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 etc.
Table of Contents
- Internal Audit Checklist for Top Management:
- Internal Audit Checklist for the QA department
- 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 Sale
- Internal Audit Checklist for Maintenance
- 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 |
| 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 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. actual records available? | 7.1.5.1.1 |
| Is the daily rejection being monitored & Analysis of in-house rejection and CAPA is being filled 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 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 previous internal audit NC closer | 9.2.2 |
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 maintained documented information for setup personnel? | 8.5.1.3 |
| Is there a 4M change W I 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 needed as per replacement for expendable supplies | 8.5.2 |
| Ensured the calibrated equipment are 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, whistleblowing policy) defined & Implemented? | 5.1.1 |
| Are there any risks and opportunities identified? Any Mitigation actions for 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 interval? | 7.2.1 |
| Status of 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 risks identified? | 6.1.2.1 |
| Is the condition of materials/products lying in stocks 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 previous internal audit NC closer. | 9.2.2 |
Internal Audit Checklist for Marketing and Sale
| 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 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 business plan & monitoring of the business plan | 9.3 |
| Status of 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 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 process equipment necessary to produce 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 |
Types of Observations in an Internal Audit:
Positive Observation (O+):
The Presence of the 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 results achieved, based upon the auditor’s judgment and experience in that commodity, is not optimal.