Monday, 5 June 2017
Used Oil Analysis: Proper Sampling Produces More Reliable Results
http://www.chevronlubematters.com/2017/03/23/used-oil-analysis-proper-sampling-produces-more-reliable-results/#sthash.igVTbxf2.72nID7jq.dpbs
GLOBAL FOOD SAFETY INITIATIVE
GLOBAL FOOD SAFETY INITIATIVE
The Global Food Safety Initiative
(GFSI) is a private organization, established and managed by the
international trade association, the Consumer Goods Forum under Belgian law in
May 2000. The GFSI maintains a scheme to benchmark food safety standards
for manufacturers as well as farm assurance standards.
The GFSI objectives are to:
- Reduce food safety risks by delivering equivalence and convergence between effective food safety management systems
- Manage cost in the global food system by eliminating redundancy and improving operational efficiency
- Develop competencies and capacity building in food safety to create consistent and effective global food systems
- Provide a unique international stakeholder platform for collaboration, knowledge exchange and networking. (Wikipedia, 2017)
The Global Food Safety Initiative
(GFSI) has defined the Food Safety Management Umbrella to include HACCP
(hazard/ Food Safety), TACCP (threat/ Food Defense) and VACCP (vulnerability/
Food Fraud). These are defined as three separate pillars that will need to
be addressed individually.
Hazard analysis and critical control
points
or HACCP (/ˈhæsʌp/) is a systematic preventive
approach to food safety from biological,
chemical,
and physical hazards in production processes that can cause the finished
product to be unsafe, and designs measurements to reduce these risks to a safe
level. In this manner, HACCP attempts to avoid hazards rather than attempting
to inspect finished products for the effects of those hazards. The HACCP system
can be used at all stages of a food chain, from food
production and preparation processes including packaging,
distribution, etc. (Wikipedia, 2017).
HACCP (Hazard Analysis Critical Control
Point)
What is HACCP?
- HACCP = food safety
- Prevention of unintentional accidental adulteration, Science based, Food borne illness.
- Is a production control system for the food industry. It is a process that identifies where potential contamination can occur (the critical control points or CCPs) and strictly manages and monitors these points as a way of ensuring the process is in control and that the safest product possible is being produced. HACCP is designed to prevent rather than catch potential hazards.
Who & When?
- Is not owned or regulated by any organisation. The principles of HACCP are codified (written down) by the World Health Organisation (WHO), which is part of the United Nations (UN), in a set of documents called the Codex Alimentarius, The principles of HACCP are described in the Annex of the Codex GENERAL PRINCIPLES OF FOOD HYGIENE CAC/RCP 1-1969.
HACCP expanded in all realms of the
food industry, going into meat, poultry, seafood, dairy, and has spread now
from the farm to the fork.
Principles
1. Conduct a hazard analysis
Plans determine the food safety hazards
and identify the preventive measures the plan can apply to control these
hazards. A food safety hazard is any biological, chemical, or physical property
that may cause a food to be unsafe for human consumption.
2. Identify critical control points
A critical control point (CCP) is a point,
step, or procedure in a food manufacturing process at which control can be
applied and, as a result, a food safety hazard can be prevented, eliminated, or
reduced to an acceptable level.
3. Establish critical limits for each
critical control point
A critical limit is the maximum or
minimum value to which a physical, biological, or chemical hazard must be
controlled at a critical control point to prevent, eliminate, or reduce that
hazard to an acceptable level.
4. Establish critical control point
monitoring requirements
Monitoring activities are necessary to
ensure that the process is under control at each critical control point. In the
United States, the FSIS
requires that each monitoring procedure and its frequency be listed in the
HACCP plan.
5. Establish corrective actions
These are actions to be taken when
monitoring indicates a deviation from an established critical limit. The final
rule requires a plant's HACCP plan to identify the corrective actions to be
taken if a critical limit is not met. Corrective actions are intended to ensure
that no product is injurious to health or otherwise adulterated as a result if
the deviation enters commerce.
6. Establish procedures for ensuring the
HACCP system is working as intended
Validation ensures that the plants do
what they were designed to do; that is, they are successful in ensuring the
production of a safe product. Plants will be required to validate their own
HACCP plans. FSIS will not approve HACCP plans in advance, but will review them
for conformance with the final rule.
Verification ensures the HACCP plan is
adequate, that is, working as intended. Verification procedures may include
such activities as review of HACCP plans, CCP records, critical limits and
microbial sampling and analysis. FSIS is requiring that the HACCP plan include
verification tasks to be performed by plant personnel. Verification tasks would
also be performed by FSIS inspectors. Both FSIS and industry will undertake
microbial testing as one of several verification activities. Verification also
includes 'validation' – the process of finding evidence for the accuracy of the
HACCP system (e.g. scientific evidence for critical limitations).
7. Establish record keeping procedures
The HACCP regulation requires that all
plants maintain certain documents, including its hazard analysis and written
HACCP plan, and records documenting the monitoring of critical control points,
critical limits, verification activities, and the handling of processing
deviations. Implementation involves monitoring, verifying, and validating of
the daily work that is compliant with regulatory requirements in all stages all
the time. The differences among those three types of work are given by
Saskatchewan Agriculture and Food.
How to implement?
- Codex Alimentarius, http://www.codexalimentarius.org/standards/list-of-standards/en/?provide=standards&orderField=fullReference&sort=asc&num1=CAC/RCP
- Annex of the Codex document GENERAL PRINCIPLES OF FOOD HYGIENE CAC/RCP 1-1969. You can download a copy of the actual document here.http://www.mhlw.go.jp/english/topics/importedfoods/guideline/dl/04.pdf
TACCP (Threat Assessment Critical
Control Point)
What is TACCP?
Threat assessment and critical control point applies well-understood
HACCP principles to protect food and beverage products from intentional and
malicious contamination.
Ensuring
consumer safety is one of our prime and major objective in food businesses. Be
it farming, processing, manufacturing, distribution, food transportation,
catering and hospitality, the essence of (food) safety can’t be ignored.
- TACCP = prevention of malicious threats to food, such as sabotage, extortion or terrorism.
- Prevention of intentional adulteration, Behaviorally or ideologically Motivated.
- Stated as “The main generic threats are malicious contamination with toxic materials, sabotage of the supply chain and misuse of food and drink materials for terrorist or criminal purposes. A successful attack could disrupt business and undermine brands, and could lead to illness and death.”
Who & When?
- The TACCP concept was introduced and implemented in the British Standards institute’s Public Available Standard 96 Food Defence (PAS 96).
How to implement?
- The PAS 96 Food Defence Guide https://www.food.gov.uk/sites/default/files/pas96-2014-food-drink-protection-guide.pdf
- Food Defense Guide http://www.fsis.usda.gov/shared/PDF/Food_Defense_Plan.pdf
Watch a clip from YouTube
on TACCP?
Click here: https://www.youtube.com/watch?v=0O6BaEfzIuA
VACCP (Vulnerability Assessment Critical
Control Point)
What is VACCP?
The issue of food fraud in the supply
chain is becoming increasingly important in the food industry. Hence the need
for a systematic approach to identify the threat of economically motivated
adulteration and assess the vulnerable points within the supply chain to
satisfy the requirements of Clause 5.4 in the BRC Global Standard for Food
Safety Issue 7
Vulnerability
Assessment and Critical Control Point applies well-understood HACCP principles
to protect food and beverage products from fraud and adulteration.
- VACCP = prevention of economically motivated food fraud.
- According to John Spink, assistant professor and director of the Food Fraud Initiative (FFI), Michigan State University. A vulnerability is a state of being that could lead to an incident. For example, GFSI defines food fraud, including the subcategory of economically motivated adulteration (EMA), as “the deception of consumers using food products, ingredients and packaging for economic gain and includes substitution, unapproved enhancements, misbranding, counterfeiting, stolen goods or others.
Who & When?
In July 2012 the GFSI Board of
Directors requested that a Food Fraud Think Tank (FFTT) be created to review
the topic and explore if or how Food Fraud could be incorporated in the GFSI
Guidance Document. The group was originally called “economic adulteration”
but broadened the scope to all types of Fraud.
How to implement?
- Guide for applying VACCP & TACCP https://www.wowlink.com.au/cmgt/wcm/connect/6ff995004cdc517fad4bbdcb17e68709/28.07.16+How+To+Guide-+VACCP,+TACCP+V1.pdf?MOD=AJPERES
Difference
between HACCP, TACCP and VACCP
They all sound very similar and all are
involved in the safety of the food we manufacture, but what exactly is the
difference between HACCP, TACCP and VACCP?
HACCP – Hazard
Analysis Critical Control Point
HACCP, as many of you will know, was
initially developed in the 1960s by NASA to prevent astronauts from contracting
food poisoning in space. It has since been refined and is now part of every
major food manufacturer/supplier’s day-to-day routine. It stands for Hazard
Analysis and Critical Control Points and can be approached either by product or
process.
The HACCP team evaluates the entire
production process step by step from delivery intake to packaging and transport
of the completed product. During this process any stages where the product
could be subject to physical, microbiological or chemical contamination are
identified. Measures are put in place for those deemed critical (i.e. metal
detectors, temperature controls, cleaning etc.) and these are regularly
monitored to ensure that the end product is safe for human consumption.
TACCP – Threat
Assessment Critical Control Point
Relatively new, TACCP, by comparison
stands for Threat Assessment Critical Control Point. An essential part of food
safety management and required under the latest BRC version 7 Global Standard,
it was developed in reaction to the increase in food fraud detected in recent
years. The most widely reported was, of course, the horsemeat scandal but food
fraud manifests itself in a variety of different ways.
Whereas HACCP is concerned with the
prevention of food-borne illnesses and the prevention of unintentional or
accidental hazards/threats to food safety, TACCP is concerned with the
prevention of deliberate and intentional food fraud. This can take the form of
substitution of ingredients, passing off of one foodstuff for another, false or
misleading statements for economic gain that could impact public health,
product tampering, fake or incorrect labelling etc. Product traceability
throughout the supply chain is hence of vital importance.
VACCP – Vulnerability
Assessment and Critical Control Points
TACCP and VACCP go hand in hand in the
quest to demonstrate product authenticity. Both are designed to prevent the
intentional adulteration of food. TACCP identifies the threat of behaviourally
or economically-motivated adulteration; VACCP identifies how vulnerable various
points in the supply chain are to the threat of economically-motivated
adulteration.
References:
1.
Verner Wheelock
Associates Training Blog http://vwa.co.uk/blog/news/haccp-taccp-vaccp-whats-the-difference/
2.
Food
Engineering http://www.foodengineeringmag.com/articles/95205-vaccp-haccp-for-vulnerability-assessments
3.
Robby
Manullang (2016) HACCP, TACCP and VACCP - The Three Pillars; https://www.linkedin.com/pulse/haccp-taccp-vaccp-three-pillars-robby-manullang-?
Monday, 29 May 2017
Quality Process in the Purification of Drinking Water in 12 Steps
Quality Process in the Purification of Drinking Water in 12 Steps
 |
| (c) Nestle Waters |
- Water is carefully collected and received through stainless steel pipes from either a local well or municipal water supply. Quality testing of the original source is conducted regularly to monitor for abnormalities.
- This step is taken when the water originates from a municipal or public drinking water system. It consists of removing chlorines and THMs (trihalomethanes) through a daily-monitored activated carbon filtration process.
- A water softener is used to reduce water hardness.
- Demineralisation removes unwanted minerals (through reverse osmosis or distillation).
- Water received in storage tanks is monitored on a daily basis.
- Selected minerals are added to cater to consumer taste preferences.
- Pharmaceutical grade micro-filtration removes particles as small as 0.2 microns. It is also capable of removing potential microbiological contaminants. This is monitored on an hourly basis.
- Ultra-violet filtration provides additional product disinfection. This is monitored on an hourly basis.
- Ozone disinfection is the third disinfection step (steps 7-9), using a highly reactive form of oxygen. This is monitored on an hourly basis.
- The filling room is highly sanitary to ensure bottling is conducted in a microbiologically controlled environment. It is continuously monitored and controlled.
- Packaging quality assurance is conducted by human inspection and the latest in modern equipment designed to ensure the removal of any packaging defects.
- Line sanitation includes automated cleaning equipment to ensure maximum cleanliness, effectiveness and control.
SOP on Handling of Deviations
SOP on Handling of Deviations
- Objective :To describe a procedure for handling of deviations which may occur during the execution of various activities in written procedures in facility.
- Scope:This Standard Operating Procedure shall be applicable to all the departments responsible for carrying activities related to the manufacture of the product, in the formulation plant of (Pharmaceutical Company Name).
- Responsibility
- Personnel of concerned department shall be responsible to notify immediately their respective superiors when any deviation occurs or is noticed.
- Head-Regulatory Affairs or his/her designee shall be responsible for facilitating prior notification or intimation to the regulatory authority, if the deviation has impact on the concerned regulatory submissions.
- Head of the concerned department or his/her designee, and Head-Quality Assurance or his/her designee of respective location shall be responsible for implementation and compliance of this SOP.
- Accountability
4.1 QA Head shall be
accountable for implementation of this SOP.
- Abbreviations and Definitions
BMR:Batch manufacturing
record; a controlled regulated copy, which comprises the recordings against the
manufacture of a batch.
PDR :Planned deviation
report
UDR :Unplanned deviation
report
cGMP:Current good
manufacturing practices
BPR:Batch packing record
ICH:International
conference on harmonization
Written Procedures :Written
procedures are the approved and controlled documents which are followed for the
execution of various activities performed in the organization viz.,Batch
Manufacturing Records detailing manufacturing and packaging procedures,
Standard Operating Procedures (SOPs), Standard Testing Procedures (STPs).
General Test Procedures and various protocols followed for the execution of
validation studies, stability studies, etc.
Deviation : Any non-conformance
/disobeyance in written approved procedures of quality system in the
organization.
Or
We have any written
procedure like standard operating procedure, standard test
procedure, BMR etc. and works against this, then it is called deviation. It
means deviation from any written procedure that we have implemented.
Critical Deviation: The
deviation is likely to or will have a significant impact on critical attributes
of the product.
For example: Manufacturing
instructions are not followed, wrong batch details are printed,
SOPs or methods
of testing not followed during analysis etc.
Major Deviation : The
deviation could or may have a significant impact on critical attributes of the product.
For example: Raw material is
received in a damaged container, manometer readings in the
sampling booth are crossed the action limits etc.
Minor Deviation:The
deviation is unlikely to have a detectable impact on critical attributes of the
product.
For example: Line Clearance is not taken
from QA, physician sample wrongly printed with price, etc.
Critical Attribute :A
critical attribute is one that defines the product and contributes to safety, identity,
purity, strength or quality. Critical attributes are usually
detectable during product testing.
Unplanned Deviation: An accidental
or unanticipated
non-conformance or deviation observed or noticed during or
after the execution of an activity. An unplanned deviation can be
a critical or major or minor in nature.
For example: deviation in
failure of procedure, utility, material, equipment or any system is occurred.
We can consider it as any change from the previous or our written procedure.
Planned Deviation : Any
deliberate or intentional non-conformance or deviation Planned prior to
the execution of an activity, which is to be undertaken following documented,
justifiable and approved rationale. No critical or major deviation, which has potential
to alter the quality of the product, shall be planned.
For example: Calibration or
validation is not carried out as per schedule due to delay for various reasons.
- Procedure
- Deviations may be classified into following two categories:
- Planned Deviation
- Un-planned Deviation
Unplanned & Planned
deviations shall be sub classified on the basis of their impact of product
quality in critical, major or minor.
- Planned Deviation (Planned Deviation Report)
- Any departure from established and approved procedures observed or noticed prior to the execution of an activity, such as SOPs, STPs, processes, systems, standards and protocols, which is done under compulsion or for continuous quality improvement programs will be categorized as planned deviation.
- No critical or major planned deviation shall be allowed, which has potential to alter the quality of the product, only minor deviation shall allow to plan.
- Such a planned deviation shall be taken / implemented only after proper evaluation, risk assessment and pre-approval from Quality Assurance.
- Such planned deviation shall be properly reported, assessed / evaluated for its impact on product quality, process performance or GMPs.
- Any personnel from concerned department shall initiate the “Planned Deviation Format” by detailing the reason for deviation as per Annexure I.
- The department head shall review the proposal of planned deviation, justification given for its potential impact on the product quality and compliance to regulatory requirements for necessity / feasibility of the deviation, by providing supporting data.
- After review by concerned Head of department, the proposal shall be forwarded to Plant Head.
- After review by Plant Head, the proposal shall be forwarded to QA for review and approval.
- QA shall assign a unique number to each planned deviation as follows:
- The numbering system for a planned deviation shall consist of ten (10) alphanumeric characters.
- For example, PDR/16/001 shall be assigned to the first planned deviation of year 2016.
- In the above planned deviation report number, the 1st, 2nd & 3rd characters ‘PDR’ stand for ‘Planned Deviation Report’.
- The 4th character “/” is a forward slash.
- The 5th & 6th characters ‘16’ represent the last two digits of the year 2016.
- The 7th character “/” is again a forward slash.
- The 8th, 9th & 10th characters ‘001’ represent sequential number.
- Head QA shall review the planned deviation with respect to impact on product quality, necessity / feasibility of the deviation proposed, rationale / justification & compliance to cGMP / regulatory requirements, along with the adequacy of the supporting data attached.
- Head QA shall assess the requirement for any additional testing or checks for quality monitoring of the Planned Deviation and documents for the same.
- QA shall consult Regulatory Affairs, where applicable, for any planned deviation before providing approval. The RA may provide inputs as necessary based on GMP and regulatory requirements.
- Head QA shall approve / reject the Planned Deviation with appropriate recommendations.
- If approved, the deviation shall be applicable for a defined number of batch (es) or defined number of days as mentioned in the Planned Deviation Report.
- After QA approval, the concerned department shall implement the planned deviation and the observations and data generated shall be documented.
- QA shall review the implementation and documented data obtained from respective departments to ensure that the recommendations are complying with quality profile of the batch (es) impacted by the deviation. This data shall support with the “Planned Deviation Report”.
- The closure of planned deviation shall be the responsibility of the Department Head and Head-QA.
- If the deviation is related to the batch which is for sale, then the batch shall be released only after QA approval and closure of deviation.
- Recommendations may be conferred during the review.
- If the planned deviation in the process / procedures leads to improvement in the product quality / process / assurance / GMP, then the deviation / change can be made permanent by following the change control procedure (SOP on change control procedure).
- In conclusion, Head of concerned department and Head QA shall close out the deviation.
- QA shall maintain a logbook for the approved planned deviations as per Annexure III.
- Unplanned Deviation (Unplanned Deviation Report)
- While carrying out day-to-day activities, there is a probability of unplanned deviations (unforeseen deviations) occurring. Such unexpected events may be related to any procedures, processes, systems, equipment and utilities. These deviations may occur for many reasons, such as following (not all inclusive):
- Equipment failure / Breakdown / Malfunctioning.
- Power supply failure / interruption.
- Accident in the plant.
- Breakdown in support services / utilities.
- Documentation Errors
- Laboratory failure / Error.
- An unplanned deviation report (UDR) shall be initiated as a part of the approved system for handling of deviations, in order to provide a mechanism for ensuring the recording of the deviation and assess the impact on product quality. If required, corrective and preventive action shall be performed to ensure product quality.
- User department shall make request for issuance of unplanned deviation Format to Quality Assurance department through Issuance from.
- Any individual on the job shall inform concerned department supervisor regarding the occurrence of deviation and details of initial observations.
- The concerned department personnel shall fill the details of the unplanned deviation along with cause and investigation details as per Annexure II and forward the same to department head for review, assessment and comments.
- While review, concerned head of the department shall incorporate corrective and preventive action based on assessment. Then the ‘Unplanned Deviation Report’ shall be forwarded to Plant Head for review.
- Then ‘Unplanned Deviation Report’shall be submitted to the QA for review and approval.
- QA shall assign a unique number to each unplanned deviation report as follows;
- The reference number for an unplanned deviation report shall consist of ten (10) alphanumeric characters.
- For example, UDR/16/001 shall be assigned to the first unplanned deviation of year 2016.
- In the above unplanned deviation report number, the 1st, 2nd & 3rd characters ‘UDR’ stands for ‘Unplanned Deviation Report’.
- The 4th character “/” is a forward slash.
- The 5th & 6th characters ‘16’ represent the last two digits of the year 2016.
- The 7th character “/” is again a forward slash.
- The 8th, 9th & 10th characters ‘001’ are a sequential number.
- QA shall maintain a logbook for the unplanned deviations as per Annexure III.
- The filled form shall be forwarded to QA head after review by QA.
- Head – QA & Head – concerned department shall assess unplanned deviation for its impact on product quality. Details shall be documented as per Annexure II.
- Head QA may recommend for performing any additional studies, if required.
- If the deviation does not affect product quality, Head – QA shall allow further processing of the batch in question.
- If there is probability of product quality getting affected, Head – QA shall assess the impact on product quality before allowing further processing of the batch.
- Product may be “Quarantined” in sealed containers, if required. Containers shall be labeled, indicating product name, Batch No., Manufacturing Date, Expiry Date & Batch size. The labeled containers shall be kept in secured quarantine area.
- Head – QA along with the Head of concerned department shall investigate & find out the root cause of the problem that resulted in the deviation as per SOP on CAPA.
- Based on the investigation, the proposed corrective and preventive action shall be taken to avoid any such reoccurrence and the same shall be implemented.
- If required Formulation Research & Development (FR&D) shall be consulted by QA to review impact on product quality and decide upon the future course of action(s).
- Closure of Deviation
- In conclusion, Head – QA shall close the deviation by reviewing and assessing the impact of deviation on the quality of the product.
- Any supporting data and comments required to close the deviation (e.g.stability data) shall be recorded or attached to the deviation report.
- The time line for closure of deviation (planned or un-planned) shall be not more than 30 working days. If required, extension should be taken.
- Both planned and unplanned approved deviations shall be controlled by QA and the same shall be documented in the respective BMR also.
(Note:
The planned deviation shall be implemented after
the approval of QA).
- Forms and Records (Annexures)
- Planned Deviation Report – Annexure-I
- Unplanned Deviation Report – Annexure-II
- Logbook for Planned/Unplanned Deviation Reports – Annexure-III
- Distribution
- Master Copy- Quality Assurance
- Controlled Copies -Engineering, Human Resource, Production, Quality Assurance, Quality Control, Regulatory Affairs, Warehouse
- History
Date
|
Revision Number
|
Reason for Revision |
–
|
00
|
New SOP |
Annexure – I
Planned Deviation
Report
1.0
Review by Department Head
(Comments):
|
|||
Reviewed
by
|
Name
|
Signature
|
Date
|
2.0
Review by Plant Head(Comments):
|
|||
Reviewed
by
|
Name
|
Signature
|
Date
|
- QA Review / Approval
- Comments received from QP attached: Yes /No / NA
- Any additional studies required: Yes / No
- Stability Studies, Additional Quality Testing,Others
___________________________________________________________________________
- QA Comments:
___________________________________________________________________________
- Deviation: Approved Rejected
- The Planned Deviation is limited to time / No. of Batches: _________________
Review
by Head – QA
|
Name
|
Signature
|
Date
|
- Implementation of Deviation
- Deviation implemented by (department) :_______________________________
- Observations (If any):______________________________________________
- Data Generated (If any): _________________________________________________
- Quality Profile of batches affected (If applicable): _____________________________
Implemented By
Department Head
|
Name
|
Signature
|
Date
|
- QA Review of Implementation & Closure
- QA comments: ____________________________________________________
All recommendations
fulfilled: Yes /No
- If No, Justification: ______________________________________________________
- Data generation completed: Yes / No
- If No, Justification: ______________________________________________________
- Can the Deviation/Change be made permanent through change control? Yes/ No
- Remarks (If any): _______________________________________________________
- Affected batch can be released? Yes/No
Closure
Approved By Department Head / Nominee
|
Name
|
Signature
|
Date
|
Closure
Approved By Head-QA/ Nominee
|
Annexure – II
Unplanned Deviation
Report
Date _______
- Deviation Initiation
1.1
|
Unplanned
Deviation Report No.:
|
________________
(to be assigned by QA)
|
||||||
1.2
|
Deviation
Reported By
(Department):
|
|||||||
1.3
|
Product
Name: ___________
|
Batch No.:
_________
|
Market:
___________
|
|||||
1.4
|
Batch
Size: ______________
|
Mfg. Date:
_________
|
Expiry
Date: _______
|
|||||
1.5
|
Deviation
related to:
|
Procedure
Process
Equipment
Standard Batch Size
Others(
If any) specify:
|
||||||
1.6
|
Potential
Impact On
|
Quality
Yield GMPs
Manufacturing Process Others ( If any)
specify :
|
||||||
1.7
|
Deviation
Details:
|
|
||||||
1.8
|
Cause for
Déviation
|
|
||||||
1.9
|
Investigation
Details:
|
|
||||||
1.10
|
Proposed
Corrective Action
|
|
||||||
1.11
|
Proposed
Preventive
Action
|
|
||||||
Initiated
By
|
Name
|
Signature
|
Date
|
|||||
2.0
|
Review
by Department Head (Comments):
|
||
Reviewed
by
|
Name
|
Signature
|
Date
|
3.0
|
Review
by Plant Head(Comments):
|
||
Reviewed
by Plant Head
|
Name
|
Signature
|
Date
|
4.0
|
QA
Review for implementation of CAPA (Comments):_____________
|
||
Details
of any additional studies Required / Performed:
|
|||
Reviewed
by QA
|
Name
|
Signature
|
Date
|
5.0
|
Review
& Deviation Closure by Head – QA (Comments):
|
||
Reviewed
by
Head-QA
|
Name
|
Signature
|
Date
|
Annexure -III
Log Book for Planned/Unplanned Deviation Reports
Sr.
No.
|
Date
|
PDR/UDR
No.
|
Deviation
Related to
|
Initiated
By
& Deptt.
|
Expected
date for Implementation
|
Approved
/ Rejected
|
Closed
out on
(sign/date)
|
Remarks
|
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