Documenti di Didattica
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Cosmetics Products
* Example Report *
North America
+1-813-252-4770
Latin America
+52-1-333-2010712
India
+91-120-4291971
Email
info@proqc.com
www.proqc.com
GMP
GMP for for Cosmetics
Cosmetics Rev
Rev.
SUMMARYPHOTO
FACTORY 11
CONTACT PERSONNEL
AUDIT RESULTS
Complies Needs Improvement Does Not Comply
Personnel
Documentation Training 100.0% 0.0% 0.0%
Personnel Hygiene and Health
Change Control 100.0% 0.0% 0.0%
Premises
Complaints
36. Record and Recalls card
ofPest
process 100.0% 37. Record
0.0% of in-process
0.0% inspection.
Control
Non-conforming products 100.0% 0.0% 0.0%
Equipment
SubcontractingCalibration
Manufacturing #DIV/0! #DIV/0! #DIV/0!
Waste Control
Maintenance 100.0% 0.0% 0.0%
RawQuality Control
Materials Laboratory
and Packaging 100.0% 0.0% 0.0%
Finished Products
Identification and Status 100.0% 0.0% 0.0%
Packing Operations Storage 100.0% 0.0% 0.0%
Production
Bulk Product Storage 100.0% 0.0% 0.0%
Bulk Product Storage
Production 100.00% 0.00% 0.00%
Packing Operations
Storage 100.00% 0.00% 0.00%
Finished Products
Identification and Status 100.00% 0.00% 0.00%
Quality Control Laboratory
Raw Materials and Packaging Materials 75.00% 25.00% 0.00%
Waste Control
Maintenance
Subcontracting Manufacturing 100.00% 0.00% 0.00%
Calibration
Non-conforming products 100.00% 0.00% 0.00%
Equipment
Complaints and Recalls 100.00% 0.00% 0.00%
37. Photo of production 38. Data analysis of defectives from production
Pest Control
Change Control 100.00% 0.00% 0.00%
Premises Documentation 88.89% 11.11% 0.00%
Personnel Hygiene and Health
0% 10% 20% 30% 100.00%
40% 0.00% 60%
50% 0.00%
70% 80% 90% 100%
Complies Needs Improvement Does Not Comply
Training 75.00% 25.00% 0.00%
Personnel 100.00% 0.00% 0.00%
JUDGEMENT & RECOMMENDATIONS
Passed,SUPPLIER
the QMS is effective, you could consider this supplier a reliable business partner.
INFORMATION CLIENT INFORMATION
Passed, the QMS is acceptable with minor NCFs (see Audit Report), you could consider this
supplier a reliable business partner, but continue to require improvement to reduce risk.
On-hold, the QMS presents a few major NCFs (see Audit Report), you could request them to
provide a CAPA before engaging in any business with them.
Failed, the QMS presents major NCFs (see Audit Report) that could impact upon
your business. The better solution would be to source another supplier.
Summary/Recommendation:
The audited factory XXXXXXXXXXXXXXXXXXXX was founded in 1992, it specializes in the production of
cosmetics products such as Cosmetic Pencils, Powder Series, Color Cosmetics, Cosmetic Kits, Newness
...etc.
The company is located in XXXXX city which is considered the biggest small commodity center in the
world. The factory covers an area of 30000 square meters and has around 200 employees working full
time. The factory has 4 mains buildings, one for offices, a workshop of 4 floors for production under
100,000 class level air purification plant,and one building for dormotories.
The main market covers US, Europe, Russia, Japan, South America, Africa, etc, where they have been
selling around 1000 various professional products.
However, the factory must improvement enhance employee skill / training with effective evaluation
system, others details of opportunities of improvement are listed here below:
Strengths:
1) Certified to ISO 22716: 2007, USA FDA and EU.
2) Well maintained cleanroom of 100,000 class level.
3) Production manager with more than 12 years experience in the cosmetics industry.
4) Large show room, and enough space in the production area to enlarge production capacity.
C = Complies with the requirements, I = Improvement Needed, NC = Does Not Comply, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE FINDINGS SCORE
3.0 Personnel
3.4 36. Record of process card Training 37. Record of in-process inspection.
C = Complies with the requirements, I = Improvement Needed, NC = Does Not Comply, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE FINDINGS SCORE
C = Complies with the requirements, I = Improvement Needed, NC = Does Not Comply, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE FINDINGS SCORE
Is there any notice to prohibit eating, Yes, notice to prohibit eating, drinking,
1) Photograph if any in production.
3.5.1.5 drinking, chewing, smoking posted on- chewing, smoking is posted on-site C
2) Photograph in warehouse
site? (See photo 14)
4.0 Premises
C = Complies with the requirements, I = Improvement Needed, NC = Does Not Comply, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE FINDINGS SCORE
C = Complies with the requirements, I = Improvement Needed, NC = Does Not Comply, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE FINDINGS SCORE
5 Equipment
5.1 Calibration
C = Complies with the requirements, I = Improvement Needed, NC = Does Not Comply, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE FINDINGS SCORE
5.2 Maintenance
C = Complies with the requirements, I = Improvement Needed, NC = Does Not Comply, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE FINDINGS SCORE
Are Sampling plans and AQL defined Yes, sample plan and AQL defined and
1) Sample plan defined?
6.0.2 for incoming inspection of raw used sheet Q/MX 308011 (See photo C
36. Record of process card 2) AQL defined? 37. Record of in-process inspection.
material? 27)
C = Complies with the requirements, I = Improvement Needed, NC = Does Not Comply, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE FINDINGS SCORE
6.1 Identification and Status
Are the raw materials provided with Yes, the procedure is MX-2-PG-063,
labels which contain information on 1) Photograph the label on raw Rev A/0.
6.1.1 C
the supplier / producer, identity and material. Identifiable labels are posted on each
badge? material on-site (See photo 31)
Are the materials identified Yes, material that is retained for futher
1) Photograph the label of "Accepted",
physically as “accepted”, “rejected” or decision is placed in a separate place.
"rejected" or "quarantined".
6.1.4 “quarantined” or is this ensured by It was discovered that a paper, size A4, C
2) Photograph the area where it
another system with the same level of with the words "PENDING FOR
stored.
assurance? DECISION" was posted in one place.
6.2 Storage
36.
AreRecord of process
the materials stored card 37. Record of in-process inspection.
Yes, materials are stored in cartons
6.2.2 closed and off the floor (eg on 1) Photograph the warehouse C
placed on pallets.
pallets)?
7 Production
C = Complies with the requirements, I = Improvement Needed, NC = Does Not Comply, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE FINDINGS SCORE
Is there an established Control Plan 1) Review the control plan, Yes, inspection plans are defiined in file
7.0.2 C
for production? photograph it. MX-2-PG-001 ¬ 010.
C = Complies with the requirements, I = Improvement Needed, NC = Does Not Comply, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE FINDINGS SCORE
Has a maximum bulk 1) Storage condition Yes, each product has an expiration
7.1.2 product storage duration been date. Each warehouse has a device to C
defined? 2) Note storage time keep storage condition in normal env.
8 Finished Products
Are there any specifications for Yes, there are SOPs / specifications for
8.0.1 finished products including 1) Work Instrcuion for FQC finished products, as per procedure MX- C
acceptance criteria? 2-PG-059.
36. Record of process card 37. Record of in-process inspection.
C = Complies with the requirements, I = Improvement Needed, NC = Does Not Comply, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE FINDINGS SCORE
10 Waste Control
Are wastes disposed of in a timely Procedure for waste control, Yes, there is a program for waste
10.0.1 C
and sanitary manner? document number disposal.
Are the types of waste for the given Yes, there is a waste management
production processes that could affect List of type of waste from production, procedure, MX-2-PG-026, in which
10.0.2 C
the quality of the finished products and control method arrangements for waste control are
defined? defined.
C = Complies with the requirements, I = Improvement Needed, NC = Does Not Comply, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE FINDINGS SCORE
Are the individual measures Yes, each workshop has a specific box
of collection, transportation, storage for collection of waste. And waste is
10.0.3 C
and disposal of wastes adequately collected every day and taken off the
documented? premises.
11 Subcontracting Manufacturing
34. SOPs
Are checks on site
and audits by the contract 35. Identification of semi-finish on site
The factory has no service to
11.0.2 giver at the contract acceptor 1) record of last check/audit N/A
subcontract, Not applicable
contractually fixed?
12 Non-conforming products
C = Complies with the requirements, I = Improvement Needed, NC = Does Not Comply, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE FINDINGS SCORE
14 Change Control
Has a process been defined for Yes, there is a procedure for change
changes (plants, material, process control MX-2-YW-001, Rev A/0. Change
14.0.1 Procedure to handle change C
etc.) which could affect the quality of often happens in raw materials, quality
the product? in the client PO…etc.
C = Complies with the requirements, I = Improvement Needed, NC = Does Not Comply, N/A = Not Applicable
QUESTIONNAIRES EVIDENCE FINDINGS SCORE
15 Documentation
FACTORY PHOTO 1
FACTORY PHOTO
Supplier Name Audit Date Report No.
XXXXXXXXXX XXXXXXXXXX XXXXXXXX
Supplier Name Audit Date
XXXXXXXXXX XXXXXXXXXX
FACTORY PHOTO 1
FACTORY PHOTO
Supplier Name Audit Date Report No.
XXXXXXXXXX XXXXXXXXXX XXXXXXXX
Supplier Name Audit Date
XXXXXXXXXX XXXXXXXXXX
11, 12 Hand washing facilities and instruction 13. Employee wearing clothes
FACTORY PHOTO 1
FACTORY PHOTO
Supplier Name Audit Date Report No.
XXXXXXXXXX XXXXXXXXXX XXXXXXXX
Supplier Name Audit Date
XXXXXXXXXX XXXXXXXXXX
16. Leave record of employee in illness condition 17. Signature of commitment of visitor
20. Certificate of conformity of Cleanroom 21. Cleaning agents usedfor hand washing
36. Record of process card 37. Record of in-pr
GMP for CosmeticsGMP for Cosmetics
Rev
FACTORY PHOTO 1
FACTORY PHOTO
Supplier Name Audit Date Report No.
XXXXXXXXXX XXXXXXXXXX XXXXXXXX
Supplier Name Audit Date
XXXXXXXXXX XXXXXXXXXX
22. 75% Acohol agents used at hand washing 23. System to avoir pest enter in the workshop
25. Record of incoming inspection of Raw Material 27. Identification of Raw Material in warehouse
36. Record of process card 37. Record of in-pr
GMP for CosmeticsGMP for Cosmetics
Rev
FACTORY PHOTO 1
FACTORY PHOTO
Supplier Name Audit Date Report No.
XXXXXXXXXX XXXXXXXXXX XXXXXXXX
Supplier Name Audit Date
XXXXXXXXXX XXXXXXXXXX
30. Annual performance of supplier 31. Quality Status of Raw Material, with Green label
32. Raw Material waiting for further decision 33. Packaging process
FACTORY PHOTO 1
FACTORY PHOTO
Supplier Name Audit Date Report No.
XXXXXXXXXX XXXXXXXXXX XXXXXXXX
Supplier Name Audit Date
XXXXXXXXXX XXXXXXXXXX
FACTORY PHOTO 1
FACTORY PHOTO
Supplier Name Audit Date Report No.
XXXXXXXXXX XXXXXXXXXX XXXXXXXX
Supplier Name Audit Date
XXXXXXXXXX XXXXXXXXXX
39. Record of CAP from internal NCFs 40. Record of CAP from external client's complaint