Managing Your Audit - Safe Food Alliance › wp-content › uploads › 2014conf...non-conformities...

BRC Global Standards. Trust in Quality.

Managing Your Audit

Effective Preparation to Successful Certification

John Kukoly BRC Global Standards



Agenda

•  Preparing for the audit •  Managing the audit •  Non-conformities •  Corrective Action •  Root Cause Analysis



Intent of the Audit

•  Gather evidence of conformance •  Identification of risks or non-

compliance •  Opportunity for improvement •  Certification



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



Preparing for the Audit Long Term Planning

•  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



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



Worst Things to Do

•  “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



Preparing for the Audit Who is Involved

•  All staff •  QC, QA, production •  Pest control •  Maintenance, purchasing, receiving,

shipping, •  Reception •  Setting senior management expectations



Preparing for the Audit Short Term

•  Preparing materials •  Last minute efforts •  Running the business while the audit

happens •  Informing staff •  Service suppliers



Preparing for the Audit Logistics for the Day

•  Opening meeting •  Protective equipment •  Taking care of the auditor •  Runners •  Daily recap •  Closing meeting



The Audit •  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



The Audit Timing of Events

•  Gaining understanding •  Training •  Implementation •  Pre-assessment •  Audit •  Corrective actions •  Communications



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



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



Dealing with problems

•  Appeals •  Debates •  Disagreements



The Auditor

•  Getting the most out of the auditor •  Understand their role, needs and

position •  Provide space and time when needed •  Unacceptable auditor activities



Most common NC’s Document Control Glass Control Hygiene Chemical Control Correc5ve Ac5on Recall Test Doors Temporary Repairs Walls Record Control HACCP Plan



Document Control

•  Version control •  Consistency across documents •  Complete information and instructions •  Tracked changes, with reason •  Uncontrolled documents



Glass Control

•  Relevant complete list •  Condition •  Appropriate checks •  Complete procedure for loss or

breakage



Correction and Corrective Action

•  Immediate actions to protect product integrity

•  Short term corrective action •  Corrective action •  Root cause analysis •  Everyone knows and uses it!



Hygiene - Cleaning

•  Non production areas •  Deep assessments •  Procedures •  Verification and validation



Chemical Control

•  Cabinets •  Unapproved chemicals •  Secret stashes, uncontrolled

materials •  Over the counter products



Corrective Action

•  Missing for documented non-conformities

•  Incomplete corrective actions •  No corrective action in procedure •  Not following procedure



Recall Test

•  Packaging •  Once, or twice annually? •  Unacceptable ranges or results •  Full trace test, finished product, and

ingredients



Doors

•  Condition •  Seals



Temporary Repairs

•  Extended times •  Not tracked •  Creates new risks



Walls

•  Condition •  Temporary construction becomes

permanent •  Poor choice of materials



Record Control

•  Inaccessible •  Review performed as required? •  Unidentified errors



HACCP Plan

•  Missed risks •  Diagram not representative •  Not up to date



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



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.

Definitions



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.

Proposed Action Plan

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.

Definitions

Causal Factors are any behaviour, omission, or deficiency in the process that if corrected, eliminated, or avoided probably would have prevented the non-conformity.

Causal Factor



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



Symptom

Symptom

Symptom

Cause or

causes

Identifying the cause



What is the aim of RCA?

Identification of the root cause

Implementation of suitable action

The key question: What in the system or process failed such that this problem could occur?

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



Factors in Corrections

•  Stop the problem •  Identify the scope of the impact •  Correction (clean up the mess) •  Corrective action •  Root cause analysis


Step 5 Verification & Monitoring of Effectiveness

Step 1Define the Non-Conformity

Step 3 Create Proposed Action Plan & Define Timescales

Step 4 Implement Proposed Action

Step 2 Investigate the Root Cause(s)

Process overview



Asking the Right Questions

OPEN •  Who? •  What? •  Where? •  Why? •  When? •  How?

PROBING CLOSED

•  To drill further into specifics

•  To check understanding



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

The Methods



SOME RCA Methods

•  The 5 Whys •  Fishbone (Ishikawa) Diagram •  Cause and Effect •  Pareto’s Principle



The investigator keeps asking the question ‘Why?’ until meaningful conclusions are reached.

It is important to ensure that the questions continue to be asked until the real cause is identified rather than a partial conclusion.

Why? Why? Why? Why? Why? Root Cause

Once you have asked ‘why?’ you need to prove the answer by either gathering data or objective evidence.

5 Whys?



Investigation Techniques

•  Interview personnel •  Observe the process •  Try the process •  Conduct specific inspections •  Review the system data •  Specific testing if necessary



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.

5 Whys?



a.  Why did the operator make the error? Operator unfamiliar with procedure.

b.  Operator trained but no supervision or sign off to confirm training was satisfactory.

Why Is that?

c.  Why was the training not satisfactory? Both ingredients look identical and were not labelled.

Why Is that?

d.  Labels were removed during the last clean and not replaced.

Why Is that?

e.  Cleaners didn’t consider potential for error & checking labels not part of anyone’s duties.

Why Is that?

An operator should have weighed out ingredient A on line 2. However inadvertently used ingredient B. Why is this happening?

5 Whys?



Fishbone or Ishikawa Diagram



A second commonly used method of root cause analysis, is the fishbone. This is most useful when the ‘5 whys’ is too basic diagrams.

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 categories.

Primary Cause

Secondary Cause

Equipment Process People

Materials Environment Management

EFFECT

Ishikawa



PeopleEquipmentEnvironment

ProcessMaterialsManagement

An operator should have weighed out ingredient A. However inadvertently used ingredient B.

Checking the labels didn’t form part of anyone’s duties.

Significance of delay & the potential for an error not considered by cleaners.

Labels were removed during the previous clean and not replaced.

Operator unfamiliar with procedure.

Both ingredients looked identical and were not labelled.

Incomplete training procedure for cleaners.

Operator trained but no sign off.



Pareto Principle

20% Causes 80% Problems

•  Not a tool for Root Cause Analysis

•  A tool for determining where to start your analysis



PeopleEquipmentEnvironment

ProcessMaterialsManagement

An operator should have weighed out ingredient A. However inadvertently used ingredient B.

Checking the labels didn’t form part of anyone’s duties.

Significance of delay & the potential for an error not considered by cleaners.

Labels were removed during the previous clean and not replaced.

Operator unfamiliar with procedure.

Both ingredients looked identical and were not labelled.

Incomplete training procedure for cleaners.

Operator trained but no sign off.



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.

Proposed Action Plan



Unmanageable ConclusionsRoot 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.

PeopleThe true root cause establishes what system, policy or process

allowed the human error.

Proposed Action Plan Doesn’t Prevent Re-occurrence

It may be necessary to re-visit and identify additional causes

and appropriate controls.

Extra ChecksExtra checks are often required for verification or monitoring, it is

preferable that the proposed action plan is not solely an extra check.

Common mistakes



Proposed action plan That prevents

re-occurrence of the non-conformity is in place.

Preventive ActionWhat other systems exist that might have the same

root cause present?

Proposed Corrections Have been taken.

VerificationDemonstrates

non-conformity can no longer occur.

What does success look like



RCA and BRC Global Standards Food Standard Issue 6: Clause Requirement

1.1.10 Senior management to ensure the root cause of audit non-‐conformi5es have been effec5vely addressed to prevent recurrence.

3.7.1 Iden5fica5on of the root cause of non-‐conforming products and implementa5on of any necessary correc5ve ac5on.

3.10.1 Root cause analysis and associated ac5ons rela5ng to customer complaints.

Audit Protocol 9.2 & 9.2.2

Following an audit, the root cause of non-‐conformi5es shall be iden5fied and an ac5on plan to correct this, including 5mescales, must be provided to the Cer5fica5on Body.

Consumer Products Standard Issue 3 2.4.2 Review of risk assessment and evalua5on of complaints / incidents 3.7.4 Correc5ve ac5ons and preven5on 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 “correc5ve ac5on taken (with considera5on of root cause)” in the audit report.



Consider…

•  Could it have been prevented from happening?

•  Could it have been identified earlier?

•  Known’ s and unknowns…



How should RCA appear in the audit report?

Audit report



Real Examples



Your Examples for RCA

Questions?


[email protected] 905-892-9469

www.brcglobalstandards.com

Managing Your Audit - Safe Food Alliance › wp-content › uploads › 2014conf...non-conformities...

Documents

Transcript of Managing Your Audit - Safe Food Alliance › wp-content › uploads › 2014conf...non-conformities...