Root Cause Analysis for labelling NC - AG - LinkedIn Profile.pdf

ROOT CAUSE
ANALYSIS
REPORT
FOR BRC GLOBAL STANDARDS
ABSTRACT
This document contains an example of a full root
cause analysis investigation report for a non-
conformity regarding a pack labelling incident
affecting quality and legality of finished product.
Adrian Garcia
Root Cause Analysis for BRC Global Standards
Course Assignment, MAR 2022

ROOT CAUSE ANALYSIS FOR LABELLING NON-CONFORMITY
RCA COURSE ASSIGNMENT COMPLETED BY:
ADRIAN GARCIA (SENIOR QA)
Page 1 of 7 Prepared by: AG // Reviewed by: AD // Authorised By: LA Technical Dept.
DETAILS OF NON-CONFORMITY
Source: On 10/11/2021, Retail Customer Technical Manager informed company’s National Account Manager and
Technical Services Manager of a non-conformity incident flagged by a Retail Customer store regarding product coded
GC227 Retail Customer FT Ground Coffee 227g.
Consequence: This NC resulted in a complaint from Retail Customer. There is the potential for a fine for the business
due to contract breach, which is under discussion at this moment in time.
Issue reported: packs from latest delivery of this product were found with incorrect FOP label product description
stating ‘Coffee beans’ instead of correct ‘Ground Coffee’, hence making a false / misleading claim with regards to the
contents of the pack. The pack contents were correct (i.e., Ground Coffee), and the BOP label as well as the outer case
label had the correct product description (Retail Customer FT Ground Coffee 227g). Pictorial evidence of the issue was
provided as well as the thermal print with the batch code and packing time.
Upon receipt of the details from the incident, the Technical Services Manager shared the information with
manufacturing site’s Technical Manager to initiate investigation of the issue raised. After this, in order to identify the
origin of the non-conformity and prevent re-occurrence a complete root cause analysis must be completed to as the
client could threaten to leave the business: this is not the first incident of this type in the last 5 years.
Product batch affected:
Item Type Product
Product Code GC227
Product Description Retail Customer FT Ground Coffee 227g
Batch Code (JDC) 1279 (Packed 06/10/2021)
Packing Time 15:15
Shelf-Life (BBE) OCT 2022
Works Order No. WO031190
Date Complaint was Reported 10/11/2021
Qty. Manufactured for the Batch 2 full pallets: 450 cases x 6 packs per case = 2,700 packs
Qty Despatched to Customer 225 cases (1 case flagged until 10/11/2021, quarantined)
Qty. Remaining in Warehouse 225 cases (1 whole pallet, quarantined)
Summary of packaging issue as reported by the client:
Packaging Item Conforming / Non-Conforming
FOP Label Non-conforming – Shows beans instead of ground
BOP Label Conforming – Shows roasted and ground coffee
Outercase Label Conforming – Shows roasted and ground coffee
Pack Thermal Print Conforming – Nominal weight correct, batch code correct, shelf-life correct

INVESTIGATION OF THE NON-CONFORMITY
Personnel involved: Senior QA (traceability, investigation of NC), Production Manager (production records), QC (stored
sample checks, quarantined pallet checks), Supply Chain Admin (ERP management). Summary:
1. Technical Manager requested Senior QA to perform a traceability exercise to provide information regarding
the product and batch code flagged. The outcome of the traceability showed that approx. 2 pallets were
produced for WO031190, of which 1 full pallet was still on site’s warehouse by the moment the issue was
flagged. A full pallet of 225 cases has been shipped to customer’s DC so far.
2. Senior QA requested Supply Chain Admin to quarantine the remaining stock in the ERP system so it cannot be
picked and issued to customer until checked. Location in the warehouse was identified as F.01.
3. Senior QA requested QC on duty to review production samples in the sample store. Stored sample for the
works order WO031190 was taken at the start of the batch run as usual at 12:36, showing correct FOP.
4. Upon review of the documentation in the traceability exercise, the batch run started at 06/10/2021 12:35.
Line Clearance form was completed before start-up and samples of film and FOP / BOP labels were attached.
All of the checks were correct at this point. The electronic QA report showed that packaging checks were also
carried out every hour at 12:36 and 13:32, marked with a PASS by the operator in both cases. Operator running
the batch was an experienced operator.
5. QA report showed that the batch run was interrupted at 06/10/2021 13:52 for the shift changeover. Then an
entry was made at 06/10/2021 14:12 by the operator continuing the run, in this case a new operator still in
training. Packaging check marked as PASS.
6. Line clearance form shows samples of the film / FOP / BOP at the time of re-start; samples were correct and
matching product type (ground), however there is only time filled in, the rest was left blank by the operator.
7. Line clearance form shows that at 15:08 there was an FOP changeover, a sample was attached into the sheet.
However, it was showing the wrong product type (beans) whilst still running ground coffee in the line. Again,
no other information was filled in into the sheet by the operator. Next QA check logged into the report at
15:10 showed a PASS for the packaging check.
8. Run ended at 06/10/2021 15:49. End of run packaging check marked as PASS by the operator, no further
entries into the Line Clearance sheet.
9. Senior QA requested QC on duty to check pack’s packing times and FOP on random samples from bottom,
middle and top layers of quarantined pallet for works order WO031190 location F.01 in the warehouse racking.
The bottom layer (1st layer placed on the pallet) sample check showed that packing time was 15:21, the FOP
was incorrect. The middle and top layer random checks showed wrong FOP in all cases. With the evidence and
information at hand, the conclusion is that most of the stock in customer hands should be correct with the
exception of cases made from FOP changeover at 15:08 until cut-off time 15:21 (start of 2nd
pallet). At an
average production speed of 24 packs/minute with no downtime, for a 13-minute period and 6 packs per case
we are looking at an estimate maximum amount of 52 cases of non-conforming product in customer hands,
mostly located on the top 2 layers of the first pallet delivered.
10. Production efficiency records provided by the Production Manager showed that no downtime was recorded
for WO031190 from 15:08 to 15:21. No inline reworked product recorded within that period either.
11. The issue with the incorrect FOP label was not flagged by the QC in the shop floor on the production day. A
new, inexperienced QC was on duty on the day. No record of this issue was found in the NC log either.
12. Senior QA reviewed packaging picking records from the Warehouse team for this works order. These showed
that quantities and codes of the FOP picked for this production correspond to a batch of the “ground” FOP,
hence the quantities of incorrect “beans” FOP picked for this works order were incorrectly recorded and
attributed to “ground” FOP; these wrongly picked FOP labels were mixed with the correct FOP.
IMMEDIATE CORRECTIVE ACTION:
1. Customer Retail Customer notified of the NC investigation findings.
2. Customer reported that 215 cases of batch code 1279 were still in their depot, quarantined.

3. Company agreed to collect the remaining cases of batch code 1279 from Retail Customer depot to screen out
any remaining NC product, re-issue good stock back to Retail Customer, and destroy any non-conforming stock
found.
4. Retail Customer to notify all stores that received stock from batch code 1279 so far to review their product,
and if found non-conforming to allocate to staff to reduce waste rather than disposal as product is safe to
consume.
5. Retail Customer Technical Manager requested full root cause analysis report to identify the origin of the non-
conformity and prevent any further re-occurrence. If satisfactory, customer will not pursue a fine as the
volumes involved are not large, most product is not on the shelves, and the non-conforming product quantities
and locations were identified quickly.

ROOT CAUSE ANALYSIS (RCA)
ROOT CAUSE ANALYSIS (RCA) TEAM:
The following positions were assembled 11/11/2021 to carry out and document this RCA for Retail Customer:
1. Technical Manager (facilitator and organiser / actioner of the resulting action plan).
2. Senior QA (to share details of NC investigation, document the RCA and take part in the action plan).
3. Production Manager (to share insight regarding packing process and take part in the action plan).
4. Supply Chain Manager (to share insight regarding packaging handling and take part in the action plan).
5. NPD Manager (to share insight on customer requirements for packaging and take part in the action plan).
METHOLOGY CHOSEN FOR ROOT CAUSE ANALYSIS:
Focused brainstorm discussion guided & documented via CAUSE & EFFECT (FISHBONE) DIAGRAM. Rationale:
ADVANTAGES of the C&E FISHBONE method DISADVANTAGES of the C&E FISHBONE method
1. It is simple and easy to use, most individuals in the
RCA team are already familiar with it.
2. Provides a starting framework with pre-set RC
categories acting as prompts which should facilitate
a more effective, focused discussion for better use
of time.
3. As the customer Retail Customer is unhappy due to
re-occurrence, it is crucial to identify as many
potential issues contributing to this NC as possible
(including those underlying that could have been
missed so far) so we can address; this will also help
with other customers: this method fits within this
idea and should be helpful.
1. It does not weigh the importance of the root causes
contributing to the NC; depending on the number &
type of them a separate methodology or weighed
scoring system might need to be used so resources
needed to correct the root causes identified are
adequately prioritised and planned. In this instance,
as the scope of the issue at hand is not too broad,
this disadvantage is not considered crucial to the
point of discouraging the use of this method.
CONDUCTING ROOT CAUSE ANALYSIS:
RCA team assembled and conducted a 40-minute-long focused brainstorm discussion with the aid of a Fishbone
diagram for the resolution of this NC. A number of causal factors (physical, human, organisational) and contributing
factors creating the conditions that lead into the NC were identified as a result.
Summary of incident reported by Retail Customer and internal investigation (as discussed at the start of the RCA
meeting): Retail Customer store identified finished ground coffee packs where the FOP label stated ‘Beans’ instead of
‘Ground’, which did not match information on the BOP label, outercase label, and the product itself inside the packs
which was ground. Production and QA records for this batch show that in fact roast & ground product was intended
to be produced as per the production schedule, and seemingly during a FOP changeover the operator running the
batch at that moment recorded a sample of the wrong FOP but failed to do the information check hence continued
using the wrong FOP until the end of the batch run. This went unnoticed by the QC on duty during the production run
and when doing the daily document review. Warehouse team picked x1 wrong FOP label reel for this production that
was mixed with x1 correct FOP label reel.
See page overleaf for C&E Diagram.

Cause & Effect (Fishbone) Diagram. See below list of CAUSAL FACTORS identified that contributed to the outcome:
CAUSE
MANPOWER /
TRAINING
1. Failure to identify
FOP label was wrong
and hence identify
the NC and take
corrective action
2. Failure to use visual
product aid provided
3. Failure to carry out
and correctly record
label checks
METHOD / PROCESS
1. WH operative picked wrong
FOP label stock and issued
to the packing operator
2. Packing operator failed to
check label information
during changeover
3. QC operative failed to check
line clearance record and
verify product in the line as
it was packed, hence no NC
was registered
MATERIALS
1. FOP label for “Retail
Customer FT Ground
Coffee 227g” and
“Retail Customer FT
Coffee beans 227g” look
very similar: artwork
design and colour
palette is identical
barring product
description and “coffee
type” logo
EFFECT
Wrong FOP
label placed
on finished
product
ending in
customer
store
ENVIRONMENT
1. Label store racking is
not well organised
and beans and
ground labels are
mixed
EQUIPMENT
None identified
MEASUREMENT
None identified
In summary, a different way to categorise the main causal or contributory factors identified in this NC are:
PHYSICAL CAUSES HUMAN CAUSES ORGANISATIONAL CAUSES
1. Labels for the same product
origin are difficult to
differentiate
1. Lack of awareness of the need of
correctly checking the packaging
at different stages
2. Some individuals involved have
recently joined the business and
are inexperienced / lack training
1. Label store racking is not well
organised allowing for picking
mistakes
2. Procedures in place for pack
presentation checks not being
followed, records not correctly
filled in
See page overleaf for Root Cause Analysis Preventive Action Plan (PAP) Summary Table.

ROOT CAUSE ANALYSIS PREVENTIVE ACTION PLAN (PAP) SUMMARY TABLE:
#
Causes
Category
Causal Factor
Identified
Preventative Action Plan (PAP) Est. Target Date Responsible
Monitoring of
Effectiveness
Reasons for
Review inc.
Timescales
1
Physical
Materials
Labels for the
same product
origin are
difficult to
differentiate
1. NPD team to investigate
opportunities on redesign Retail
Customer's FOP 227g labels for coffee
beans & ground coffee to make the
product unique and easy to
differentiate. Discuss options with
Retail Customer NPD team; if possible,
agree timescale for change
2. NPD team to immediately
incorporate orientation to customers
regarding easy-to-differentiate
packaging design as part of the NPD
process critical path, as this will also
benefit the end consumer; NPD to also
draft guidelines document on the
matter
3. Supply Chain team to discuss with
label supply base suggested system to
differentiate label reels from beans to
ground: film holding the labels to be
colour-coded for easy identification, in
addition all reels to be marked with
product code, type and description
inside the inner carboard core tube;
agree timescales with the suppliers for
implementation once current stocks
run out to reduce waste and cost to the
business
1. TBC with
customer in next
NPD meeting
2. 30/11/2021 for
creation and
implementation of
packaging design
guidelines
document for
retailers
3. 31/12/2021 for
discussion with
packaging supply
chain base and
start receiving new
stock of label reels
with colour coding
and new bigger
product
identification labels
1. NPD team
2. NDP team
3. Supply
Chain team
- NPD to provide
evidence of
email chain with
retail customer
regarding
acknowledgeme
nt for the next
product artwork
design update
rollout Q3 2022
- NPD to provide
1st draft of
customer
packaging
orientation
guideline by
target date for
review
- Review before
mid of Q2 2022
during NPD
meeting with
retail customer
to see if the
pack
presentation
suggestions
have been
factored in
- Review at end
of Q1 2022 the
effectiveness of
the
implementation
of colour coded
label reels as
well as the new
packaging
identification
labels for
changes
2
Human
Manpower
/
Training
Lack of
awareness of
the need of
correctly
checking the
packaging at
different
stages
1. Supply Chain Manager to retrain WH
operatives in the updated Procedure
14 Warehouse picking & returning
packaging process once issued by
Technical Dept. Individuals able to
check packaging codes in BOM against
labels in packaging materials
themselves and record the check
2. Production Manager to retrain
Packing operators in the updated
Procedure 14 Warehouse picking &
returning packaging process once
issued by Technical Dept. Individuals
able to check packaging codes in BOM
against labels in packaging materials
themselves and record the check
1. 16/11/2021 for
start of training of
WH operatives
2. 16/11/2021 for
start of training of
Packing operatives
1. Supply
Chain
Manager
2.
Production
Manager
- Competence
assessment of
individuals a
week after
training date
(individuals
must conduct
and record a
pack
presentation
check inc.
verification of
label info.)
during
changeover
- Review at end
of Q1 2022:
review of NC
wrong picking
and packaging
issues to verify
if there is trend
of reduction
after
implementation
of PAP
3
Human
Manpower
/
Training
Some
individuals
involved have
recently
joined the
business and
are
inexperienced
/ lack training
1. Technical team to amend PoI
Induction Procedure to incorporate
simple and visual packaging awareness
guide as well as basic guidance
regarding packaging changeovers for
new starters and agency workers as
reference; this updated document to
be issued to Production and Supply
Chain for their review and to train new
workers
1. 30/11/2021 for
amendment of PoI,
review and issue to
stakeholders
1. Technical
team
- Competence
assessment a
week after
induction
training inc.
pack
presentation
checks as
relevant for the
individual
- Review at end
of Q1 2022:
interview new
starters until
that period to
verify PAP
increased their
pack
presentation
awareness and
for re-training
or PoI further
amendment
needs

#
Causes
Category
Causal Factor
Identified
Preventative Action Plan (PAP) Est. Target Date Responsible
Monitoring of
Effectiveness
Reasons for
Review inc.
Timescales
4
Organisational
Environment
Label store
racking is not
well
organised
allowing for
picking
mistakes
1. Technical team, Supply Chain
Manager, Production Manager
together with Senior WH operative and
Senior Packing Operator to gather and
review packaging returns and picking
process for improvements in the
location and flow of packaging trolleys
as well as packaging picking & returns
process
2. Technical team to amend Procedure
14 Warehouse picking & returning
packaging process with the new flow
and validate procedure; once final, to
hand over to Supply Chain and
Production Management for training of
operatives
3. WH team to organise label racking
store, segregating ground product
labels from beans labels an keep it that
way going forward as per the amended
PR14
4. Technical team to incorporate
random label segregation checks in the
GMP checklist
1. 11/11/2021 for
review of packaging
picking & returns
flow
2. 12/11/2021 for
amendment of
Procedure 14
Warehouse picking
& returning
packaging process.
15/11/2021 for
validation of
updated PR14.
3. 15/11/2021 for
supervised
organisation of
label racking
4. 11/11/2021 to
add line in GMP
checklist for WH
regarding label
segregation checks
1. Technical
team, Supply
Chain
Manager,
Production
Manager
together
with Senior
WH
operative
and Senior
Packing
Operator
2. Technical
team
3. WH team
4. Technical
team
- Random label
segregation
checks in WH
GMP audits
- Awareness
assessment of
random
production &
WH operatives
during GMP
audits
- Review at end
of Q1 2022:
meet with
senior WH and
senior packing
operatives for
review of the
effectiveness of
the new picking
& returns flow
and discuss
GMP findings
on the matter
for further
changes if
necessary
5
Organisational
Method
/
Process
Procedures in
place for pack
presentation
checks not
being
followed,
records not
correctly filled
in
1. Technical team to issue new version
(more visual) of Work Instruction 32
Checking the Correct Coffee Type in the
Pack and train the WH Operatives,
Packing Operators and the QCs in the
shop floor
2. Production Management team to re-
train Packing operator in filling in
PC042 Line-Clearance sheet to ensure
changeovers are correctly logged
1. 11/11/2021 for
update and review
of WI32.
12/11/2021 to
start training
individuals
2. 12/11/2021 to
start training
individuals
1. Technical
team
2.
Production
Manager
- Random line-
clearance
document
checks during
document GMP
audits
- Monitoring of
development of
new-starter QC
at the first 3-
month review
mark
- Review at end
of Q1 2022:
check GMP
audit log for
findings
regarding
document
check fails.
Discuss findings
with production
manager for
retraining if
needed
NOTE regarding image copyrights: All rights over the cover image used in this project’s front sheet belong to its author. This document is freely shared non-
profit. Due to the difficulty searching the origin the image used the original author is not included. If you wished to either be credited by the image or request
its removal, please contact me by email at adoriangp@gmail.com. Thank you for your comprehension and please accept my apologies for the inconvenience.

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