Managing Your Audit

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

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

3. Intent of the Audit • Gather evidence of conformance • Identification of risks or non-compliance • Opportunity for improvement • Certification

4. The AuditWhat Happens • Arrival • Opening meeting • Document review • Site review • Interviews • Evidence documented • Closing meeting • Corrective actions to lose NC’s • Certification or report

5. Preparing for the AuditLong 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. 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. 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

8. Preparing for the AuditWho is Involved • All staff • QC, QA, production • Pest control • Maintenance, purchasing, receiving, shipping, • Reception • Setting senior management expectations

9. Preparing for the AuditShort Term • Preparing materials • Last minute efforts • Running the business while the audit happens • Informing staff • Service suppliers

10. Preparing for the AuditLogistics for the Day • Opening meeting • Protective equipment • Taking care of the auditor • Runners • Daily recap • Closing meeting

11. 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. The AuditTiming of Events • Gaining understanding • Training • Implementation • Pre-assessment • Audit • Corrective actions • Communications

13. 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. 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

15. Dealing with problems • Appeals • Debates • Disagreements

16. The Auditor • Getting the most out of the auditor • Understand their role, needs and position • Provide space and time when needed • Unacceptable auditor activities

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

19. Glass Control • Relevant complete list • Condition • Appropriate checks • Complete procedure for loss or breakage

20. 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. Hygiene - Cleaning • Non production areas • Deep assessments • Procedures • Verification and validation

22. Chemical Control • Cabinets • Unapproved chemicals • Secret stashes, uncontrolled materials • Over the counter products

23. Corrective Action • Missing for documented non-conformities • Incomplete corrective actions • No corrective action in procedure • Not following procedure

24. Recall Test • Packaging • Once, or twice annually? • Unacceptable ranges or results • Full trace test, finished product, and ingredients

25. Doors • Condition • Seals

26. Temporary Repairs • Extended times • Not tracked • Creates new risks

27. Walls • Condition • Temporary construction becomes permanent • Poor choice of materials

28. Record Control • Inaccessible • Review performed as required? • Unidentified errors

29. HACCP Plan • Missed risks • Diagram not representative • Not up to date

30. 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. Definitions The underlying cause of the problem which, if successfully addressed, will prevent a recurrence of that problem. Root Cause 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.

32. 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 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. Preventative Action 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. 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

34. Identifying the cause • Symptom • Symptom • Symptom • Cause or causes

35. 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?

36. Factors in Corrections • Stop the problem • Identify the scope of the impact • Correction (clean up the mess) • Corrective action • Root cause analysis

37. 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

38. Asking the Right Questions OPEN • Who? • What? • Where? • Why? • When? • How? • To drill further into specifics PROBING CLOSED • To check understanding

39. 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

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

41. 5 Whys? • Why? • Why? • Why? • Why? • Why? • Root Cause 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. Once you have asked ‘why?’ you need to prove the answer by either gathering data or objective evidence.

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

43. 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.

44. 5 Whys? An operator should have weighed out ingredient A on line 2. However inadvertently used ingredient B. Why is this happening? • Why did the operator make the error? Operator unfamiliar with procedure. Why Is that? • Operator trained but no supervision or sign off to confirm training was satisfactory. Why Is that? • Why was the training not satisfactory? Both ingredients look identical and were not labelled. Why Is that? Why Is that? • Labels were removed during the last clean and not replaced. • Cleaners didn’t consider potential for error & checking labels not part of anyone’s duties.

45. Fishbone or Ishikawa Diagram

46. 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 categories.

47. Management Materials Process Significance of delay & the potential for an error not considered by cleaners. Labels were removed during the previous clean and not replaced. Checking the labels didn’t form part of anyone’s duties. An operator should have weighed out ingredient A. However inadvertently used ingredient B. Operator unfamiliar with procedure. Operator trained but no sign off. Both ingredients looked identical and were not labelled. Incomplete training procedure for cleaners. People Equipment Environment

48. Pareto Principle • Not a tool for Root Cause Analysis • A tool for determining where to start your analysis 20% Causes 80% Problems

49. Management Materials Process Significance of delay & the potential for an error not considered by cleaners. Labels were removed during the previous clean and not replaced. Checking the labels didn’t form part of anyone’s duties. An operator should have weighed out ingredient A. However inadvertently used ingredient B. Operator unfamiliar with procedure. Operator trained but no sign off. Both ingredients looked identical and were not labelled. Incomplete training procedure for cleaners. People Equipment Environment

50. 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.