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Effective Preparation to Successful Certification

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1 Effective Preparation to Successful Certification
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 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 Corrective Action 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 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 Indications from the first year of audits to Issue 6 of the BRC Standard suggests that RCA is not well understood by the food industry. Although well know in other sectors, in the food industry we have been rather slower at introducing this useful tool. Therefore the aim of this training is to: 1: Define what RCA is 2: Thereby eliminate confusion 3: to improve both auditor and food industry understanding 4: to understand the importance of RCA 5: ensure that we can undertake RCA competently 6: practice some RCA and understand how to perform it correctly

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 We need to begin by understanding some of the common terms used in RCA and the specific terminology used by the BRC Food Standard: 1: Read definition – could be cause or causes – we will obviously spend most of the course looking at this 2: Read definition - It is important once a non-conformity is identified, that corrective action is taken to address the issue. The term ‘immediate corrective action’ is sometimes used in the USA which emphasises that it is the action that should take place as soon after detecting the non-conformity as possible. Corrective action might include – complaint management, incident management, product recall, etc. 3: The Food Standard specifically uses the term Corrective Action Plan in relation to the Enrolment programme. Following an audit, a site in the Enrolment programme must submit a Corrective action plan to their certification body within 28 days of the audit. We will not be covering CAPs in the rest of this presentation but it is included here to avoid future confusion. 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. 1: Of more importance – a proposed action plan is the output of the RCA. Once a site has identified the root cause of a problem or non-conformity, it must introduce corrective action/controls to correct the root cause and prevent recurrence of the non-conformity. I.e. it describes what will be done and when. Following an audit, the site is required to submit its proposed action plan, complete with timescales for completion of the actions. The proposed action plan must be submitted within 28 days of the audit. 2: Preventative action is not mentioned in the food Standard however, on some occasions a RCA can identify a cause which suggests that systems or processes other than the one where the non-conformity occurred, are susceptible to the same failure. In these situations it is good practice to complete preventative action on these implicated systems before a non-conformity actually occurs. 3: read definition 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 REMOVE BULLET POINT 4 AND THE RELEVANT NOTE BELOW AND ADD INFORMATION TO SLIDE 8 SO ALL OF THIS MESSAGE IS IN ONE PLACE RCA is therefore a problem solving process for conducting an investigation into an identified incident, problem or non-conformity. 1: RCA is looking for the process or system that failed or allowed the non-conformity to occur. It is not a blame game – we are not looking for who but what. 2: It is always tempting to assume we know what happened – any hypothesis of this type should be tested for accuracy rather than assumed – don’t jump to conclusions without supporting facts 3: RCA is a completely different process to incident management and immediate corrective action, although these activities are often completed in close proximity – but must be considered as separate processes to avoid confusion. AS ABOVE THIS POINT TO GO TO SLIDE 8: 4: RCA requires the investigator(s) to look beyond the immediate problem to understand the underlying or fundamental cause of the situation. In this respect it is often compared to the difference between an illness and a symptom; immediate corrective action manages the immediate symptom, but RCA seeks to diagnose and address the illness that causes the symptoms. 5:6: The over-arching aim is to introduce action which eliminates the cause and prevents re-occurrence

34 Identifying the cause Symptom Symptom Symptom Cause or causes
Go through diagram Like peeling back the layers of an onion until we get to the cause

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 THIS SLIDE HAS A LOT OF DUPLICATION – RECOMMEND: DELETE BULLETS AS ALREADY COVERED MOVE BULLETS 3, 4 & 5 TO SLIDE 7 ‘GOOD SOLUTIONS’ AMEND BULLET 3 TO READ: ‘Ultimately, the benefit of RCA is an improvement in systems’ What does the Standard expect? Go through slide 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 Step 3 Step 4
Investigate the Root Cause(s) Step 3 Create Proposed Action Plan & Define Timescales The first step in the process is to define the problem – this might sound obvious but some immediate corrective actions, especially those involving a product withdrawal or recall, often employ ‘all inclusive’ or ‘scattergun’ approaches to ensure that all product is managed, however, this can mask the precise details of the non-conformity and therefore make RCA more difficult. Go through slide It should be noted that this is a simplified process flow, which is typical of the majority of situations required by the Standard. However, for a complex non-conformity, such as a serious incident involving a microbiological outbreak, root cause analysis will become proportionally more detailed, require extra activities and can require considerable time and investment. In these situation the use of a RCA team rather than a single individual is recommended – cross-category for all possible activities implicated eg technical, QA, production, etc. 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 You have probably encountered the Question Funnel which highlights that there are different ways of asking questions: Open – get explanation – who, what, where, when, etc? Probing – get as much information as possible – drill down into specifics Auditors will also be familiar with the BRC requirement to use challenging questions (ie asking the site how they know the conclusion/output/critical limit is correct) and this technique is also useful in this context with the investigator clarifying how the information they are provided is known to be correct Closed – usually get Yes/No answer and have limited use – but useful to confirm you have understood the information you have been given

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 Go through slide

40 SOME RCA Methods The 5 Whys Fishbone (Ishikawa) Diagram
Cause and Effect Pareto’s Principle We will spend the next part of the course looking at some of the common methods that can be used

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. 1: 2: As you probably guessed from the video the investigator keeps asking the question ‘why?’ until meaningful conclusions are reached. It is generally assumed that this will require asking the question at least 5 times (hence the name), but it is important that the questions continue to be asked until the real cause is identified. 3: When completing RCA it is important to avoid pure speculation, therefore each answer should be supported by either objective evidence or data gathering. For example, if the answer appears to be that the procedure doesn’t work, then it may be necessary for the investigator (or an experienced operative) to follow the procedure to identify the exact nature of any short-comings, other supporting evidence might include discussions with staff (eg to establish staff awareness or understanding) or conducting and evaluating product tests.

42 Investigation Techniques
Interview personnel Observe the process Try the process Conduct specific inspections Review the system data Specific testing if necessary Explain the options within each bullet along with its value

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. 1: 2: Lets consider an example in which an operator is instructed to complete a simple task, ‘weigh out ingredient A’, however the operator inadvertently uses ingredient B. 3: An immediate reaction is that this must be an operator error. 4: 5: However, whilst this might be true, it does not establish the cause or prevent it re-occurring in the future. The RCA must ask a series of Why? Questions, for example:

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. 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? Labels were removed during the last clean and not replaced. Why Is that? 1: Why did the operator weigh out the wrong ingredient = Perhaps the operator was unfamiliar with the procedure. Which naturally leads to the question: 2: Why was an operator, unfamiliar with the procedure, asked to complete the task? = Operator was trained but there was no supervision or sign-off 3: Why was the training not satisfactory? = On this occasion both the ingredients look identical and were not labelled 4: Why werent the ingredients labelled? = The labels wew removed during the last deep clean and not replaced 5: Why werent the labels replaced? = Cleaning staff didn’t consider the potential for error and checking the labels were not part of anyone’s duties Cleaners didn’t consider potential for error & checking labels not part of anyone’s duties. Why Is that?

45 Fishbone or Ishikawa Diagram
The next tool originated in the Japanese car industry hence it is sometimes referred to as an Ishikawa diagram but a fishbone diagram is more common name in many parts of the world.

46 Ishikawa This type seeks to understand the possible causes by asking:
A second commonly used method of root cause analysis, is the fishbone. This is most useful when the ‘5 whys’ is too basic diagrams. Primary Cause Secondary Cause Equipment Process People Materials Environment Management EFFECT The fish bone name comes from the form the diagram takes as it is constructed This is most useful when the ‘5 Whys?’ are too basic or where it is useful to trend significant amounts of data. It works by breaking down the various aspects of the problem, to allow the investigator to consider one section at a time and to visualise the relevant information. These constituent sections are not fixed but generally include aspects such as equipment, people, raw materials, processes, manufacturing environment, etc The investigator then asks why?, when?, who?, where?, etc. in relation to each of the sections to gain information regarding the possible root cause. If planning to use the fishbone it is often useful to prepare a series of prompts to ensure that everything in each section is covered i.e. what you might need to ask or investigate in each section – do this first time and keep the prompts for future use – you wont need all the prompts for every occasion but they are then ready when/if needed. For example: People – training/competency/PPE/Illness Materials – Specifications/handling/temperatures/Stock controls/traceability/labelling Environment – humidity/lighting/temperature/cleanliness Equipment – Maintenance/calibration/suitable access e.g. for cleaning/location Procedures – available/working correctly/up to date 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 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. An operator should have weighed out ingredient A. However inadvertently used ingredient B. Operator trained but no sign off. Operator unfamiliar with procedure. SEE NOTE BELOW If we use the same example as before with the use of the wrong ingredient we find: Go through slides THE FOLLOWING HAS GENERATED A LOT OF INTEREST ON BOTH OCCASSIONS THAT THE COURSE HAS RUN – I THINK IT WOULD BE WORTH GENERATING A NEW SLIDE WITH A SIMPLE TABLE ON IT SO THAT THE POINT CAN BE FULLY DISCUSSED Some sites have indicated that they like the concept of Isikawa diagrams but find the diagram cluttered or unhelpful and is it therefore possible to use the concept without the diagram eg by tabulating and having a column for each of the sections instead of the fishbone diagram – the answer is YES – the important bit is getting to the root cause in a logical manner how that is done can be chosen by the site. Incomplete training procedure for cleaners. Both ingredients looked identical and were not labelled. Environment Equipment People

48 Pareto Principle Not a tool for Root Cause Analysis
80% Problems Not a tool for Root Cause Analysis A tool for determining where to start your analysis 20% Causes Pareto's Principle is named after the man who first discovered and described the '80:20' phenomenon, Vilfredo Pareto ( ), an Italian economist and sociologist. Pareto was born in Paris, and became Professor of Political Economy at Lausanne, Switzerland in An academic, Pareto was fascinated by social and political statistics and trends, and the mathematical interpretation of socio-economic systems. Vilfredo Pareto first observed the 80/20 principle when researching and analysing wealth and income distribution trends in nineteenth-century England (some people suggest this was Italy; I say England, or Britain), in which, broadly he noted that 20 percent of the people owned 80 percent of the wealth. Beyond this he also noted that this 'predictable imbalance' could be extrapolated (extended) to illustrate that, for example, 10 per cent would have 65 percent of the wealth, and 5 percent of people would own 50 percent of the wealth. Again these other ratios are what Pareto found in this particular study - they are not scientific absolutes that can be transferred reliably to other situations. Pareto then tested his principle (including related numerical correlations) on other countries, and all sorts of other distribution scenarios, by which he was able to confirm that the 80:20 Principle, and similarly imbalanced numerical correlations, could be used reliably as a model to predict and measure and manage all kinds of effects and situations. 80 percent of revenue comes from 20 percent of customers 80 percent of problems come from 20 percent of causes 80 percent of profit comes from 20 percent of the product range 80 percent of complaints come from 20 percent of customers 80 percent of sales will come from 20 percent of sales people

49 Management Materials Process 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. An operator should have weighed out ingredient A. However inadvertently used ingredient B. Operator trained but no sign off. Operator unfamiliar with procedure. AMEND ANIMATION ON THIS SLIDE – IT SHOULD APPEAR ALL AT ONCE (ON SLIDE 25 ANIMATION IS NEEDED BUT NOT HERE) If we consider the previous exercise as an example – wrong ingredient man: Incomplete training procedure for cleaners. Both ingredients looked identical and were not labelled. 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. In this situation our PAP will have a number of aspects as there were a number of causes: Go through slide NB colour coding might be another option to labels

51 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. There are some common mistakes which we need to be aware of – as they can prevent effective RCA and PAP 1: Read – However it is often tempting to conclude ‘not enough time or money’, ‘made a mistake’, or ‘staff off sick’, whilst these factors might be true they are not helpful in preventing future occurrence as they are not controllable. The investigator needs to consider ‘what failed?’ Was it a process or system or method that allowed these events to occur? For example, staff sickness should be managed by identifying and training suitable deputies. 2: Read – Therefore the PAP should never be a duplication of the immediate corrective action. 3: PAP doesn’t prevent re-occurrence of the problem – there are a number of possible reasons - incomplete initial RCA, failing to identify the true root cause - multiple root causes, some of which haven’t been identified or controlled - failure to implement the PAP or train the new procedures to staff It will be necessary for the investigator to re-visit the analysis to establish why the PAP has not been effective. 4: People are rarely the cause – RCA is not a blame game – the RCA must therefore consider what policy or procedure allowed the human error. In some situations PAP will involve aspects of training or re-training but where re-training is genuinely needed, consideration must be given to the format of the training, on the basis that, if the original training was ineffective then it is unlikely that just repeating the same training material will solve the problem. 5: The final common mistake is the introduction of extra checks or monitoring. It is preferable that the PAP is not solely an extra check as: - monitoring isn’t solving the cause of the non-conformity - monitoring involves an on going commitment of time and therefore cost. Of course, some monitoring will be needed to ensure the PAP was effective but this shouldn’t be the PAP itself 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. AMEND ‘PROPOSED CORRECTIONS’ TO ‘PROPOSED ACTION PLAN IMPLEMENTED’ What does success look like? Firstly, that the RCA identifies the cause(s) allows PAP to be taken. That any relevant preventative action on other systems is addressed and completed. That the PAP has been completed and embedded into the normal working practices of the site. Any verification confirms that the non-conformity can no longer occur.

53 RCA and BRC Global Standards
Food Standard Issue 6: Clause Requirement 1.1.10 Senior management to ensure the root cause of audit non-conformities have been effectively addressed to prevent recurrence. 3.7.1 Identification of the root cause of non-conforming products and implementation of any necessary corrective action. 3.10.1 Root cause analysis and associated actions relating to customer complaints. Audit Protocol 9.2 & 9.2.2 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 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 the audit report. Go through clauses of the Standards

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?
Explain audit report Go through slide

56 Real Examples

57 Real Examples

58 Real Examples

59 Real Examples

60 Real Examples

61 Your Examples for RCA Questions?

62


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