, Incoming material inspection, monitoring & measurement of product etc.
• Are there any risks and opportunities identified? Any mitigation actions for risks identified?
• Is the rule defined in the procedure for time taken to analyze and close the customer complaint?
• Customer complaint monitoring and CAPA on customer complaints.
• Are the Calibration Plan vs. Actual, History card , NABL Scope, NABL certificate, Master certificates of instrument calibrations, and Acceptance criteria of instruments after calibration with records available?
• Is the annual Layout inspection plan and report available?
• Is the MSA Plan Vs Actual records available?
• Is the daily rejection being monitored & Analysis of in-house rejection and CAPA is being filled for the same?
• Is the CAPA raising Criteria defined in the cases of internal rejection and supplier rejection?
• Evidence of Horizontal deployment of corrective action if the corrective action is effective.
• Is Setup approval done at the initial run, Material change, or Job changeover? Is First off & Last off validation of part being done & part are kept for Reference & records are kept for evidence?
• Is the record have the following requirements, identification, storage, Protection, retrieval, retention and disposal of records & the record matrix available & retention period defined for each of the records?
• Status of previous internal audit NC closer

Internal Audit Checklist for the Production Department:

• Is there a documented procedure for Prod Department? i.e Production, Process validation.
• Management & Records of production planning
• Are there any risks and opportunities identified? Any Mitigation actions for risks identified?
• Is there job setup performed such as the Initial run of a Job, material change over or job change requiring a new setup?
• Is there maintained documented information for setup personnel?
• Is there 4M change W.I available & displayed on the shop floor & 4M Changes are implemented in case of changes?
• Is the retroactive actions are taken in case of 4M Changes & the material is kept separately?
• Are the process inspection & testing is being carried out as per the defined frequency in Control Plan/Inspections standards/WI etc.
• Is the material and parts flow secured against mix-ups/exchanges by mistake and is traceability guaranteed?
• Do you have a traceability system implemented at the shop floor at all stages?
• Are the Production Equipment ( Dies, Punches) that affect the quality and identify critical spare needed as per replacement for expendable supplies
• Ensured the calibrated equipment are used for production purposes.
• Status of previous internal audit NC closer.

Internal Audit Checklist for HR department:

• Are there a documented procedure for training/competency & motivation of employee i.e Competence, training & awareness, Suggestion scheme, Employee motivation & empowerment?
• Are the Corporate Responsibility policy (Anti-bribery policy, employee code of conduct, whistleblowing policy) defined & Implemented?
• Are there any risks and opportunities identified? Any Mitigation actions for risks identified?
• Do you prepare the training plan for employee by skill level for new joinee & existing employees?
• Do you perform the practical training ( On job ) of Workers & prepare the individual employee records?
• Are the skill level defined as per skill level of the employees? Are the question papers available as per skill level?
• Is there the training material available for operator & staff for all the training topics?
• is there Job responsibilities & Competency matrix defined for each employee as per the designation?
• Is the competence defined for the personnel performing Production process & Re-evaluate as defined interval
• Status of previous audit NC closer.

Internal Audit Checklist for Store and Dispatch:

• Is there a documented procedure for Store Department? i.e Receipt, storage & issue of material & Inventory management ( ITR )
• Are there any risks and opportunities identified? Any Mitigation actions for risks identified?
• Is the condition of materials/product laying in stocks assessed?
• Is there FIFO system Implemented?
• Do you take any action to prevent the dust, rust, moisture & rain etc. for stock & unfinished products.
• Is there Preservation, packaging & labeling as per requirement of customer?
• Is system for inventory management defined & is there Min-Max inventory level defined?
• How are the obsolete products/components/materials lying in stores dealt?
• Status of previous internal audit NC closer

Internal Audit Checklist for Marketing and Sale:

• Availability of latest procedure as Inquiry handling & Contract review , Customer satisfaction & Business plan.
• Are there any risks and opportunities identified? Any Mitigation actions for risks identified?
• Status of Mitigation actions implementation and effectiveness?
• Is the statutory, regulatory and customer requirement followed?
• Are the inquiry received from the customers are reviewed & put in the inquiry register?
• Are the relevant document amended and communicated to the relevant department in case of amendment to the order?
• Are the customer satisfaction rating received from customer or internal assessment is carried for customer satisfaction?
• Availability of business plan & monitoring the business plan
• Status of previous internal audit NC closer.

Internal Audit Checklist for Maintenance:

• Is there a documented Procedure available for Maintenance Department? i.e Breakdown Maintenance & Preventive Maintenance
• Are there any risks and opportunities identified? Any Mitigation actions for risks identified?
• Is Contingency Plan tested for suitability and reviewed annually with CFT including top management?
• Is there Identification provided of process equipment necessary to produce confirming product?
• Is there availability of replacement parts for the equipment/machines identified?
• Preventive and predictive maintenance – plan and records
• Is there machine check sheet is daily updated ?
• Is the Breakdown intimation record available & history card for Machine is maintained?
• Is the 4M Change Records are maintained after the breakdown or preventive maintenance?
• Is the competency defined for the personnel performing maintenance process ?
• Status of previous internal audit NC closer.