BRSM Form 009 Qms Fsms - Ar

BRSM
Systems:QMS ISO 9001 (2008)‐FSMS ISO 22000 (2005)

Assessment Report/Checklist
Form 009

CLIENT‐ORGANIZATION (NAME):
Aras Taban Co
PHYSICAL LOCATION(s):
Amol Ind. Zone, Amol, Iran
Stage II Audit Date(s):
26 & 27 May 2016
Stage I Audit Date(s):
3,4 May 2016
NAICS (or NACE) CODE
10.91‐D1

EXCLUSIONS: 7‐3/7‐5‐2/7‐5‐4(for ISO 9001:2008)

Assessment objectives: Verifying the company’s scope and
documentation for the requested regulators and
ISO 22000:2005 & ISO 9001:2008 requirements
to protect consumers and communities

ASSESSMENT TEAM INFORMATION
Assessment Team Leader, ATL Vahid Salahi
Assessor 2 Nahid Zandi

Note: Adjusting the language within this form to the type of activity and nature of the organization is acceptable.
REFERENCE, AS
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We pursuit to assure that client‐organization adheres to the protection of communities and consumers. This is to
1 follow the intent to the substitution of the word “identify” to the word “determine” as part of the importance to the
processes being capable of achieving desired outputs (including consumer’s well‐being).
2 Scope of activities Production of Di calcium phosphate (DCP)
Codex:
ISIRI 2513
Legal status
Industrial and Mines regulations:
3 Other: Iran FDA
Obligatory applicable standard which Iran FDA Regulations

organization has to follow ISIRI 2513
This Clause
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9001 22000 Observations Verified,
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CLAUSES CLAUSES Reference Clause please Tick
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Quality/ Food safety

4 4 A
management system
In stage I were checked, organization has established ISO 9001 and ISO
4.1 4.1 General requirements A
22000 more than 3 years
Documentation Documentations were checked in stage I
requirements Process map was observed in the organization there are all organization
General processes such as management, management representative, sales,
Quality manual purchasing and production are included in this form.
4.2 4.2
4.2.1 Control of documents Inputs and outputs and the interaction between the processes specified in the
4.2.1 process map and have been determined based on the monitoring to be
4.2.2 Updating of preliminary
4.2.2 carried out. A
7.7 information and documents
4.2.3 4.2.3 specifying the PRPs and the Resource provision and management review process has been considered as
4.2.4 8.5.2 HACCP plan the main indexes of management process.
Control of records
Updating the food safety
management system
Management
5 5
responsibility A
Management approved Quality policy and objectives .refer 5.2
5.1 5.1 Management commitment A
Emergency Preparedness procedure has been documented. And they had PR-21-01
planned to drill for storm conditions and shower (rain). For September
Emergency preparedness
N/A 5.7 2016. NC
and response
But records of Pest control of were not observed.
There is evidences that shows management commitment such as action

5.2 Customer focus taken regarding customer complaints
7.2.3 5.6.1 External communication Customer satisfaction increase A
8.2.1 Customer satisfaction Reduction in Number of complaints
Refer to 8.4 and 5.3 of this report
5.3 5.2 Quality/ Food safety policy Integrated food quality and safety policy has been set. The most important A
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 Page 2 of 10
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5.4.1 And objectives objectives in the policy include:

- Acquisition of customer satisfaction in order to increase competitiveness
in the market.
- Establishing proper infrastructure and improve the resources, equipment
and technology of organization
Increase knowledge and awareness of personnel and-
The organization's management system standards ISO9001-ISO22000
Planning
5.4 have been integrated.
5.3 Quality/ Food safety A
5.4.2 According to the organizations risk management system appropriate.
management planning Documentation system has been implemented..
M.D has appointed Mr Sarouze as Food safety team leader
Management representative
5.5.2 5.5 Food safety team leader
Team member are Qualified .Job description and qualifications and A
educations records for the team were observed.
Organizational chart was reviewed.
From 3 personnel about policy were asked. They were aware about policy
and their responsibilities
5.6 Internal communication and Suggestion Box is installed in the organization in order to collect
5.5.3 External Comment and suggestion of staff. A
5.6.2 Communication Consumer instruction and Lot number for tacking are installed in
products.
External communication is done by email letter and web site.
Letter to FDA Iran on 20 Feb 2016 was observed.
5.5 Responsibility, authority and Job description of Food safety team leader, QC staff, was checked.
communication Job Qualification Of this 2 staff is compatible with Job description.
5.5.1 5.4 A
Responsibility and authority
Internal communication
Management review are planned every annually. This commission is
5.6 5.8 held on 94.12.3 (March 2015). All inputs observed in record .
Management review
5.6.1 5.8.1 General review Some of Outputs are:
Input
A
5.6.2 5.8.2 Updating Analyzing data procedure by end of the year and using
Out put
5.6.3 5.8.3 integrated software
Painting Production Entrance
6 6 Resource management A
6.1 6.1 Provision of resources Refer to 6.2 and 7.4. A
Training procedure is documented.
Courses that are planned in the first half of 95 are as follows: methods of
production and control characteristics associated with the production
Human resources (15/02/95) April 2016 risks associated with the production (04/27/95)
6.2 6.2
General The first courses were held timely as Plan.
6.2.1 6.2.1 A
Competence, awareness The production Supervisor score (conducted on April 2016(15/02/95) was
6.2.2 6.2.2
and training 83%.
The effectiveness of the courses was evaluated. The evaluation records
for production Supervisor was observed. The evaluation Score was 82%
which was acceptable
6.3 Infrastructure Manufacturing equipment have been designed, constructed, properly
6.3
6.4 Work environment established and placed for proper operation. Infrastructure according to A
6.4
7.2/7.2.1 Prerequisite programs
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/7.2.2/7. (PRPs) the requirements of the FDA.

2.3 The overall work environment of company is decent.
In accordance 7.2/7.2.2/7.2.3 ISO 22000
As sample following case were checked
Dropped ceiling was appropriated in production departments.
Light has safe coverage.
Window meshes are appropriated.
Metal Pallet in storage
Production floors are washable.
The floor is corrosion resistant
Wall and floor edge are rounded and curve
PRP inspection from MOH has been done on February 2016 and grade is
840 from 1000.
- Raw material storage was observed. Classifications separation of raw
materials has been done. Is wedge-shaped corner wall. Raw material
storage is washable..
Health Card of 2 production staff was observed, health examination has
done based on the plan
Maintenance program (in accordance with repair and maintenance
procedure) of Industrial Mill machine on Sep 2016 was observed..
7 7 Product realization A
Raw materials are Caco3 and h3po4 after inspection they mix these two
materials and after that company dries it, and with industrial Mill, they make
it to powder. They pack it and send it to quarantine. After confirmation of
QC, it can send to customer or final production warehouse, all this are in
Planning of product
7.1 7.1 FR.41.04 which I asked from manufacturing manager. A
realization
Company plans for production with stock inventory and at least there should
be three MT in stock.
Company uses procedure to ensure asking customer needs such as

quantity, price and delivery time.
Such as:
Customer-related processes Order of customer received on 94.11.20 (March 2016) with no: 610
7.2 Determination of includes: 10 Cartons was observed.
N/A requirements related to the A
7.2.1 Inventory was 21Carton and date for delivery of order was 94.11.25 .(
product
7.2.2
Review of requirements Order has been sent to customer on 95.11.25from stock.
related to the product
Customer order no. 690 on 95.02.02(April 2016):. Order has been sent to
customer on 95.02.10(April 2016)
All specification for feed DCP described in ISIRI 2513.
7.3 Design and development 7.3 Excluded from ISO 9001:2008
7.3.1 Design and development
N/A planning A
7.3.2
inputs
7.3.4
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outputs
7.3.6
Design and development
7.3.7
review
verification
validation
Control of design and
development changes
Purchase procedure has been developed. When a supplier is selected,
necessary work permits will receive. For example technical documents,
Data Analysis sheets (standard license) were received.
List of acceptable supplier includes 7 supplier was observed.
Also filled out evaluation check list for supplier were observed: carton &
Nayloon Fazel with 73% score, cargo company (Rahbar) with 80%, and
Arya Phosphoric: Trading Company supplying phosphoric acid:
Purchasing assessment score 83%
7.4 Pasargad provider of maintenance equipment and devices: assessment
Purchasing process
7.4.1 score 85%were observed.
N/A Purchasing information A
7.4.2 organization identified a method in order to ensure that the product
Verification of purchased received conforms to the specifications, is finished, holds appropriate
7.4.3
product identity
Purchase orders for Potassium dehydrogenate phosphate and Ammonia in
Jan 2016 were observed.
Also Order form of 25 carton of Calcium Carbonate in 94/10/02(Jan
2016) were observed .this product in accordance order for was received in
warehouse in 94/11/13(Feb2016) ,also control form in 94/11/13 was
observed. Mr Jalali was responsible for test control s
‫ا‬For more evidence refer to 7.3 ISO 220000
Characteristic qualities of products been identified and documented. ISIRI
2513 has described main characteristics of DCP.
Work instruction and plan are installed in production unit.
For example in accordance Di-Calcium Phosphate control instructions
Production and service
(Code: SOP.10.01)
provision
Determine the amount of phosphorus (based on second method) was done
7.5 Control of production and .in April 2016.
7.5.1 service provision
Validation of production and Raw material storage was observed. Classifications separation of raw
7.5.2 N/A A
service provision materials has been done. Is wedge-shaped corner wall. Raw material
7.5.4 storage is washable.
Identification and Customer
7.5.5 Inventory storage is recorded appropriately as an example inventory of
property Preservation of packaging Carton was 500 carton
product Items are entered and exited in FIFO
Storage general condition is appropriate, in case of temperature and
moisture, 27c with 32% humidity.
As non -conformity they use wooden pallet in ware house which is
against FDA regulation.
7.9 Identification Identification and traceability procedure has been defined,
7.5.3 7.10.4 Traceability All final product and semi product have label
A
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withdrawals Non-conforming products and all semi products are labeled according to
identification procedure
Production of 500 kg has start on 94/02/20.(09 April 2016) Bach No of
this is DC-A1-950220. According to procedure this semi product is
traceable.
For final product with Bach No DC-A1-950220 ,the Traceability were
checked. For example for this batch test control of Preparation of
Hydrochloric Acid (3 + 1) was observed.
They have plan in event of withdraw, until now there was not need to
withdraw products
PH meter and scale precision 0001/0 g of Laboratory calibration
certification were checked.
Hydrometer -where in manufacturing saloon- has been identified with
Control of monitoring and code 834 and calibration certificate CDR-92834 has been observed.
7.6 8.3 A
measuring devices
Calibration list of measuring device has been observed.
Measurement, analysis
8 and improvement
Validation, verification and
8.1 8
improvement of the food A
8.2 safety management
system
Internal audit planning for this year observed. Interval for internal audit are
once a year. The internal audit has held on 94.12.02 .(March 2015)
checklist of internal audit were observed. Evidences have recorded
8.4.1 completely.
8.2.2 Internal audit A
one nonconformity For ISO 9001 nonconformities Such as Correctives
action was not Considered, refer to 8.5.1 9001
HACCP plan were of checked:

This table also cover some of evidences in clause 7.4, 7.6,7.8
First part :
Product phase OP hazard Description Effect Acceptable severity Occurrence Score
No of hazard criteria
DCP Production 12 Physical The use of Increasing In 4 1 4
recycled heavy Accordance
materials metals COA
DCP Packaging 16 Physical The 1.5% 1 1 1
addition of Increasing
Food safety management external

substances
ash in the
final
system verification due to product
8.4.2 incomplete
Sewing
N/A Analysis of results of A

8.4.3
verification activities
8.2
Validation of control Second Part analysis :
measure combinations
controls
effects
Monitoring possibility
System
failure possibility
Severity of failer
Deployment to reduce
Resonance effect
RPN
Action
heavy metals 4 1 1 3 4 1 1 15 CCP

Packaging 4 3 1 3 1 4 1 17 CCP
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Part 3
Monitoring Action
Controlli Acceptan Controlli Control Responsi Monitori Correctio Correctiv

ng ce criteria ng retention ble of ng ns e action
Method equipmen Control Documen
t ts
Internal Daily test optical Annual M.R Internal recall Root
Audit Audit cause
Check analysis
list
Internal Daily test optical Annual M.R Internal recall Root
Audit Audit cause
Check analysis
list
Verification
Validation method Acceptance criteria retention Responsible Documentation
method
External Analysis In accordance COA 3 month Mr Jalal Test report
Standard sampling Standard Labeling 3 month Mr Jalal Test report
External validation has been done by Iran Standard office(ISIRI) or Amol

Standard ,the reports of March 2016 was observed.
Monitoring and According to the data analysis procedure monitoring processes were
measurement of processes observed. Organization collect, identify and analyze appropriate data to
8.2.3 Evaluation of individual demonstrate efficiency.
N/A verification results If score of customer satisfaction below than 75 or every item be zero A
8.4 corrective action must be done. Score of customer satisfaction for was 80.
Analysis of data
Acceptable Deviation of production is 2%,the result is 1.6%
final inspection form from the national standard (ISIRI 2513) has been
done on 11 Jan 2016,
Test Acceptable limits
Characters ---
Chloride ≤ 0.02%
Monitoring and Sulphates ---
measurement of product Iron ---
8.2.4 8.4.2 System for the monitoring of Arsenic ≤ 0.003% A
critical control points Pb 0.011%≤
Hg 0.00002%≤
Cd 0.005%≤
Flouride 0.3%≤
Assay Not less than 54% of P2O5
Control of nonconforming Records of nonconforming product were obsereved. Control the of raw

7.6.5 product
materials and record the results in the two cases, 3 cases have been
8.3 7.10 Actions when monitoring A
results exceed critical limits
observed in the production line. All this is to determine the control items.
7.10.3
Handling of potentially Records of non-compliance was observed in microbial test.for both of the
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unsafe products appropriate action were considered..

Corrective and preventive action has been documented.
The records of corrective action where observed ,
8.5 8.5 Improvement
Continual improvement As an example records
8.5.1 8.5.1
Corrective action one corrective action has been taken in recent period is to retraing A
8.5.2 7.10.2 Preventive action production staff about Working with prodution machine.
8.5.3 7.10.1 corrections
For ISO 9001 nonconformities which found in internal Such as
Correctives action was not Considered, refer to 8.5.1 9001

Form FR.41.02/02 A
Physical chemical Microbiological
In accordance COA which is based on ISIRI 2513

Mr Jalal
Preliminary steps to enable

Test report
N/A 7.3
hazard analysis
Shelf life one year after production
Contraindications: overdose would cause crippled
chickens
A
Prod phase OP haz Description of Effect Accept se Oc Sc
uct No ard hazard able ve cur ore
criteria rit ren
y ce
DCP Product 12 Ph The use of Increa In 4 1 4
ion ysi recycled sing Accord
cal materials heavy ance
metals COA
DCP Packagi 16 Ph The addition of 1.5% 1 1 1
ng ysi external Increa
cal substances due sing
to incomplete ash in
Sewing the
7.4 Hazard analysis final
produ
ct
N/A 7.6 Establishing the HACCP plan
7.8 Verification planning
Verification
Validation method Acceptance criteria retention Responsible Documentation
method
External Analysis In accordance COA 3 month Mr Jalal Test report
Standard sampling Standard Labeling 3 month Mr Jalal Test report
refer to 8.4, 8.4.3, 8.2
PRP is done based on “PR-40-01” in organization, Last A

PRP audit is done on February 2016 based on MOH PRP
checklist.
Total grade is 830 from 1000, corrective action based on
Establishing the this audit has been observed such as:
operational NC: record of “health card” for packaging personnel was
N/A 7.5 prerequisite
expired for 1 week.
programmers
(PRPs) Root cause: lack of notice of administration
Correction: sending Mr. Akbary and Mohebi to labor
clinic of Amol
Corrective action: penalty of 50000 Rials for each week of
delay for each person.
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By exception, we indicate the specific Strengths and weakness of the organization in light of the management system, as we perceive and seen through
processes in reference to requirements of the criteria being ascribed as these apply and relate to the assessment plan and planning of the assessment.
This aspect relates to Accreditation Body as it does to the protection of consumers in the client-organization’s role within their respective supply – chain.
Disclaimers: (1) herein, we reiterate that any suggestion or opinion that the assessment team expresses does not construe to be a contractual
requirement. (2) The degree of certainty in conclusions increases by the competence of the assessment team as well as the attestation within the
assessment protocol, values, mission and vision under which we operate for the protection of consumers, still remains a certain level of uncertainty.
Strength Weakness
Marketing and sales Distance between lab and manufacturing site
Laboratory Equipment ‐
Traceability ‐

action Request Type I Form-008 – as we indicate and that each of the RA addresses the basic four (4) questions
as seen in Form-008:N/A
action Request Type II Form-008 – as we indicate and that each of the AR addresses the basic four (4) questions
as seen in Form-008:
Records of Pest control of march were not observed.
Observation Form-018 – with uniquely specific identification: N/A
ATL: Vahid salahi DATE: 4 May 2016
END of REPORT
FORM-014 – Opening Meeting Checklist FORM-009 – MS Reporting,

FORM-017 – Closing Meeting Checklist FORM-008 – RA / AR, as requires
FORM-005 – Participants of opening & closing meetings FORM-018 – OBS, as requires
FORM-004 – Assessment Plan FORM-010 – As requires, recommendation for CoR
FORM-007 – Planning onto -004, as process determined FORM-026 – Assessment documents check-sheet, optional

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Quality/ Food safety

There is evidences that shows management commitment such as action

5.4.1 And objectives objectives in the policy include:

/7.2.2/7. (PRPs) the requirements of the FDA.

Company uses procedure to ensure asking customer needs such as

7.3.5 Design and development

HACCP plan were of checked:

Food safety management external

N/A Analysis of results of A

heavy metals 4 1 1 3 4 1 1 15 CCP

Controlli Acceptan Controlli Control Responsi Monitori Correctio Correctiv

Standard sampling Standard Labeling 3 month Mr Jalal Test report

External validation has been done by Iran Standard office(ISIRI) or Amol

Test Acceptable limits

Control of nonconforming Records of nonconforming product were obsereved. Control the of raw

unsafe products appropriate action were considered..

In accordance COA which is based on ISIRI 2513

Preliminary steps to enable

Standard sampling Standard Labeling 3 month Mr Jalal Test report

refer to 8.4, 8.4.3, 8.2

PRP is done based on “PR-40-01” in organization, Last A

Records of Pest control of march were not observed.

Observation Form-018 – with uniquely specific identification: N/A

ATL: Vahid salahi DATE: 4 May 2016

FORM-014 – Opening Meeting Checklist FORM-009 – MS Reporting,

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