Self audit check list - QAD

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Description of requirements Status

1 Documentation requirements
Do you have the Quality objectives for your function Is it aligned to the business objective Do you have the list of all major and sub major processes to meet the your quality objectives and Business results Does the already available procedures cover all your activities to meet the goal Who are all authorised the to approve the changes in the procedures, control documents

2 Engineering specification
Do you have the list changes introduced in the product and manufacturing process. Do you have the document when these changes implemented, for what and what is the present stautus.

3 Control of records
Do you have the reports on Customer complaints, Rework, Scrap. Can they be easily retrieved; accessible to all engineers and managers How long do you maintain such records How do you dispose these records. How are ensuring confidentiality in disposing sensitive documents Do you have the list of records which are required to be maintained for your function

4 Process efficiency
Do you have the review of the results and processes How often it is reviewed. How do you document the review outputs What are all your review inputs Can you show the action plans and completed records.

5 Responsibility, Authority and Communication

All executives and Managers to have the R&A document filled and signed by the Department head / Section head What is the process you have to inform managers with responsibility and authority for corrective action of products and processes which don't conform to requirements Do you have evidence to show the process is alive.

6 Internal communication
How the communication is being sent among the sections on the requirements and status of the common projects, common issues

7 Management reviews
What are all the reviews in your department / sections

What is the review frequency How do you document the review output How are you documenting and standardising the improvement. Can you show the evidence Will your review cover - Gap analysis, timeliness, error rates, corrective action effectiveness, Cost of poor quality etc. Do you have problem bank, list Can you show the various review inputs like results of audit, Customer feedback, Process performance, Product conformity, Status of preventive and corrective action, follow-up action from previous management reviews, recommendation for improvement etc. Can you show the review output like MOM, Decisions etc.

8 Human resources
How do you determine the skill requirement of the Workmen, Engineers and Managers How do you determine the training need of the Workmen, Engineers and Managers How do you record the skill level and training needs How do you measure the effectiveness of the training How do you train the new recruits How do you train the mid career recruits How do you retrain the personnel How are you creating awareness to your personnel on the relevance and importance of their activities How do you maintain the records of the training, skills and experience How do you identify the tools for the skill achievement How do you decide the applicable tools for workmen, engineers and managers How do you train the workmen, engineers and managers on the consequence of their work on product and customer

9 Motivation:
What are all the motivational processes followed Motivation vs. Objectives - do you have any guideline Achievement of quality objectives, Continual improvement, Innovation - do you have different scheme How the employee is aware of these motivational schemes? Is it displayed How the improvements are given merit for award qualification

10 Infrastructure
How do you determine the requirment of Inspection, Testing equipments How do you determine the material handling, storage requirement How do you determine the IT supports Have you identified factor affecting product quality, safety from infrastructure point of view; Do you have the action plan and progress review?

11 Contingency plan
Have you identified the emergency situation in Field & Shop floor from product performance point of view.

Have you identified the potential causes for Customer complaints and Production loss Have you identified the alternate actions to overcome the emergency situation in Field and at Shopfloor Has it been agreed by all and in the documented form How do you plan, communicate and record the contingency plan How do you ensure the correct quantity and quality material is available to production on everyday.

12 Work environment
Have you identified the risk involved to workmen and executives in their work place How do you document and make corrective action How do you create awareness to employees on safety issues Have you identified the risk areas in the work place. Have you created awareness to all employees How you plan your processes to address the safety of the personnel and product

13 Cleanliness, Orderliness of premises

Have you earmarked areas for the unwanted articles like drawing, records, samples, machineries, Tools, fixtures etc. How are you disposing the oils, plastics, chemicals Do you have the relevant work instructions/guidelines for the disposal activity How do you store the material in your store What is identification and traceability of these items in store How do you identify the technical reports and retrieve it within shortest possible time Have you marked the work places for location of items. Is the lighting system adequate in your work area How do you save the electrical energy Is your filing system satisfactory

14 Product / Process realisation

Do you have the list of quality objectives and requirement of the product as specified by the customer Do you have requirements not stated by the R&D engineers but necessary for specified use of the product Do you have the list of statutory and regulatory requirement related to the product, Consumables Have you understood the special characteristics requirements in the part Have you identified the special characteristics in the part and manufacturing process Have you listed the new requirements of process for the given product specification

15 Acceptance criteria
Do you have the acceptance criteria for Product, Part, Process; How did you arrive this. Are they in the form of samples, Drawings, Sketches? Are they mutually accepted by all concerned. Who are they? Are they authorised

16 Confidentiality
How do you protect the sensitive information in your department

17 Change control
When product requirements are changed, how do you ensure the units are having the latest drawing and documents. Have you informed the relevant personnel on these changes and How? If some requirements are not met, have you got approval from the Apex body or Management; do you have evidence. How do you manage the cost and implementation time arising out the change. How do you track the lead-time for the change implementation and improving it. How are validating the changes. Is it being done before implementation Do you have records of change made Are you tracking the effectiveness of change How do you ensure sustenance.

18 Manufacturing feasibility
Are you participating in the study of manufacturing feasiblity What are all the inputs you generate for this study. Are you involved in the risk analysis of project and process. What kind of input you generate How do you standardise this activity

19 Communication to service providers and Facility suppliers

How the communication with suppliers happening for parts, tool and die improvement requirement Do you have the list of preferred service providers How do you certify them

20 Manufacturing process design input

Do you have design output document like drawing, FMEA, Test standards, Acceptance criteria etc. Does it include functional and performance requirements Does it include statutory and regulatory requirements Does it include information derived from previous product and process problems. Are these inputs adequate for the development with the supplier Have you ensured the special characteristics identification in the process How do you ensure Identification and Traceability requirements in the product Have you considered the Packaging, Transportation requirement as a Part and Product Have you considered the competitor product manufacturing process detail Have you considered the supplier feed back Have you fixed the targets for Quality,

Have you completed the Process FMEA with PED How do you prioritize the actions for the points arrived in Process FMEA Have you considered the improvement coming out of TPM initiatives Have you identified the error proofing requirement in the process.

21 Manufacturing process design output

Did the process design output meet the process design input Does the input to the cell contain all relevant details? Have you indicated the product acceptance criteria Have you identified the safety issues and addressed. Did you incorporate the error proofing in the process design Do you have the list of those error proofing Does the unit maintain relevant design and development documents Have you completed the Process Design review Do you have the records for these reviews Have you completed the action for those points highlighted in the review Have you vetted the design through VA/VE Have you incorporated the improvement actions in the design Have you considered the servicing requirement in the design Are you monitoring the development process considering the cost, time, quality risks etc. Do you have the evidence to that effect? Have you approved the process flow chart Did you conduct Mfg.process FMEA Is the control plan satisfactory Is the work instruction satisfactory Have you prepared process approval acceptance criteria Have you consolidated data for quality, reliability, maintainability and measurability. Have you identified and recommended methods of rapid detection and feed back of mfg.process nonconformities. Have you installed visual control

22 Process design Verification and Validation

Do you have the process design verification plan Have you completed the verification Does your test standard adequately meet the requirements of process design and customer Have you made a report on findings Is the result matches the input requirements? If not do you have the action plan Have you completed the actions identified? Have you completed the process design validation. Have you recorded the findings Do you have the action plan for the gap. What is the status of the action identified Have you compared the new design with a similar proven design Anybody reviewed the entire development documents before it is finalised What is his review methodology

23 Prototype programme
Do you have the prototype programme Do you have the prototype control plan Does your tooling, supplier and process are similar to production method?

24 Product approval process

Do you maintain records for timely completion of proving activities and conformity to requirements Have you given input to production on product and part acceptance criteria Have you completed the EJO Have you proved the manufacturing cell input and output requirement Have you signed off the entire documents necessary for running the production. Have you made available information that describes the characteristics of the product Have you made available the Work Instruction. Are they user friendly Have you made available all equipments and spares needed for running the production Have you made available suitable monitoring and measuring devices Have all the measuring equipments are studied for R&R Have you made available the control plan. Does it take care of all FMEA points Have you given the reaction plan incase nonconformities happen in production Have you identified the controls over the special characteristics

25 Control of design and development changes

Have you recorded the design and process changes Did you review the effect of changes, verified and validated before approving the change Do you maintain the records for the above Does your engineers follow the guidelines for handling the changes in Supplier, Part and Process How do you know he had followed the guidelines

26 Purchasing process
Do you plan for evaluation and reevaluation of suppliers. How do you determine the reevaluation requirement Do you have the records for the above.

27 Regulatory conformity
Do you have the list of Regulatory and Statutory requirements. Have you ensured all the material bought meet the Applicable regulatory requirement Do you have the list of material and applicable regulatory requirement

28 Supplier quality management system

Are your suppliers are ISO 9001 or TS 16949 certified Do you have the plan for the certification Are you monitoring the supplier's performance on quality and delivery How do you improve him on performance

29 Customer approved sources

Do you have list of preferred sources for raw material from where your supplier to get the material How do you select your raw material source How do you manage your agreements with them

30 Purchasing information
Do you have the purchase order procedure and check lists Does your purchase order cover the following: Requirements for approval of product, procedure, process and equipment Requirements for qualification of personnel Quality management system requirement Adequacy of specified purchase requirements

31 Verification of purchased product

Have you specified in the purchase order the intended verification arrangement Purchase order to cover method of product release. Method of verification of incoming product quality

32 Supplier monitoring
Do we track and take action on, Deliverd product quality Customer complaint including field returns(Warranty) Delivery schedule performance

33 Incoming product quality

Are you receiving statistical data from the supplier on the product quality What is the nature of assessment done on the supplier How do you communicate the supplier on the quality and how you drive the improvement activities

34 Control of production and service provision

Does the supplier have all system requirement as specified in the ISO / TS Is he having good preventive and predictive maintenance system in his plant

35 Control plan
Do you have control plan for all the operation in the shop floor. Does it reflect the latest process in action Will the control plan, Drawing, Operation standards and other relevant check list match each other on various data Does the control plan has link with FMEA document Have you considered the methods to be followed for controlling the special characteristics Does the control plan contains the reaction plan incase of non conformity occurs in the production process How often the control plan will be revisited. When it underwent change last; can you show the evidence

36 Work instructions
Do you have the work instructions(SOPS) for workmen and executives Are they trained on these work instruction Are you auditing the adherence. Do you have evidence for the same

37 Verification of job setups

Under what circumstances the job set up will be performed. Do you have SOP for the same Who are responsible for the job set up and approval Do they know the procedure; are they adhering to the procedure. Can you show the evidence for adherence

38 Preventive and predictive maintenance

Do you have the list of key processes and equipments. Do you have the plan for the Preventive and Predictive maintenance Can you show the evidence for adherence. How do you document the findings and take corrective action How do you implement the improvement at all applicable areas. How do you protect the unused machineries, tooling etc How do you plan for the critical spares Do you have the system to manage the tool Do you use statistical technique for improvement activities

39 Management of production tooling

How do you inspect the new tooling How do you approve the reworked tooling How the tool change requests are handled How are you controlling the tool cost How are you identifying the tools for various application

40 Identification and traceability

Do you have a location for rework, scrap and customer complaint parts storage How do you identify the suspect part/product. What is the system you have to trace the product in field. Can you demonstrate your system

41 Preservation of product
How the finished and in-process products are stored Do you have the packaging standard How the packaging, storage etc are validated What kind of SOP is available

42 Storage and Inventory

How do you ensure FIFO for the raw material and finished product

43 Measurement system analysis

Are all your gauges and instruments underwent MSA study. Is there a concern? If so, what is the action taken Can you show a record on MSA study.

44 Calibration / Verification records

Are all the gauges, instruments, equipments are calibrated Do you have the calibration schedule. What is the adherence level.

What is the action for missing gauges, broken gauges How are you identifying the gauges for calibration Do the engineers and operators aware of the consequences of non availability of gauges and non conforming product impact on customer How do you ensure such awareness.

45 Laboratory requirement
Are your standards room personnel qualified for operating the equipments Are your equipments are periodically calibrated by a qualified agency Do you have a lab manual and are you checking the requirement periodically. Can you show the evidence for the same. Are you getting services from the external laboratory. How do you select those laboratory Do you have the record for the master gauge calibration

46 Application of statistical tools

Are you using statistical tools for problem solving and Improvement activities What are all the tools you are using How do you ensure the engineers are aware of these tools and extensively using Can you demonstrate the competence related to statistical concepts How do you train your personnel; how do you qualify them.

47 Customer satisfaction
Who are all your customers Have you conducted the survey and taken action on the findings What are the measure used to determine the customer satisfaction

48 Audit
How many of layers of audit you have; do you have self audit schedule Do you have the schedule How do you handle the audit findings Do you have the evidence for the same Who are all the auditors for you What is the lead-time for closing a non conformance How these audit findings are linked to performance targets of the unit and the business results Are you updating the system based on the non conformance reports and the corrective action report How do you select, train and qualify the internal auditors How do you plan your audit; How you revise your plan and how often. What are all the different audit you are responsible How do you drive the improvement activities based on the audit finding

49 Monitoring and measurement of Processes

Are you conducting process studies on all new manufacturing processes What is the status of process capability Are control plans and process flow are implemented Have you installed correct sampling plans; how do you arrive the sampling plan Have you prepared and implemented the reaction plans for the non conformances likely to appear. Do you have a system for handling non conforming product / process How these non conformances are closed; what kind of review system you have

50 Monitoring and measurement of the product

Are you inspecting the product for its performance characteristics. How often you do. How do you act incase of non compliance happens Do you have the document evidence for these activities

51 Layout inspection and functional testing

Are you conducting layout inspection. What is the frequency. How do you decide the frequency Can you show the evidence for action taken based on the layout inspection

52 Appearance items
Do you have the list of appearance item Do you have standards for the appearance items Are the personnel involved in the appearance item inspection are qualified. What is the method of qualification How often they will be subjected to qualification

53 Control of non conforming product

How are you identifying the non conforming product. How are you controlling the non conformance from reappearing. Who is authorised to deal with the non conforming product / process Can you demonstrate the process for handling a non conforming part by showing relevant documents. If the non conforming product reaches the end customer, and you come to know of it, how do you handle. What kind of system you have. Can you show some examples How the reworked product is released to production and to field.

54 Customer waiver
Do you have the customer waiver system ( ECF system) in your place. Do you maintain record of these waivers How do you ensure the compliance before the waiver period expires.

55 Analysis of data
How do you analyse the data on Line rejection, Lot rejection, Customer complaints, non conformances in product/process, vehicle loss, cost of poor quality. What are all the improvements made so far and how the operating system got improved

56 Continual improvement
What are all the improvement projects completed What technique is used for the improvement activities Corrective action is not continual improvement. How many corrective actions are done.

57 Problem solving
What are all the tools used for problem solving Can you demonstrate on such tool usage How the corrective action is standardised. How the learning's are institutionalised.

58 Error proofing
Do you have the list of error proofing facility installed How do you determine the error proofing requirement How do you maintain the error proofing facility

59 Corrective action impact

Are you applying the learning's to other similar application How many such improvement done

60 Rejected product analysis ( Warranty and PPFR )

What is the cycletime for analysing the field return parts What is the cycle time for implementing the improvement action

61 Preventive action
Are you conducting reviews to determine action to eliminate potential non conformities to prevent their occurrence Do you have the procedure for the same