Transcript Document

Managing Your Audit
Effective Preparation to Successful Certification
John Kukoly
BRC Global Standards
BRC Global Standards. Trust in Quality.
Agenda
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Preparing for the audit
Managing the audit
Non-conformities
Corrective Action
Root Cause Analysis
BRC Global Standards. Trust in Quality.
Intent of the Audit
• Gather evidence of conformance
• Identification of risks or noncompliance
• Opportunity for improvement
• Certification
BRC Global Standards. Trust in Quality.
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The Audit
What Happens
Arrival
Opening meeting
Document review
Site review
Interviews
Evidence documented
Closing meeting
Corrective actions to lose NC’s
Certification or report
BRC Global Standards. Trust in Quality.
Preparing for the Audit
Long Term Planning
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When do you want the audit
Who is performing the audit
Who will be involved
Practice with employees
Use internal auditing – continual
practice through living it
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5 Best Things to Do
• Assign responsibility to departments,
manage through senior management
• Train and inform everyone
• Get good at internal auditing
• Look for help
• Organize, and anticipate
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Worst Things to Do
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“it’s a QC responsibility”
“leave something for the auditor”
“we’ve been auditor before”
Try to misdirect or hide
Stopping after the audit
Unrealistic expectations
Lack of preparation
BRC Global Standards. Trust in Quality.
Preparing for the Audit
Who is Involved
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All staff
QC, QA, production
Pest control
Maintenance, purchasing, receiving,
shipping,
• Reception
• Setting senior management expectations
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Preparing for the Audit
Short Term
• Preparing materials
• Last minute efforts
• Running the business while the audit
happens
• Informing staff
• Service suppliers
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Preparing for the Audit
Logistics for the Day
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Opening meeting
Protective equipment
Taking care of the auditor
Runners
Daily recap
Closing meeting
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The Audit
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What to offer
Gaining clarity on issues
Arguing your position
Defending your facility
Providing evidence, documents and
materials
• Failures during the audit
• Managing the auditor
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The Audit
Timing of Events
Gaining understanding
Training
Implementation
Pre-assessment
Audit
Corrective actions
Communications
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During the Audit - DO
• Anticipate and provide
• Show off where you do things well or
good results
• Lead the audit
• Question and ask for explanation
• Expect breakdowns, let the process
take over
BRC Global Standards. Trust in Quality.
During the Audit – DON’T
• Waste time or stall
• Hide, misdirect, show partial
information
• Interrupt interviews or audit flow
• Expect a perfect result
• Argue every point, or where evidence
does not support
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Dealing with problems
• Appeals
• Debates
• Disagreements
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The Auditor
• Getting the most out of the auditor
• Understand their role, needs and
position
• Provide space and time when needed
• Unacceptable auditor activities
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Most common NC’s
Document Control
Glass Control
Hygiene
Chemical Control
Corrective Action
Recall Test
Doors
Temporary Repairs
Walls
Record Control
HACCP Plan
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Document Control
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Version control
Consistency across documents
Complete information and instructions
Tracked changes, with reason
Uncontrolled documents
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Glass Control
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Relevant complete list
Condition
Appropriate checks
Complete procedure for loss or
breakage
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Correction and Corrective
Action
• Immediate actions to protect product
integrity
• Short term corrective action
• Corrective action
• Root cause analysis
• Everyone knows and uses it!
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Hygiene - Cleaning
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Non production areas
Deep assessments
Procedures
Verification and validation
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Chemical Control
• Cabinets
• Unapproved chemicals
• Secret stashes, uncontrolled
materials
• Over the counter products
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Corrective Action
• Missing for documented nonconformities
• Incomplete corrective actions
• No corrective action in procedure
• Not following procedure
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Recall Test
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Packaging
Once, or twice annually?
Unacceptable ranges or results
Full trace test, finished product, and
ingredients
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Doors
• Condition
• Seals
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Temporary Repairs
• Extended times
• Not tracked
• Creates new risks
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Walls
• Condition
• Temporary construction becomes
permanent
• Poor choice of materials
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Record Control
• Inaccessible
• Review performed as required?
• Unidentified errors
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HACCP Plan
• Missed risks
• Diagram not representative
• Not up to date
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Root Cause Analysis
• Define Root Cause Analysis
• Improve understanding of the requirement for
RCA
• Understand how to undertake Root Cause
Analysis
• Perform a Root Cause Analysis
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Definitions
Root Cause
The underlying cause of the problem which, if successfully
addressed, will prevent a recurrence of that problem.
Corrective Action
(Immediate
Corrective
Action)
Action taken to manage a non-conformity (the non-conformity
may originate from any source, e.g. a product incident, site audit
or product testing). Corrective action should be completed as
soon after detecting the non-conformity as possible.
Corrective Action
Plan
Following an audit, sites in the Enrolment Programme are
required to develop a Corrective Action Plan which outlines the
non-conformities and the action that has/will be taken to
address the non-conformity.
BRC Global Standards. Trust in Quality.
Definitions
Proposed Action
Plan
Following root cause analysis, the site must develop a proposed
action plan to correct each of the root causes, such that they
prevent recurrence of the non-conformity.
Preventative
Action
Root cause analysis can identify a cause that indicates other
systems or that are susceptible to the same failure. In these
situations it is good practice to complete preventative action on
the implicated systems before a non-conformity actually occurs.
Causal Factor
Causal Factors are any behaviour, omission, or deficiency in the
process that if corrected, eliminated, or avoided probably would
have prevented the non-conformity.
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Good Solutions
• Most problems are systemic
• Don’t jump to conclusions
• Are separate from immediate
corrective action
• Diagnose and address the illness
• Eliminate the cause(s)
• Prevent re-occurrence
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Identifying the cause
Symptom
Symptom
Symptom
Cause
or
causes
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What is the aim of RCA?
Identification of the root cause
Implementation of suitable action
Ultimately, the point of a RCA is to improve the systems such
that a repetition of the incident is prevented
Verification & monitoring activity demonstrates that the action
has been effective
The key question: What in the system or process failed such
that this problem could occur?
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Factors in Corrections
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Stop the problem
Identify the scope of the impact
Correction (clean up the mess)
Corrective action
Root cause analysis
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Process overview
Step 1
Define the Non-Conformity
Step 2
Investigate the Root Cause(s)
Step 3
Create Proposed Action Plan & Define Timescales
Step 4
Implement Proposed Action
Step 5
Verification & Monitoring of Effectiveness
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Asking the Right Questions
• To drill further
into specifics
• To check
understanding
OPEN
PROBING
CLOSED
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Who?
What?
Where?
Why?
When?
How?
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The Methods
There is no single prescribed method of conducting root
cause analysis.
The choice of root cause methodology may be:
• Matter of personal choice
• Company policy
• Dependent on the type of non-conformity being
investigated
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SOME RCA Methods
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The 5 Whys
Fishbone (Ishikawa) Diagram
Cause and Effect
Pareto’s Principle
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5 Whys?
The investigator keeps asking the question ‘Why?’ until meaningful
conclusions are reached.
Why?
Why?
Why?
Why?
Why?
Root
Cause
It is important to ensure that the questions continue to be asked until the
real cause is identified rather than a partial conclusion.
Once you have asked ‘why?’ you need to prove the answer by either
gathering data or objective evidence.
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Investigation Techniques
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Interview personnel
Observe the process
Try the process
Conduct specific inspections
Review the system data
Specific testing if necessary
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5 Whys?
For example:
• An operator is instructed to perform a simple action ‘weigh out
ingredient A’.
• The operator inadvertently used ingredient B.
• An immediate reaction = operator error was the cause.
• This does not establish the reason why the error occurred or
prevent it happening in future.
• The root cause analysis insists that a series of ‘Why?’s are asked.
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5 Whys?
An operator should have weighed out ingredient A on line 2.
However inadvertently used ingredient B. Why is this happening?
a. Why did the operator make the error?
Operator unfamiliar with procedure.
Why Is that?
b. Operator trained but no supervision or
sign off to confirm training was
satisfactory.
c.
Why was the training not satisfactory?
Both ingredients look identical and
were not labelled.
d. Labels were removed during the last
clean and not replaced.
Why Is that?
Why Is that?
Why Is that?
e. Cleaners didn’t consider potential for
error & checking labels not part of
anyone’s duties.
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Fishbone or Ishikawa Diagram
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Ishikawa
A second commonly used method of root cause analysis, is the fishbone.
This is most useful when the ‘5 whys’ is too basic diagrams.
Equipment
Process
People
Primary Cause
Secondary Cause
EFFECT
Materials
Environment
Management
This type seeks to understand the possible causes by asking:
‘What’, ‘When?’, ‘Where?’ ‘Why?’, ‘How?’ and ‘So what?’
A possible cause is identified and the consequences are
investigated for each of the group
BRCcategories.
Global Standards. Trust in Quality.
Management
Materials
Process
Significance of delay & the
potential for an error not
considered by cleaners.
Checking the labels didn’t
form part of anyone’s
duties.
Operator trained but no
sign off.
Both ingredients looked
identical and were not
labelled.
Environment
Equipment
Labels were removed
during the previous clean
and not replaced.
An operator should have
weighed out ingredient
A. However
inadvertently used
ingredient B.
Operator unfamiliar
with procedure.
Incomplete training
procedure for
cleaners.
People
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Pareto Principle
20% Causes
80%
Problems
• Not a tool for
Root Cause
Analysis
• A tool for
determining
where to
start your
analysis
BRC Global Standards. Trust in Quality.
Management
Materials
Process
Significance of delay & the
potential for an error not
considered by cleaners.
Checking the labels didn’t
form part of anyone’s
duties.
Operator trained but no
sign off.
Both ingredients looked
identical and were not
labelled.
Environment
Equipment
Labels were removed
during the previous clean
and not replaced.
An operator should have
weighed out ingredient
A. However
inadvertently used
ingredient B.
Operator unfamiliar
with procedure.
Incomplete training
procedure for
cleaners.
People
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Proposed Action Plan
Update training procedure to ensure sign off (& possibly a
supervision step).
Replace ingredient labels – if practical with ones that cannot be
removed.
If labels must occasionally be removed, ensure that post cleaning line
checks include a check of signage.
Ensure an individual is authorised and responsible for post-cleaning
line sign off.
Ensure cleaners fully understand and are trained in the need to return
labelling (and all equipment) in a fully operational state.
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Common mistakes
Unmanageable Conclusions
Root cause analysis should lead
to controllable, manageable or
adjustable processes.
Duplication of the Corrective
Action
The purpose of root cause
analysis is to look beyond the
immediate non-conformity.
Proposed Action Plan
Doesn’t Prevent
Re-occurrence
It may be necessary to re-visit
and identify additional causes
and appropriate controls.
People
The true root cause establishes
what system, policy or process
allowed the human error.
Extra Checks
Extra checks are often required for verification or monitoring, it is
preferable that the proposed action plan is not solely an extra check.
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What does success look like
Proposed action plan
That prevents
re-occurrence of the
non-conformity is in place.
Preventive Action
What other systems exist
that might have the same
root cause present?
Proposed Corrections
Have been taken.
Verification
Demonstrates
non-conformity can no
longer occur.
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RCA and BRC Global Standards
Food Standard Issue 6:
Clause
Requirement
Senior management to ensure the root cause of audit non-conformities
1.1.10
have been effectively addressed to prevent recurrence.
Identification of the root cause of non-conforming products and
3.7.1
implementation of any necessary corrective action.
Root cause analysis and associated actions relating to customer
3.10.1
complaints.
Audit
Following an audit, the root cause of non-conformities shall be identified
Protocol
and an action plan to correct this, including timescales, must be provided
9.2 &
to the Certification Body.
9.2.2
Consumer Products Standard Issue 3
2.4.2
Review of risk assessment and evaluation of complaints / incidents
3.7.4
Corrective actions and prevention of re-occurrence
3.12.4
Analysis of complaint data
Packaging Standard (Issue 4)
There are no requirements for root cause analysis in the Packaging
Standard, but sites are required to state “corrective action taken (with
consideration of root cause)” in theBRC
audit report.
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Consider…
• Could it have been prevented from
happening?
• Could it have been identified earlier?
• Known’ s and unknowns…
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Audit report
How should RCA appear in the audit report?
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Real Examples
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Real Examples
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Real Examples
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Real Examples
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Real Examples
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Your Examples for RCA
Questions?
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[email protected]
905-892-9469
www.brcglobalstandards.com
BRC Global Standards. Trust in Quality.