QMS Audit -SMIL

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Questionarries

Quality Assurance

6.2) Verify process KPIs and related performance targets are established
9.1.1.2) Is Important process is identified , quality assurance condition is visualized at the process and actually controlled.
6.1) Are risks and opportunities of planning process determined, analyzed and mitigation plan evident for continual improvement?
9.1.1.2 )DO Special characteristics are documented in the drawings,FMEA,Control plans & work standards with specific markings
9.1.1.1) Verify are process parameter run as per standard WPS parameter?
8.5.1.3) Are First part approval (FPA) & LPA process implemented effectively
8.5.1)Are process capability study evident for monitoring of special characteristics?
10.2) Are Red bin analysis conduct regularly and effectively?
8.5.2)Do you maintain the part tractability i.e. lot number, tool calendar, date, shift & operator code?
8.5.1) Are product and process parameters matched in Control plan, Inspection standard, 2D drawings, MISP & work instruction?
8.5.1)Do you have process parameter periodic revalidation plan?
8.5.1) Do you conduct in-process/ patrol inspection as defined frequency?
8.5.1.5) Do you conduct JH abnormality tagging monthly on machines?
8.5.1)Do you conduct patrol inspection as defined interval?
8.7.1.7) Do you identify nonconforming parts and keep in red bin?
8.5.6.1) Are non-conforming product handled adequately?
8.7.1.4) Do you maintain repaired/ rework product traceability

Production

6.2) Verify process KPIs and related performance targets are established
8.5.6.1.1)Do you maintain record planned/ unplanned and temporary/ permanent 4M changed?
8.5.6.1) Do you validated the part prior to implementation in production (layout, & performance report)?
6.1) Are risks and opportunities of planning process determined, analyzed and mitigation plan evident for continual improvement?
8.5.1.7) Do you upload customers schedule (CDP) in ERP?
8.5.1.7) Do you run master production schedule (MPS)?
8.5.1.7) Do you run material requirement planning (MRP)?
8.5.1.7) Do you monitor production plan vs actual on daily basis and variances analysis evident?
8.5.1.7) Do you define safety stock of BOP in ERP?
8.5.2)Do you maintained raw material loading sheet include lot detail and traceability?
6.2) Verify the welding process KPIs are met the targets?
6.1) Are welding process risks and opportunities are determined, review periodically and prevent to reduce undesired effects.
8.5.3.2.1) Are the Welding process parameters monitoring records maintained?
8.5.3.2.1) Are the Welding process parameters monitoring records maintained?
7.5) Do you register setup & process reject part quantity in eMpro?
8.7.1.7) Do you keep NOK parts in red bin and dispose off at the end of shift?
8.5.4) Are raw material, WIP & Finish good parts identification, traceability maintain and free from contamination, dust, dirt, scratch, deformation and rain water?
8.5.6.1.1) Do you use 4M change lot tag to identify production lot until dispatch?
8.5.6.1) Do you validated change prior to lot production (layout & performance report)?
7.5.3) Do you amend process and product related documents after change?
8.5.1.2) Do you record abnormal situations occurred during production?
8.5.6.1)Do you perform retroactive check of suspected product when abnormality occurred?
10.2) Are actions decided in red bin analysis implemented and effective?
8.5.1) Do you have welding_ process revalidation plan?
8.5.1.3) Do you perform re-startup check during job changeover, breakdowns, and planned shutdown?
8.5.1.3) Do you identify and retain first parts till batch production ends?
8.5.1) Are special characteristics managed in the production?
3.1) Do you perform Poke-Yoke verification with negative samples

PPC & Logistics

8.5.4.1) Is all products (parts, material, WIP and finished products) are preserved with identification,handling,contamination control,packaging,storage, transportation & Protection to be ensured
6.2) Verify process KPIs and related performance targets are established
6.1) Are risks and opportunities of planning process determined, analyzed and mitigation plan evident for continual improvement?
8.5.4.1) Is WIP and Final product inventory is monitored and controlled
8.5.1)Is Production Trigger system is available with document or IT system and visualized at the shop floor
6.1) Are risks and opportunities of purchase process determined, analyzed and mitigation plan evident for continual improvement?

Store Management

6.2) Verify process KPIs and related performance targets are established
6.1) Are risks and opportunities of store process determined, analyzed and mitigation plan evident for continual improvement?
8.5.2) Verify material lot details (expiry & batch no) on bar code match with material test report?
8.5.4) Do you store material at defined location?
8.7.1.3) Uninspected material, do you it kept at separate locations?
8.7.1.7) Do you quarantine rejected supplier material and dispose off periodically?
8.5.4) Do you maintain FIFO?
8.5.4) Do you issue material against work-order and FIFO maintained
8.5.4) Do you maintain packaging condition and check is product safe from dust, dirt and damage?
8.5.4) Are ERP Vs physical stock quantity matched?

Final PDI inspection

6.2) Verify process KPIs and related performance targets are established
6.2) Are all inspectors are qualified and trained?
6.1) Are risks and opportunities of planning process determined, analyzed and mitigation plan evident for continual improvement?
8.7.1.5 )Are defect outflow inspectors wise monitored?
8.6.3) Are inspection stations equipped with relevant documents, reference sample & lux level monitoring record?
8.7.1.5 ) Are rejection are recorded and analysis?
10.2) Are ICAR raised when product not meeting the requirements and actions evident?

Plant Maintenance

6.2) Verify process KPIs and related performance targets are established
6.1) Are risks and opportunities are determined and prevent to reduce undesired effects
8.5.1.5) Do you conduct periodic maintenance as per plan and maintain records?
8.5.1.5) Do you maintain and monitor spare part inventory ?
10.2) Do you analyse machine breakdowns and countermeasure implemented to prevent reoccurrence?
7.5.3) Do you add countermeasure in PM and check sheet for routine checkup)
7.1.4.1) Do you prevent oil, air, leakage from equipments?
10.2) Do you emphasis production team to register equipment breakdowns in CMMS?
7.1.5.2.1) Are machine pressure gauge and temperature controller calibrated?
7.2.1) Are maintenance technician are competent for maintenance work?
10.2) Do you maintain preventive maintenance of machines/jigs/fixtures and it is followed
10.2 ) Do Machines/jigs/inspection equipments in process are equiped with fool proof devices and the devices can not be easily disarmed by the operators.

Tool Maintenance

6.2) Verify tooling process KPIs and related performance targets are established
7.5.3.2.1) Do you maintain tool maintenance records?
6.1) Are risks and opportunities are determined and prevent to reduce undesired effects
8.5.1.5) Do you conduct Tool health checkup if tool life goes beyond the 80% shots life?
8.5.1.5) Do you maintain and monitor tool spare inventory level?
10.2) Do you analyse machine breakdown and countermeasure implemented to prevent reoccurrence?
7.5.3) Do you add countermeasure in maintenance and online check sheet?
7.2.1) Do you have competent person for tool maintenance work?
8.5.1.6) Do you protect tools from dust, dirt, birds spits?

Quality Lab

6.2) Verify process KPIs and related performance process KPIs and related performance targets are established
7.1.5.1.1) Do you conduct attribute and variable MSA study as per plan?
6.1) Are risks and opportunities of planning process determined, analyzed and mitigation plan evident for continual improvement?
8.6.2) Do you conduct product layout as per plan?
7.1.5.2) Do you calibrate all measuring and testing equipment's?
7.1.5) Is internal laboratory scope defined and documented (incase calibration done internally)
7.1.5) Are internal laboratory personnel competent for internal calibration?

Customer Focus

10.2.6)Is customer complaint handling procedure is defined and actions are implemented
6.2) Verify process KPIs and related performance process KPIs and related performance targets are established
10.2.6) Is warranty actions are effective and actions are implemented
6.1) Are risks and opportunities of planning process determined, analyzed and mitigation plan evident for continual improvement?
9.1.2) Is documented process for determining customer satisfaction including delivered part quality,delivery performance,customer disruptions,field returns,records vaulable
7.5.2) Is documents are reviewed whenever customer complaints, field complaints or 4M change happens and updated in control plan, work instructions,PFD,PFMEA
10.2.3) Is corrective action & preventive action to improve customer satisfaction is in place and closed loop review
6.1.2.3) Is contingency plan to satisfy customer requirement in the event of emergency due to utility interuption,labour shortages,key equipment failures and filed returns
6.2) Do you analyse PDCA KPI where targets not achieved and implement actions?

Purchase

6.2) Verify process KPIs and related performance process KPIs and related performance targets are established
8.5.4.1) Is procedure is in place for restricted substances. MSDS available & displayed in appropriate places
6.1) Are risks and opportunities of planning process determined, analyzed and mitigation plan evident for continual improvement?
7.3.6.2)Are same suppliers, tooling's & manufacturing processes used in production which are used in prototype?
7.3.6.3)Is product approval process used, applied to suppliers (own or customer approved)?
7.4.1)Are the suppliers used, evaluated & approved based on ability to supply product as per requirement ?
7.4.1)Are the purchased products conforms to the purchasing requirements?
7.4.1)Does type & extent of control applied to suppliers and purchased product depend upon the effect on subsequent product realization or final product?
7.4.1.1)Whether purchased products satisfy regulatory requirement?
7.4.1.3)Are customer approved suppliers used as per specified contract with the customer for purchasing products if any?
7.4.2)Is purchasing information (Pos) includes requirement for approval of product, procedures, processes & equipment's, requirement of qualification of personnel and QMS requirement if any?
7.4.2)Is adequacy of specified purchase product requirement ensured before communication to the supplier?

Supplier Management

6.2) Verify process KPIs and related performance process KPIs and related performance targets are established
6.1) Are risks and opportunities of planning process determined, analyzed and mitigation plan evident for continual improvement?
8.4.1.2)Is supplier selection control procedure available and followed in selection, approval and auditing suppliers
8.4.2.4) Is supplier performance monitoring procedure available and followed to monitor supplier performance
8.4.2.4.1)Is supplier audit procedure available, audit criteria for audit is clear. Procedure adhered to audit supplier and grading is monitored
8.4.2.5) Is supplier product and process validation procedure available and adhered to validate process and product during development and records maintained
8.5.6.1) Do you track suppliers 4M change management
8.4.1)Do you check lot as per inspection standard during GRN authorization
6.1.2.2 )Do you review SCAR counter measure
8.3.4.4)Do you receive supplier PPAP documents and review at the time of ASL linkage
8.4.2.3)Supplier QMS development ultimate objective of becoming certified to IATF 16949
8.4.2.5) Are suppliers provide new parts supplier under initial production control norm?

QMS

6.2) Verify process KPIs and related performance process KPIs and related performance targets are established
6.1) Are risks and opportunities of planning process determined, analyzed and mitigation plan evident for continual improvement?
9.2.2.2)Is ISO 9001/IATF 16949 Certification is certified by third party and No NC during previous audits
7.5.1.1)Is quality manual, quality procedures with process mapping done. Procedures are well documented and implemented at applicable areas and evidenced
8.7.1) Is control of NC products are well defined and implemented
9.1.1.2)Is statistical tools used to analyze and monitoring of effectiveness is adequate
9.2.2.1)Is internal audits such as system, product and process audits are planned and conducted.
9.3)Observations are reviewed by management and actions are initiated. Frequency adjusted to non confirming trends
9.3.2.1)Is management review meetings to review performance of all processes-are held as per schedule.minutes are evidenced with action plan
8.3.5.2) Is display of documents in applicable areas such as work instructions, safety instructions, other display for ensuring quality & safety are available in all applicable areas.
7.3.1)Is operators and staffs are well aware of the consequences of violation of quality system
6.2.2.1)Is department has goals that are well defined,measured and reviewed by top management with action plans
7.5.3.2.2) Is process in place to assure the timely review, distribution and implementation of all customer engineering standards/specifications and relevant records maintained
8.5.6.1)Is process in place to assure the implementation, review of all 4M changes affecting QMS/Customer requirement and relevant records maintained. Customer kept informed.

NPD

6.2) Verify process KPIs and related performance process KPIs and related performance targets are established
6.1) Are risks and opportunities of planning process determined, analyzed and mitigation plan evident for continual improvement?
8.3.3.2) Is procedure available for design & development, for all projects with key milestones, evidence of training, input and output documents for each in place
8.3.5.1)Is process in place to ensure key elements of product design &development
9.1.1.2)Is statistical tools are used by employees and are involved in the collection, analysis, and management of statistical data and it is included in the PQP,DFMEA,PFMEA& control plan
8.3.3.2)Is process in place to ensure key elements of process design & development
8.3.5.1)Is technical resources are adequate and available for new projects(in house experts are aligned to meet the requirement)
8.3.4.4)IS PPAP/Customer required documents are available and meet the requirement.PSW approval process in place as per customer requirement and evidenced.
8.3.5.1) Is Tools and parts are assured of quality before start of SOP,All relevant records are maintained
7.2.2.)Is staffs are competent to meet the requirement of development process-through education,experience,through training in the organization
8.3.5.2)Is plant and floor layout are adequate and review happens
4.4.1.2) Is product safety is identified in each stage of process up to delivery from production line to dispatch.

HR& Training

6.2) Verify process KPIs and related performance process KPIs and related performance targets are established.
6.1) Are risks and opportunities of planning process determined, analyzed and mitigation plan evident for continual improvement?
7.2.2)Is formalized procedure available to identifying training needs for skill development at all levels (staffs) available and met the requirements of organization.
7.2.2)Is training plan and actual training hours meet the requirement. effectiveness of training monitored
7.2.2)Is procedure for on the job training is available, training records maintained?
7.2.2)Is man, machine, material handling safety issues are addressed in procedure and training conducted ?
7.5.3.2.1)Is statutory and regulatory requirements are addressed and met
6.4.2)Is process in place to implement,monitor,review and improve 3C&5S in shop floor. Teams are assigned with responsibilities, good housekeeping maintained
5.4.1)Are quality objectives derived from business plan & established for relevant functions or processes
6.2.1) Are the personnel's performing work affecting product quality are competent on the basis of Education, Training, skill & Experience ?
6.2.2.) Does personnel's are aware of the relevance and importance of their activities & how they contributes to achieve quality objectives?
6.2.2.4) Does process for Employee Motivation & Empowerment available to achieve quality objectives?

Responsibility

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Auditee
Functional Heads

QMS Audit -SMIL

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Quality Assurance

Production

PPC & Logistics

Store Management

Final PDI inspection

Plant Maintenance

Tool Maintenance

Quality Lab

Customer Focus

Purchase

Supplier Management

QMS

NPD

HR& Training

Responsibility

Related checklists

QMS Audit -SMIL

Free QMS Audit -SMIL Checklist

Go digital today!

Convert your paper checklists into digital forms

Quality Assurance

Production

PPC & Logistics

Store Management

Final PDI inspection

Plant Maintenance

Tool Maintenance

Quality Lab

Customer Focus

Purchase

Supplier Management

QMS

NPD

HR& Training

Responsibility

Related checklists