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

Transcription

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 noncompliance Opportunity for improvement Certification

4 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

5 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 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 Audit Who is Involved All staff QC, QA, production Pest control Maintenance, purchasing, receiving, shipping, Reception Setting senior management expectations

9 Preparing for the Audit Short Term Preparing materials Last minute efforts Running the business while the audit happens Informing staff Service suppliers

10 Preparing for the Audit Logistics 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 Audit Timing 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

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

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 nonconformities 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 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.

32 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.

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 To drill further into specifics To check understanding OPEN PROBING CLOSED Who? What? Where? Why? When? How?

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 RCA Methods The 5 Whys Fishbone (Ishikawa) Diagram Cause and Effect Pareto s Principle

41 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.

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? 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. 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? Why Is that? e. 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. Checking the labels didn t form part of anyone s duties. Operator trained but no sign off. Labels were removed during the previous clean and not replaced. Operator unfamiliar with procedure. An operator should have weighed out ingredient A. However inadvertently used ingredient B. Both ingredients looked identical and were not labelled. Incomplete training procedure for cleaners. Environment Equipment People

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

49 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. Labels were removed during the previous clean and not replaced. Operator unfamiliar with procedure. An operator should have weighed out ingredient A. However inadvertently used ingredient B. Both ingredients looked identical and were not labelled. Incomplete training procedure for cleaners. Environment Equipment People

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.

51 Common mistakes Unmanageable Conclusions Root cause analysis should lead to controllable, manageable or adjustable processes. Proposed Action Plan Doesn t Prevent Re-occurrence It may be necessary to re-visit and identify additional causes and appropriate controls. 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. 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.

52 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.

53 RCA and BRC Global Standards Food Standard Issue 6: Clause Requirement Senior management to ensure the root cause of audit non- conformi5es have been effec5vely addressed to prevent recurrence Audit Protocol 9.2 & Iden5fica5on of the root cause of non- conforming products and implementa5on of any necessary correc5ve ac5on. Root cause analysis and associated ac5ons rela5ng to customer complaints. 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 Review of risk assessment and evalua5on of complaints / incidents Correc5ve ac5ons and preven5on 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 correc5ve ac5on taken (with considera5on of root cause) in the BRC audit report. Global Standards. Trust in Quality.

54 Consider Could it have been prevented from happening? Could it have been identified earlier? Known s and unknowns

55 Audit report How should RCA appear in the audit report?

56 Real Examples

57 Real Examples

58 Real Examples

59 Real Examples

60 Real Examples

61 Your Examples for RCA Questions?

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