Date:
Auditor(s) Name:
MEAD JOHNSON NUTRITIONALS
EVANSVILLE, INDIANA
This is a broad-bad guideline. When conducting asssments utilizing this document, locally appropriate regulations must also be addresd
Note: In event a raw material supplier providing a material that is dry blended into a Stage 1 Infant Formula product is being assd – complete Attachment “A” of this form.
AUDIT PLAN
1. Opening Meeting
a) Introduction – auditor(s) and supplier management team.
b) Objective – Ass abilities of the facility to supply Mead Johnson Company with materials (packaging/raw materials) of suitable quality that conforms to applicable regulatory and Company standards.
c) Audit Scope – GMP’s and appropriate laboratory practices/procedures.
d) Reporting – closing meeting (Summary of Audit Findings), Final report and respon time.
加拿大出国留学费用e) Potential Audit Rating: Acceptable, Provisionally Acceptable, Not Acceptable.
f) Miscellaneous – Plant rules (GMP, Safety), Lunch breaks and audit guide.
2. Management Prentation
a) General plant information – organizational charts, products and manufacturing facilities within the site, Quality programs and associated activities.
b) Manufacturing Process Overview – raw material receipt (sources and suppliers), manu
facturing process and transportation/shipping.
3. Audit Sequence
a) Incoming Materials (physical storage conditions, receipt and acceptance, stock rotations & issuance to production, inventory control, traceability).
b) In-process Operations (material weighings, in-process production and batch records).
c) Finished Materials (Identification & Labeling, Net Content Control, Change Control, Storage facilities, Distribution & Shipping, Traceability).
d) Engineering Utilities (air, water, steam and compresd air).
e) Equipment ( maintenance, cleaning procedures and calibration).
f) Facility Design
g) Personnel Hygiene and GMP Training
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h) Pest Control Programs
i) Quality Assurance/Quality Control
j) Laboratories
k) Documentation
NOTE: Any findings made during the audit, will be discusd at the time they are made.
4. Closing Meeting
a) why so rious音译Discussion and clarification of findings
b) discussion of action plans and follow-up respons needed/required.
GENERAL INFORMATION
A. 简爱读后感英文Name of firm:
B. Plant location:
Address:
Phone:
Fax:
Contact Person:
E-mail:
C. Quality Compliance audit ratings:
1. Current:
2. Previous:
3. Is a follow-up audit necessary? If so, what is the recommended time frame?
NOTE: STANDARDIZED AUDIT RATINGS
Acceptable - No obrvations. Or, if obrvations are noted, they can be corrected within a reasonable period of time (90 days), and none are deemed to prent significant regulatory risk. No follow up audit is required, although monthly action plan updates must be received from the supplier.
培训课Provisional – Numerous obrvations noted, enough to po a moderate regulatory risk to the product and/or MJ operations. Immediate attention should be given to addressing the concerns. A follow up audit must be scheduled, unless the auditor feels that sufficient evidence of corrective action has been provided within a reasonable period of time.
Unacceptable - Critical obrvation(s) noted. An immediate focud effort is required to correct deficiencies. Global Quality Assurance must be contacted immediately to determine the approval status of a supplier receiving an unacceptable rating. A recommendation to Global Procurement to cea operations or not to establish a busines
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s relationship with a firm may result.
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Definitions:
Obrvations - tho findings that po a low or moderate regulatory risk with no immediate impact on MJ operations or consumer safety. An example would be a supplier that has quality systems in place, but fails to comply completely with them, or lacks sufficient documentation of such.
Critical Obrvations - tho findings that would place the supplier and/or MJ at high regulatory risk. This also applies to any finding that places consumer safety at risk due to product adulteration. An example would be a supplier that lacks a key quality system, such as GMP training, equipment calibration, or HACCP plan.
D. Materials supplied to Mead Johnson Nutritionals:comely
1. Product usage:
2. Summary of Production Process:
3. Lot coding system:
4. Lot or Batch Size:
E. Facility Information:
1. Are steroids, antibiotics, pesticides, herbicides, fungicides or other high-risk, toxic materials handled or manufactured at this facility?
2. List other types of products manufactured at this location:
3. List other products manufactured in the same facility as Mead Johnson Nutritional products/materials:
4. In general does the firm have a system of procedures and/or work instructions?
5. Are they properly maintained?
6. Facility maintenance:
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a. Raw Material Warehou:
b. Finished Product Warehou:
c. 护肤技巧Processing/Packaging areas:
Recommendation: One plastic piece in the foot of changing cabinet of pouch line had been found , suggest to repair it and keep well
