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BRC Global Standards. Trust in Quality. Managing Your Audit Effective Preparation to Successful Certification John Kukoly BRC Global Standards.

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Presentation on theme: "BRC Global Standards. Trust in Quality. Managing Your Audit Effective Preparation to Successful Certification John Kukoly BRC Global Standards."— Presentation transcript:

1 BRC Global Standards. Trust in Quality. Managing Your Audit Effective Preparation to Successful Certification John Kukoly BRC Global Standards

2 BRC Global Standards. Trust in Quality. Agenda Preparing for the audit Managing the audit Non-conformities Corrective Action Root Cause Analysis

3 BRC Global Standards. Trust in Quality. Intent of the Audit Gather evidence of conformance Identification of risks or non- compliance Opportunity for improvement Certification

4 BRC Global Standards. Trust in Quality. The Audit What Happens Arrival Opening meeting Document review Site review Interviews Evidence documented Closing meeting Corrective actions to lose NCs Certification or report

5 BRC Global Standards. Trust in Quality. 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

6 BRC Global Standards. Trust in Quality. 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

7 BRC Global Standards. Trust in Quality. Worst Things to Do its a QC responsibility leave something for the auditor weve been auditor before Try to misdirect or hide Stopping after the audit Unrealistic expectations Lack of preparation

8 BRC Global Standards. Trust in Quality. Preparing for the Audit Who is Involved All staff QC, QA, production Pest control Maintenance, purchasing, receiving, shipping, Reception Setting senior management expectations

9 BRC Global Standards. Trust in Quality. Preparing for the Audit Short Term Preparing materials Last minute efforts Running the business while the audit happens Informing staff Service suppliers

10 BRC Global Standards. Trust in Quality. Preparing for the Audit Logistics for the Day Opening meeting Protective equipment Taking care of the auditor Runners Daily recap Closing meeting

11 BRC Global Standards. Trust in Quality. 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

12 BRC Global Standards. Trust in Quality. The Audit Timing of Events Gaining understanding Training Implementation Pre-assessment Audit Corrective actions Communications

13 BRC Global Standards. Trust in Quality. 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

14 BRC Global Standards. Trust in Quality. During the Audit – DONT 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

15 BRC Global Standards. Trust in Quality. Dealing with problems Appeals Debates Disagreements

16 BRC Global Standards. Trust in Quality. The Auditor Getting the most out of the auditor Understand their role, needs and position Provide space and time when needed Unacceptable auditor activities

17 BRC Global Standards. Trust in Quality. Most common NCs Document Control Glass Control Hygiene Chemical Control Corrective Action Recall Test Doors Temporary Repairs Walls Record Control HACCP Plan

18 BRC Global Standards. Trust in Quality. Document Control Version control Consistency across documents Complete information and instructions Tracked changes, with reason Uncontrolled documents

19 BRC Global Standards. Trust in Quality. Glass Control Relevant complete list Condition Appropriate checks Complete procedure for loss or breakage

20 BRC Global Standards. Trust in Quality. Correction and Corrective Action Immediate actions to protect product integrity Short term corrective action Corrective action Root cause analysis Everyone knows and uses it!

21 BRC Global Standards. Trust in Quality. Hygiene - Cleaning Non production areas Deep assessments Procedures Verification and validation

22 BRC Global Standards. Trust in Quality. Chemical Control Cabinets Unapproved chemicals Secret stashes, uncontrolled materials Over the counter products

23 BRC Global Standards. Trust in Quality. Corrective Action Missing for documented non- conformities Incomplete corrective actions No corrective action in procedure Not following procedure

24 BRC Global Standards. Trust in Quality. Recall Test Packaging Once, or twice annually? Unacceptable ranges or results Full trace test, finished product, and ingredients

25 BRC Global Standards. Trust in Quality. Doors Condition Seals

26 BRC Global Standards. Trust in Quality. Temporary Repairs Extended times Not tracked Creates new risks

27 BRC Global Standards. Trust in Quality. Walls Condition Temporary construction becomes permanent Poor choice of materials

28 BRC Global Standards. Trust in Quality. Record Control Inaccessible Review performed as required? Unidentified errors

29 BRC Global Standards. Trust in Quality. HACCP Plan Missed risks Diagram not representative Not up to date

30 BRC Global Standards. Trust in Quality. 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

31 BRC Global Standards. Trust in Quality. 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

32 BRC Global Standards. Trust in Quality. 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

33 BRC Global Standards. Trust in Quality. Good Solutions Most problems are systemic Dont jump to conclusions Are separate from immediate corrective action Diagnose and address the illness Eliminate the cause(s) Prevent re-occurrence

34 BRC Global Standards. Trust in Quality. Symptom Cause or causes Identifying the cause

35 BRC Global Standards. Trust in Quality. 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

36 BRC Global Standards. Trust in Quality. Factors in Corrections Stop the problem Identify the scope of the impact Correction (clean up the mess) Corrective action Root cause analysis

37 BRC Global Standards. Trust in Quality. Step 5 Verification & Monitoring of Effectiveness Step 1 Define 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

38 BRC Global Standards. Trust in Quality. Asking the Right Questions OPEN Who? What? Where? Why? When? How? PROBING CLOSED To drill further into specifics To check understanding

39 BRC Global Standards. Trust in Quality. 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

40 BRC Global Standards. Trust in Quality. SOME RCA Methods The 5 Whys Fishbone (Ishikawa) Diagram Cause and Effect Paretos Principle

41 BRC Global Standards. Trust in Quality. 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? Root Cause Once you have asked why? you need to prove the answer by either gathering data or objective evidence. 5 Whys?

42 BRC Global Standards. Trust in Quality. Investigation Techniques Interview personnel Observe the process Try the process Conduct specific inspections Review the system data Specific testing if necessary

43 BRC Global Standards. Trust in Quality. 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?

44 BRC Global Standards. Trust in Quality. 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 didnt consider potential for error & checking labels not part of anyones 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?

45 BRC Global Standards. Trust in Quality. Fishbone or Ishikawa Diagram

46 BRC Global Standards. Trust in Quality. A second commonly used method of root cause analysis, is the fishbone. This is most useful when the 5 whys is too basic diagrams. 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. 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 EquipmentProcessPeople MaterialsEnvironmentManagement EFFECT Ishikawa

47 BRC Global Standards. Trust in Quality. People Equipment Environment Process MaterialsManagement An operator should have weighed out ingredient A. However inadvertently used ingredient B. Checking the labels didnt form part of anyones 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.

48 BRC Global Standards. Trust in Quality. Pareto Principle 20% Causes 80% Problems Not a tool for Root Cause Analysis A tool for determining where to start your analysis

49 BRC Global Standards. Trust in Quality. People Equipment Environment Process MaterialsManagement An operator should have weighed out ingredient A. However inadvertently used ingredient B. Checking the labels didnt form part of anyones 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.

50 BRC Global Standards. Trust in Quality. 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

51 BRC Global Standards. Trust in Quality. Unmanageable Conclusions Root cause analysis should lead to controllable, manageable or adjustable processes. 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. Duplication of the Corrective Action The purpose of root cause analysis is to look beyond the immediate non-conformity. People The true root cause establishes what system, policy or process allowed the human error. People The true root cause establishes what system, policy or process allowed the human error. Proposed Action Plan Doesnt Prevent Re-occurrence It may be necessary to re-visit and identify additional causes and appropriate controls. Proposed Action Plan Doesnt Prevent Re-occurrence It may be necessary to re-visit and identify additional causes and appropriate controls. 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. 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. Common mistakes

52 BRC Global Standards. Trust in Quality. Proposed action plan That prevents re-occurrence of the non-conformity is in place. 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? 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. Verification Demonstrates non-conformity can no longer occur. What does success look like

53 BRC Global Standards. Trust in Quality. RCA and BRC Global Standards Food Standard Issue 6: ClauseRequirement Senior management to ensure the root cause of audit non-conformities have been effectively addressed to prevent recurrence Identification of the root cause of non-conforming products and implementation of any necessary corrective action Root cause analysis and associated actions relating to customer complaints. Audit Protocol 9.2 & Following an audit, the root cause of non-conformities shall be identified and an action plan to correct this, including timescales, must be provided to the Certification Body. Consumer Products Standard Issue Review of risk assessment and evaluation of complaints / incidents 3.7.4Corrective actions and prevention of re-occurrence 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 the audit report.

54 BRC Global Standards. Trust in Quality. Consider… Could it have been prevented from happening? Could it have been identified earlier? Known s and unknowns…

55 BRC Global Standards. Trust in Quality. How should RCA appear in the audit report? Audit report

56 BRC Global Standards. Trust in Quality. Real Examples

57 BRC Global Standards. Trust in Quality. Real Examples

58 BRC Global Standards. Trust in Quality. Real Examples

59 BRC Global Standards. Trust in Quality. Real Examples

60 BRC Global Standards. Trust in Quality. Real Examples

61 BRC Global Standards. Trust in Quality. Your Examples for RCA Questions?

62 BRC Global Standards. Trust in Quality


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