ISO 9001:2015, Department Wise Audit Questionnaire
1.
QMS & G!"A# $"O%D"S:'
(1) (1)
How How do you you meas measur ure e effec effecti tive vene ness ss of of syst system em for for worki working ng of you yourr compa company ny? ? How do do you collec collectt neces necessar sary y inform informati ation on for the same? same? Are Are you gettin getting g inform informati ation on 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 $hat are are the needs needs and and expect expectati ation ons s of inter interest ested ed partie parties s in %nvir %nvironm onment ent manage managemen mentt system? $hat procedure or process is followed to understand interested parties re&uirements? re&uirements?
How How do you esta esta!l !lis ish h the the %'? %'? How How do you !rin !ring g cont contin inua uall impr improv ovem emen entt in %nvironment management system in accordance of * +,,1-2,1.? (/) (/)
How How do you you plan plan for for manag managem emen entt review review mee meeti ting ng and and who who are are comm commit itte tee e mem! mem!er er? ? 0o you you circu circulat late e agenda agenda for 'anag 'anageme ement nt review review meetin meetings gs in advanc advance? e? 0o you you prep prepar are e minu minute tes s of 'ana 'anage geme ment nt revi review ew meet meetin ing g with ith the the acti action ons s deci decide ded d in management review meeting? How do you monitor effectiveness of the system? Are you having any &uantifia! &uantifia!le le o!ectives o!ectives for managemen managementt review? review? $hen do you review it?
(.)
Have you done any planning for how to achieve the environmental o!ectives? 0oes this plan cover what will !e done3 resource details and responsi!ilities3 target date? How the results are evaluated 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 conformities encountered?
(6)
How do you improve the suita!ili suita!ility3 ty3 ade&uacy ade&uacy33 and effectivene effectiveness ss of the 7' to enhance enhance performance? Have you determined is there needs or opportunities that are addressed as a part of continual improvement? improvement?
(8) (8)
Are Are you you doin doing g foll follow ow-u -up p for for comp comple leti tion on of acti action on deci decide ded d in 'ana 'anage geme ment nt revie review w meetings? How? $hat is input and output of 'anagement review meetings?
(+) (+)
0oes 0oes the the maste masterr list for for docum documen ente ted d infor informa matio tion? n? how how us late latest st revi revisi sion on of 7ual 7uality ity '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 different types of documents? How do you get information for changes in the procedure 9 documented information? How do you inform to all the concerned person?
(1,) (1,)
How docum document ents s are identi identifie fied d for contro control9u l9unco ncontr ntroll olled ed : o!sole o!solete? te?
(11 (11)
0o you you prese preserve rve o!s o!sole olete te docu documen ments? ts? $he $here re do you you pres preserv erve e it?
(12) (12)
0o you you have have list list of train trained ed audi audito tors rs? ? $ho $ho has has give given n trai traini ning ng to them them as per per * * +,,1;2,1.? How many days? Have you made audit plan : audit schedule? 0uring auditing do the auditor check and monitor results of 7uantifia!le criteria reported !y the functional heads? 0oes all the 5<=’s communicate to respective function heads? Are they closed? Have you prepared plan for internal &uality audit for whole year? How do auditors carry out internal &uality audit? %xplain us how do you use audit checklist? Have you done any audit summary for department-wise 9
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ISO 9001:2015, Department Wise Audit Questionnaire (1#)
How do you carryout audit for >urchase department? Have you checked effectiveness of training given and competence of auditors? How?
(1/)
0o you maintain documented information for the actual audit carried out against audit planned 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 to that department are audited in internal &uality audit? How do you see effectiveness of action taken on audit 5<=? $here is it documented?
(14)
s the 7uality >olicy well understood at all levels? Have you arrange training on 7uality policy?
(16)
Have you documented customer re&uirements !ased on the customer need? Have you documented statutory and regulatory re&uirements applica!le to your product? How do you 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!lish control 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 and action taken !y concerned department? %xplain details of corrective and action procedure? How do you monitor it? Have you done analysis of audit 5<=’s? ased on that have you taken any corrective and action?
(21)
how us master copy of format with approval for all the formats and exhi!its applica!le in 7' area? Have you made 7uality >lan for different activities and inter-linkage of your various departments?
(22)
Have you prepared o! description specification for different level of employees in the company? How do you communicate the same to the various employees?
(2#)
$ho will identify need for statistical techni&ues? How it is identified and implemented?
(2/)
Have you identified the process needed for the 7uality 'anagement ystem? How is it applied throughout the organisation? Have you identified critical processes? How do you identify interaction of processes as well as criteria and methods needed to ensure that !oth the operation and control of the processes are effective? How do you m onitor3 measure and analyse the processes?
(2.)
Have you identified any exclusion? $hat ustifications are given for the same? Have you documented the same? $here?
(24)
(26)
Have you made any mechanism for ensuring availa!ility of resources vs further re&uirements? How do you identify resource re&uirements? How do you fulfil the same? A#(A)AA %OM$A!* + .a-a/aa.om
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ISO 9001:2015, Department Wise Audit Questionnaire (28)
Have you identified customer re&uirements to enhance the customer satisfaction? How do you ensure promotion of awareness of customer re&uirements throughout the organisation?
(2+)
$hat kind if communication process is esta!lished within the organisation? How the communication takes place regarding the effectiveness of 7uality 'anagement ystem? Have you made any procedure for the same? How is it implemented?
(#,)
How do you ensure competence of persons performing work affecting conformity of the product? $hat kind of infrastructure do you provide? How do you identify and convey your need for the resources?
(#1)
How do you ensure customer satisfaction? Have you done any customer survey? Have you analyse data for the 7uestionnaire su!mitted !y the customer? Have you taken actions !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 time cycle 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? $here? How do you review the effectiveness of the action taken?
(#.)
Have you fixed any action plan for the achievement of 7uantifia!le criteria? y which data and how it will !e achieved? how us action plan for achieving the same
2.
QA#I* %O!"O#: '
(1)
Are acceptance : reection criteria specified for different process parameters and product tested !y your company? Have you prepared overall inspection test plan covering references of work instruction3 acceptance criteria3 format and parameters tested for different types of products for incoming3 in process and final stage of inspection?
(2)
Are you inspecting 9 verifying all the critical products3 new developed products or purchased material? How? Any documented information are kept for the same? Are you testing raw materials? How?
(#)
Have you trained staff for follow up of operating procedures : work instruction of 7A3 @a!oratory : test methods for testing of various products? Have you received any test method given !y your customer?
(/)
How do you carry out cali!ration of la!oratory instruments used !y your personnel for department testing work? How do you maintain cali!ration status? How do you control : maintain instruments in your department?
(.)
Have you done cali!ration of e&uipment like la!oratory instruments3 weighing !alance3 etc? s it tracea!le to approved national 9nternational standards? f such tracea!ility is A#(A)AA %OM$A!* + .a-a/aa.om
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ISO 9001:2015, Department Wise Audit Questionnaire not availa!le then is it cali!rated against documented method or esta!lished methodology? (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 test reports9 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 regulatory re&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 final stages 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 : meet customer re&uirements? How do you carry out final inspection of product to !e supplied to different segment like replacement market3 defence3 exports etc? $here are you keeping documented information?
(12)
Have you attended management review meetings? $hich was discussion related to your areas? Have you completed actions decided in management review meeting in your area?
(1#)
How do you get special test re&uirements of customers and how it is carried out? 0o you 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? All type of documented information including computerised documented information maintained !y you is covered in the master list of documented information? n your all the files record name and format no (f applica!le) is written? >roper document control is esta!lished !y you?
(1.)
Have you !een audited? How many 5<=’s given to you? Have you taken actions to close the same?
(14)
Are you using any su!ective criteria for inspection and testing? How do you esta!lish control for the same?
(16)
$hat is the process approach in your department? $hat is the input and output in your la!oratory? Have you prepared 7uantifia!le criteria for you area? How do you monitor it? Have you conveyed the same to the concerned person? Have you prepared any action plan for the achievement of 7uantifia!le criteria?
(18)
How do you carryout process audit?
(1+) (2,) (21)
How do you prevent3 or reduce3 undesired effects related to risk? Have you define a &uality risk assessment process? how me $hat are the things you consider in your department at the time of change in organiation? A#(A)AA %OM$A!* + .a-a/aa.om
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ISO 9001:2015, Department Wise Audit Questionnaire (22)
s there necessary infrastructure and environment in your department for the operation of 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 you having list of approved 0ealer 9 Agent list for the same?
(2)
Have you prepared your company !rochure? Are you having price list? $ho approve it? How do you finalise price for the new product?
(#)
How do you participate in defining re&uirements for new products? How do you get information 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 you communicate it to 0esign3 'anufacturing3 7<3 packing etc?
(.)
How do you sale your products? How do you understand re&uirements related to the products as !elow;
1
=e&uirements specified !y the customer
2
=e&uirements not specified !y the customer for intended use
#
tatutory and regulatory re&uirements applica!le to the product
/
Any additional re&uirements considered necessary !y the organisation
(4)
$hat are the 7uantifia!le criteria for your department? How do you monitor it? Have you given any further criteria for your other sales staff? $hat process approach do you adopt? $hat is input and output of your department? Have you done any analysis for timely completion of orders or delay is delivery? How do you amend the order?
(6)
How do you monitor effectiveness of department?
(8)
How do you know plant capa!ility for manufacture of different types of product? How do you given delivery schedule? Have you done internal contract review any time? $here are contract review report? How do you convey the same to the plant? How do you confirm capa!ility for new product development with the customer as well as convey the same to plant?
(+)
$hat are the things you consider in your department at the time of change in organiation?
(1,)
How do you handle customer complaints? Any documented information are maintained? $hen do you close such complaints? How fast you close the customer A#(A)AA %OM$A!* + .a-a/aa.om
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ISO 9001:2015, Department Wise Audit Questionnaire complaints? Have you done any analysis for customer complaints and warranty claims attended !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 laid down?
(12) (1#) (1/)
How do you prevent3 or reduce3 undesired effects related to risk? Have you define a &uality risk assessment process? how me s there necessary infrastructure and environment in your department for the operation of 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 in management review meeting?
(16)
How do you maintain documented information in your area ? All type of documented information including computerised documented information maintained !y you is covered and maintained?
(18)
Have you !een audited? How many 5<=s are given to you? Have you taken actions to close the same?
(1+)
Have you update risks !ased on such investigation in documented information?
(2,)
How do you determine and implement effective arrangements for communicating customers for product information (@ist of your !rand products)3 order handling3 complaints etc Have you fixed any timeframe for the effective communication with customer?
(21)
How do you measure customer satisfaction? Have you defined methods for the same? Have you analysed such data? Have you taken any corrective action for the same? $hat is input for customer satisfaction survey? Have you fixed any criteria for customer satisfaction?B
4.
$"OD%IO! A"AS: '
(1)
Are production Head3 n charge3 supervisors : workers trained for the methods : skills to perform their task as well as applica!le * +,,1;2,1. documented information? Are the operators aware of their work instructions for operation on respective work area?
(2)
$hat is the process approach in your manufacturing activity? $hat is the input and output in your various processes? Have you prepared 7uantifia!le criteria for your process? How do you monitor it? Have you conveyed the same to the concerned person like supervisors and workers?
(#)
s there necessary infrastructure and environment in your department for the operation of process?
(/)
Have you identified operational control points of your activities? Are you having documented operational control plan? Are you maintaining documented information as per the re&uirements of operational control plan? how me documented information
(.)
0o you implement action from risks and opportunities?
(4)
Have you update risks !ased on such investigation in documented information? A#(A)AA %OM$A!* + .a-a/aa.om
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ISO 9001:2015, Department Wise Audit Questionnaire (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 any documented 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? How do you
(11)
How do you ensure that outsourced process is controller or influenced $hat type and extent of control or influence is applied to the >rocess is defined within the 7' for such outsourced process? Have you esta!lished system for selection of vendors and outsourced activities and how do you communicate such controls to them?
(12) (1#)
How do you prevent3 or reduce3 undesired effects related to risk? $hat methods for monitoring3 measurement3 analysis and evaluation are followed to ensure valid 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 on customer complaint or production feed!ack for particular lot? How do you identify finished 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 you carryout 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 s there appropriate control of materials3 e&uipment’s : critical parameters of process? How do you monitor and control your >rocesses? Are you maintaining documented information for process control monitoring? How do you get the information for the mixing of various products?
(18)
(1+)
s there inspection : test status given for downgrade materials? How? Are there appropriate documented information for disposal of non-conforming materials : who is authorised 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? 0o you maintain the documented information for the same? Are ade&uate e&uipment used for storage : Handling?
(21)
s training provided at all levels of workman in the company? $here are documented information? 0oes management evaluate training effectiveness? ased on training effectiveness documented information are you giving retraining?
A#(A)AA %OM$A!* + .a-a/aa.om
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ISO 9001:2015, Department Wise Audit Questionnaire (22)
0o you analyse your documented information to find out route cause for taking corrective actions to product and process nonconformity? $here do you documented results 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 the manufacturing processes? $hat are std Calues : tolerances? Are you using any su!ective criteria for inspection or process control? How do you maintain documented information for the same? Have you done eye checking of the persons doing the checking?
(2/)
How do you receipt and issue materials within and outside your department? $here is it 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<=’s are given to you? Have you taken actions to close the same?
(26)
Have you attended management review meetings? $hat was discussion related to your areas? Have you completed actions decided in management review meeting in your area?
(28)
$hat kind of communication process is esta!lished within the organisation? How the communication takes place regarding the effectiveness of 7uality 'anagement ystem? How is it implemented?
(2+)
How do you ensure competence of persons performing work affecting the 7uality? Have you identified competence level for employees? $hat kind of infrastructure do you provide? How do you identify and convey your need for the resources?
(#,)
$hen do you take actions for the effect of the potential pro!lems? How do you determine potential nonconformity and their causes? How do you document results of action taken? How do you review the effectiveness of the action taken? How do you review actions in the management review meetings?
(#1)
Have you analysed documented information for the conformity of product re&uirements of characteristics and trends of processes and products including opportunities for improvement?
(2#)
How do you ensure achievement of 7uantifia!le criteria? y which date you will achieve it? How? $here is action plan for the same?
5.
!GI!"I!G 7I#I* A!D MAI!!A!%8: '
(1)
Have your documented preventive maintenance schedule? s it !ased on manufacturer’s suggestions? Are you timely following it? $here is it documented? Are you having e&uipment history data? Are you maintaining !reakdown maintenance data? Are you doing analysis of !reakdown maintenance and taking necessary corrective actions?
(2)
Are you following methods for process control and process monitoring on utility e&uipment? $hat is the control parameter during the processes? $hat is std Calues : "olerances?
A#(A)AA %OM$A!* + .a-a/aa.om
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ISO 9001:2015, Department Wise Audit Questionnaire (#)
s there appropriate control of materials3 e&uipment and critical parameters of utility process? How do you monitor and control your processes? Are you maintaining documented information for process control monitoring?
(/)
Have you !een audited? How many 5<=’s are given to you? Have you taken actions to close the same?
(.)
Have you attended management review meetings? $hat was discussion related to your areas? Have you completed actions decided in management review meeting in your area?
(4)
$hat is the process approach in your maintenance activity? $hat is the input and output in your various processes of your utilities as well as plants? Have you prepared 7uantifia!le criteria for your department to monitor the effectiveness? How do you monitor it? Have you conveyed the same to the concerned person like supervisors and workers? $hat is action plan for achievement of &uantifia!le criteria? How do you achieve it?
(6)
How do you ensure competence of persons performing work affecting the 7uality? $hat kind of infrastructure do you provide? How do you identify and convey your need your need for the resources?
(8) (+)
How do you prevent3 or reduce3 undesired effects related to risk? 0o you implement action from risks and opportunities?
(1,)
Have you update risks !ased on such investigation in documented information?
(11) (12)
Have you define a &uality risk assessment process? how me Are you analysing !reakdown data? How? Are you taking any corrective actions !ased on it? $hen do you take actions for the effect of the potential pro!lems? How do you determine potential nonconformity and their causes? How do you document results of actions taken? How do you review actions in the management review meetings?
(1)
$hat competence3 education and experience are re&uired for your employees? $hat have your documented it? ased on that any gap is found in your department? How do you maintain the documented information for the same? $hat are the things you consider in your department at the time of change in organiation?
(2) (#)
s there necessary infrastructure and environment in your department for the operation of process?
.
$"%AS: '
(1)
Have you selected vendor and suppliers? Have you prepared Approved Cendor @ist? $hat is a selection criterion? 0o you maintain documented information for AC@ : Cendor selection9 evaluation?
(2) (#) (/)
How do you prevent3 or reduce3 undesired effects related to risk? Have you define a &uality risk assessment process? how me $hat are the things you consider in your department at the time of change in organiation?
(.)
Have you update risks !ased on such investigation in documented information?
(4)
Have you prepared any &uestionnaire for selection of vendor?
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ISO 9001:2015, Department Wise Audit Questionnaire (6)
Have you prepared clear specification for all the purchase items? How do you get information on purchasing data form user department? Have you prepared purchase specification for raw materials and are you referring the same document in the purchase 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 you esta!lished any control on them? How do you select su!contractor for o! contract? How do you esta!lish control on them?
(+)
(1,)
How do you ensure that outsourced process is controller or influenced $hat type and extent of control or influence is applied to the >rocess is defined within the 7' for such outsourced process? Have you esta!lished system for selection of vendors and outsourced activities and how do you communicate such controls to them?
(11) (12)
Have you done periodic evaluation and vendor rating of your supplier? $hich items are included 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 operation of process?
(1.)
$ho is reviewing and approving purchase order for ade&uacy of the specified re&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 instrument3 transport etc? 0o you prepare >*?
(16)
Are you going to vendor’s place for inspection of the product and are you conveying vendors for test certificate re&uirement as re&uired !y you?
(18)
How do you keep track for re&uirement vs purchase order release vs materials receipt and monitor your purchase activity? How do you keep track for pending re&uirements and descri!e purchase order cancellation procedure? How do you keep track for pending purchase order? How do you amend the purchase order? how us documented information?
(1+)
Are you using any vendor’s standard documents or master sample and who is controlling the same?
(2,)
0o you *ut sourced any of the processes?
(21)
How do you control the su!contracted processes?
(22)
Have you !een audited? How many 5<=’s are given to you? Have you take actions to close the same?
(2#)
0o you implement action from risks and opportunities?
(2/)
Have you attended management review meetings? $hat was discussion related to your areas? Have you completed actions decided in management review meeting in your area? A#(A)AA %OM$A!* + .a-a/aa.om
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ISO 9001:2015, Department Wise Audit Questionnaire (2.)
Have you documented o! description with authority and responsi!ility to all the concerned 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 conveyed the same to the concerned person staff mem!ers in your department? $hat is action plan for achievement of &uantifia!le criteria? y which data? $hat is action plan for the same?
(26)
$hat kind of communication process is esta!lished within the organisation? How the communication takes place regarding the effectiveness of 7uality 'anagement ystem? Have you made any documented information for the same? How is it implemented?
6.
SO"S 7"AW MA"IA# A!D S$A"S8: '
(1) (2) (#)
How do you prevent3 or reduce3 undesired effects related to risk? 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 you having persons list for the issue of materials for the same? How do you maintain documented information for the issue and receipt of material?
(.)
s the method for >reserving material ade&uate? How do you take care for the preservation 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 inform concern 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 you involved in raising the indent for follow up of indent for the indent raised !y various departments? How do you keep tack for the pending indents?
(1#)
$hat types of controls are esta!lished to avoid deterioration of 7uality of material during storage? $hat controls are followed for self-life material used?
(1/)
How do you dispose off non-confirming materials?
(1.)
0o you implement action from risks and opportunities?
(14)
0o you verify 7uality3 !rand and type of materials with respect to purchase order on receipt in the store
A#(A)AA %OM$A!* + .a-a/aa.om
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ISO 9001:2015, Department Wise Audit Questionnaire (16)
$hat is the process approach in your department? $hat is the input in the 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 conveyed the same to the concerned staff mem!ers in your departments?
(18)
Are you having '0 for all the chemicals stored in the raw materials stores? How do you take care for the various sym!ols put on the packing of raw materials and what is the meaning of the same? Have you got any training for the safety issues?
.
$A%(I!G A!D DS$A%: '
(1) (2) (#)
Are you putting identification la!el as per contract made with customer? How do you prevent3 or reduce3 undesired effects related to risk? 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 documented information of same 0o you implement action from risks and opportunities?
(/) (.) (4) (6) (8)
(+)
(1,) (11) (12) (1#) (1/) (1.) (14) (16)
How do you get information for packing and despatch of different types of pigments? 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? 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 you getting 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 the same? $hat care is taken for the same? Have you define a risk assessment process? how me Have you update risks !ased on such investigation in documented information? 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 $hat care are taken for product &uality during packing? 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? $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? $hat are the things you consider in your department at the time of change and what is the change management process followed !y you? s there necessary infrastructure and environment in your department for the operation of process?
9. ADMI!IS"AIO!S A!D "AI!I!G: ' (1)
(2)
(#)
Have you determine competence of personnel performing work affecting conformity to the product re&uirements? How? ased on that how do you identify training needs or recruitment of new person for the various levels of employees? Are you having competence chart for the various levels of employees? How do you ensure the competence and are you having annual appraisal to ensure competence of employee? How do you prevent3 or reduce3 undesired effects related to risk? A#(A)AA %OM$A!* + .a-a/aa.om
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ISO 9001:2015, Department Wise Audit Questionnaire (/)
s there necessary infrastructure and environment in your department for the operation of process?
(.)
How do you provide the training or necessary actions to achieve necessary competence competency need for the various levels of employees? $hat mechanism if followed !y you so that all the personnel are aware for the relevance and importance of their activities and how can they contri!ute to the achievements of the &uality o!ectives?
(4)
(6)
(8)
(+)
(11)
(12)
Have you update risks !ased on such investigation in documented information?
(1#)
$hat are the things you consider in your department at the time of change in organiation?
(1,)
(1/) (1.)
Have you identified any training need for special activity !ased on multi skill analysis? 0o you get timely resources or delay to get resources? $hat are the step at the time of un availa!ility of resources?
(14)
0o you provide training or take other actions to achieve the necessary competence? Have you define what is appropriate education3 training and experience for different category of persons? $here do you maintain such documented information? Have you ensure that the necessary competence has !een achieved? $hat actions are taken to ac&uire the necessary competence? How do you evaluate the effectiveness of action taken for example written test3 mock trail3 review of effectiveness of training etc? $hat action was taken to upgrade the competence of people? Are you maintaining appropriate information and documented information of education3 training3 skills and experience and &ualifications as an evidence of competence?
(16)
(18)
10.
"SA"% A!D D;#O$M!: '
(1)
How do you get information for the new = : 0 work and product or process related development work? Are you carrying out any design and development planning? How do you prevent3 or reduce3 undesired effects related to risk? How do you identify various design and development stages covering design review3 verification and validation? How do you maintain he documented information for the same? How do you carryout interfaces with different department for = : 0 work? How do you assign responsi!ility for = : 0 work to various team mem!ers? How do you get input for the design and development activities? $here do you maintain documented information for the new products as well as application related changes in the existing product or input for all the modification proects? How do you document design input?
(2) (#)
(/) (.)
A#(A)AA %OM$A!* + .a-a/aa.om
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ISO 9001:2015, Department Wise Audit Questionnaire (4) (6)
Have you define risk assessment process? how me? $hat are the risk and opportunity related to your activities? $hat are the things you consider in your department at the time of change and how change management is followed !y you?
(8)
Have you update risks !ased on such investigation in documented information?
(+)
Are you considering all the statutory and regulatory re&uirements like use of anned products3 process limitation3 and 'aximum pressure limits? A"' or standards? $here of you maintain the documented information for the same? How do you make design calculations? How so you document design outputs? 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 you monitor performance of the trial run? Hoe do you document design output covering information related to purchase3 production etc $here do you document acceptance criteria for the products? How do you ensure product application for example paper3 textile3 plastic etc for the various pigments developed !y you? $here do you document stages of design review in the design plan? How do you carry out design review? $ho are the team mem!ers for the design review? Are you making any action plan? $here do you documented information results of review? How do you carry our design and development verification? efore releasing the product from la!oratory are you documenting product specification in documented form? How do you monitor the same? How do you validate the design? $here do you maintain the documented information for the same? s there necessary infrastructure and environment in your department for the operation of process?
(1,) (11)
(12)
(1#)
(1/)
(1.) (14) (16)
(2,)
$hat is the different document generated form your departments? How do you esta!lish control for design and development changes? $hat is the process approach made !y you? $hat is input to your department? $hat is output from your department? How do you monitor your &uantifia!le criteria? How do you analyse results? $hat is action plant for achieving the same? $hen do you take corrective actions for the effect of the potential pro!lems? How do you determine potential nonconformities and their casues? How do you documented information results of action taken? 0o you implement action from risks and opportunities?
11.
O$ 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? $here? How do you ensure that it is implemented !y all the employees? 0oes the 7' o!ectives are in
(18)
(1+)
line with strategic direction of the organiation?
(2)
(#)
How do you provide evidence of your commitment to the development and implementation of the 7uality 'anagement ystem and continually improving its effectiveness? How do you ensure customer re&uirement are determined (tated product related3 Application related or intended use3 statutory and regulatory and additional) and met with the aim of enhancing customer satisfaction as a part of customer focus? How do you communicate the same to all the employees 9 A#(A)AA %OM$A!* + .a-a/aa.om
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ISO 9001:2015, Department Wise Audit Questionnaire (/)
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 measure 7uality >olicy o!ectives? $here? s it supported with o!ective evidence? $hat are the prime o!ectives for going for * +,,1;2,1. 7uality 'anagement ystem? $hat is your experience after implementing *; +,,, systems in last four months?
(4)
(6) (8)
Have you determine the !oundaries and applica!ility of the 7uality management system?
(+)
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 and opportunity and what actions are planned? $hat is your next . years vision and to achieve goals 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 do you review effectiveness of system with respect to 7uality o!ectives and *; +,,1 re&uirements? 0o you receive any report from H*0 for review on effectiveness of system? $hich points are discussed in 'anagement =eview 'eeting? How do you get information for re&uirement of resources? 0oes management provided ade&uate resources for installation of 7uality 'anagement ystem like (1) Human resources (
(11)
$hat are the advantages gain !y the company after implementation of * +,,1;2,1. 7uality 'anagement ystem?
(12)
$hat are the needs and expectations of interested parties in 7uality management system? $hat process is followed to understand interested parties re&uirements?
(1#)
Have you define authority and responsi!ility for all personnel? s delegation of authority and responsi!ility clearly defined? Have you define any growth rate D? How do you see future of your industries? $hat will !e company’s role in your industry? $hat is your future plan? How do you identify training need for senior personnel? How do you give feed!ack for new product development to = : 0? How do you get such information?
(1/) (1.) (16)
A#(A)AA %OM$A!* + .a-a/aa.om
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