Sie sind auf Seite 1von 11

BRSM 

Systems:QMS ISO 9001 (2008) 

Assessment Report/Checklist 
Form 009 

 
CLIENT‐ORGANIZATION (NAME):    KIMIA TARABE PARS CO. 

PHYSICAL LOCATION(s):   No.10 , block 107 , Nastaran st. , site felez tarash 
, khavaran Ind. Zone , Emam Reza rd. , Tehran , 
Iran . 
Stage II Audit Date(s):    07.Jan.2016(1 day) 

Stage  I Audit Date(s):    27.Dec.2015(0.5 day) 

NAICS (or NACE) CODE 22.19  /25.94   

ISO 9001 EXCLUSIONS:    7.3/7.5.2/7.5.4 

 
Assessment objectives: Attesting requirements of quality management 
system have been met in client’s management 
system
 
 
ASSESSMENT TEAM INFORMATION 
Assessment Team Leader, ATL Ms. Azadmanesh
Assessor 2 Mr. Mohajer
Assessor 3  
Assessor 4
Assessor 5
Assessor 6
 
 
 
Note: Adjusting the language within this form to the type of activity and nature of the organization is acceptable.
REFERENCE, AS
This Clause

APPLICABLE1 
Has been
REFERENCE CRITERIA FOR GUIDANCE TO FOLLOW UPS – PLEASE WRITE ANNOTATION OR X TO INDICATE SPECIAL Verified,
  Reference Clause  ATTENTION WILL BE REQUIRE   please Tick
mark √ 
 

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 rubber and metal gaskets. All technical specifications provided by customer.
2  Scope of activities 
Excluded clauses are: 7.3/7.5.2/7.5.4 because nature of organization. 

3  Legal status  Ministry of Industries & Mines   


4  Quality Management System 
General  According to QATI06 , processes are determined and are : planning and
Requirements –  production , repair and maintenance of infrastructure , calibration ,
4.1  What is the  inspection and test of product and control of non-conforming product , 
implementation /  purchasing and supplier evaluation , training. interaction and acceptance
transition date?  criteria of the processes are determined in QATI06

All required procedure documented and addressed in DMQM01; also for


Documentation 
managing the documents & records in an integrated system organization
4.2  Requirements 
has developed Control of records procedure with code QAPR01&

(includes records) 
Control of records procedure with code QAPR01.

Quality manual with code DMQM01 documented and required procedure


identified in that. The interval of quality manual reviewing is once in a
4.2.2  Quality Manual year. 
The clauses 7.3/7.5.2/7.5.4 are not applicable and excluded because of
nature of procedures. 
Control of documents procedure with code : QAPR02 observed. . List of
documents and situation of validation defined in list of documents and
records with code: QAFO26.
Control of 
4.2.3 
Documents 
The method of document coding has been mentioned. For approving the 
document they use blue colored stamp “approved” and for obsolescing
the documents they use black colored stamp “canceled”. Such as the
procedure “ QAPR01” which have approved stamp
Control of records procedure with code QAPR01 observed. List of
records observed in QAFO26. All required records have kept in
Control  of  organization. The period of records retention has been determined in this
4.2.4  Records  –  Are  procedure such as quality objective ( QATI02) will be retained for 3 years 
records…  and after that the report of quality objectives accomplishment will be
retained for 5 years. Financial record shall stay 2 years in current and 7.5
years in morgue and after that records shall be eliminated.
By assigning Management representative, developing quality policy,
Management  determining quality objectives & allocation of resources, the senior

Commitment  management has indicated its commitment 

FORM‐009_V4_QMS                                      Issued: July 9, 2003                                                               Revised: 6 Nov 2015                                                       Page 2 of 11 
REFERENCE, AS
This Clause

APPLICABLE1 
Has been
REFERENCE CRITERIA FOR GUIDANCE TO FOLLOW UPS – PLEASE WRITE ANNOTATION OR X TO INDICATE SPECIAL Verified,
  Reference Clause  ATTENTION WILL BE REQUIRE   please Tick
mark √ 
 

Customer  Focus  –  Focusing on customer satisfaction has been mentioned in quality policy,
5.2  (may  relate  to  also organization has developed customer satisfaction and complaint 
7.2.1 and 8.2.1)  procedure ( QAPR07). 

Quality policy with code QATI01 observed and approved by top


management on dec-2015.
The main targets of implemented QMS are Continues improvement in
5.3  Quality Policy
productivity, reduction of cost , on time delivery for customer satisfaction

, increasing staff awareness and knowledge.
The period of reviewing quality policy has been determined annually.
Quality objectives with code QATI02 have been determined. All
objectives are in accordance the main targets in quality policy 5.3. They
Planning;5.4.1
have developed 4 quality objectives:
Quality
1- Increasing 10% annual sales rate in comparison last year
Objectives/5.4.2
5.4 
quality
2- Increasing 15% training courses in comparison last year 
3- Reducing on time delivery 3% less than organization situation in
management
last year
system planning
4- Reducing production process waste rate 5% less than
organization situation in last year
5.5 
Organization chart with code of QATI05 was observed.
Responsibilities and authorities determined in QAJO01 to QAJO15.
For example the job description of production manager including its
responsibilities, authorities, needed infrastructure, needed training courses
was observed. Such as:
Responsibility,   Planning and organising production schedules.
5.5.1 
Authority    Assessing project and resources requirements.

 Estimating, negotiating and agreeing budgets and timescales with
clients and managers.
 Determining quality control standards.
 Overseeing production processes.
 
Management representative (Mr. Torabi) has appointed and he is quality
assurance manager. His responsibilities have been determined; the official
letter for his assignment in Nov-2015 with confirming of managing
director in letter number of 94.64825 was observed.
Job description has been observed such as:
Management   ensure Quality Management System processes are “established,
5.5.2 
Representative  implemented and maintained”,

 report to “top management” on the QMS performance and where
improvements are needed,
 ensure that everyone in the organisation is aware of customer
requirements.

FORM‐009_V4_QMS                                      Issued: July 9, 2003                                                               Revised: 6 Nov 2015                                                       Page 3 of 11 
REFERENCE, AS
This Clause

APPLICABLE1 
Has been
REFERENCE CRITERIA FOR GUIDANCE TO FOLLOW UPS – PLEASE WRITE ANNOTATION OR X TO INDICATE SPECIAL Verified,
  Reference Clause  ATTENTION WILL BE REQUIRE   please Tick
mark √ 
 

Organization chart approved by top management with code: QATI05.


Relation between units has been determined in that.
Internal Internal communication between sale department and production
5.5.3 
Communication department has implemented by related forms such as: production order.

Also the means for internal communication are phone, information
boards, official letter.
5.6 

5.6.1  General  Management review has planned to be conducted once in a year.   

Management review has been held on 94.10.07 (Dec-2015). All inputs


5.6.2  Review Inputs  have been discussed & recorded and analyzed. Such as: corrective and 
preventive actions.

Outputs of this review are recorded Such as:


- improvement of packaging
- implementation of 5S principles ,
5.6.3  Review Output - Recruiting 2 staff for sales department 
The responsible staff and teams for executing the outputs have been
determined.

6  Resource Management

6.1  Refer to 6.2, 6.3, 7.4 ,8.2.1


6.2  Human Resources 

6.2.1  General  
Training needs has determined by managers and heads of departments.
Such as: for technical engineer has planned course of repair and
maintenance of machinery and for one of production operator has planned
Competence,  production and assembling course. Training schedule including 8 courses
6.2.2  Awareness  and  has been developed and observed. 
Training 
Effectiveness of production and assembling course in Oct-2015 has
evaluated by production head and score was 95 and was effective.

FORM‐009_V4_QMS                                      Issued: July 9, 2003                                                               Revised: 6 Nov 2015                                                       Page 4 of 11 
REFERENCE, AS
This Clause

APPLICABLE1 
Has been
REFERENCE CRITERIA FOR GUIDANCE TO FOLLOW UPS – PLEASE WRITE ANNOTATION OR X TO INDICATE SPECIAL Verified,
  Reference Clause  ATTENTION WILL BE REQUIRE   please Tick
mark √ 
 

List of machinery observed in POFO2 , such as : equipment for


production of gasket with size above 8 inch. For this machine
(6:01:NG01 ) has planned preventive maintenance activities includes :
6.3  Infrastructure  cleaning and lubricating of rails (weekly) , control of driving rubber    
(every mount) , control of forming ( every 2 mounts) . Records of these
activities in Nov-2015 were observed. The record repairing of packaging
equipment in Sep-2015 was checked.
In production line , layout of equipment was favorable. All machines
have been labeled. They have prepared red colored baskets for collecting
Work  the production waste. Cleaning of equipment and floor of production hall
6.4  has done according to developed plan. The cleaning activities in this plan    
Environment  
are weekly and monthly basis. Layout of warehouse items was observed.
The condition of items retaining in warehouse is only keeping in a dry
place.

7  Product Realization 

Production planning is based on the market demand estimation derived


from sales department every 3 months; also the customer orders which
are more than production planning will be informed to production
department such as customer order no.94-701 in Sep-2015.
Orders came from sales department from past data, they estimate market
needs and produce for that except company have an inquiry more than
500, in this situating sales department gave an order to manufacturing
department and after that production manager will produce as need such
as inquiry 94-018 on November 2015 for 720 rubber gasket Mr asadi.
Which is manufactured within a day and dispatched on same day to Mr
Planning of 
asadi?
7.1  Product     
Realization  QC records has been observed for mentioned dispatch in “ QCF003”
Operational process chart for production of metal gaskets with tow ring
(internal and external) was checked. Parts of this product must be
according to ASTM 3677-10(15) , ASTM D 2240-05(2010). Acceptance
criteria have determined in these standards, manufacturing process is
fully automatic and operator for example (Mr Joshaghani) controls every
15 Mins with a go, no go gauge.
Main standard for this product is ASME B16.20 and 21.
Specifications (acceptance criteria) for product has determined in
QCF003.

FORM‐009_V4_QMS                                      Issued: July 9, 2003                                                               Revised: 6 Nov 2015                                                       Page 5 of 11 
REFERENCE, AS
This Clause

APPLICABLE1 
Has been
REFERENCE CRITERIA FOR GUIDANCE TO FOLLOW UPS – PLEASE WRITE ANNOTATION OR X TO INDICATE SPECIAL Verified,
  Reference Clause  ATTENTION WILL BE REQUIRE   please Tick
mark √ 
 

Determination  of  Customer order requirements are recorded in customer order or the
Requirements  contract between organization and customer. One of orders that received
7.2.1  from customer observed (order no.94-017 in Oct-2015): SHEET :    
Related  to  the 
dimension : 1400mm*6mm , material : rubber neoprene hardness 70-75
Product  
shore A , Qty: 30meter.

7.2  Customer‐Related Processes 

Review of  Reviewing of contracts done by control of warehouse inventory by


Requirements  coordination with production manager and also order under production
7.2.2  checked by him to plan time delivery of received orders. Such as : order    
Related to the 
number 94-735in Oct-2015 that Time delivery has determined 15 days
Product  
later.
Communication with customer starts from receiving orders. After
receiving of orders, invoice and technical specification of product will be
communicated and confirmed, such as for order no.: 94- 017records in
Oct. 2015. This order technical specification was : spiral gasket with
Customer  internal and external ring , size : 4 inch , weight : 300 lbs , filer from
7.2.3 
Communication 
  
graphite , inner ring of stainless steel 304 and external ring of carbon
steel. The confirmation of customer is taken by its signature.

7.3  Design and Development 

Design and 
7.3.1  Development  Excluded  ‐‐‐   
Planning 

7.3.2  D & D Inputs  Excluded  ‐‐‐   

7.3.3  D & D Outputs  Excluded  ‐‐‐   

D & D 
7.3.4  Excluded  ‐‐‐   
Reviewing 

7.3.5  Verification  Excluded  ‐‐‐   

7.3.6  Validation  Excluded  ‐‐‐   

Control of (D & D) 
7.3.7  Excluded  ‐‐‐   
Changes 
7.4  Purchasing 
Purchasing  Purchasing procedure with code : COPR01 documented, according to this
7.4.1 
Process 
  
procedure , verification of purchased materials has done by certificate

FORM‐009_V4_QMS                                      Issued: July 9, 2003                                                               Revised: 6 Nov 2015                                                       Page 6 of 11 
REFERENCE, AS
This Clause

APPLICABLE1 
Has been
REFERENCE CRITERIA FOR GUIDANCE TO FOLLOW UPS – PLEASE WRITE ANNOTATION OR X TO INDICATE SPECIAL Verified,
  Reference Clause  ATTENTION WILL BE REQUIRE   please Tick
mark √ 
 

Purchasing  analysis from main producer / third party lab. Or initial quality control.
7.4.2 
Information   Such as: Certificate of compliance for sheet brass 70B (8* 660*2000)   
ANNEAL (O) 0 , ACCORDING TO STANDARD JIS H3100 and for
sheet copper TPC (1.5*660*2000) NNEAL (O) . the record of purchase
order ( POFO18) for packaging nylon in June-2015 was checked.
Raw rubber verification record has been observed on 10/7/1394
(September 2015).
Verification of  Evaluation of suppliers has done on form QAFO04. Criteria for
7.4.3 
Purchases  evaluation is : price , distance to factory , on-time delivery , acceptance of 
non conform parts , credit and having high quality , … , evaluation of row
gasket and graphite supplier (mehran plastic co.) with grade of 81%,
supplier of tools (abzar mahdi co.) with grade of 74% in Aug-2015
observed and they have approved for cooperation.
 

7.5  Production and Service Provision 

Production planning for June, July &August-2015 was observed.


Order no.: 94-701 communicated to ring production unit. In list of
packing, packing conditions for this order has been determined and
communicated to packing unit. Packing must be done in woody pallet,
instruction for packing of gaskets documented in QC-KTP-01.
Control of 
7.5.1  Production and  Control during production for order no.94-349 includes: to be flat and no   
Service Provision  flash on gasket and for stage of welding and assembling, correct welding
and fitness of product has been controlled.
The record of weekly, monthly and Trimester production report for the
June, July &August-2015 was checked, the average deviation from the
production planning was 1.3% and the criteria of deviation has been
determined 3%. 

Validation of 
Processes for 
7.5.2 
Production and 
EXCLUDED  ---  
Service Provision 

FORM‐009_V4_QMS                                      Issued: July 9, 2003                                                               Revised: 6 Nov 2015                                                       Page 7 of 11 
REFERENCE, AS
This Clause

APPLICABLE1 
Has been
REFERENCE CRITERIA FOR GUIDANCE TO FOLLOW UPS – PLEASE WRITE ANNOTATION OR X TO INDICATE SPECIAL Verified,
  Reference Clause  ATTENTION WILL BE REQUIRE   please Tick
mark √ 
 

The identification & traceability procedure (POPR04) was checked.


All orders are traceable to : required specification , control during
production and final quality control by order no. such as: 94- 017that
observed result of chemical analysis , hardness test result , quality control
Identification  and  during production and final quality control, production order to unites (
7.5.3 
Traceability 
POFO23), final product identity card storage( POFO14); also they have   
developed traceability form ( POFO25) for controlling product
transferring between units which for this order the related completed form
was observed.
One package observed in warehouse with order no: 94-349. This was
traceable to name of customer.
Customer 
7.5.4 
Property 
EXCLUDED  ---  

Warehouse has racks for keeping row material . but some semi-finished
products observed in floor of production hall that have no identification

POPR01 
Preservation of  labeling and not determined situation of that about acceptance. Inventory
7.5.5  AR
Product  controls by warehouse soft ware and input, output materials recorded in
that for example the record of inventory flow report for O-ring 32 was
observed, the last inventory level was 82 pieces.

Control of  List of testing and investigating tools observed in QCF011. Includes: 3


Monitoring and  calipers. Calibration certificate for one of them with code RZ147697
7.6 
Measuring 
and has label of calibration by “Tanzim Co.” with calibration date (July-   
2015). These tools have annual calibration planning. Error of this tool
Devices 
was zero.
8  Measurement, Analysis and Improvement 
By developing Internal Audit procedure (QAPR08), Non-Conforming
product control procedure (QCPR02), corrective and preventive actions
procedure (QAPR03), customer satisfaction and complaint procedure (
8.1  General 
QAPR07), process monitoring & data analysis report (QAFO105) in the
   
organization, implemented quality management systems can be measured,
monitored and continues its movement toward the improvement
8.2  Monitoring and Measuring 
Customer satisfaction and complaint procedure ( QAPR07).
Collecting customer reviews observed on form QAFO18. Questions are:
primary product quality, functional quality, on-time delivery, adequacy
of labeling and signing of packed products; the records of customer
Customer 
8.2.1 
Satisfaction 
satisfaction in Sep-2015 were checked such as Mr. Asadi with score of   
76%, Mr. Behroozi with score of 92%, Kamyaran Production Co. with
score of 84%, Iran Basteband Co. with score of 72%.
Since the implementation of the quality management systems in
organization, there is no any report of customer complaint.

FORM‐009_V4_QMS                                      Issued: July 9, 2003                                                               Revised: 6 Nov 2015                                                       Page 8 of 11 
REFERENCE, AS
This Clause

APPLICABLE1 
Has been
REFERENCE CRITERIA FOR GUIDANCE TO FOLLOW UPS – PLEASE WRITE ANNOTATION OR X TO INDICATE SPECIAL Verified,
  Reference Clause  ATTENTION WILL BE REQUIRE   please Tick
mark √ 
 

Annual planning for internal audit observed on : Dec-2015. Processes


audited were: management-planning and production-testing and
inspection and control of non-conform products-preventive and
maintenance of infrastructure-purchasing –training.
8.2.2  Internal Audits 
3 non conformities recorded in internal audit. They have recorded in form
  
of audit findings and results audit. Such as: no planning of production
according to time delivery of order. Corrective action of This non
conformity issued and monitored and corrected.
The process monitoring & data analysis report in QAFO105 was
observed and some evidences are as follows:
- An acceptance criterion for waste is up to 3% and result was 2%.
- Acceptance criteria for delay of order delivery is 0% and no
Monitoring  and  record of delay reported
- The average deviation from the production planning ( June, July
8.2.3  Measurement 
&August-2015 ) was 1.3% and the criteria of deviation has been
  
Process 
determined 3%
- Average of training effectiveness was 84%, the determined
criteria was 75%
- Average of customer satisfaction score was 79% and the
determined criteria was 70%.
Final quality control has done according to acceptance criteria in form
QCF003. attribute control are : size , class and diameter of inner and
external ring , type , thickness according to customer order , visual
controls for gaskets (no twist of edge and oval and no fraction ) , correct
function( assembling quality and no spaces between ring and rubber ,
Monitoring  and  welding every 8 mm). for order no. 94-349 , all parts checked and
approved by QC man according to ASTM 16.20
8.2.4  Measurement  of 
Before sending shipment for customer, sample of that sent to third party
  
Product 
lab. Chemical Analysis of produced parts according to ASTM 3677-
10(15) and hardness test report according to ASTM D 2240-05(2010)
observed for order no: 94-735. Such as: hardness was in range of 66-69
and standard level is 70-75. QC man told customer approved invoice of
this order after sending to their and they approved that and this means
these shipment approved by customer.
Control of Non‐ For order no.: 94-735, result of hardness test was out of range but this
shipment accepted by customer; this led to a discount (2%) for the
8.3  Conforming 
customer “Mr. Zanjani” in Sep-2015. The issued corrective action with
  
Product 
result of changing the supplier and modifying control plan was observed.

FORM‐009_V4_QMS                                      Issued: July 9, 2003                                                               Revised: 6 Nov 2015                                                       Page 9 of 11 
REFERENCE, AS
This Clause

APPLICABLE1 
Has been
REFERENCE CRITERIA FOR GUIDANCE TO FOLLOW UPS – PLEASE WRITE ANNOTATION OR X TO INDICATE SPECIAL Verified,
  Reference Clause  ATTENTION WILL BE REQUIRE   please Tick
mark √ 
 

The process monitoring & data analysis report in QAFO105 was


observed and some evidences are as follows:
- An acceptance criterion for waste is up to 3% and result was 2%.
- Acceptance criteria for delay of order delivery is 0% and no
record of delay reported
- The average deviation from the production planning ( June, July
8.4  Analysis of Data  

 
&August-2015 ) was 1.3% and the criteria of deviation has been
determined 3%
- Average of training effectiveness was 84%, the determined
criteria was 75%
Average of customer satisfaction score was 79% and the determined
criteria was 70%.
8.5  Improvement 
Organization concentrates on continual improvement by conducting
Continual 
8.5.1 
Improvement 
internal audit, process monitoring and data analysis & determining   
quality objectives.
Corrective and preventive actions procedure (QAPR03) has been
8.5.2  Corrective Action  developed and was observed. They have issued 7 corrective actions , 3 of
them was result of internal audit, 1 from nonconforming product and 3 of
them were for changing the lubricating oil type (June-2015), nylon type
for packaging (Sep -2015) & changing the storage software (Oct-2015).   
8.5.3  Preventive Action  All taken actions have been closed and effectiveness of the actions have
been approved by management representative.
Since the implementation of quality management systems in organization,
they have not issued a preventive action.
 

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

Awareness and orientation level of staff on Storage


Cleanness and Discipline procedure POPR01 principles 
 

action Request Type I Form-008 – as we indicate and that each of the RA addresses the basic four (4) questions

FORM‐009_V4_QMS                                      Issued: July 9, 2003                                                               Revised: 6 Nov 2015                                                       Page 10 of 11 
REFERENCE, AS
This Clause

APPLICABLE1 
Has been
REFERENCE CRITERIA FOR GUIDANCE TO FOLLOW UPS – PLEASE WRITE ANNOTATION OR X TO INDICATE SPECIAL Verified,
  Reference Clause  ATTENTION WILL BE REQUIRE   please Tick
mark √ 
 

as seen in Form-008: N/A

action Request Type II Form-008 – as we indicate and that each of the RA addresses the basic four (4) questions
as seen in Form-008:

1- some semi-finished products observed in floor of production hall that have no identification labeling and not
determined situation of that about acceptance

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

ATL: Marjan Azadmanesh DATE: 7.Jan.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

FORM‐009_V4_QMS                                      Issued: July 9, 2003                                                               Revised: 6 Nov 2015                                                       Page 11 of 11 

Das könnte Ihnen auch gefallen