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

 
Assessment Report/Checklist 
Form 009 

 
CLIENT‐ORGANIZATION (NAME):    Aras Bazar Pharmaceutical Co. 

PHYSICAL LOCATION(s):   Amol Ind. Zone, Amol, Iran 

Stage II Audit Date(s):    17‐21 July 2016 

Stage I Audit Date(s):    11 June ‐12 June 

NAICS (or NACE) CODE 21.10/K 

EXCLUSIONS:    7‐5‐2/7‐5‐4  ISO9001:2008 

 
Assessment objectives: Third party assessment , Attesting requirements 
of ISO 9001:2008, ISO22000:2005 in 
management system of the client company 
 
 
ASSESSMENT TEAM INFORMATION 
Assessment Team Leader, ATL Akbar Shams 
Assessor 2 Nahid Zandi 
 
 
Note: Adjusting the language within this form to the type of activity and nature of the organization is acceptable.
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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). 
Production of: Mineral & Vitamin Supplement and Feed Additives,
Antibiotics, Anticoccidials and Growth Promoters, Vitamins in Feed
2  Scope of activities  Supplements form, Feed Additives, Water Soluble Powders and Oral
Liquids for Livestock, Poultry and Aquaculture, and Disinfectants in
liquid & powder forms for warehouse Hygiene  

Legal status  FDA Iran

There are 7 groups production licenses:

- Vitamin and mineral supplements
- Water-soluble powders include Vitamins, antibiotic, and anti-
3  parasitic
Obligatory applicable standard which 
- Oral liquid drugs include Vitamins, antibiotic, and anti-parasitic
organization has to follow 
- Injecting drug
- Vaccine
- Disinfection of livestock and poultry
- minerals
This Clause

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9001 22000

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4 4 Quality/ Food safety management system
The process map include 15 processes:
- Sale QM.03.02
- Product Realization QM-02-02
- Management review QM.04.01
- Purchase QM.06.02
- Maintenance QM.09.03
- QC /QM-10-02
- Calibration QM-11-03
- Control of nonconforming product QM-13-03
- Corrective action / preventive QM-14-03
4.1 4.1 General requirements A
- Preserving product QM-15-02
- Internal audit QM-17-01
- Training QM-18-03
- Production planning QM-19-02
- Production QM-26-02
- Continuous improvement QM-32-01
- HACCP QM-36-01
The process of communication between has been
,for example processes sale and Production planning
checked.
4.2 4.2 Documentation requirements the quality/food safety management system includes
4.2.1 4.2.1 General Manual, procedures and work instructions as well as A
4.2.2 4.2.2 Quality manual

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 2 of 16 
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4.2.3 7.7 Control of documents forms and external instructions and standards if
4.2.4 4.2.3 Updating of preliminary applicable
8.5.2 information and documents
specifying the PRPs and the the documents of the company have been reviewed in
HACCP plan stage I one assessment and all mandatory procedures
Control of records have been in place,
Updating the food safety Nonconformity was removed.
management system
Quality/food safety Manual documents are
established/recommended by any member of the
organization, then the management representative
reviews and approves it initially and with signature of
the management the document is valid to be used.
Control of documents and records addresses the
document and record control; all records are subject to
be kept up to 5 years after sale.
Records of Identification and risk management are keep
for 10 years
Records of C&D are kept for 5 years.
After expiration dates filed records.
Last –step of HACCP: review of information and
documents related to PRP and plan HACCP has done
.No Need to revise
Covering the requirements of the standard procedures, 
They include control of document, control of record,
internal audit, Control of nonconforming product,
Corrective action / preventive, Identification and
traceability, withdrawals, haccp ,...
Scope is defined in the manual of the organization.
5 5 Management responsibility
Management commitment observed through checking
of the process within the company, such as resource
5.1 5.1 Management commitment A
provision, policy, management review meeting, and the
opening and closing meeting
Emergency Situation:
- Shortage of Row Material in the market.
- The return of the consumer arena
- Spread of infection
- Disruption of transportation fleet
- Lack of water / water contamination
- Product contamination
Emergency preparedness and
N/A 5.7
response
Collect all contaminated and suspected products from A
warehouses and production lines and creating
conditions for quarantine
Collecting of distributed products in accordance
withdraw procedure
Testing and making decision how to deal with
contaminations
Informing the authorities and destruction of infected

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 3 of 16 
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products
Investigating method and ways to eliminates and
removing contamination and take appropriate actions
Food safety team includes technical Manager and
M.R(MR Aryana),production Manager ,Sales Manager,
PM Manager ,
Records of contamination drills on 95/03/12 (June
2016) was observed. For Serial number 82-26-MV
(AD3E) withdrawal has been done.
Selling information products has been recorded in the
form of product output.
- Records of customer survey such as
Mr Nobakht for vitamin, date October 2015 score
88/100
Dr Sirati for all product date march 2016 score 90/100
Dr Modanloo for antibiotics score 86/100
Mr Rashidi for vitamin score 77/100
- Average customer satisfaction 83.15/100
Target: 90/100
5.2 Customer focus Duration: 6 months
7.2.3 5.6.1 External communication Average Survey items: quality92- Timely delivery A
8.2.1 Customer satisfaction 89- comunication97…
2 corrective action is derived from survey results
No records of Complaints.
Records of IMOH visit from organizations on
95/02/12(may 2016) was observed.
PRP has been audited on April 2016, result is 845 from
1000. This is acceptable in this sector.
Changes in legal requirements have been investigated in
date 31/3/1395 (June 2016)

Integrated policy quality and food safety is set. The

most important objectives in the policy include:
- Acquisition of customer satisfaction in order to
increase competitiveness in the market.
- Establishing proper infrastructure and improve
5.3 Quality/ Food safety policy the resources, equipment and technology
5.4.1 5.2 Quality/ Food safety objectives organization A
- Increase knowledge and awareness of personnel
and training specialists according to the needs of
businesses and organizations in the market.
- Producing various products with innovation
- Increase product safety
- Reduce waste
Informing policy to personnel were investigated:

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 4 of 16 
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training- Installed in Production Hall

Ms.Tanazi And Mr Joneidi was asked.
The retention of reviewing of policy is annual
The obligation to comply with legal requirements stated
in the policy. .
Objective are Measurable for example Customer
satisfaction index is 90%, duration 6 months
Responsible manager director
Preventive form contamination index: final microbial
test must one product in the year. In last year no
contamination reported.
executable program ,For example:
- Washing and disinfection system reform
- Create R & D
Full implementation OPRPs

Integrated Management system planning ISO9001-

ISO22000 has been done.
Planning General requirements have been established based on
5.4
5.4.2
5.3 Quality/ Food safety risk levels. Systems has implemented For 6 months, A
management planning and records has been established and maintained for 6
months. Then the documentation requirements were
reviewed in Management review. there was no need to
revise
Management representative (Mr Aryana) appointed Food
Management safety leader .official letter of 92/06/12 was observed. Food
5.5.2 5.5 representative safety team includes technical Manager, Management A
Food safety team leader representative, production Manager, Sales Manager, PM
Manager. QC manager
Organizational chart was reviewed. 4 level hierarchy under
the management of Director has been determined. last
version 12/2/93 (may-2014)
Suggestion Box is installed in the organization.
5.6 Internal communication Winning Informing to the latest changes in laws and
5.5.3
5.6.2 Communication regulations is installed in a place of rest. A
Policies have been installed in different parts of the
organization.
The organization has three senior management: Commercial- 
Factory- Technical.
Job descriptions and authorities for Production worker and
Responsibility, authority technical Manager and programing manager were observed.
and communication For example for production Worker:
Responsi job description such as:
5.5
5.5.1 bility and . The realization of the objectives of the organization's
5.4
authority quality policy is in line with efforts
A
Internal . efforts to produce quality products at the scheduled time
communic . perform all responsibilities have been handed
ation
. Clean your work area and the machine
. Wear Uniforms

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 5 of 16 
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.comply with all health and safety issues

Qualifying Conditions production worker:
Secondary education, work experience 2 year
Training: personal hygiene –working by machine instruction
Skills: detect pollution
Mr. Yaser Firooz Por(concentrate operator)& MS Nahid
Esmaeel Poor (Supplement ) was controlled Qualifying
Some Example Duties Technical Manager:
1. The cooperation in the preparation of the technical
information needed to perform the required,
-. supervision of all tests
-. Follow the calibration of all devices need to be calibrated
Examples Job Qualifications:
Bachelor degree on food/drug
At least 4 years relevant experience
Familiar with ISO 22000-haccp-ISO-gmp-ISO19011
Eskandar Parkavoosi was controlled
Management review dated 12/12/94 (march 2016)
Inputs were checked. Inputs are included standards
requirements, such as: Analysis of product conformity with
the requirements& customer satisfaction
Out puts such as:
Do not use DHCP powder supplements for animals
25-liter autoclave calibration
5.6 5.8 Management review Production line injectable drugs
5.6.1 5.8.1 General review Replacing fluid reservoir construction sector
5.6.2 5.8.2 Input To buy 60CC of liquid filling machine A
5.6.3 5.8.3 Out put Data analysis and verification result:
Based on Identifying and evaluations hazards :30 hazards
identified 15 OPRP and 8 CCP and 7 CP
For all CCP and OPRP verification plan was considered.
For all CCP specification form control of Critical point was
observed.
Identified OPRP appropriate verification was considered.
Management review is conducted courses for 6 months
6 6 Resource management
The appropriated resource was provided. Human resources
6.1 6.1 Provision of resources
and equipment and working environment.
In last year (1394) 10 Course was conduct. Such as Personnel
Hygiene, ISO 22000 requirements, ISO9001 requirement,
Risk management. HACCP, first aid
The effectiveness of the courses was evaluated. The
evaluation records for production operator & Technical
Human resources supervisor for HACCP course was observed. The evaluation
6.2 6.2
General Score was 88% which was acceptable
6.2.1 6.2.1
Competence, awareness and A
6.2.2 6.2.2 At least 15Hours of training per person was Considered In
training
1394, which objective has been achieved.
Courses that are planned in the first half of 1395 are as
follows: methods of production and control characteristics
associated with the production
Technical supervisor training records were for the safety

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 6 of 16 
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team manager were reviewed Qualifying is sent.

Personal training Fr-18-01 / 2 Ms Mehr Asa Yasini
(laboratory)& ali rodgar (Drug Production Manager ) were
found

Competent for lab personnel:

- Education: Bachelor
- Training: HACCP- ISO9001- ISO22000- FDA- Pharma
cope
- Skill: 3years
- Experience: Testing method

Operator: MS Mosavi

Manufacturing equipment have been designed, constructed,

properly established and placed for proper operation.
Infrastructure according to the requirements of the FDA.
The overall work environment of company is decent
PRP
In accordance 7.2/7.2.2/7.2.3 ISO 22000 table code
As sample following case were checked :LI1701
- Positive air Flow in production unit.
- Light has safety coverage..
- Window meshes are appropriated.
- Metal Pallet in storage
- Production floors are washable.
- The floor is corrosion resistant
- Wall and floor edge are round
- Production Entrance doors have jack
- The temporary refrigerator were checked
Infrastructure - Break was controlled conditions
6.3 Work environment
6.3 - FIFO observed in controlled warehouse
6.4
6.4 Prerequisite programs A
7.2 - Detergents were evaluated storage conditions
(PRPs) - 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 (Adel
Hoseini-Davood Esfandiari), health examination has
done based on the plan
Maintenance program (in accordance with repair and
maintenance procedure) of was observed:
List of machines for each section were. For example
Machinery manufacturing sector, including:
- Filling 9 Nozells code QN01 85 liters per minute,
Greasing- Weekly, Springs Visitors nozzles and
nozzle base- monthly, Transmission Control- yearly
- Filler device code QFL03, Press the jaw control
filler- daily, Visitors distilled water- Weekly,
Cleaning the filter pump- Yearly,

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 7 of 16 
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Records were kept for January 2016.

MOH PRP audit has been conducted on may 2016
2 NC raised by MOH auditors which was as below:
1- Storage and packaging of chemicals have been isolated
2-air conditioner need to be repair
Company raised two corrective action regarding the NCs
which is sent to MOH
7 7 Product realization
Produced by the Organization include:
1.Vitamins
2. Antibiotics
3. Antiseptics
4. Anti-parasitic and Anti-coccidiosis
5. Food additives premixes treatment
6. Aquaculture
7. Concentrate
7.1 7.1 Planning of product realization
Stages of the production process in OPC diagram was observed. A
Control Specifications for each step in the control plan has been
determined.
Flow Chart for the product Premix Vitamin K3 were
examined: Weighing- mix- Cooking- packing
Specifications control during production include Temperature-
Weight- Humidity

Order of Representatives for order or invoice is received and

Customer-related processes recorded, The order and the date on the check inventory,
Determination of Inventory shortages is production planning, Is written change
7.2
requirements related to
7.2.1 N/A
the product
order, Orders including quantity, delivery time and product A
7.2.2 type, for example:
Review of requirements related
to the product Premix Vitamin K3 packing:10kg, date of order: Feb 2016,
delivery: 14 days, Order quantity: 300 pack
Costumer name: Dr Ziraki
Design and development process were (QM-02-02) owner :
Technical Assistant,
Steps have been set as follows:
Design and development
Design and development - Engineering team to control quality and write on
planning D&D
Design and development - Write all stages of production including process-
7.3 inputs related parameters SETUP process-percent
7.3.1 substances and process specifications
7.3.2 Design and development
outputs - Understand the technical characteristics of the
7.3.3
7.3.4
N/A Design and development product by reading the input data A
7.3.5 review - Identify the specific characteristics of the product
7.3.6 Design and development - Identification Special features on the characteristics
7.3.7 verification of the product processes are effective.
Design and development - D&D verification
validation - D&D validation
Control of design and
Product Design and development records was such as:
development changes
Amprocox 20% code 76-4-AC, Compounds: Amprolum
hydro chloride 200mgr, Indications: Prevention and
treatment of coccidiosis caused by Ymryatlla, poultry

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 8 of 16 
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(chickens-laying hens-mother) Turkey and also

recommended for the prevention and treatment of
coccidiosis in calves and lambs, Storage conditions: The
lower temperature of 25 ° C and dry place away from light
and out of children's reach, packaging: 100gr, rate of usage:
for poultry 100 gr in 300 litr water for 2 weeks, attention: 3
days before slaughter stop taking your medicine
Date of design and development issue 4/1394(July 2015)
Purchasing process was QM-06-02. Purchasing done
according to regulations. Raw materials needed to develop
and evaluate technical specifications on the basis of reference
books done in the form of FR-06-02. The samples will be
sent to the laboratory. After receiving the certificate of
analysis in the form of FR-10-07 and confirms the prototype
shopping done. Wheat bran 45000kg the purchase records to
be viewed as follows:
Buying Date: 02/14/94 (3may 2015)
Date of receipt of samples: 2/16/94 (5 may 2015)
Purchasing According to laboratory analysis: 2/17/94 (6 may 2015)
7.4 Purchase order: 2/17/94 (6 may 2015)
Purchasing process
7.4.1
7.4.2
N/A Purchasing information Verification of purchased goods: 2/19/94(8 may 2015) A
Verification of purchased Product delivery receipt to the warehouse: 2/19/94 (8 may
7.4.3
product 2015)
QM-23-03 was observed process of evaluating and selecting
suppliers. grade A:71-100 Qualified, grade B: 61-70
conditional, grade C:51-0 black list.
Records were reviewed to evaluate suppliers:
- Pars namak saveh: score85.55 date 15/6/94
(September 2015)
- Plastic daroo (Packing containers): score 82.35 date
10/6/94 (September 2015)
- Tehran boric (sulfuric acid): score 88
- Gohar podr (calcium carbonate) : score 95

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 9 of 16 
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Production planning process was. QM-19-02 owner: product

manager,
- Receive orders from Commerce
- Reviews the adequacy of the resources needed to
produce and material supply planning
- There are production units Concentrate –
Supplementation- Liquids, disinfection and
pulverization
The daily production reports to date of 25/09/94 and
30/10/94 in the form of FR-19-01, respectively. FR.19.03
moisture recorded was for the date 12/03/94. FR.19.07
weight during production was for the date 3/12/94. product
Production and service control during production was observed on 29.11.94
provision In units of liquid volume control during production, printing

FR.06.01
7.5 Control of production and and packaging to be done
7.5.1 service provision Product record for Premix Vitamin K3 date 25/11/94
7.5.2
N/A
Validation of production and AR
(February 2016) 2000 kg:
7.5.5 service provision
- Vitamin K3(MSB OR MPB) code 1010104‐ 10.000kg
Identification Preservation of
product - Wheat     meal code 1010301
- Calcium    Carbonate code 1010302
- Foil bags code 2010111‐ number 200
expiration date for Vitamin meat 9 months, multi vitamin
2 years, Flumequine; 2 years

The order point was controlled for raw materials: cobalt

10000 gr - manganese 10000 gr- Copper 15000 gr- Iodine
5000mlitr-
Order point for Iron raw material 1500 gr Is set but in
storage 750 gr there are and Not Purchase request.
Record of product sulfatrim batch number: 1222005
expire date 17/4/95 were.
Traceability information include: entry date, product date,
expire date, batch number, quantity, supplier, Code
Warehouse, Sampler, QC personnel, date of QC, Purity
For example code 925010: virucidal product 5000gr Date
Identification
7.9 of manufacture 2015 batch number 10
7.5.3
7.10.4
Traceability
Identification based paint:
A
withdrawals
Green label: QC Ok
Red label: QC Reject
Pink label: QC hold in laboratory
Blue label: sample for regulator
External calibration is Laksar Company: under the NACI
credit license. Its certification was observed.
All equipment have Label
PH Meter:
Control of monitoring and Certificate number: 94-12200
7.6 8.3
measuring devices Serial Number: FJFF33145 Model: PHS-25CW A
Number of certificate: 9408126
date of issue: 11/3/1394
standard: PH Simulator & reference solutions-ISIRI 4125
Environment Condition :T:+23+_ 3 C

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 10 of 16 
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Refrigerator thermometer
Serial Number: 1825641
Date: 15/3/1394
Incubator :
Serial Number: 1825613
Date: 15/3/1394
The error has been installed on the device
Setting : 25.6
By reading: 25.6
Measurement, analysis and
8 improvement Validation,
8.1 8 verification and
8.2 improvement of the food
safety management system
Base on plan frequency is every six month.
Audit has done on end of 19 May 2016(95/02/30) in
accordance ISO 22000:2005 and ISO 9001:2008 requirements
in checklist
4 NC were found
As example :
8.2.2 8.4.1 Internal audit Records of QC for batch number 8 vitamin were not observed. A
Also 3 recommendation for improvements such as
Use of Statistical software for data analysis
Independency and impartiality were checked.
Internal Audit certification of 2 Auditors Mr Aryana and Mr
Matin Saberi were checked.
The observations will be recorded in the check list.
eleventh step :planning of Verification and validation
The results of the water analysis conducted by Regulatory
(Health of work environment central Office)
Workplace Health Center on 01/25/95(13 April 2016)
- PH = 7.1
Food safety management
- Free chlorine residual = 0.5
system verification
8.4 - Coliforms per 100 ml: 0
Analysis of results of
N/A 8.4.3 - Escherichia coli per 100 ml: 0 A
8.2 verification activities - S. 100 ml: 0
Validation of control Responsible of testing: Mohseni
measure combinations Validation of control measure combinations were. Final
product Di-calcium phosphate Tested by regulatory
authorities in April 2016 and MOH PRP audit has been
conducted on may2016
Control measures has not changed.
According to the data analysis procedure monitoring
Monitoring and processes were observed. Organization collect, identify and
measurement of processes analyze appropriate data to demonstrate efficiency.
8.2.3 Evaluation of individual , if score of customer satisfaction below than 75 or every
8.4
N/A
verification results item be zero corrective action must be done. Score of
A
Analysis of data customer satisfaction for was 83.5 .
Supplier evaluation process after supplier evaluation for the
first time, 2 suppliers removed from the list. Because of the

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 11 of 16 
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score was under acceptable define criteria.

Acceptable Deviation of Delivery is 2%,the result is 1.8%
Index for production process is Production than planned,
result 94% acceptable 90%
Index for training is Per capita education for per person result
15 hours acceptable 10 in 1394 years.
QC process was QM-10-02.
Control production items include:
- Section Liquids: batch number- PH- temp
- Concentrate: Humidity- ash- Phosphorus- calcium-
protein- fiber- cl- TVN- energy- potassium
Monitoring and
Record of QC:
measurement of product
Date: 19/7/94(10 October 2015)
8.2.4 8.4.2 System for the monitoring
Product: multi vitamin
of critical control points
Color and clarity: visual
Density: 1.0779gr (1.06-1.09)
Purity: 105.55(90-150)
Ph: 4.2(4-6)
Ecoli: negative
Salmonella: negative
Tenth step: take the necessary actions in case deviation from
Control of nonconforming of the Critical Criteria: NO Case
product Records of nonconforming product were checked. Two cases
7.6.5
Actions when monitoring Control the appearance of raw materials and record, 3 cases
8.3 7.10
results exceed critical limits A
7.10.3 in the production line have been observed. For All this is to
Handling of potentially unsafe
products determine the corrective action.

2 project for improvement is in progress:

1- Motivation system for personel
2-incresing production line, project started in 94/11/20.
There are 12
Corrective and preventive action procedure was. PR‐14‐01
Improvement 7 case Corrective and preventive action were observed.
8.5 8.5
Continual improvement
8.5.1 8.5.1 They are effective.
8.5.2 7.10.2
Corrective action A
Preventive action 94-4: certificate extension request has been sent to MOH,
8.5.3 7.10.1
corrections but, MOH needs audit PRP results for this issue, Audit is
postponed by MOH auditors for 6 weeks that is out of our
hands
94-6: we did not use fan system in winter, it will be repaired
on new year (spring) holiday.
95-1(preventive action): Change detergent to prevent
contamination of equipment
   

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 12 of 16 
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The first step: forming the food safety team: A

Ms. Mr Aryana- Parvane Bahrestaghi- Mehdi Nikjo-
Yaser Firooz Por- Nahid Esmaeel Por- Adel Asadi
Second step :Product Specifications
Product Description
Multi Vitamins code 76-10-MV
- Human consumer groups: All
- Limit consumption: none
- Ingredients: vitamin A, vitamin D3, vitamin E, B1, B2,
B12, C, K3, calcium D-Pantothenate, niacinamide
- Important physical characteristics: color uniformity –
Clarity
- Chemical characteristics: Density(1.06-1.09),
Purity(90-150), PH(4-6)
- Microbiology characteristics: E coli, Salmonella
- Storage: dry place- temp lower 25- Away from light
- Storage time: 9 month
- Packaging: 500 gr
- Transportation: Car

Raw Material Description:

Vitamin B2 code 6975
- Storage: Humidity(lower 45%), temp (lower 20)
- Storage time: 2 years
Preliminary steps to enable
N/A 7.3 - physical characteristics: color uniformity – Clarity
hazard analysis
- Chemical characteristics: Density, Purity, PH
- Microbiology characteristics: E coli, Salmonella
Step Four: OPC
Weighing- mix- Cooking- packing
Fifth step: Verification of OPC and processing and
verification of control Measure: Approval of safety team
in accordance with the production line and OPC.
Responsible Mr Aryana
Sixth step: Hazard identification and determination of
acceptable levels

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 13 of 16 
 REFERENCE, AS
This Clause

APPLICABLE 
Has been
  Reference Clause  Observations  Verified,
please Tick
mark √ 
 

Hazards more than 4 will be analysis

Step: Weighing
Hazard: Entry of foreign bodies (physical)
Severity: 3 Occurrence: 2 Significance: important
Storage:
Hazard: drop in temperature - microbial contamination
Severity: 4 occurrence: 1 Significance: important
Seven step: selection and assessment of control
measures
evaluated Items: the impact ,of possibility of
monitoring, control measures place in system, failure
possibility , Severity, Exclusive use action to remove or
reduce risk, Synergistic effects of
Points are from 1 to 4 .Scores are based on total points.
CCP = more than points 20
OPRP = less than points 20
Example:
Risk in Weighing step: Change in the amount of
materials, result: Impact on health, action: check
amounts of ingredients and formulas by QC
Score :3+2+2+2+4+4+3=20 CCP
Risk in Mix step: Entering foreign materials, result:
Physical risks, action: close all the doors, Installing air
curtains, Install window guards
Eighth and ninth Steps
Score :1+3+1+2+2+2+2=13 OPRP
7.4 Hazard analysis
mix stage:
N/A
Hazard: physical objects, Severity :2, Occurrence AR
7.6 Establishing the HACCP plan
:1, Importance: Significant
7.8 Verification planning
Control measures: individual health control and
control of appearance, score 16, Action Type:
PRPs
Storage in refrigerator:
Hazard: drop in temperature - microbial
contamination
Severity: 4 occurrence: 1 Significance: important
Control measures: PM of cold air system
Score: 17, Action Type: PRPs
10-12 step:
Data analysis and verification result:
Based on Identifying and evaluations hazards :28 hazards
identified 12 OPRP and 11 CCP and 5 CP
For all CCP and OPRP verification plan was considered.
For all CCP, specification form control of Critical point
was observed.
Identified OPRP appropriate verification was considered.
Risks related to raw materials vitamin is not detected

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 14 of 16 
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This Clause

APPLICABLE 
Has been
  Reference Clause  Observations  Verified,
please Tick
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Personal hygiene: A
Health card of following staff were observed
issued 94/8/15 Mohsen Behmanesh
issued 94/8/15 Hasan Babaki
issued 94/8/15 Zahra Ghorban Nejad
Personal protective equipment, including Cap -
work clothes - mask ,Gloves
Culture (V.R.B.A) has prepared base on
Establishing the
operational
instruction.
N/A 7.5 prerequisite Records were reviewed for Mr. Pashani in May.
programmes
(PRPs) Washing and disinfectant:
Cleaning of Salon is done according to C & D
schedule. Raw materials are stored on pallets.
Separation is done to avoid cross-contamination.
Temperature is check consistently records for
last month was observed.
Cleaning program operator equipment were
investigated. Daily Cleaning and disinfectant is
done.
   

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 15 of 16 
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This Clause

APPLICABLE 
Has been
  Reference Clause  Observations  Verified,
please Tick
mark √ 
 

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

The variety of products

Exclusive of formulation 
Packaging
Having technical people 

High production capacity
 

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:  

Risks related to raw materials vitamin is not detected

Order point for Iron raw material 1500 gr Is set but in storage there are 750 gr

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

ATL: Akbar Shams DATE: 21 July 2016

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

END of REPORT

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 16 of 16