ISO9001-2015 Departmentwise Audit Questionnaire

8/16/2019 ISO9001-2015 Departmentwise Audit Questionnaire

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ISO 9001:2015, Department Wise Audit Questionnaire

1. QMS & G!"A# $"O%D"S:'(1) How do you measure effectiveness of system for working of your company? How do

you collect necessary information for the same? Are you getting information for corrective action taken and it’s effectiveness for discussion in the management review

meeting?(2) Have you considered the context of the organiation’s overall !usiness activities and issues

and environmental conditions affected !y your activities? "o whom you have identified your interested parties?

(#) $hat are the needs and expectations of interested parties in %nvironment managementsystem? $hat procedure or process is followed to understand interested parties re&uirements?

How do you esta!lish the %'? How do you !ring continual improvement in%nvironment management system in accordance of * +,,1-2,1.?

(/) How do you plan for management review meeting and who are committee mem!er?0o you circulate agenda for 'anagement review meetings in advance? 0o you

prepare minutes of 'anagement review meeting with the actions decided inmanagement review meeting? How do you monitor effectiveness of the system? Areyou having any &uantifia!le o!ectives for management review? $hen do you reviewit?

(.) Have you done any planning for how to achieve the environmental o!ectives? 0oes this plancover what will !e done3 resource details and responsi!ilities3 target date? How the results areevaluated including indicators for achievement of this o!ective?

(4) Have you update risks !ased on investigation and opportunities determined during planning?How do you ensure corrective action taken is appropriate to the effects of the 5on conformitiesencountered?

(6) How do you improve the suita!ility3 ade&uacy3 and effectiveness of the 7' to enhanceperformance? Have you determined is there needs or opportunities that are addressed as apart of continual improvement?

(8) Are you doing follow-up for completion of action decided in 'anagement reviewmeetings? How? $hat is input and output of 'anagement review meetings?

(+) 0oes the master list for documented information? how us latest revision of 7uality'anual and other documented information? How do you inform all the persons for changes in any documents? $ho is responsi!le for approval and control of differenttypes of documents? How do you get information for changes in the procedure 9documented information? How do you inform to all the concerned person?

(1,) How documents are identified for control9uncontrolled : o!solete?

(11) 0o you preserve o!solete documents? $here do you preserve it?

(12) 0o you have list of trained auditors? $ho has given training to them as per *+,,1;2,1.? How many days? Have you made audit plan : audit schedule? 0uringauditing do the auditor check and monitor results of 7uantifia!le criteria reported !y thefunctional heads? 0oes all the 5


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(1#) How do you carryout audit for >urchase department? Have you checked effectivenessof training given and competence of auditors? How?

(1/) 0o you maintain documented information for the actual audit carried out against auditplanned as well as summary of audit done? $here do you maintain such documented

information?

(1.) How do you ensure that all departments are covered for all the clauses applica!le tothat department are audited in internal &uality audit? How do you see effectiveness of action taken on audit 5olicy well understood at all levels? Have you arrange training on 7ualitypolicy?

(16) Have you documented customer re&uirements !ased on the customer need? Have youdocumented statutory and regulatory re&uirements applica!le to your product? How doyou ensure that it is fulfilled at all the levels? How do you promote customer

re&uirements within the organisation?(18) How do you identify maintain : store documented information? Are they legi!le?

$here do you document information retention period? How do you esta!lish control for computerised documented information?

(1+) $ho is responsi!le for control of data? How is it controlled? How do you esta!lishcontrol on computerised data?

(2,) Are you taking corrective for process3 product3 and system and customer complaint?$hen do you take corrective actions? $ho review the effectiveness of corrective andaction taken !y concerned department? %xplain details of corrective and actionprocedure? How do you monitor it? Have you done analysis of audit 5


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(28) Have you identified customer re&uirements to enhance the customer satisfaction? Howdo you ensure promotion of awareness of customer re&uirements throughout theorganisation?

(2+) $hat kind if communication process is esta!lished within the organisation? How the

communication takes place regarding the effectiveness of 7uality 'anagementystem? Have you made any procedure for the same? How is it implemented?

(#,) How do you ensure competence of persons performing work affecting conformity of theproduct? $hat kind of infrastructure do you provide? How do you identify and conveyyour need for the resources?

(#1) How do you ensure customer satisfaction? Have you done any customer survey? Haveyou analyse data for the 7uestionnaire su!mitted !y the customer? Have you takenactions !ased on the same?

(#2) How do you measure effectiveness of training? How do you ensure training given to the

auditor is effective?(##) Have you analysed date for;

a) roduct conformities like inspection for incoming3 inprocess and final stage inspection

c) >rocess trends and opportunities for the improvement for example yield control3 timecycle reduction etc

d) uppliers

(#/) $hen do you carry out corrective actions? How do you identify causes of

nonconformity? Have you documented results of actions taken? $here? How do youreview the effectiveness of the action taken?

(#.) Have you fixed any action plan for the achievement of 7uantifia!le criteria? y whichdata and how it will !e achieved? how us action plan for achieving the same

2. QA#I* %O!"O#: '(1) Are acceptance : reection criteria specified for different process parameters and

product tested !y your company? Have you prepared overall inspection test plancovering references of work instruction3 acceptance criteria3 format and parameterstested for different types of products for incoming3 in process and final stage of inspection?

(2) Are you inspecting 9 verifying all the critical products3 new developed products or purchased material? How? Any documented information are kept for the same? Areyou testing raw materials? How?

(#) Have you trained staff for follow up of operating procedures : work instruction of 7A3@a!oratory : test methods for testing of various products? Have you received any testmethod given !y your customer?

(/) How do you carry out cali!ration of la!oratory instruments used !y your personnel for department testing work? How do you maintain cali!ration status? How do you control: maintain instruments in your department?

(.) Have you done cali!ration of e&uipment like la!oratory instruments3 weighing !alance3etc? s it tracea!le to approved national 9nternational standards? f such tracea!ility is

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not availa!le then is it cali!rated against documented method or esta!lishedmethodology?

(4) How do you identify un-inspected3 inspected : non-conforming samples in your department? How do you downgrade the materials after la! testing? How do you

identify downgrade material? Are you putting remarks for * 9 not * in the testreports9 who is authorised for the review and approval of test reports?

(6) How do you get details for third party inspection or product approval !y customers?How do you get information for the statutory and product related regulatoryre&uirements? How do you ensure fulfilment of the same?

(8) How do you get information for the customer re&uirements and ensure its fulfilment? Are you inspecting reprocessed material? how us documented information?

(+) Are you carrying out testing of all the critical incoming material3 in process and finalstages for each lot? How do you maintain documented information? How do you

maintain status of inspection?(1,) $hat action have you taken after receiving customer complaints? How do you analyse

customer complaints?

(11) How do you ensure that product has passed through all the inspection : meetcustomer re&uirements? How do you carry out final inspection of product to !e suppliedto different segment like replacement market3 defence3 exports etc? $here are youkeeping documented information?

(12) Have you attended management review meetings? $hich was discussion related toyour areas? Have you completed actions decided in management review meeting inyour area?

(1#) How do you get special test re&uirements of customers and how it is carried out? 0oyou get any test method for testing of product from the customer? How do you follow it?

(1/) How do you maintain master list of documented information with retention period? Alltype of documented information including computerised documented informationmaintained !y you is covered in the master list of documented information? n your allthe files record name and format no (f applica!le) is written? >roper document controlis esta!lished !y you?

(1.) Have you !een audited? How many 5


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(22) s there necessary infrastructure and environment in your department for the operationof process?

(2#) 0o you implement action from risks and opportunities?

(2/) Have you update risks !ased on such investigation in documented information?

3. MA"(I!G: '(1) How do you carryout marketing of your product? Are you having agents? How do you

select such channel of distri!ution? $ho is authorised for selection of them? Are youhaving list of approved 0ealer 9 Agent list for the same?

(2) Have you prepared your company !rochure? Are you having price list? $ho approveit? How do you finalise price for the new product?

(#) How do you participate in defining re&uirements for new products? How do you getinformation for new products? How do you provide information for your product to you

customer as well as plant people?

(/) Have you define customer expectations : product re&uirements? How do youcommunicate it to 0esign3 'anufacturing3 7


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complaints? Have you done any analysis for customer complaints and warranty claimsattended !y the company? $hat corrective actions are taken for the same?

(11) How do you convert customer in&uiry in to contract? 0oes the total re&uirements laiddown?

(12) How do you prevent3 or reduce3 undesired effects related to risk?

(1#) Have you define a &uality risk assessment process? how me

(1/) s there necessary infrastructure and environment in your department for the operationof process?

(1.) 0o you implement action from risks and opportunities?

(14) $ho has attended management review meeting? Have you decided any action for your department? How? 0oes marketing monitor : report customer feed!ack inmanagement review meeting?

(16) How do you maintain documented information in your area ? All type of documentedinformation including computerised documented information maintained !y you iscovered and maintained?

(18) Have you !een audited? How many 5


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(6) Are you having any special processor? $hat do you mean !y is? Are you operator for special process? How do you monitor such special process? 0o you keep anydocumented information for the same? Are you doing periodic process 7ualification?efore finalising process parameters have you done study for your past process data

to consider the process parameters?(8) How do you identify the material and for what parameters at incoming3 in process3 and

final storage area?

(+) Are e&uipments 9 instruments used !y your departments are cali!rated? $hat is your mechanism for cali!ration?

(1,) How can you ensure that implemented control of the processes is as per defined criteria? Howdo you rocess is defined within the 7' for such outsourcedprocess? Have you esta!lished system for selection of vendors and outsourced activities andhow do you communicate such controls to them?


(1#) $hat methods for monitoring3 measurement3 analysis and evaluation are followed to ensurevalid results?

(1/) $hat are the things you consider in your department at the time of change ?

(1.) Have you esta!lished any tracea!ility system to recall defective product !ased oncustomer complaint or production feed!ack for particular lot? How do you identifyfinished materials as well semi finish lot? Have you esta!lished any codification system

for the lot num!ering?(14) s production planned for all the different departments? 0o you carryout production

planning and product realisation? How do you monitor plan vs actual? How do youcarryout routine work? $hat processor do you follow for internal communication?

(16) Have you define a risk and opportunity? How risk assessment process is followed?how me

(18) s there appropriate control of materials3 e&uipment’s : critical parameters of process?How do you monitor and control your >rocesses? Are you maintaining documentedinformation for process control monitoring? How do you get the information for themixing of various products?

(1+) s there inspection : test status given for downgrade materials? How? Are thereappropriate documented information for disposal of non-conforming materials : who isauthorised for the same?

(2,) Have you finalised critical limits for you processes? Have you documented the same?$here? How do you control process parameters? How do you monitor the same? 0oyou maintain the documented information for the same? Are ade&uate e&uipment usedfor storage : Handling?

(21) s training provided at all levels of workman in the company? $here are documentedinformation? 0oes management evaluate training effectiveness? ased on training

effectiveness documented information are you giving retraining?



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(22) 0o you analyse your documented information to find out route cause for takingcorrective actions to product and process nonconformity? $here do you documentedresults of effectiveness of corrective actions?

(2#) Are you following methods for process control3 process &ualification : process

monitoring on manufacturing machines? $hat are the control parameters during themanufacturing processes? $hat are std Calues : tolerances? Are you using anysu!ective criteria for inspection or process control? How do you maintain documentedinformation for the same? Have you done eye checking of the persons doing thechecking?

(2/) How do you receipt and issue materials within and outside your department? $here isit documented?

(2.) $hat are the steps followed for identifying : disposal of non-conforming materials?How do you identify uninspected3 conforming : not * material?

(24) Have you !een audited? How many 5


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(#) s there appropriate control of materials3 e&uipment and critical parameters of utilityprocess? How do you monitor and control your processes? Are you maintainingdocumented information for process control monitoring?

(/) Have you !een audited? How many 5


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(6) Have you prepared clear specification for all the purchase items? How do you getinformation on purchasing data form user department? Have you prepared purchasespecification for raw materials and are you referring the same document in thepurchase order? How are you getting details for the spares and hardware and o! work

items? How are you getting specification for the same? How do you give codification for part num!er?

(8) Have you made agreement for &uality assurance with your su!contractor? Have youesta!lished any control on them? How do you select su!contractor for o! contract?How do you esta!lish control on them?

(+) rocess is defined within the 7' for such outsourcedprocess? Have you esta!lished system for selection of vendors and outsourced activities and

how do you communicate such controls to them?

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(12) Have you done periodic evaluation and vendor rating of your supplier? $hich items areincluded for the same?

(1#) How do you carry out cash purchase? $ho is authorised to purchase against letter of indent?

(1/) s there necessary infrastructure and environment in your department for the operationof process?

(1.) $ho is reviewing and approving purchase order for ade&uacy of the specifiedre&uirements prior to release? $here is the list of authorised person for the same?

(14) How do you carry out purchase of service like la!our contract3 cali!ration of instrument3transport etc? 0o you prepare >*?


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(2.) Have you documented o! description with authority and responsi!ility to all theconcerned persons in your department?

(24) $hat is the process approach in your department? $hat is the input and output in your various activities done !y you? Have you prepared 7uantifia!le criteria for your

department to monitor the effectiveness? How do you monitor it? Have you conveyedthe same to the concerned person staff mem!ers in your department? $hat is actionplan for achievement of &uantifia!le criteria? y which data? $hat is action plan for thesame?

(26) $hat kind of communication process is esta!lished within the organisation? How thecommunication takes place regarding the effectiveness of 7uality 'anagementystem? Have you made any documented information for the same? How is itimplemented?

6. SO"S 7"AW MA"IA# A!D S$A"S8: '

(1) How do you prevent3 or reduce3 undesired effects related to risk?(2) Have you define a &uality risk assessment process? how me

(#) How do you maintain account for o! work materials send with gate pass?

(/) $hich methods are followed for receipt and issue of materials form store? Are youhaving persons list for the issue of materials for the same? How do you maintaindocumented information for the issue and receipt of material?

(.) s the method for >reserving material ade&uate? How do you take care for thepreservation of materials?

(4) $hat are the things you consider in your department at the time of change in

organiation?(6) s there necessary infrastructure and environment in your department for the operation

of process?

(8) Have you update risks !ased on such investigation in documented information?

(+) 0o you maintain proper inspection and test status for materials lying in store area?

(1,) How do you identify uninspected3 * : not * materials? How do you informconcern department person for arrival of materials to carry out necessary inspection?How do you control shelf life material?

(11) How do you maintain stock documented information? Have you specified location for

the storage of different items? How do you keep track for the same?

(12) Have you specified minimum inventory level at any place for critical items? Are youinvolved in raising the indent for follow up of indent for the indent raised !y variousdepartments? How do you keep tack for the pending indents?

(1#) $hat types of controls are esta!lished to avoid deterioration of 7uality of materialduring storage? $hat controls are followed for self-life material used?

(1/) How do you dispose off non-confirming materials?

(1.) 0o you implement action from risks and opportunities?

(14) 0o you verify 7uality3 !rand and type of materials with respect to purchase order onreceipt in the store



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(16) $hat is the process approach in your department? $hat is the input in the variousactivities done !y you? Have you prepared 7uantifia!le criteria for your department tomonitor the effectiveness? How do you monitor it? Have you conveyed the same to theconcerned staff mem!ers in your departments?

(18) Are you having '0 for all the chemicals stored in the raw materials stores? How doyou take care for the various sym!ols put on the packing of raw materials and what isthe meaning of the same? Have you got any training for the safety issues?

. $A%(I!G A!D DS$A%: '(1) Are you putting identification la!el as per contract made with customer?


(#) Are you control-packaging materials and follow same packing method as per agreement with customer?

(/) Are you inspecting and testing the packing materials? how the documentedinformation of same

(.) 0o you implement action from risks and opportunities?

(4) How do you get information for packing and despatch of different types of pigments?(6) How do you get carrying out a !lending of materials? Are you inspecting the !lended

lot? $hat is the system of giving the lot num!er?(8) How do you get information form the 7< for the inspection test status and who is

authorised to release the materials !ased on final inspection and testing? How are yougetting the information for lot ready for despatch?

(+) How do you get information for customer re&uirements for example packing materials3

hipping mark3 >acking weight etc? How do you esta!lish proper control for thesame? $hat care is taken for the same?

(1,) Have you define a risk assessment process? how me


(12) Are ade&uate instructions provided for packing and how do you take care for &uality of materials for delivery to destination or customer’ s place

(1#) $hat care are taken for product &uality during packing?(1/) How do you control and store materials in the packing area? Have you identified areas

for storage of different materials? How do you maintain stock for the same?(1.) $hat is input to your department? $hat is output form your department? Have you

identified any 7uantifia!le criteria? How do you monitor the same?(14) $hat are the things you consider in your department at the time of change and what isthe change management process followed !y you?

(16) s there necessary infrastructure and environment in your department for the operationof process?

9. ADMI!IS"AIO!S A!D "AI!I!G: '(1) Have you determine competence of personnel performing work affecting conformity to

the product re&uirements? How? ased on that how do you identify training needs or recruitment of new person for the various levels of employees?

(2) Are you having competence chart for the various levels of employees? How do you

ensure the competence and are you having annual appraisal to ensure competence of employee?

(#) How do you prevent3 or reduce3 undesired effects related to risk?



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(/) s there necessary infrastructure and environment in your department for the operationof process?

(.) How do you provide the training or necessary actions to achieve necessarycompetence competency need for the various levels of employees?

(4) $hat mechanism if followed !y you so that all the personnel are aware for therelevance and importance of their activities and how can they contri!ute to theachievements of the &uality o!ectives?

(6)


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(4) Have you define risk assessment process? how me? $hat are the risk andopportunity related to your activities?

(6) $hat are the things you consider in your department at the time of change and howchange management is followed !y you?


(+) Are you considering all the statutory and regulatory re&uirements like use of annedproducts3 process limitation3 and 'aximum pressure limits? A"' or standards?$here of you maintain the documented information for the same?

(1,) How do you make design calculations? How so you document design outputs?(11) How do you plan for trial production3 = : 0 experiments and new ig development

during = : 0 stage? $here do you maintain the documented information? How do youmonitor performance of the trial run?

(12) Hoe do you document design output covering information related to purchase3production etc $here do you document acceptance criteria for the products? How do

you ensure product application for example paper3 textile3 plastic etc for the variouspigments developed !y you?

(1#) $here do you document stages of design review in the design plan? How do you carryout design review? $ho are the team mem!ers for the design review? Are you makingany action plan? $here do you documented information results of review?

(1/) How do you carry our design and development verification? efore releasing theproduct from la!oratory are you documenting product specification in documentedform? How do you monitor the same?

(1.) How do you validate the design? $here do you maintain the documented informationfor the same?

(14) s there necessary infrastructure and environment in your department for the operation

of process?

(16) $hat is the different document generated form your departments? How do youesta!lish control for design and development changes?

(18) $hat is the process approach made !y you? $hat is input to your department? $hatis output from your department? How do you monitor your &uantifia!le criteria? How doyou analyse results? $hat is action plant for achieving the same?

(1+) $hen do you take corrective actions for the effect of the potential pro!lems? How doyou determine potential nonconformities and their casues? How do you documentedinformation results of action taken?

(2,) 0o you implement action from risks and opportunities?

11. O$ MA!AGM!: '(1) How do you made your 7uality >olicy? How do you demonstrate leadership : commitment

with 7'?How? Have you documented your 7uality >olicy o!ectives? $here? How doyou ensure that it is implemented !y all the employees? 0oes the 7' o!ectives are inline with strategic direction of the organiation?

(2) How do you provide evidence of your commitment to the development andimplementation of the 7uality 'anagement ystem and continually improving itseffectiveness?

(#) How do you ensure customer re&uirement are determined (tated product related3

Application related or intended use3 statutory and regulatory and additional) and metwith the aim of enhancing customer satisfaction as a part of customer focus? How doyou communicate the same to all the employees 9



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(/) Have you determine external and internal issues in the 7uality management system (7')?0oes this issues are relevant to its purpose and a!ility to achieve intended outcome of 7'?

(.) s there 7uantifia!le o!ectives defined from 7uality >olicy? How do you measure7uality >olicy o!ectives? $here? s it supported with o!ective evidence?

(4) $hat are the prime o!ectives for going for * +,,1;2,1. 7uality 'anagementystem? $hat is your experience after implementing *; +,,, systems in last four months?

(6) Have you determine the !oundaries and applica!ility of the 7uality management system?(8) $hat are the advantages gain !y the company after implementation of * +,,1;2,1.

7uality 'anagement ystem?(+) Have you considered the context of the organiation’s overall !usiness activities and issues

and conditions affected !y your activities? ased on that have you identified risk andopportunity and what actions are planned? $hat is your next . years vision and to achievegoals how do you see organiation commitment for 7uality management system?

(1,) Are regular 'anagement =eview 'eetings held to review 7uality system? How 'any

management review meetings are held? Any agenda or circular for the same? How doyou review effectiveness of system with respect to 7uality o!ectives and *; +,,1re&uirements? 0o you receive any report from H*0 for review on effectiveness of system? $hich points are discussed in 'anagement =eview 'eeting?

(11) How do you get information for re&uirement of resources? 0oes management providedade&uate resources for installation of 7uality 'anagement ystem like (1) Humanresources (

Documents

ISO9001-2015 Departmentwise Audit Questionnaire