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PRODUCT AUDIT
Audit Trail & Traceability
Divulged by Anil M V
๏‚— WHAT IS AUDITING
๏‚— Auditing is the examination or validation of
Critical Control Points or Critical Control
Documents in the chain of custody by an
Operation/facility/Company which duly envisages
the accuracy and completeness on the Traceable
Standard Operating Procedures.
- A verification of the effectiveness of a system.
- Through inspect materials, processes, finished
product, records, systems and other activities.
- There always two type of audits Internal Audit and
external audit
โ€ข Traceability is the procedure of tracking (and
documenting) all your raw materials,
parts, and finished goods throughout your
manufacturing process, such as production,
processing and handling.
โ€œ
Trackingโ€ (or Trace forward) โ€œ
Traceabilityโ€ most of all
companies use software, lot
numbering, batch numbering ,
barcoding etc
- RAW MATERIAL
PROCESSING
OR
HANDLING
UNIT
FINISHED PRODUCT
STORAGE WITH
PROPER
LABELLING FOR
IDENTIFICATION
LOGISTIC FLOW FROM RM TO FG
1 . Tr a c k i n g a n d R e c o r d - K e e p i n g
I f y o u e v e r n e e d t o d o a p r o d u c t r e c a l l , y o u r p r i o r i t y i s
g o i n g t o b e i d e n t i f y i n g a l l t h e a ff e c t e d p r o d u c t s , s o y o u c a n
b e t t e r i n f o r m t h e p u b l i c wh e n y o u p u t o u t t h e n o t i c e .
2 . S u p p l y C h a i n Vi s i b i l i t y
P r o d u c t t r a c e a b i l i t y i n m a n u f a c t u r i n g n o t o n l y n e e d s
i n s i g h t s i n t o y o u r o wn p r o d u c t i o n b u t i m p r o v i n g p r o d u c t
t r a c e a b i l i t y a l s o n e e d s a b e t t e r u n d e r s t a n d i n g o f y o u r
s u p p l y c h a i n .
3 . P r o a c t i ve M o n i t o r i n g
O n e o f t h e g o a l s o f i m p r o v i n g y o u r p r o d u c t t r a c e a b i l i t y i s
t h e a b i l i t y t o s p o t p r o b l e m s s o o n , s o y o u c a n n i p a n y
p o t e n t i a l i s s u e s i n t h e b u d a n d a v o i d i t t u r n i n g i n t o a n e v e n
b i g g e r p r o b l e m .
4 . M o c k R e c a l l s P e r f o r m i n g p e r i o d i c m o c k r e c a l l s wi l l
a l l o w y o u t o d e t e r m i n e h o w l o n g i t t a k e s y o u r b u s i n e s s t o
r e c o u p t h e d e f e c t i v e p r o d u c t s .
A l l p a r t i c i p a n t s i n m o d e r n s u p p l y c h a i n s a r e e x p e c t e d t o
h a v e e ff e c t i v e p r a c t i c e s i n p l a c e t h a t a l l o w f o r t h e r a p i d
i d e n t i f i c a t i o n , l o c a t i o n , a n d wi t h d r a w a l o f f o o d l o t s wh e n
p r o b l e m s a r e s u s p e c t e d o r c o n f i r m e d . T h i s r e q u i r e s
t h e identification and adoption of business
pract ices t h a t e n a b l e t r a d i n g p a r t n e r s i n t h e f o o d
i n d u s t r y t o t r a c k a n d t r a c e a p r o d u c t t h r o u g h o u t t h e
e n t i r e s u p p l y c h a i n . Tr a c e a b i l i t y c a n b e u t i l i z e d a n d / o r
i s n e c e s s a r y f o r a v a r i e t y o f b u s i n e s s p u r p o s e s ,
i n c l u d i n g :
โ€ขProduct R ecalls/Market Wit hdraw als;
โ€ขRegulatory Compliance;
โ€ขMarket A ccess;
โ€ขPublic H ealt h Trace - backs;
โ€ขFood Saf et y and Qualit y A ssurance; and
โ€ขProcess and Order Management .
There are two perspectives when it
comes to product traceability:
Chain traceability
T h i s i s f o r wa r d a n d b a c k wa r d p r o d u c t
t r a c e a b i l i t y. M e a n i n g m a n u f a c t u r e r s c a n t r a c k
p r o d u c t s f r o m r a w m a t e r i a l t o t h e d i s t r i b u t o r.
A n d t h e d i s t r i b u t o r s o r c o n s u m e r s c a n
u n d e r s t a n d wh e r e t h e p r o d u c t c a m e f r o m .
Internal Traceability
T h i s m e a n s p r o d u c t t r a c e a b i l i t y wi t h a l i m i t e d
s c o p e , s u c h a s m o n i t o r i n g o n e s p e c i f i c
m a n u f a c t u r i n g p l a n t .
Record Keeping is an act of maintaining track of
activities expedited in the Operation with
respective specific details duly showing
traceability and accountability. All records shall
be safely stored and held secure and in
confidence to the operator, for a minimum
period of five years . The record keeping system
shall be transparent and enable easy
retrieval/traceable on information.
Farm
Container Yard
Storage Processing
plant
Farm
Importer Processor
Distributor
Document flow
Retail store
Retail store
RECORDS THAT CAN BE VERIFIED
FOR TRACEABLILITY
โ€ข Daily activity register
โ€ข Stock activity register
โ€ข Transport register
โ€ข Delivery notes, receipts, Transaction
certificate,Transport vouchers,
โ€ข Processing records
โ€ข Cleaning records
โ€ข Pest and Mgmt Records
โ€ข Transport monitoring records
โ€ข Invoices and Purchases records
โœ“Describe the audit trail system used,
listing each component
โœ“Explain the lot/Batch numbering system.
โœ“Track 1 to 3 sales of organic product
through the system. Report the results.
โœ“Complete one audit balance, comparing
production with sales and storage records
for respective Product.
Is the system functional, current and
accessible?
Can input consumption be traced?
Can out-going product be traced back?
Is the output Plausible to capacity and
sourced Input of the operation?
โ€ข How is this done?
1. Check the FSSAI certificate, or check records for total
average production per day per shift for Capacityโ€ฆ..
2. Check RM vouchers, Production Register, FG
stocking etc
3. Obtain Beginning and Ending inventories
4. Validate inline to SOP and flow charts.
5. Deduct losses Conversion %, Recovery.
6. Check for Bleed run/Flush/Purge Quantity
conducted
THANK YOU

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AUDIT TRAIL AND TRACEABLILTY OF PRODUCTS

  • 1. PRODUCT AUDIT Audit Trail & Traceability Divulged by Anil M V
  • 2. ๏‚— WHAT IS AUDITING ๏‚— Auditing is the examination or validation of Critical Control Points or Critical Control Documents in the chain of custody by an Operation/facility/Company which duly envisages the accuracy and completeness on the Traceable Standard Operating Procedures. - A verification of the effectiveness of a system. - Through inspect materials, processes, finished product, records, systems and other activities. - There always two type of audits Internal Audit and external audit
  • 3. โ€ข Traceability is the procedure of tracking (and documenting) all your raw materials, parts, and finished goods throughout your manufacturing process, such as production, processing and handling. โ€œ Trackingโ€ (or Trace forward) โ€œ Traceabilityโ€ most of all companies use software, lot numbering, batch numbering , barcoding etc
  • 4. - RAW MATERIAL PROCESSING OR HANDLING UNIT FINISHED PRODUCT STORAGE WITH PROPER LABELLING FOR IDENTIFICATION LOGISTIC FLOW FROM RM TO FG
  • 5. 1 . Tr a c k i n g a n d R e c o r d - K e e p i n g I f y o u e v e r n e e d t o d o a p r o d u c t r e c a l l , y o u r p r i o r i t y i s g o i n g t o b e i d e n t i f y i n g a l l t h e a ff e c t e d p r o d u c t s , s o y o u c a n b e t t e r i n f o r m t h e p u b l i c wh e n y o u p u t o u t t h e n o t i c e . 2 . S u p p l y C h a i n Vi s i b i l i t y P r o d u c t t r a c e a b i l i t y i n m a n u f a c t u r i n g n o t o n l y n e e d s i n s i g h t s i n t o y o u r o wn p r o d u c t i o n b u t i m p r o v i n g p r o d u c t t r a c e a b i l i t y a l s o n e e d s a b e t t e r u n d e r s t a n d i n g o f y o u r s u p p l y c h a i n . 3 . P r o a c t i ve M o n i t o r i n g O n e o f t h e g o a l s o f i m p r o v i n g y o u r p r o d u c t t r a c e a b i l i t y i s t h e a b i l i t y t o s p o t p r o b l e m s s o o n , s o y o u c a n n i p a n y p o t e n t i a l i s s u e s i n t h e b u d a n d a v o i d i t t u r n i n g i n t o a n e v e n b i g g e r p r o b l e m . 4 . M o c k R e c a l l s P e r f o r m i n g p e r i o d i c m o c k r e c a l l s wi l l a l l o w y o u t o d e t e r m i n e h o w l o n g i t t a k e s y o u r b u s i n e s s t o r e c o u p t h e d e f e c t i v e p r o d u c t s .
  • 6. A l l p a r t i c i p a n t s i n m o d e r n s u p p l y c h a i n s a r e e x p e c t e d t o h a v e e ff e c t i v e p r a c t i c e s i n p l a c e t h a t a l l o w f o r t h e r a p i d i d e n t i f i c a t i o n , l o c a t i o n , a n d wi t h d r a w a l o f f o o d l o t s wh e n p r o b l e m s a r e s u s p e c t e d o r c o n f i r m e d . T h i s r e q u i r e s t h e identification and adoption of business pract ices t h a t e n a b l e t r a d i n g p a r t n e r s i n t h e f o o d i n d u s t r y t o t r a c k a n d t r a c e a p r o d u c t t h r o u g h o u t t h e e n t i r e s u p p l y c h a i n . Tr a c e a b i l i t y c a n b e u t i l i z e d a n d / o r i s n e c e s s a r y f o r a v a r i e t y o f b u s i n e s s p u r p o s e s , i n c l u d i n g : โ€ขProduct R ecalls/Market Wit hdraw als; โ€ขRegulatory Compliance; โ€ขMarket A ccess; โ€ขPublic H ealt h Trace - backs; โ€ขFood Saf et y and Qualit y A ssurance; and โ€ขProcess and Order Management .
  • 7. There are two perspectives when it comes to product traceability: Chain traceability T h i s i s f o r wa r d a n d b a c k wa r d p r o d u c t t r a c e a b i l i t y. M e a n i n g m a n u f a c t u r e r s c a n t r a c k p r o d u c t s f r o m r a w m a t e r i a l t o t h e d i s t r i b u t o r. A n d t h e d i s t r i b u t o r s o r c o n s u m e r s c a n u n d e r s t a n d wh e r e t h e p r o d u c t c a m e f r o m . Internal Traceability T h i s m e a n s p r o d u c t t r a c e a b i l i t y wi t h a l i m i t e d s c o p e , s u c h a s m o n i t o r i n g o n e s p e c i f i c m a n u f a c t u r i n g p l a n t .
  • 8. Record Keeping is an act of maintaining track of activities expedited in the Operation with respective specific details duly showing traceability and accountability. All records shall be safely stored and held secure and in confidence to the operator, for a minimum period of five years . The record keeping system shall be transparent and enable easy retrieval/traceable on information.
  • 9. Farm Container Yard Storage Processing plant Farm Importer Processor Distributor Document flow Retail store Retail store
  • 10. RECORDS THAT CAN BE VERIFIED FOR TRACEABLILITY โ€ข Daily activity register โ€ข Stock activity register โ€ข Transport register โ€ข Delivery notes, receipts, Transaction certificate,Transport vouchers, โ€ข Processing records โ€ข Cleaning records โ€ข Pest and Mgmt Records โ€ข Transport monitoring records โ€ข Invoices and Purchases records
  • 11. โœ“Describe the audit trail system used, listing each component โœ“Explain the lot/Batch numbering system. โœ“Track 1 to 3 sales of organic product through the system. Report the results. โœ“Complete one audit balance, comparing production with sales and storage records for respective Product.
  • 12. Is the system functional, current and accessible? Can input consumption be traced? Can out-going product be traced back? Is the output Plausible to capacity and sourced Input of the operation?
  • 13. โ€ข How is this done? 1. Check the FSSAI certificate, or check records for total average production per day per shift for Capacityโ€ฆ.. 2. Check RM vouchers, Production Register, FG stocking etc 3. Obtain Beginning and Ending inventories 4. Validate inline to SOP and flow charts. 5. Deduct losses Conversion %, Recovery. 6. Check for Bleed run/Flush/Purge Quantity conducted