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BULL Sample Report For Factory Audit - 2 Man-Day
BULL Sample Report For Factory Audit - 2 Man-Day
INSPECTION REPORT
Factory Audit
Report No. : H-XXXXXXXX
INSPECTION INFORMATION
Client xxxx
Factory Name xxxx
Factory Address XXXX, Dongguan City, Guangdong, China /.>
Contact Person Kevin Yin Telephone xxxx /4.,(,,
Mobile Phone xxxx Fax. xxxx . ....---..... ',,
E-mail xxxx Web: xxxx :. / .
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Date of Audit xxxx Auditor(s) Justin Li - .. :.:.-:_--;
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Audit Stage [8Jlnitial Audit Follow-up Audit 0 Re-Audit .( . "-.'
Audit Regulation GWI-PE-TQA-020 \ \, \ '
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Participators from the factory: ... '
Name Department Position Name Department Position
xxxx Marketing Director xxxx Technical Engineer
Approved by Supervisor:
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to Europe, America and Asia.
The factory has obtained the certificate of GMPC and approval of ISO22716:2007.
The factory owns an internal lab which has various kinds of testing appliances. 1/ t/',
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FOLLOW UP SUGGESTIONS
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For factory: / J
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For client: '\ i. \\ V
Does the factory have adequate machines/equipment/fixtures for production of the intended
2.1 B
products?
Does the factory implement procedures to maintain the machines/equipment/fixtures regularly to B
2.2
ensure their continuing process capability?
Does the factory calibrate the machines/equipments interval or adjust prior usage which needed B
2.3
to ensure the accuracy/precision?
Do operators or specified person check/lubricate/clean the machines daily in accordance with
2.4 B
the machine instruction manual?
In case of machine/equipment problems occurred, does the operator stop using the machine B
2.5
until it is repaired?
2.6 Based on observation on-site, are the machines/equipment/fixtures in good condition? B
Based on observation of machines/equipment/fixtures and the products worked out, is the
2.7 B
accuracy/precision of them conform to the requirements of production?
Part 3 Production Process Control
Are the arrangement of production plan is reasonable and in accordance with the requests of
3.1 B
orders and production ability?
Does the factory adopt a proper way to make on-the-spot workers understand the concrete B
3.2
requirements of orders/ plans and the amendments of production?
Does the factory formulate operating instructions for key working process where the absence of B
3.3
such instructions could adversely affect quality?
Do the operating instructions correctly stipulate the process parameters, product characteristics
3.4 B
and workmanship criteria?
Are the required operation instructions present on related workstations? Do the operation B
3.5
workers strictly follow the instructions?
Does the factory adopt adequate ways to monitor and control the suitable parameters and B
3.6
product characteristics on key process?
Do workers operate correctly and meet the requirement in those processes where no operating
3.7 B
instructions are available?
Does the production flow operate smoothly? Are there any bottlenecks affecting the production B
3.8
lead time?
Are those raw materials, semi-finished products, finished products in workshop arrayed/stocked B
3.9
in good order and carefully protected to avoid any confusion or damage?
Does the factory adopt a suitable way such as marking or labeling to identify the raw
3.10 B
materials/semi-finished products/finished products to avoid confusion?
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No. Check and Audit Grade
Points
3.11 Does the factory adopt a suitable way such as marking or labeling to distinguish this client's raw B
materials/semi-finished products/finished products/samples from other clients'?
If some problems occur, can operators trace back to relevant product according to the B
3.12
identifications and records?
Part 4 Purchase and Subcontract
Have the factory established and maintained procedures to evaluate and select suppliers to
4.1 B
ensure that the production materials purchased from them conform to specified requirements?
Dose the factory clearly describe the specifications such as type, grade, quality etc in the B
4.2 purchasing document?
Does the factory monitor the quality of purchased goods and adopt adequate actions if the B
4.3 goods provided by the supplier often not conform to the requirement, such as using a new
supplier?
Has the factory established and maintained procedures to evaluate and select subcontractors
4.4 based on their ability to meet subcontract requirements? B
Does the factory stipulate the detailed specifications such as technical parameter, quality B
4.5
requirement, delivery date etc. in subcontract?
Does the factory adopt an adequate way to trace and monitor the subcontracted products during B
4.6 production to ensure they conform to the requirement?
Part 5 Packing, Handling and Storage
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Does the factory use adequate method/material to pack the products to ensure conformance
5.1 with specified requirements? B
Does the factory use proper methods/containers/utensils for handling and delivery of products to B
5.2 prevent damage or deterioration?
Does the factory have sufficient warehouse /stock rooms to meet the requirement of goods B
5.3 storage in accordance with the production capability and schedule?
In case that the products are stored in the open air due to short of warehouse capacity, does the
5.4 factory adopt proper solutions to shelter the products from rain and sunshine?
B
5.5 Are warehouses kept clean and bulk goods piled up suitably? B
Does the factory adopt appropriate methods to prevent the stored goods from improper B
5.6 pressing, crashing, sun burning, leaking, mildewing or insects bite?
Does the factory adopt a suitable way such as making, labeling, etc. to distinguish the
5.7 specified client's goods from others'?
B
Does the factory have an appropriate working procedures or methods to control receipt and B
5.8 dispatch process in storage area? Can the factory ensure that the quantity of goods is always
right in the process of receipting, dispatching, and loading?
Part 6 Training, Knowledge, Skill, and Experience
Does the factory have and implement training procedures I plans to monitor the performance
6.1 B
of personnel who may affect product quality?
6.2
Have those related operators been trained or explained the main points of requirements or B
operations for every client's orders prior to operation?
Base on observation or exam on-spot, are those workers well-trained and skillful for the B
6.3 assigned work?
Are the workers with good attitude towards production, quality requirements, inspections and
6.4 B
re-work action?
Has the factory ever provided enough training of product standard and inspection/testing to B
6.5
the Q.C/inspectors?
6.6 Are there any records of training for operators and inspectors kept in the factory? B
Based on observation or exam on-spot, do those Q.C/inspectors have suitable knowledge/ability
6.7 B
/skill to meet the requirements for their assigned work?
6.8 Do the leader of Q.C department IQ.Cl inspectors have good working attitude and deal with B
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quality problems objectively?
Are the leader of Q.C department and managers of workshop with good attitude towards the 2nd B
6.9
and 3rd party inspection or audit?
Part 7 Inspection/Testing and Quality Control
Does the factory carry out incoming inspection/testing when they receive the purchased
7.1 B
materials and subcontracted products?
Are the frequency, criteria and method of incoming inspection reasonable and in accordance B
7.2 with the specified requirement or documented procedures/plans?
Have the factory set up adequate inspecUtesting stations in suitable process of production to B
7.3
ensure that the quality of product conformed to the specified requirement before released?
Do the inspectors of the factory carry out the in-process inspections according to reference
7.4 B
standards/operation instructions and/or documented procedures?
Does the factory designate an adequate number of inspectors to perform the in-process B
7.5
inspection and testing?
Does the factory carry out the final inspection for all batches of products in accordance with the B
7.6
final inspection standard?
Does the factory formulate the final-inspection standard for all products? Are all related
7.7 B
parameters/characteristics/criteria and inspection methods stipulated in the standard?
Does the factory ensure that only when the results of final inspection meet specified requirement B
7.8
or standard that the products can be released?
7.9
Are the factory equipped with adequate types and quantities of inspection and testing B
equipments/ apparatus for the incoming, in-process and final inspection?
Have the factory established and implemented procedures to calibrate and maintain inspection,
7.10 measuring and test equipments?
B
Are the inspection/ measurement and test equipments used on -site well maintained and B
7.11 calibrated?
7.12 Have those samples used for comparison been confirmed by client or appointed manager? B
7.13 Does the factory adopt a proper way to identify, preserve and use the samples? B
Part 8 Control of Nonconforming Product
When nonconforming products are found, does the factory identify and pick them out
8.1 immediately? B
8.2 Does the factory make any record when they find and dispose the nonconforming products? B
Have those nonconforming products been disposed properly such as reworked, repaired etc B
8.3
before reused?
8.4 Does the factory carry out re-inspection/testing for all reworked and repaired products? B
When non-conformity continuously occurs or a batch of nonconforming product are found, does B
8.5 the factory analyze the reasons and implement corrective or preventive actions to eliminate
the cause of nonconformities?
8.6
Have the rate of non-conformity been recorded as statistic data? Is the rate of non- B
conformity ascending or descending?
Part 9 Documentation of Management/ Records Control
Does the factory have document such as management manual to describe the quality
9.1 management system?
A
Dose the factory has document to define the responsibility and authority of the personnel who A
9.2
manage, perform and verify working procedures that may affect quality?
Have the factory established and documented basic management procedures on the key A
9.3
process which may significantly influence the quality?
Does the factory have regular procedures of collecting, filling, filing and maintaining quality
9.4 B
records?
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9.6 Are those records well identified, indexed, filed and maintained? B
9.7 Are those quality records clear, integrated, veracious and signed by related recorder? B
Part 1O Senior Managers and Corporate Responsibility
Does the manager of related department/workshop well implement the defined responsibility,
10.1 B
authority and duty?
Does the department of quality control get enough right for assigned work and perform its B
10.2
duty normally and independently?
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10.3 Do the senior managers have profound knowledge, experience and ability B
Are senior managers with positive attitude towards client's requirements, 3rd party inspection,
10.4 B
nonconforming product and corrective action? ' ' -:
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10.5 Are senior managers with good attitude towards this audit? B
10.6 Does the factory respond to customer's complaint in time and deal with it correctly?......... ' B
Is the factory willing to undertake their relevant responsibility if any problem comes up in
10.7 B
trade business?
10.8
and the client asks for compensation?
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Is the factory willing to indemnify the client's lost if they fail in meeting the client's requirements
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B
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PHOTO ATTACHMENT
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12 lab (2)
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17 pure water system (1) 18 pure water system (2)
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19 material warehouse (1) 20 material warehouse (2)
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47 packing workshop (7) 48 finished goods and packing material warehouse
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71 final inspection report 72 test reports for pure water (1)
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74 maintenance records
79 supplier evaluation procedure and records (4) 80 supplier evaluation procedure and records (5)
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83 training records (2) 84 training records (3)
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