SUMMARY OF AUDIT FINDINGS

Executive Summary

Ancom Crop Care is the sole manufacturer of agrichemical active ingredients in South East Asia, and it is
also one of the largest in the Asia Pacific region. Among the products that the company manufactures,
formulates, and markets are herbicides, pesticides, fungicides, insecticides, and rodenticides such as MSMA,
Diuron, Bromacil, Glyphosate, 2,4-D, Glufosinate Ammonium, and Brodifacoum, among others.

Ancom Crop Care has grown tremendously since its humble beginnings in 1969 as a pioneer in crop
protection. The company now has two factories in Malaysia, one in Shah Alam and the other in Port Klang. It
serves the local market while also exporting to more than 40 countries around the world, including ASEAN,
the United States, Latin America, Africa, and Oceania.

Due to the increase in COVID-19 cases and the government-imposed travel restrictions, the on-site audit
could not take place. As a result, the audit sessions were conducted entirely via Zoom Meeting, and the
documented information was reviewed remotely. The audit examined the activities within the certification
scope of "Provision of manufacturing and sales of agricultural chemicals, timber preservative
products and other chemical products”.

Findings from this assesment

Quality Management System (QMS)

On 15th February 2021, the organization established a Quality Manual (ACC-QM) to address the requirements
of ISO 9001:2015, and it was revised on 9th April 2021.

External and Internal Context

Individual departments, such as Customer Service (CS), Engineering (EG), Human Resource (HR), Laboratory
(LB), Manufacturing (Shah Alam), Manufacturing (Port Klang), Marketing (LOC/SEA/ROW), Material
Management (MM), Maintenance (MT), Warehouse (Shah Alam), Warehouse (Port Klang), and Technical (TC)
have had their internal and external issues updated based on the Risk Register. Issues such as, product
registration for new products, availability of products on time, product quality and compliance, a pandemic
outbreak (Covid-19), shipment delay and order backlog, insufficient space for the installation of new
machines, price competitiveness among suppliers, delay in delivery and possible cargo damage in transit, and
other relevant issues were identified.

Requirements of Interested Parties

The organization has identified the interested parties, as well as the relevant needs and expectations for
each department, which are listed in the Risk Register. A number of interested parties, including shipping
agents, transporters, DOE, production, sales and finance, human resources, customers, vendors, the
Pesticide Board, and employees, were identified.

Action to address risks and opporunities

In the Risk Register, which includes all departments, the risks were determined by taking into account issues
as well as relevant needs and expectations of interested parties. Following the completion of the risk
assessment, five risks were identified and classified as "High Risk," including "contaminated, out of
specs/substandard products, leaked or damaged packaging & faulty documentation – Product Recall, rejection
& compensation- Marketing Department," "spread of Covid-19 virus among staff – Laboratory Department,"
"breakdown repair delay due to a lack of spare parts – Maintenance Department," and "product recall,
rejection & compensation- Manufacturing Department.". To address risks and opportunities, the organization
has determined which actions will be taken, how those actions will be integrated and implemented, and how
the effectiveness of those actions will be measured.

Customer Satisfaction, Complaints & Corrective Action

 Customer satisfaction was monitored by the organization using a Customer Survey Form. The form was
distributed to 219 customers, including those in East Malaysia, West Malaysia, SEA, and ROW (Rest of The
Word). The Customer Survey Form was returned by a total of 80 respondents. The following conclusions were
made:
1) West Malaysia scored the highest point (5) which is “Very Good”.
2) East Malaysia scored 4 points which is “Good”.
3) SEA scored 4 points which is “Good”.
4) ROW scored 4 points which is “Good”.

Since the implementation of the quality management system the organization received 1 customer complaint,
and appropriate corrective action was taken.

Performance against Quality Objectives

The organization has established quality objectives in the Quality Objectives (KPI), Target & Action Plan for
Fiscal Year 2021 ~ 2022 for 12 Departments such as:
1) Material Management – 5 Objectives
2) Technical – 3 Objectives
3) Marketing (ROW/SEA/LOC) – 7 Objectives
4) Manufacturing (Shah Alam) – 7 Objectives
5) Warehouse (Shah Alam) – 4 Objectives
6) Manufacturing (Port Klang) – 7 Objectives
7) Warehouse (Port Klang) – 3 Objectives
8) Human Resource & Admin – 3 Objectives
9) Laboratory – 3 Objectives
10) Customer Service Department – 5 Objectives
11) Engineering Department – 10 Objectives
12) Maintenance Department – 9 Objectives

These objectives are monitored on a monthly basis and the data will be presented during the next
management review meeting, as the data was limited during their first management review meeting held in
June 2021. This will be verified during the next on-site audit.

Statutory and Regulatory requirements

Below is the list of statutory & regulatory requirements which includes licenses/permits that need to be abide
by the organization:

Requirements / Licenses / Feedback From Remarks

Interested Parties
The Companies Commission of Malaysia
(SSM)
ISO 17025:2017 Certification
NO: SAMM 009
Manufacturing License
(Industrial Co-Ordination Act 1975)
Manufacturing License
(Industrial Co-Ordination Act 1975)
Licence to Sell Pesticide
(Pesticide Act 1974)
Port Klang Factory
Licence to Sell Pesticide
(Pesticide Act 1974)
Shah Alam Factory
Business License (Admin Office)
(Majlis Bandaraya Shah Alam)
Company Registration Number: 0148170X
Issued Date: 27/3/2021 ~ 26 November 2021
“2, 4-D acids, MCPA acids, 2, 4-D salts and esters
and MCPA salts and esters”
License No: A 004329
“Glyphosate Formulations”
License No: A 004329
Class: 1a, 1b, II, III, IV
License No: SEL2021/616/057(SJ)
Validity: 2/4/2021 ~ 1/4/2024
Class: 1a, 1b, II, III, IV
License No: SEL2021/011/272(SJ)
Validity: 4/2/2021 ~ 3/2/2024
License No: 015030620110008
Valid until 31 December 2021

Business License (Shah Alam Factory) License No: 01501051979003

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 (Majlis Bandaraya Shah Alam) Valid until 31 December 2021
Business License (Port Klang Factory) License No: 0102094723819919
(Majlis Perbandaran Klang) Valid until 31 December 2021

Service Processes
The audit was conducted through a Zoom Meeting, WhatsApp Video Call, and document review in order to
review the organization's operation activities. In both the Port Klang and Shah Alam factories, production
activities include receiving sales forecasts (for the local market, the SEA market, and the Rest of The World),
production planning (capacity planning, material planning, manpower allocation), bulk manufacturing, packing
and inspecting the finished goods, and releasing the goods to the warehouse. For Shah Alam Factory, the
audit reviewed orders from customer such as, Terre Enterprise Sdn. Bhd. (Sales Order No.: SOLEM-13116),
Bismi Agroscience Sdn. Bhd. (Sales Order No.: SOLOCA-49795) Ban Bee Agrochemical And Hardware Trading
(Sales Order No: SOLOCA-50368), Kossan Paint (M) Sdn Bhd (Sales Order No: SOLOCA:49143), PT. Sari
Kresna Kimia (Sales Order No: SOASEN-1384) and Sipcam Nichino Brasil (Sales Order No: SOEXP:2919). For
Port Klang Factory, the audit has reviewed the customer order for FGV Plantation (Malaysia) Sdn. Bhd. (Sales
Order No.: SOLEM-12981), Sime Darby Sarawak (Sales Order Number: SOLEM:12913), Axichem PTY LTD
(Sales Order No: SOEXP-2900) and Leads Agricultural Products Corporation (Sales Order No: SOASEN:1366).
Records related such as Purchase Order, Profoma Invoice, Invoice, Delivery Order, MSMA reaction Log,
Evaporation Log, MSMA Crude preparation status chart, Shift Report, Plant Status Chart, Reaction Log, Butir-
butir sample untuk dianalisa di makmal, Purchase Requisition, QA inspection Request, Lable, Production BK
Sheet, Finish Goods Despatch, etc. were sighted during the audit. Furthermore, the organisation has a
Research and Development department, which is responsible for New Product Development as well as
Material Change Management activities. The audit examined documentation pertaining to Research and
Development, such as a customer sample form, an R&D-synthesis and formulation sheet, minutes of
meetings, a report, a safety data sheet, and other similar documents.

Internal Audit
Internal Audit was conducted from 26th April 2021 ~ 21st May 2021 by trained auditors. A total of 28 NC’s
and 28 OFI’s were raised and appropriate corrective actions was taken.

Management Review, Leadership & Commitment

Management review meeting was conducted on 4th August 2021, and the minutes of the meeting was
sighted. As this was the first meeting since the implementation of the quality management system in April
2021, the data related to review inputs was limited. The management representative informed that they will
be conducting a second review meeting once sufficient data are collated.

The Executive Director / COO – Mr Anthony Tan was interviewed and he has demonstrated his commitment
on the implemenatation of the quality management system. The organization has sufficient resources to
handle the current operations and some engineering projects has been identified for both Shah Alam and
Klang factories for FY2022.

Other Requirements
The audit also reviewed procedures and records for Documented Information, Customer Service, Inbound
Logistics, QA-Laboratory, Warehouse, Human Resources, Purchasing, Maintenance and SHE.

The audit reviewed documented information including creating, updating and control of documents such as
Procedures, Work Instructions and Forms. Records such as Standard Document Application Sheet (F-QA-
010), Obsolete Form (F-QA-015), Documents Masterlist (F-QA-008), External List (F-QA-009) were reviewed
during this audit. The documents authorization signatories are in accordance with Document Control
Procedure (QP-QA-001).

For Customer Service department, the audit has examined Sales Order Processing for Local and Export Sales
as well as Stock Transfer to East Malaysia. Records has been sampled for customers from Local (East and
West Malaysia), Southeast Asia and Rest of the World (ROW) including Job Memo (F-CS-001), Purchase

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 Order, Sales Order, Delivery Order, Invoice, internal communication by email, Proforma Invoice, Declaration
of Dangerous Goods in Container & Container Packing, Shipping Instructions and Commercial Invoice.

Process for Inbound (Incoming) Logistics has been reviewed and 2 shipments under CIF (cost, Insurance
and Freight) and CF (Cost and Freight) have been sampled with records such as PO, Permit, Waybill,
Commercial Invoice, Cargo Transportation Insurance Policy, Container Request Form (F-LG-001),
Declaration of Good Imported from Jabatan Kastam Diraja Malaysia, Arrival Notice, Container Despatch
Advice and Delivery Note (Blue Form) etc.

For Laboratory department, process for QC such as Incoming Raw Material Inspection and Product and
Finish Goods, Laboratory Trial for New Product Development and Raw Material Changes have been reviewed
and records for product such as 2,4-D-Sodium Salt and Arsenic Acid including Raw Material Inspection Sheet
(F-LB-017), Product Adjustment Form ((F-LB-017), Test Method such as HPLC method, Certificate of
Analysis (COA), Analysis Assignment Form (F-LB-013), Test Report (F-LB-039) and Request for New BOM
Form (F-LB-008) has been reviewed and sighted during virtual audit. Other records such as Product
Reference Files (ATF-14) and Laboratory Analytical Manual (ATF 8), Batch Report, Sample List Form, Packing
Form (F-MF-024) has also been reviewed. Preventive Maintenance (PM) Schedule for laboratory equipment
is updated and well maintained. Records such as Calibration report and PM Labelling sticker has been
sighted for equipment such as Analytical Balance, Titrator and Inductive Coupled Plasma.

The audit for Warehouse was done and process for Incoming and Outgoing has been checked with records of
3 DO/Consignment Note have been sampled for Incoming and Outgoing Goods, respectively. Other records
such as Job Memo, Container Dispatch Advice and Container Inspection Info (F-WH-005) as well as
Container Request Form (F-LG-001). Furthermore, Inventory/Stock Counting for Raw Materials and Finish
Good products has been sighted via Mystic System. During audit, handling of Non-Conforming Products has
been confirmed via video call and stacking of goods, segregation, and quarantine area as well as safety
practices in the warehouse has been confirmed.

For audit in Human Resources, the process for recruitment, training, administration, and IT process has
been reviewed. For recruitment, records such as Requisition Form for Employment (F-HR-002), along with
Job Description, New Employee Induction Checklist (F-HR-040) and Probation Progress Form have been
sighted for Adibah Mohammed Diah (Customer Service Executive) and Mohammed Nazeri bin Shariff
(Warehouse Asisstant). The training for existing employees is listed in Training Plan 2021/2022 which most
of the training are planned to be done externally however, due to Covid-10 pandemic, only 2 trainings which
are ISO 9001: 2015 Internal Quality Auditor Training and Digital Human Resource has been completed.
Training Attendance Record (F-HR-012), Training Course Evaluation Report (F-HR-009), Post Training
Evaluation Forms for Manager (F-HR-035) were sighted for employees such as Rasidah binti Rohani (ISO
9001: 2015 Internal Quality Auditor Training), Rozaimah binti Pozi (ISO 9001: 2015 Internal Quality Auditor
Training), K.S Serimen (ISO 9001: 2015 Internal Quality Auditor Training) and Haryati binti Puji (Digital
Human Resources).

During audit, licenses required for ACC Shah Alam and ACC Port Klang have been reviewed. Other than that,
procedure related to staff claim, staff travel by air, company vehicles, company uniforms, outside services
such as cleaning, security, canteen, laundry has been checked. Under IT process, services related to
hardware, software and Mystic system has also been reviewed during the audit. The competencies for
Registered Chemist (Norafiza binti Zainal), Safety and Health Officer (Nordin bin Rosdin), Certified
Environmental Professional in Scheduled Waste Management, CePSWaM (Mohd Razie bin Mohd Nazri) were
also sighted.

Under Material Management/Purchasing Department, the process for Vendor Assessment and Purchasing
has been reviewed and records such as Approved Vendor List 2021 and New Vendor List 2021 are well
maintained and sampling has been done for Purchase Requisition (PR) and PO of Raw Materials (Chemicals)
and Machinery/Equipment from local and overseas suppliers. It was noted that Vendor Re-Assessment was
done once every 2 years however from 2020 onwards, the assessment will be done yearly. Other than that,
the approval of New Vendor Assessment has been confirmed to be in accordance with Ancom Crop Care
Discretionary Authority Limits.

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 The audit in Maintenance Department involved General Maintenance and Maintenance/Contractor Work
process with processes of Scheduled and Unscheduled Breakdown, Calibration and Services, Maintenance
Inventory, Write Off and Scrapping, History Card and Work Permit for Hot Work, General Work and Confined
Space. Records such as PPE Daily Take out (F-MT-007) for August 2021, Forklift Hour Record (F-MT-008) for
July 2021, Forklift Damaged Accecories Record, Plant Yearly Schedule Maintenance (F-MT-003), Maintenance
Daily Breakdown Report (F-MT-11) dated 18 August 2021, Inspection List (F-MT-028) for Formulation Plant
Jetmill 2, MSMA MR’S Reactors, AAP Tower, Scrap Collection Requisition Form (F-IL-001) for item Scrap
Iron, Asset Disposal Form (F-FN-007) for item Mild Steel Tank-Bulk Tank Storage (Asset Code : 1PM0307/1)
with quotation for scrap process, Asset Ledger and Depreciation Report, Machineries Historical Card (F-MT-
005) for Jetmill 3 at Formulation Plant area and Reactor G at Timber Preservative area, General, Hot Work
and Confined Space Work Permit (Serial No : 00848) were sighted.

AREAS OF NON-COMPLIANCE WITH STANDARD

MAJOR CORRECTIVE ACTION REQUESTS

NIL

MINOR CORRECTIVE ACTION REQUESTS

ACCREDITATION MARK & LOGO -
CLAUSE 4 : CONTEXT OF THE ORGANIZATION 1
CLAUSE 5 : LEADERSHIP -
CLAUSE 6 : PLANNING -
CLAUSE 7 : SUPPORT -
CLAUSE 8 : OPERATION -
CLAUSE 9 : PERFORMANCE EVALUATION -
CLAUSE 10 : IMPROVEMENT -

OBSERVATIONS
1) The scope of certification stated in the quality manual should be changed.
2) The organization shall determine risk and opportunities after updating the context of the organization and
requirements of relevant interested parties.
3) The process mapping should include the processes needed and their interactions in accordance with the
requirements of ISO9001:2015 Standard.
4) The internal audit plan/program should also include and make reference to all SOPs/WIs to ensure the
organization’s own requirements for its quality management system are audited.
5) The correction and corrective actions should be taken without undue delay and as required by the internal
audit procedure.
6) The data related to quality objectives and effectiveness of actions taken to address risks and opportunities
should be presented during the next management review meeting.
7) It is recommended to conduct internal audits and management review meetings after each financial year.

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 8) The Reference and Attachment in Procedures need to be updated to include all necessary forms and
attachments as mentioned in Process Workflow. For example: Section 6.0 Reference Document for
Document Control (QP-QA-001) and Sales Orde Processing (QP-CS-001).

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DETAILS OF CORRECTIVE ACTION (1 OF 1 FOR 2021)
Company Name: Ancom Crop Care Sdn Bhd.
ISO Standard & Clause No.: 9001:2015 & 4.2
ISO Activity: Understanding the needs and expectations of interested parties
Company Area/Activity: Risk Register – F-QA-005
Auditor Responsible: Satheesh Karat Classification: Minor

SECTION 1 - (BY THE AUDITOR)- DETAIL OF NON CONFORMANCE IDENTIFIED:

The organization shall determine the requirements of interested parties that are relevant to the
quality management system, inorder to meet applicable statutory and regulatory requirements. The
risk register dated 9/4/2021, however did not include all relevant interested parties. For eg: MKN,
KKM, Immigration, Bomba, Board of Directors, insurance Cos, DOSH(CHRA) etc.

Company Representative's Acknowledgement: ………………………………………….. Date: 20th August 2021

SECTION 2 - (BY THE COMPANY) - DETAILS OF COMPANY RESPONSES ON THE ROOT CAUSE :

SECTION 3 - (BY THE COMPANY)- DETAIL OF COMPANY RESPONSES RELATED TO CORRECTION :

Company Representative's Acknowledgement: …………………………………………… Implementation Date: ……………………

SECTION 4 - (BY THE COMPANY) - DETAIL OF COMPANY RESPONSES ON THE CORRECTIVE ACTION :

Company Representative's Acknowledgement: …………………………………………… Implementation Date: ……………………

SECTION 5 - (BY AJA AUDITOR) INDICATE STATUS OF CAR BY MARKING IN APPROPRIATE BOX
FOR MINOR CAR - Responses accepted as appropriate & complete CAR CLOSED

FOR MINOR CAR - Responses accepted as appropriate but effectiveness CAR RELEASED BUT
requires further evaluation at time of next Surveillance REQUIRES SURVEILLANCE VERIFICATION

FOR MAJOR CAR - Responses accepted as appropriate but further CAR OPEN BUT REQUIRES
audit required to verify effectiveness of the actions described CLOSE OUT VISIT

FOR MAJOR CAR - Responses accepted as appropriate to allow CAR OPEN BUT REQUIRES
downgrade to “Minor” as actions are scheduled to be auditable at time of SURVEILLANCE VERIFICATION
next Surveillance.

For Major CAR – CAR Closed out following close out visit or CAR CLOSED
submission of definitive objective evidence.

Auditor's Authorization: Date of Review:

Auditor's Authorization: Date of Close Out:

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