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pdca.wordpress.com www.isoeasy.biz 1 of 21 Audit Questions – an aid to assist you in framing questions. Part of auditor tool one Question Purpose of the process How does the process support the business strategy and objectives? What are the process' supplier inputs and customer outputs? How do you determine what the customer requirements are; is this the ultimate customer? Where do you get your work from? Process objectives and targets How do you determine your objectives and targets? What are your objectives and targets? How do they link to and support the overall business objectives? How do you plan for future customer demands and the likely resources required to support them? The process itself Can you describe the process? How do any procedures support the process? Who is your customer? How do you know what your customer requirements are? How does this process interact with other processes in the management system? Who do consider as your supplier? How does your supplier support you? How do you determine the competencies required for those responsible for process activities? Key performance process measures How do you decide what key performance indicators to use? How are the process measures linked to business objectives and measures? How does your customer measure the performance of the process? Performance monitoring How do you know what the current performance of the process is? How often is process performance measured? How is performance data communicated to the process team? Improvement How do you identify improvement issues? How do process team members contribute to improving process performance? How to you evaluate the success of improvement activities? How have improvement actions affected process performance? How are improvement actions communicated to the process team?

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Audit Questions – an aid to assist you in framing questions.

Part of auditor tool one Question

Purpose of the process • How does the process support the business strategy and objectives?

• What are the process' supplier inputs and customer outputs?

• How do you determine what the customer requirements are; is this the ultimate

customer?

• Where do you get your work from?

Process objectives and

targets

• How do you determine your objectives and

targets?

• What are your objectives and targets? • How do they link to and support the overall

business objectives? • How do you plan for future customer demands

and the likely resources required to support them?

The process itself • Can you describe the process?

• How do any procedures support the process? • Who is your customer?

• How do you know what your customer requirements are?

• How does this process interact with other

processes in the management system? • Who do consider as your supplier?

• How does your supplier support you? • How do you determine the competencies

required for those responsible for process activities?

Key performance process

measures

• How do you decide what key performance

indicators to use? • How are the process measures linked to

business objectives and measures? • How does your customer measure the

performance of the process?

Performance monitoring • How do you know what the current performance of the process is?

• How often is process performance measured? • How is performance data communicated to the

process team?

Improvement • How do you identify improvement issues? • How do process team members contribute to

improving process performance?

• How to you evaluate the success of improvement activities?

• How have improvement actions affected process performance?

• How are improvement actions communicated to the process team?

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Objective evidence If we have established that the questions and questioning techniques you use as an auditor vary according to the person being interviewed and the level they are

working at within the process, then it must also follow that the objective evidence you obtain will also vary accordingly

In section 2 we looked at examples of documented and non documented

objective evidence, so let us now consider what types of objective evidence we

might find at difference levels in the business, depending upon who we are auditing and what questions we are asking.

Taking some of the questions from the Table 4.2, Table 4.3 outline the likely

objective evidence you might expect to find.

Question Evidence from process owner

Evidence from process staff

• How does the process

support the business strategy and

objectives? • What are the process

supplier inputs and

customer outputs? • How do you

determine what the customer

requirements are; is this the ultimate

customer?

• Clear understanding

of objectives

• Tells you what they

are

• Able to link to

customer outside their process and

describe requirements

• Understands what the

process is there to do

• Tells you what they are

• Able to link to next

step in process and describe

requirements.

• How do you determine your

objectives and

targets? • What are your

objectives and targets?

• How do they link to and support the

overall business objectives?

• How do you plan for

future customer

demands and the likely resources

required to support them?

• Link to overall company objectives

and targets

• Tells/shows you

• Clear understanding of overall company

objectives and targets and can demonstrate

linkage • Tells/shows you plan,

gives example of

having done it previously

• Understands their role in the process

• Understands process

performance

• Understands company's aims

• In touch with process

customers and makes

suggestions to process owner

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Question Evidence from process

owner

Evidence from process

staff

• Can you describe the

process?

• How do any procedures support

the process? • How does the process

interact with other processes in the

management system? • How do you

determine the

competencies required for those

responsible for process activities?

• Tells/Shows you

• Tells/shows you links to process activity

• Tells you what the

links are and how the communication

between them works • Understands roles

and competencies in

context of process activities, linked to

objectives

• Tells/shows you

• Tells/shows you when used and how

• Understands there

are links to other processes and knows

how they work • Knows own

competency and has

been appraised/review in

the last year.

• How do you decide what key

performance indicators to use?

• How does your customer measure

the performance of

the process?

• Tells/shows you the indicators and which

link to objectives

• Demonstrates customer

communication by

linkage of their needs to process measures.

• Tells/shows you process measures

being used

• Understands process performance in

relation to the

customer

• How do you know

what the current performance of the

process is? • How often is process

performance measured?

• How is performance data communicated

to the process team?

• Shows you

performance information

• Tells you

• Tells/shows you

• Tells/shows you

performance information

• Tells you

• Tells you/shows you

• How do you identify improvement issues?

• How do process team

members contribute to improving process

performance? • How to you evaluate

the success of improvement

activities?

• Able to link performance data to

improvement action

• Tells you and can

give examples from team

• Link back to

performance data to demonstrate

effectiveness

• Talks through methods/ideas and

links to process

owner • Knows ho and who to

suggest improvements to

• Communication from

process owner

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Appendix 1. Example auditor questions With the auditing principles and techniques explained, this section seeks to

provide some example questions based on the approaches used. As explained previously it is not easy to assess the effectiveness of a process or, indeed, a

system, by simply following the clauses of the standard organisations simply do not always work that way. Nonetheless the examples are grouped by clause for

each of reference together with questions that could be asked to demonstrate compliance along with those which seek to test effectiveness. This is not an

exhaustive list and all clauses are not covered in the detail needed, otherwise we

would end up with a book of questions that is not the point. One common trend you will notices is that asking a compliance question gives a definitive answer,

asking a question on effectiveness provides information – the auditor's job is then to add this information together to form the judgement on effectiveness. Also

notice that 'open' and 'closed' questions can be used in both areas – simply asking the question starting with what, how, where etc does not constitute skills

associated with effectiveness testing.

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Table A.1 Example questions for clause 4 of ISO 9001:2000

Clause No.

Requirement Question to whom

Compliance question Effectiveness question

4.1 Identification of

the processes

Senior

Management

Show me the processes

that make up the management system

How do you know the

correct processes have been identified?

Senior

Management

What management

information do you use to monitor the

processes?

How do you know that

the management information you use if

the correct information to control a process?

Senior

Management

What parts of your

processes are outsourced?

How do you assess

which parts of your process should or

shouldn’t be

outsourced? How is the management decision

made?

Management What parts of your processes are

outsourced?

How do you know that the outsourced work is

being effectively managed and

controlled?

Staff Member What jobs are given to other people outside the

business to do?

How often, roughly, is work done by other

people outside the organisation completed

wrongly or badly?

Staff Member What is your job? What is the impact on the customer if you

don't get your job done correctly?

Staff Member What part do you play

in the process?

How do you know if or

when you have done a good job?

Staff Member What do you do? How often do you get

work that is either wrong, incorrect, needs

rework or is simply

confusing?

4.2.1 General Senior

Management

Are procedures

documented? Do you

have a quality manual? Is there a statement of

quality and objectives?

How did you determine

what method and

approach is of most benefit to your

organisation?

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Clause

No.

Requirement Question to

whom

Compliance question Effectiveness

question

4.2.2 Quality manual Senior Management/

Management

Do you have a quality manual?

Show me your quality manual?

Does it contain the right information outlined in

the standards?

What is the purpose of the manual?

How is it used on a routine regular basis?

How is it content translated into everyday

activity? Why is it written the

way it is?

How does the manual support the objectives

of the organisation and its image with the

customer?

Staff Do you know where to find the manual?

Show me the quality manual?

What is the organisation trying to achieve?

How doe the organisation work?

How do we all work together to deliver

results?

How do we improve things in this

organisation?

4.2.3 Document Control

Management/ Staff

Do you approve documents prior to

issue? Do you have a

procedure? Show me how you

control the version etc

How often do you find that you use the wrong

information or documents in this

organisation? (ask many people to build up a

picture) Do you ever think that

you use out-of-date

information? How do you know you

are using the most up-to-date

information/documents?

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Table A.2 Example questions for clause 5 of ISO 9001:2000

Clause No.

Requirement Question to whom

Compliance question Effectiveness question

5.1 Management

commitment

Senior

Management

How do you

demonstrate that you are committed to the

development and implementation of the

management system?

How do you know that

the approaches you use to demonstrate

commitment are effective?

Staff member Are Management committed to the

management system?

Or: How committed are

Management to the management system in

this organisation?

When was the last time you saw/heard your

Manager concerned with

meeting the customer's needs? What was this?

What was the impact of these statements on

you and your colleagues?

Compare the answers given by both

management and staff and identify any inconsistencies

5.2 Customer focus Senior

Management

How do you focus on

the needs of the customer?

How do you prioritize

the needs of difference customers and other

stakeholders? We can't satisfy

everyone 100 per cent of the time, so how do

you manage this?

How is this information used to set business

objectives? How do you validate the

information to ensure it is correct, (otherwise

your objectives could be incorrect)?

Senior

Management /

Management

How do you identify

customer needs?

How do you know that

the process for

identifying customer needs is effective?

Senior

Management / Management

What process do you

have to identify what customers' needs are?

What is your role in this process?

How are customers'

needs translated into objectives that are

subsequently measured by customer satisfaction

activity? Hot does it all link together?

Senior

Management

Who is responsible for

this process?

How is this process

managed, controlled and improved on a

continual basis?

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Clause No.

Requirement Question to whom

Compliance question Effectiveness question

5.3 Quality policy Senior

Management

Show me your policy? What factors did you

consider in determining the policy details?

Staff member Do you know what the

quality policy is or where to find it?

What is important to the

organisation? How important is it that

you do a good job to you, to the customer, to

the organisation? If there was one thing

that this organisation

had to achieve what would it be?

5.4.1 Quality

Objectives

Senior

Management

Do you have quality

objectives?

How do you know the

objectives are correct?

Who created the

objectives?

How do you know that

the management agree

with the objectives set?

Are the objectives

measurable?

How were the measures

selected? How do you

know that these are actually achievable?

How many objectives

are there?

How do these objectives

complement and support each other to

move the organisation forward?

How do you know that they jointly deliver

everything you need to do as a business?

Link the answers to these questions with

those given in answer to sub clause 5.2. Do the answers link? Do they make sense?

Management What are your

objectives? Are they measurable?

How do you know if

your objectives link to those of the

organisation?

How were the objectives created?

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Clause

No.

Requirement Question to

whom

Compliance question Effectiveness

question

5.4.2 Quality management

system planning

Senior Management

Is the management system designed to

meet the objectives of the business?

How do you maintain the integrity of the

management system?

How do you know that the management

system has been designed to meet the

objectives set? How do you ensure that

the integrity of the management system is

maintained so that

customers are not adversely affected

during changes?

5.5.1 Responsibility and authority

Senior Management

Are responsibilities and authorities defined?

How are responsibilities communicated?

How do you know if these responsibilities

are being applied correctly?

How do you reallocate/reduce

responsibilities when

needed?

5.5.2 Management

representation

Senior

Management /

Management

Who is the management

representative?

Show me what you do (to the Management

Representative)

Who is the Management

team 'champions' the

management system? How effective is the

management representative in

helping the organisation to understand how it

delivers results and improves business

performance?

5.5.3 Internal communication

Senior Management

How do you communicate results to

the rest of the

organisation?

How do you know that the communication

methods you use are

effective?

Management How do you

communicate results to

your staff?

How do you translate

the organisation's

results into information that directly applies to

your staff rather than 'corporate/business

speak'? Does your manager

provide you with information on business

performance that

directly applies to you?

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Clause

No.

Requirement Question to

whom

Compliance question Effectiveness

question

Staff How well is the organisation performing?

Do management communicate to you on this

subject?

Does the information you are

provided with mean anything to you?

Does this information relate

directly to your job? How can you

influence these

results?

5.6 Management

review

Senior

Management/

Management

Do you hold a management

review?

What do you look at? What are the results of the

review? How do you record the

actions from the review?

How do you

management review

the performance of the business?

How effective are these methods?

How do you know the actions agreed

are aimed at delivering the

organisations'

objectives? Are discussions at

reviews based on improving results?

What subject areas are discussed?

How do they relate to the performance

of the business and its objectives?

What factors do you

use to prioritize improvement

activity?

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Table A.3 Example questions for clause 6 of ISO 9001:2000

Clause No.

Requirement Question to whom

Compliance question Effectiveness question

6.1 Provision of

resources

Senior

Management / Management

Do you allocate

resources? How do you manage

resources? What resources do you

need?

How do you know the

resources you used are aligned to the delivery

of the business objectives?

How do you know that the resources required

contribute to satisfying

customer needs/ requirements?

6.2.1 General Senior

Management / Management

How do you recruit

people who are competent?

How do you manage people's competences?

How do you balance the need for procedures

with people's competences?

How do you know the

balance between training and

competence and the need for procedures to

correct and effective? How do you know your

peoples' competences are sufficient to deliver

the business objectives?

Staff What resources do you

use?

If there was one thing

that would help you do your job better what

would it be?

6.2.2 Competence, awareness and

training

Management Have competences been defined?

Are training need identified?

Do you evaluate training interventions?

Do you have training records?

How do you communicate the

importance of your

staff's activities in meeting objectives?

How do you make them understand this?

How do you know the correct competences

have been defined? What methods do you

use to evaluate training and how do you know

when to use each? How do you prioritize

someone's learning/training needs?

What support do you

give that allows staff to apply what they have

learnt in the workplace? How do you know how

effective this support is? How do you know that

you have effectively communicated personal

objectives to staff?

Senior Management /

Management

What process do you have to identify what

customers' needs are?

What is your role in this process?

How are customers' needs translated into

objectives that are

subsequently measured by customer satisfaction

activity? Hot does it all

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link together?

Clause No.

Requirement Question to whom

Compliance question Effectiveness question

Staff Has the organisation

defined the competences you need

to do your job? Do you understand how

important your activities

are?

Do you think the

competences defined for your job are correct?

How good are Management at

reviewing your

competence and identifying where you

can improve? In your view is training

delivered generally too late or too early on

occasions? After you have received

training does someone 'test' or check to see

that you can apply the

training you have received?

How do your activities help this business

achieve its overall goals and objectives

6.3 Infrastructure Management What equipment /

assets do you have? How is this equipment

managed and

maintained? How is the equipment

purchased? Do you back up IT

systems? What processes do you

have to manage all your resources?

Does your process cover acquiring,

commissioning and

decommissioning an asset?

What approvals are gathered for asset

purchase?

How do you know that

the equipment is capable of delivering the

objectives?

How do you know that you have purchased an

commissioned the most appropriate equipment?

How do you assess the effectiveness of your

disaster recovery plans should your

infrastructure fall? How do you optimize

the performance of your

infrastructure resource? How do you know that

approvals for asset purchases follow the

agreed governance rules for the business?

Staff What equipment to you

use? How is the equipment

maintained?

How efficient is the

equipment you use? How quickly is it

repaired should it

breakdown? How often does

equipment failure affect your production/service

deliver?

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Clause

No.

Requirement Question to

whom

Compliance question Effectiveness

question

6.4 Work environment

Management What do you consider to be your working

environment? How is the working

environment managed? What legal and

regulatory requirements do you need to follow?

How do you know when to make a new

investment in the working environment?

How do you measure the impact of the

working environment on people's motivation to

work here?

How do you know that the working

environment supports the delivery of process

and product requirements?

Staff What is it like working

here? If the working

environment could be improved how would it

be?

Do Management ever ask for your opinion on

the acceptability of the environment to deliver

what customers need? Does the environment

you work in affect your performance and the

quality of what is

produced?

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Table A.4 Example questions for clause 7 of ISO 9001:2001

Clause No.

Requirement Question to whom

Compliance question Effectiveness question

7.1 Planning of

product realization

Management What are the processes

for production realization?

How do these processes operate?

How do you know the

correct processes have been identified to meet

the objectives set? How do you know that

the planning is an appropriate form for

business?

How has this been 'tested' to maximize the

operational performance of the organization?

7.2.1 Determination of

requirements related to the

product

Management How do you determine

what customers require?

What statutory and regulatory requirements

relate to the products/services?

What non-stated

requirements are there?

How do you know you

have determined the customers'

requirements correctly? How good do you think

you are at identifying what your customer's

needs really are?

How effective is the business at ensuring

you don't fall short of regulatory

requirements?

Staff How do you identify customers'

needs/requirements

How good do you think you (the organisation)

are at identifying what your customers' needs

really are?

7.2.2 Review of requirements

related to the

product

Management How do you review the organisation's capability

to deliver what the

customer requires? Show me the details.

How much wasted work is carried out in this

organisation as a result

of you, or the customer, changing what is

required?

Staff How do you know you are capable of delivering

what is required?

How often do you find that you can't actually

deliver what you have agreed to?

7.2.3 Customer

communication

Management How do you

communicate information to

customers? What provision have

you made that allows customers to raise

queries or provide you with feedback?

How do you know that

customers know how to communicate with the

organisation effectively? How has this type of

communication from the customer affected what

you do in the past six months?

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Clause

No.

Requirement Question to

whom

Compliance question Effectiveness

question

7.3.1 Design and development

planning

Management How do you plan the design and/or

development of a new product or service?

What resources do you need?

How do you optimize the use of resources you

have available to you? How do you prioritize

difference projects? How do you know that

your limited resources are being used in such a

way as to maximize the

benefit to the organization and its

customers?

Staff How are new designs / developments carried

out?

Do you think that the organization knows

which projects are more important than others?

How often do you get 'torn' between the

needs of difference projects and don’t know

which to do first?

7.3.2 Design and Development

inputs

Project Manager

What factors do you considered when

designing / developing a

product or service? What legal and

regulatory requirements are important?

How do you know the design inputs have been

identified correctly?

How often do you find, when testing a product

or service that the design inputs have not

been identified correctly?

Design/

Development Team

What factors do you

considered when designing / developing a

product or service? What legal and

regulatory requirement

are important?

How much wasted effort

do you think takes place on design and

development work? Do you think you are

careful enough when

you design or develop products and services?

7.3.3 Design and

development outputs

Project

Manager

What design/

development outputs do you have?

Do they contain the required product

acceptance criteria?

How may changes are

made to design/ development outputs

before they are correct and can be used?

How do you know that the design /

development outputs are relevant and

appropriate to the

needs of the rest of the business?

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Clause

No.

Requirement Question to

whom

Compliance question Effectiveness

question

Design / Development

Team

What design / development outputs do

you have? Do they contain the

required product acceptance criteria?

Can you give me an example of when the

design. development outputs have not been

understandable

7.3.4 Design and

development review

Project

Manager / Project team

How often do you hold

reviews? What is the purpose of

these reviews? Who attends these

reviews?

What happens at these reviews?

How often are agreed

deadlines for actions missed? Why is this?

How are disagreements or concerns on the way

forward resolved quickly

and to the benefit of the business?

Compared with your competitors how good

are you at getting products to market?

7.3.5 Design and

development validation

Project

Manager / project team

How do you test

products and services to check that you have

designed what you were supposed to design?

What records do you

keep?

How often do you

identify problems found with products and

services after they are released?

How do you balance the

need and risks to get the product or service

launched with making it perfect?

7.3.6 Design and

development validation

Project

Manager / project team

How do you test

products and services to check that you have

designed something that meets the original

customer or market needs?

How do you know that

customer requirements have been met when

you are designing the product and services?

7.3.7 Control of

design and development

changes

Project

Manager / project team

How are changes

incorporated into designs /

developments?

How do you know that

the changes to designs or developments will

have the desired

results?

7.4.1 Purchasing

process

Purchasing

Manager

What is the purchasing

process?

How does the process work?

Show me the process working

How do you know that

the suppliers you use

continue to contribute to the delivery of

business objectives?

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Clause

No.

Requirement Question to

whom

Compliance question Effectiveness

question

7.4.2 Purchasing information

Staff What purchasing information do you

include on purchase orders?

What quality management system

requirements do you insist upon?

How do you know that you provide sufficient

information to your suppliers, not too much

but too little? How do you know that

your suppliers are managing their business

in an efficient and

effective manner? How do you assess this?

7.4.3 Verification of

purchased product

Management How do you ensure that

the purchased product and services are what

you ordered? What actions do you

take to check that the goods you receive are

OK?

How do you reduce the

risk of bought in goods and service failure on

what is provided to your customers?

7.5.1 Control of production and

service provision

Management How do control operational activities to

ensure consistency and conformity of the

service or product?

What work instructions, control plans or

schedules do you sue to control operational

processes?

How do you plan the way in which

operational activities are performed to provide

sufficient controls?

How do you control the risks of operational

activities in meeting customer requirements?

Staff What information do you have to help you do

your job? Have you been trained

to do your job? Have you got the right

equipment to do your

job?

How do you know that what you are doing

meets your customers' requirements?

What are the greatest risks to not achieving

your customers'

requirements and how do you control them?

How do you know you have met your

customers' requirements?

7.5.2 Validation of

process for production and

service provision

Management Demonstrate the

validation methods in place to control

processes you cannot readily or economically

verify?

How often to revalidate the process controls?

How do you control any

processes you cannot readily or economically

verify? How do you know the

validation methods you

use are effective?

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Clause

No.

Requirement Question to

whom

Compliance question Effectiveness

question

Staff How do you test the process?

How do you test the process to ensure it

meets customer / product requirements?

What are the criteria you use to measure

process performance?

7.5.3 Identification and traceability

Management Do you identify products?

How do you identify products?

How have you determined to what

extent identification and traceability of the

product is required?

How do you know the controls for product

identification and traceability are

effective?

Staff Show me how products are identified?

Can you find the xyz product for me?

What problems does poor identification cause

you and how you control this?

7.5.4 Customer

property

Management Do you use customer

property in the process? How are problems with

customer property reported back to the

customer?

How do you know when

customer property is used in the process?

How is customer property identification

and protected?

When problems arise with customer property

how do you deal with them and ensure the

problem does not arise in the future?

Staff When do you use

customer property? Show me how you

protect customer property?

How do you report

problems with customer property?

What happens when you report a problem?

7.5.5 Preservation of

product

Management Show me how the

product is protected

How is conformity of the

product to specified requirement maintained

throughout the entire

process?

Staff Show me how the

product is stored

Show me how the product is identified

Show me how the product is handled

How do you know that

the product is

adequately protected during all stages of the

process?

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Clause

No.

Requirement Question to

whom

Compliance question Effectiveness

question

7.6 Control of monitoring and

measuring devices

Management Have you identified all monitoring and

measuring equipment? Has the equipment been

calibrated to a recognised standard

e.g. NAMAS approved? Show me the records

for monitoring and

measuring equipment Is the product recalled

and retested when a piece of monitoring or

measuring equipment fails calibration?

How do you determine what monitoring and

measurement is required?

How do you know that the results of the

monitoring and measuring can be relied

upon?

How is monitoring and measuring equipment

checked? What do you do when a

piece of monitoring or measuring equipment

fails calibration?

Staff What equipment do you use to monitor and

measure product or process performance to

specified requirements?

How do you know the monitoring or

measuring equipment you use is working

correctly?

8.2.1 Customer satisfaction

Management Do you measure customer satisfaction?

How do you measure

customer satisfaction?

What do you do with the information you get

from measuring

satisfaction? How do you know the

methods you use are effective in gathering

the information you need?

How do you know that the questions you

ask/information you

seek is the right information?

(Compare this to the answers from 5.2)

8.2.2 Internal audit Senior

Management

Show me your audit

schedule/programme?

How do you know when

to audit each process given the business risks

your organization faces?

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Clause

No.

Requirement Question to

whom

Compliance question Effectiveness

question

8.2.3 and

8.2.4

Monitoring and measurement of

processes and product

Senior Management /

Management

Show me your measures

Show me trends in performance

Show me the targets for each process

How do you know these are the correct

measures? What is the information

telling you? How do you know that

the information is accurate?

How do the measures

link to the business objectives?

How do you management the

process and identify cost and waste

efficiencies? Give me an example

Staff Show me the results

you achieve

What is this information

telling you? How can you influence

these results?

8.3 Control of non-conforming

product

Management Show me the procedure to control non

conforming product?

How do you make sure non-conforming

products do not get used accidentally?

Do you keep records of non-conforming

products?

How do you know that non conforming

products are note

reaching the customer or being used?

What is the impact on the business if they are

released accidentally? Why do you need

records? What do you do with

them?

Staff Show me the procedure to control non-

conforming products

How do you make sure non-conforming

products do not get used accidentally?

Do you keep records of non-conforming

products?

How often do you release non-conforming

products but don't

record it for operations reasons?

What is a non-conforming product?

How do you know that you handle all non-

conforming products the same way?

The compare he answers from management

and staff to make a judgement.

Management How do you handle product recalls?

How do you know that any product recall would

be handled to protect both the customer and

the image of the

organization?

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Clause No.

Requirement Question to whom

Compliance question Effectiveness question

8.4 Analysis of data Management Do you analyse

performance? How do you analyse

performance? Does the information

include data on customer satisfaction?

Does the information show trends in

performance against

targets?

How do you identify

improvements that maximize the benefit to

the business? How do you make

recommendations for improvement based on

the results achieved? How do you monitor the

impact of improvements

on the results achieved?

8.5.1 Continual

improvement

Senior

management /

management

Is there a process for

continual improvement?

How do you know that

improvements made are

managed and controlled?

How are appropriate people involved in

improvement activity? How do you know that

an improvement doesn’t have an adverse impact

on other activity?

Staff What improvements have taken place?

Have you been

involved?

Have improvements made helped you do

your job better / made

it easier? Does this organisation

learn from its mistakes to make things better

next time?

Customers Has this organisation improved?

How effective do you think the organisation is

in improving what it does?

8.5.2 Corrective

Action

Management Have you got a

procedure for corrective action that covers the

areas of the standard? Do you keep records of

corrective actions?

How do you know

everyone deals with processing / product

errors or mistakes in the same way to protect

the organisation and its

customers?

Staff What is a corrective

action?

What do you do with a processing/product

error or mistake?

How often does this

take place?

Do you think we make too many mistakes that

are really unnecessary?

8.5.3 Preventative action

Management Have you got a procedure for

preventive action that covers the areas of the

standard? Do you keep records of

preventive actions?

How do you know the correct business risks

have been identified and actions put in place to

reduce these risks?