How to Implement Corrective Action Preventive Action (CAPA)

Implement Corrective Action Preventive Action (CAPA)

There are many ways to apply the two functions of CAPA. The Quality-One Corrective Action Preventive Action approach is as follows:

CAPA के दो कार्यों को लागू करने के कई तरीके हैं। गुणवत्ता-एक सुधारात्मक कार्रवाई निवारक कार्रवाई दृष्टिकोण इस प्रकार है:

Corrective Action.

When a symptom is observed or communicated, a systematic set of activities are initiated. The activities are intended to describe the problem in sufficient detail so that the team can identify a root cause path. Once a root cause path is selected, a permanent corrective action is identified, verified, implemented and validated.
 

जब एक लक्षण मनाया जाता है या संचार किया जाता है, तो गतिविधियों का एक व्यवस्थित सेट शुरू किया जाता है। गतिविधियों का उद्देश्य पर्याप्त विस्तार से समस्या का वर्णन करना है ताकि टीम मूल कारण पथ की पहचान कर सके। मूल कारण पथ का चयन करने के बाद, स्थायी सुधारात्मक कार्रवाई की पहचान, सत्यापन, कार्यान्वयन और सत्यापन किया जाता है।

Preventive Action

Often the root cause of a root cause is the system or lack of policies, practices or procedures which supported the creation of the physical root cause. Preventive Action (PA) occurs after the physical root cause has been identified and permanent corrective action has been validated. PA recognizes the value of the information and actions taken during the CA function. This information is shared within the organization.

अक्सर मूल कारण का मूल कारण सिस्टम या नीतियों, प्रथाओं या प्रक्रियाओं की कमी है जो भौतिक मूल कारण के निर्माण का समर्थन करता है। निवारक कार्रवाई (पीए) तब होती है जब भौतिक मूल कारण की पहचान की गई है और स्थायी सुधारात्मक कार्रवाई को मान्य किया गया है। PA, CA फ़ंक्शन के दौरान ली गई सूचना और कार्यों के मूल्य को पहचानता है। यह जानकारी संगठन के भीतर साझा की गई है।

Corrective Action Preventive Action (CAPA)

Introduction to Corrective Action Preventive Action (CAPA)

Corrective Action Preventive Action (CAPA) is a process which investigates and solves problems, identifies causes, takes corrective action and prevents recurrence of the root causes. The ultimate purpose of CAPA is to assure the problem can never be experienced again. CAPA can be applied in many disciplines.

(CAPA) एक ऐसी प्रक्रिया है जो समस्याओं की जांच करती है और हल करती है, कारणों की पहचान करती है, सुधारात्मक कार्रवाई करती है और मूल कारणों की पुनरावृत्ति को रोकती है। CAPA का अंतिम उद्देश्य यह आश्वासन देना है कि समस्या को फिर कभी अनुभव नहीं किया जा सकता है। CAPA को कई विषयों में लागू किया जा सकता है

What is CAPA?

The CAPA requirement applies to manufacturers of medical devices and compels them to include CAPA in their quality management system (QMS).

CAPA आवश्यकता चिकित्सा उपकरणों के निर्माताओं पर लागू होती है और उन्हें अपने गुणवत्ता प्रबंधन प्रणाली (QMS) में CAPA को शामिल करने के लिए मजबूर करती है।

CAPA is split between two distinct but related functions.

1. Corrective Action (CA) is an extension of Root  Cause Analysis. The first goal of CA is to find the root cause, base event or error that preceded the problem. The second goal is to take action directed at the root cause or error.

करेक्टिव एक्शन (CA) रूट कॉज एनालिसिस (RCA) का विस्तार है। Corrective action का पहला लक्ष्य मूल कारण, आधार घटना या त्रुटि का पता लगाना है जो समस्या से पहले था। दूसरा लक्ष्य मूल कारण या त्रुटि पर निर्देशित कार्रवाई करना है।

2. Preventive Action :- 

The primary goal of preventive action is to inform an organization and prevent the problem from returning in other facilities lines or products.

निवारक कार्रवाई का प्राथमिक लक्ष्य एक संगठन को सूचित करना और समस्या को अन्य सुविधाओं की रेखाओं या उत्पादों में लौटने से रोकना है।

Why Implement Corrective Action Preventive Action (CAPA)

Identifying the root cause of failure is a key tenet of any effective QMS. When a problem occurs, it is often just a symptom of the real issue. Symptoms can be treated but finding out why the symptom is experienced is the true purpose for implementing CAPA. Failure to implement an effective Corrective Action Preventive Action process is a violation of FDA regulations defining Good Manufacturing Practice (GMP).

विफलता के मूल कारण की पहचान करना किसी भी प्रभावी क्यूएमएस का एक प्रमुख सिद्धांत है। जब कोई समस्या होती है, तो यह अक्सर वास्तविक मुद्दे का एक लक्षण होता है। लक्षणों का इलाज किया जा सकता है, लेकिन यह पता लगाना कि लक्षण का अनुभव क्यों है सीएपीए को लागू करने का सही उद्देश्य है। एक प्रभावी सुधारात्मक कार्रवाई निवारक कार्रवाई प्रक्रिया को लागू करने में विफलता एफडीए के नियमों का उल्लंघन है जो गुड मैन्युफैक्चरिंग प्रैक्टिस (जीएमपी) को परिभाषित करता है।

1. Verification of a CAPA system procedure(s) that addresses the requirements of the quality system regulation. It must be defined and documented.

 एक CAPA प्रणाली प्रक्रिया का सत्यापन जो गुणवत्ता प्रणाली विनियमन की आवश्यकताओं को संबोधित करती है। इसे परिभाषित और प्रलेखित किया जाना चाहिए.

2.Evidence that appropriate sources of product and quality problems have been identified.

सबूत है कि उत्पाद और गुणवत्ता की समस्याओं के उपयुक्त स्रोतों की पहचान की गई है।

3.Nonconforming product, quality problems and corrective / preventive actions have been properly shared and included in management review.

गैर-अनुरूपण उत्पाद, गुणवत्ता की समस्याएं और सुधारात्मक / निवारक कार्यों को ठीक से साझा किया गया है और प्रबंधन समीक्षा में शामिल किया गया है।

Non-conformity

Non-conformity - प्रोटेस्टेंट मतभेद / परंपरा विरोध.

Organisation.

All the organisation strat the manufacturing before making the QMS procedure and organisations manual and Dipartment procedures & dipartment Working instruction.

After that start the process,so all dipartment staff flow the instructions. than company required the busines, Indian government rules some legal documents, requirements and sartificats lick-: ISO, OHSAS,HSE etc..

So that all the sartificats given by the organisation firstly visit the company. Organisation auditor audit the company and check the company working area and documents that time finding the some mistakes and root cause.than we are saying the non-conformity.

Hard work and Smart work

Hard work:-

Hard work में शारीरिक और दिमाग की मेहनत ज्यादा करनी होती है और समय भी ज्यादा लगता है 

किसी भी काम को उसके तरीके से करना हार्ड वर्क कहलाता है।

Hard work would mean spending long hours to complete my work without any shortcuts. ...

Smart work:-

 Smart work में शारीरिक और दिमागी मेहनत पिकअप करनी होती है और समय भी कम लगता है। उसी काम को अपने तरीके से करना स्मार्ट वर्क कहलाता है।

Smart work would be aiming for the same results but with planning and prioritization of tasks.

Credit note ka matlab kya hota hai

Credit note :-

                        इस Memo को ही कारोबारी भाषा में Credit Note कहा जाता है। इस प्रकार Credit Note, एक प्रकार का acknowledgment होता है कि हां, उसने माल और माल के साथ भेजा गया debit note प्राप्त कर लिया है।

Manufacturer Organisation making a Debit note any party invoice, So that time account dipartment and purchase department responsibility the material and Debit note recieved the supplier.

than supplier received the material against create the Credit note. And send to party account dipartment and purchase department.

Debit note ka matlab kya hota hai

Debit note :- 

                     इस memo में माल वापसी का कारण और उसके लिए Amount में कटौती (Debit) का ब्योरा दिया होता है। इसीMemo को कारोबारी भाषा में Debit Noteकहते हैं।

All the manufacturing organisation purchasing the raw material according to manufacturing and PPc requirements. After that purchase dipartment making a purchase order agents the material and send the supplier and mansion the all requirements in PO. than supplier on time deliver the material and store parson received the material and making the MRN than store incharge push the material inspection area in Quality dipartment than QC inspector chack the material and making the MRI.but Quality dipartment doing the result material is rejected and mansion the MRN and MRI report. So that store parson inform the purchase department and account dipartment with MRN and MRI report. After that account dipartment create the Supplier Debit note. And purchase department shear the information to supplier. 

Abbreviations.संक्षिप्तीकरण

        संक्षिप्तीकरण

1. DAC :- 

             Design acceptance criteria.

2. ITP :- 

             Inspaction test plan.

3. KPI :-

             Key performance indicator. 

4. MAC :-

             Manufacturing acceptance criteria.

5. MOC :-

             Management of change.

6. MPS :-

             Manufacturing process specification.

7. PCP :- 

             Process control plan.

8. QAP :-

             Quality activity plan.

9. QM :- 

              Quality manual.

10. QMS :- 

              Quality management system.

11.QP :- 

               Quality plan.

Production Part Approval Process

ppap ke full information.

Introduction:-

In ppap the supplier is required to perform a production process with specified documents to achieve product approval for production.

The automotive industry action group (AIAG) has developed a common ppap standard ( 4th edition 2006 )

 It is one of 5 core tools (APQP,PPAP,SPC,MSA,FMEA)

 

PPAP is a process for the supplier not for the customer the ppap submission is an event for the customer to review and approval.

Why Ppap?

To demonstrated that supplier have met customers requirements and ready for production quality and delivery.

To ensure the a supplier cameet the manufacturability and quality requirements of the parts supplied to the customer.

To provide evidence that the customer engineering design record and specification requirements are clearly understand and fulfilled by the supplier.

 Ppap submission requirements.
Requirements of total 19type.

1. Design record

2. Engineering change documents, if any

3. Customer engineering approval,if any

4. Desi FMEA

5. Process flow Diagram

6. Process FMEA

7. Control Plan

8. Measurement System Analysis Studies

9. Dimensional Results

10. Material performance test results

11. Initial process Studies

12. Qualified laboratory documentation

13. Appearance approval report (AAR ) if application

14. Sample product

15. Master sample

16. Checking Aids

17. Records of compliance with customer specific requirements

18. Parts submission warranty

19. Bulk material check list

 

What is PPAP?

PPAP (Production Part Approval Process)

There are five phases to APQP; PPAP is triggered in Phase 4, Product & Process Validation.

was developed by AIAG (the Automotive Industry Action Group) and it is an important part of the comprehensive Advanced Product Quality Planning(APQP) approach.

What Is the Difference Between FIFO and LIFO?

FIFO के शब्द मूल f(irst) i(n,) f(irst) o(ut)

FIFO (First-In, First-Out)दुसरे शब्दों में कहें तो, items को remove किया जाता है उसी समान order में जिस order में उन्हें enter किया गया होता है. ... वहीँ FIFO का ठीक उल्टा होता है.
FIFO is a method of accounting which assumes that the oldest stock is sold first.

LIFO का Full-Form होता है “Last In, First Out.” 

LIFO एक तरीका होता है data processing करने का जिसमें की last items जिसे की enter किया जाता है, उसे ही सबसे पहले निकाला भी जाता है.

Material Stores, Identification and Traceability

Today I am learning Material stores, identification and Traceability process 

so firstly strat the material stroes process. So all the organisation think our store is well maintained,so that organisation making the document "store procedure" according to manufacturing and organisations doing flow the working for the store dipartment.

Store received the material after verification by QC inspected material, give the material identification number and Batch number and material location of the material then stores the proper handling the material in store.

Identification:- 

store received the material and give the commodity no/ WIP number and supplier batch number display in the material, color coading and after then stores the designated area in the store. 

Traceability:- 

store received the material and give the identification number and material stores the store area with maintained the documentation and records.

Inventory control process

Hi Friends,

Today I am learning inventory control process.

Dear friend all organisation shell be maintained Inventory in store . A company manufacturing for sale and the components or raw material and wip Inventory and sfg inventory. the some controlling the organisation apply the inventory store. The popular inventory control system That are being used by big manufacturing and retail unit.

There are seven type of inventory control system.

1. Inventory type is ABC controlling system.

2.  Inventory type is three- bin controlling system.

3.  Inventory type is just in time controlling system.

4. Outsourcing inventory control system.

5. Computerized inventory control system.

6.  Fixed order Quantity.

7.  Fixed period organisation system. Etc.

So dear it's done of the inventory control system.

Material outsourcing process.

Hi Dear freands

Today I am learning Material outsourcing process definition. All manufacturing company or organisation doing the outsourcing work . So student organisations find the outsource supplier and purchase  department doing the verification and supplier evaluation, then purchase dipartment approved the supplier and making approved supplier vendor list, then purchase dipartment making the purchase order after then Ppc "production planning control" send the material to supplier, for outsourcing process.

Outsourcing process lick- Material blanking,CED Coating, nitriding matrmate, phosphating process etc.....

All the organisation maintained the outsourcing activities and record, controlling

the supplier product activities.

 

Store Material issue process.

Hi Freands.

Today I am learning next topic store material issue-: Material issue process all the organisation maintained Inventory and stock availability, than start a issue process for the store department.all store incharge/ store prason material issue time give the issue slip for the material receiver. Issue slip making the formet all the organisation MR. And material issue slip shell be documented and according to QMSP. So material issue slip a most important part of store document inventory control.and issue the material store incharge shall be maintained daily basis of the record.

Store incharge all the items lick Raw materials,electrielec items etc. Issued by issue slip than maintained the store stock.

Material recieving process for the store department.

Hi Dear,

      Today am learning material receiving process,all  of the organisation making a QMSP. And material coming to company that store parson/store incharge received the material so that collect the party invoice with our company "PO" company purchase order than process start,Inform to QC inspector and store parson check the material condition and matching Quantity according to invoice and purchase order after that store incharge unloading the material with store team. Than start the material gate entry process then Store prason/store incharge making the MRN/GRN and shear the material information QC incoming inspector through MRN/GRN.

QC incoming inspector inspect the material  verification and making the MRI report and Qc inspector material with MRN/GRN submit to store department. Than store department material properly handling and storage the designated area. Store give the material location and Traceability.than complete the material receiving process.

Thanks.

What type of work in store dipartment.

Hi Dear,

Today am learning is some points of work in store dipartment. All industry and organisations making the WI "Work Instration". but some content in working is the same. So that am sharing work type in store diprtment, organisation making a QMS "Quality management system" and working procedure than start the work of organisations.

Store dipartment working rules and regulations flow according to QMSP and WI of the organisation.

So lates start the work type in store diprtment........

.1 Material recieving process.

    That company starting points and most    important in the store point. Ditals are          submitted next time.......

.2 Material issue process.

     All the industry most effective point. Ditals are submitted to next time......

.3 Material outsourcing process.

    It's very important and commercial based point in the company.

.4 Inventory Control process.

    Today is the most important part of organisations because all maney type dovelopment in future so not required inventory of the organisation. Details are submitted to next time....

.5 Material stores process.

    All the organisation QMSP according stores the material and materials value"lick FIFO and LIFO". Details are submitted to next time.....

.6 Material identification and Traceability

    All the organisation making the process and flow the instruction. Ditals are submitted to next time...

.7 Material stores assessment.

    Organisation shell be decided frequency over QMSP. Ditals are submitted to next time...

.8 All Time Material Stock Updated.

.9 Monthly Inventory process.

.10 Commercial New year Inventory process.

Dear all it's are some process in store department organisation in same.

Thanks a lot.

  

 

What is the definition of store ?

All the industry and all type company is making the store department so it's needed of department in industries so that store a one diprtment all type materials stores in the company. And store diprtment stores the all documents and Records. So we can say,that store is the stores all documents and Records organisation. 

So second words, In that ! store definition is all documents and Records are making and maintained stores is store.