Internal audit checklists are the checkpoints of different departments to perform an internal quality system audit. It covers all the requirements as per ISO 9001 and IATF 16949 standards with updated sanctioned interpretations (IATF SIs). All departments like Production, quality, maintenance, purchase, store, marketing, top management, human resources & NPD etc.
Table of Contents
- Internal Audit Checklist for Top Management:
- Internal Audit Checklist for the QA Department
- Internal Audit Checklist for New Product Development (NPD)
- Internal Audit Checklist for the Production Department
- Internal Audit Checklist for HR Department
- Internal Audit Checklist for Store and Dispatch
- Internal Audit Checklist for Marketing and Sales
- Internal Audit Checklist for Maintenance
- Internal Audit Checklist for Purchase:
- Internal Audit Checklist for QMS/MR:
- Types of Observations in an Internal Audit:
Internal Audit Checklist for Top Management:
| Check Points | Clause No |
|---|---|
| Are the Quality Policy & Quality objectives established for the quality management system & are compatible with the strategic direction of the organization? | 5.2.1 6.2.1, 6.2.2 |
| Are the Quality Policy & Quality objectives reviewed at a defined frequency & is there a plan where the targets are not met? | 5.2.1 6.2.1, 6.2.2 |
| Are the Quality Management System requirements integrated with the Business plan? | 5.1.1 |
| Are the Business plan available & risk identified & integrated with a business plan? | 5.1.1 |
| Are there any risks and opportunities identified? Any Mitigation actions for risks identified? | 6.1.1 |
| A 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. | 6.1.2.3 |
| Is the relevant document amended and communicated to the relevant department in case of an amendment to the order? | 8.2.3 |
| Customer satisfaction survey form & action plan on customer dissatisfaction factor. | 9.1.2 |
| Are the roles & responsibilities & authorities defined for each designation & are communicated & understood within the organization? | 5.3.1 |
| Status of previous internal audit NC closure. | 9.2.2 |
Internal Audit Checklist for the QA Department
| Check Points | Clause No |
|---|---|
| Availability of the Latest procedure e.g Handling customer complaints, Incoming material inspection, monitoring & measurement of products etc. | 7.5.1, 7.5.2, 7.5.3 |
| Are there any risks and opportunities identified? Any mitigation actions for the risks identified? | 6.1.2.1, 6.1.2.2 |
| Is the rule defined in the procedure for the time taken to analyze and close the customer complaint? | 10.2.3 |
| Customer complaint monitoring and CAPA on customer complaints. | 10.2.3 |
| 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? | 7.1.5.2.1 |
| Is the annual Layout inspection plan and report available? | |
| Is the MSA Plan vs. the actual records available? | 7.1.5.1.1 |
| Is the daily rejection being monitored and analysis of in-house rejection and CAPA is being filed for the same? | 10.2.3 |
| Is the CAPA raising Criteria defined in the cases of internal rejection and supplier rejection? | 10.2.3 |
| Evidence of Horizontal deployment of corrective action if the corrective action is effective. | 10.2 |
| Is the setup approval done at the initial run, Material change, or Job changeover? Is the First off & Last off validation of part being done & part kept for Reference & records kept for evidence? | 8.5.1.3 |
| Is the record have the following requirements: identification, storage, Protection, retrieval, retention and disposal of records & the record matrix available and the retention period defined for each of the records? | 7.5.3 |
| Status of the previous internal audit NC closer | 9.2.2 |
Internal Audit Checklist for New Product Development (NPD)
| Check Points | Clause No |
|---|---|
| Availability of latest procedure as New product development, Initial supply control, PFEMA, Product safety etc. | 7.5.1 |
| is the New product development procedure identified & matched with the APQP time plan & APQP matrix? | MSIL CSR |
| is the timing plan approved by Top management & review frequency defined for CFT & Top management? Are the records available for the review of the progress of the APQP time plan? | MSIL CSR |
| Are the delayed activities captured in the timing plan & action available for that? Are the TGR & TGW analyses evident for the NPD parts & the learnings are captured & deployed in a similar part or process? | MSIL CSR |
| Are the procedures defined for the Initial product & initial supply control? Are the criteria defined for IPC in case of a new part, engineering Change or process changes? | MSIL CSR |
| Are the stricter controls defined in the procedure in case of initial supply control? Are the termination criteria defined for the initial supply control sign-off? Are the criteria defined for the extension of the IPC period in the case where the targets are not met? | MSIL CSR |
| Are the past defect history sheets available & all the defects are captured i.e at the stage of development, Customer complaints, Supplier problems, warranty failure etc.? | MSIL CSR |
| Verification of PFD, PFMEA & Control Plan. Is the Annual PFMEA review plan available & being implemented accordingly? | 8.5.1.1, 8.3.5.2 |
| Have any special characteristics been identified for process capability as per PFMEA/Control Plan? Is there a process capability carried out as per plan & analysed? | 9.1.1.2/9.1.1.3 |
| Are there any risks and opportunities identified? Any Mitigation actions for the risks identified? | 6.1.2.1 |
| Ensuring the latest version of external origin documents and distribution control is on the same. | 7.5.3 |
| Is the ECN register available & a summary of ECNs is being prepared? | 8.2.4 |
| Availability of the latest PPAP documents of new & existing components. | 8.3.4.4 |
| Is the Master list of Control plan, PFMEA, Drawing, Inspection standards, Process sheet available & updated as per requirement? | 7.5.3 |
| Is the co-herence plan available to avoid the mismatch of the documents i.e customer drawing, in-process inspection report, setup approval report, PDI report, Inspection standard, process sheet etc.? | MSIL CSR |
| Control of Record: Do the records have the following requirement: Identification, storage, protection, retrieval, retention and disposal of records & the record matrix available & retention period defined for each of the records? | 7.5.3 |
| Status of the previous internal audit NC closer |
Internal Audit Checklist for the Production Department
| Check Points | Clause No |
|---|---|
| Is there a documented procedure for the Production Department? i.e Production, Process validation. | 7.5.1 |
| Management & Records of production planning, manufacturing, testing, inspection tooling and equipment. | 8.5.1.6 |
| Are there any risks and opportunities identified? Any Mitigation actions for risks identified? | 6.1.6.1 |
| Is there a job setup performed such as the Initial run of a Job, material change over or job change requiring a new setup? Is there documented information for setup personnel? | 8.5.1.3 |
| Is there a 4M change WI available & displayed on the shop floor and 4M Changes are implemented in case of changes? | MSIL CSR |
| Are the retroactive actions taken in case of 4M Changes & the material is kept separately? | MSIL CSR |
| Are the process inspection & testing being carried out as per the defined frequency in the Control Plan/Inspections standards/WI etc. | 8.6.1 |
| Is the material and parts flow secured against mix-ups/exchanges by mistake and is traceability guaranteed? | 8.5.2.1 |
| Do you have a traceability system implemented on the shop floor at all stages? Are the Production Equipment ( Dies, Punches) that affect the quality and identify critical spare parts needed as per replacement for expendable supplies | 8.5.2 |
| Ensured the calibrated equipment is used for production purposes. | 7.1.5.2.1 |
| Status of previous internal audit NC closer. |
Internal Audit Checklist for HR Department
| Check Points | Clause No |
|---|---|
| Is there a documented procedure for Training/competency & motivation of employees i.e. Competence, training & awareness, Suggestion scheme, Employee motivation & empowerment? | 7.2, 7.3, 7.5 |
| Are the quality objectives deployed in the HR department? i.e. Same objective as determined along with the quality policy and supporting department objective? | 6.2.1, 6.2.2 |
| Are the Corporate Responsibility policy (Anti-bribery policy, employee code of conduct, whistle-blowing policy) defined & Implemented? | 5.1.1 |
| Are there any risks and opportunities identified? Any Mitigation actions for the risks identified? Do you prepare the training plan for employees by skill level for new joinee & existing employees? | 6.1.2.1 |
| Do you perform the practical training ( On the job ) of Workers & prepare the individual employee records? | 7.2 |
| Are the skill levels defined as per the skill level of the employees? Are the question papers available as per skill level? | 7.2 |
| Is there training material available for operators & staff for all the training topics? | 7.2 |
| is there a Job responsibilities & Competency matrix defined for each employee as per the designation? | 5.3 |
| Is the competence defined for the personnel performing the Production process & Re-evaluated as defined intervals? | 7.2.1 |
| Status of the previous audit NC closer | 9.2.2 |
Internal Audit Checklist for Store and Dispatch
| Check Points | Clause No |
|---|---|
| is there a documented procedure for the Store Department? i.e Receipt, storage & issue of material & Inventory management ( ITR ) | 7.5.1, 7.5.2, 7.5.3 |
| Are the quality objectives deployed in the store department? i.e. the same objective as determined along with the quality policy and supporting department objective? | 7.5.3.2.1 |
| Are there any risks and opportunities identified? Any Mitigation actions for the risks identified? | 6.1.2.1 |
| Is the condition of materials/products lying in stock assessed? | 4.2 |
| Is there a FIFO system implemented? | 8.5.4.1 |
| Do you take any action to prevent dust, rust, moisture & rain etc. for stock & unfinished products? | 8.5.4.1 |
| Is there Preservation, packaging & labeling as per the requirements of the customer? | 8.5.4.1 |
| Is a system for inventory management defined & is there a Min-Max inventory level defined? | 8.5.4.1 |
| How are the obsolete products/components/materials lying in stores dealt? Are these considered and controlled as per non-conforming materials? | 7.5.3 |
| Status of the previous internal audit NC closer. | 9.2.2 |
Internal Audit Checklist for Marketing and Sales
| Check Points | Clause No |
|---|---|
| Availability of latest procedures such as Inquiry handling & Contract review, Customer satisfaction & Business plan. | 8.2 |
| Are there any risks and opportunities identified? Any Mitigation actions for the risks identified? | 6.1.6.1 |
| Status of Mitigation actions implementation and effectiveness? | 6.1.2 |
| Is the statutory, regulatory and customer requirements followed? | 7.5.3.2 |
| Are the inquiries received from the customers reviewed & put in the inquiry register? | 8.2.3 |
| Are the relevant documents amended and communicated to the relevant department in case of an amendment to the order? | 8.2.3 |
| Are the customer satisfaction ratings received from customers or internal assessments carried out for customer satisfaction? | 9.1.2 |
| Availability of the business plan & monitoring of the business plan | 9.3 |
| Status of the previous internal audit NC closer. | 9.2.2 |
Internal Audit Checklist for Maintenance
| Check Points | Clause No |
|---|---|
| Is there a documented procedure available for the Maintenance Department? i.e Breakdown Maintenance & Preventive Maintenance? | 8.5.1.5 |
| Are there any risks and opportunities identified? Any Mitigation actions for the risks identified? | 6.1.2.1 |
| Abnormal conditions/unexpected change to satisfy customer requirements in the event of an emergency such as labor shortage, utility interruption, key equipment failure etc | 6.1.2.3 |
| Is the Contingency Plan tested for suitability and reviewed annually with CFT including top management? | 6.1.2.3 |
| Is there Identification provided of the process equipment necessary to produce the confirming product? | 8.5.1.5 |
| Is there availability of replacement parts for the equipment/machines identified? | 8.5.1.5 |
| Is the competency defined for the personnel performing the maintenance process? | 7.2.2 |
| Is there a machine check sheet that is updated daily? | 8.5.1.5 |
| Is the Breakdown intimation record available & history card for the Machine is maintained? | 8.5.1.5 |
| Is the 4M Change Records maintained after the breakdown or preventive maintenance? | MSIL CSR |
| Preventive and predictive maintenance – plan and records | 8.5.1.5 |
| Status of previous internal audit NC closer. | 9.2.2 |
Internal Audit Checklist for Purchase:
| Check Points | Clause No |
|---|---|
| Are the process identified and established? i.e. New supplier selection & approval, Raw material purchasing, Supplier performance monitoring, Supplier Development, etc. | 8.4 |
| Are there any risks and opportunities identified? Any Mitigation actions for the risks identified? | 6.1.2.1 |
| Abnormal conditions / unexpected change ( Contingency Plan ): Abnormal Conditions / Unexpected change to satisfy customer requirements in the event of an emergency such as labor shortage, utility interruptions, key equipment failure | 61.2.3 |
| Are records maintained as a result of necessary actions taken for improvement in supplier performance & effectiveness? | 8.4.2.2 |
| Are the frequency of supplier visits/audits defined to determine their system development status? Are records maintained? | 8.4.1.2 |
| Action plans are prepared in joint discussion with your supplier for establishing/upgrading the system as per IATF 16949:2016 | 8.4.2.5 |
| Has the customer prescribed any source to purchase products, materials, tools or services under contractual conditions? | 8.4.1.3 |
| Has supplier performance been monitored based on the following: ●Delivery of product conformity to requirements ●Customer disruptions at the receiving plant ●Delivery schedule performance ●Number of occurrences of Premium Freight ●Customer Notification on Quality / Delivery Issues | 8.4.2.4 |
| Are there any outsourced processes identified in the organization? E.g Heat Treatment, Plating, Painting etc | 8.5.1.6 |
| Control of Record: The record has the following requirements: Identification, storage, protection, retrieval, retention and disposal of records & the record matrix available & retention period defined for each type of records? | 7.5.3 |
| Status of the previous internal audit NC closer | 9.2.2 |
Internal Audit Checklist for QMS/MR:
| Check Points | Clause No |
|---|---|
| Availability of the latest procedure e.g. Control of documents, Control of records, Internal Audit, MRM, Risk Assessment etc. | 7.5.1, 7.5.2, 7.5.3 |
| Are there any risks and opportunities identified? Any Mitigation actions for the risks identified? | 6.1.2.1 |
| Conducting Internal Audits & maintaining the audit reports. | 9.2 |
| Are the Internal Auditor (QMS+Mfg. process+Product+2nd Party auditor) Competencies defined & maintained through training whenever required? | 7.2.3 |
| Conducting MRM & maintaining the reports. | 9.3 |
| Identification of Needs & Expectations of interested parties. | 4.2 |
| Ensuring the customer requirements have been communicated to all the concerned people in the plant. | 5.1.2 |
| The Master copy of Quality Procedures, Manual, Instruction, Format, WI etc at MR. office. | 7.5.3 |
| Ensuring the latest version of documents at the point of use. | 7.5.3 |
| Control of Record 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 type of record? | 7.5.3 |
| Status of the previous internal audit NC closer | 9.2.2 |
Note: Above department-wise internal audit check sheets cover most of the points as per standard requirements. But for more detail refer to ISO 9001 and IATF 16949 Standard.
Types of Observations in an Internal Audit:
Positive Observation (O+):
The Presence of good practices of a system to meet an IATF 16949:2016 requirement. The good practices can be horizontally deployed in other processes (wherever applicable).
Major Non-Conformity (NC) :
The absence or total breakdown of a system to meet an IATF 16949:2016 requirement.
- Many minor nonconformities against one requirement can represent a total breakdown of the system and thus be considered a major nonconformity.
- Any noncompliance that would result in the probable shipment of a non-conforming product. A condition that may result in the failure or materially reduce the usability of the products or services for their intended purpose.
- Any noncompliance that judgment and experience indicate is likely either to result in the failure of the quality management system or to materially reduce its ability to ensure controlled processes and products
Minor Non-Conformity (O-):
Is a failure to comply with IATF 16949:2016, which based on judgment and experience is not likely to result in the failure of the quality management system or reduce its ability to ensure controlled processes, or products. It may be one of the following:
- is a failure in some part of the organization’s documented quality management system relative to IATF 16949:2016?
- is a single observed lapse in following one item of a company’s quality management system?
Opportunity for Improvement(O.I):-
An observed situation that is not a major or minor nonconformity, but where the results achieved, based upon the auditor’s judgment and experience in that commodity are not optimal.
You may need to know:
How to close IATF 16949 Non-conformities?
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For purchase department checklist not mentioned. Send to hkpsmgdvg@gmail.com
Thanks for your feedback
Neither product nor process design are considered in the checklist!
Thanks for the feedback. Internal audit check sheet for NPD has been updated.