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----- Forwarded by Dr Amarnath Giri/TS/KKD/NFCL/NAGARJUNA on 08/21/2017 03:42 PM -----
| From: | Dr Amarnath Giri/TS/KKD/NFCL/NAGARJUNA |
| To: | J Kanaka Prasad/PROD/KKD/NFCL/ |
| Cc: | K V S Murthy/TS/KKD/NFCL/NAGARJUNA@ |
| Date: | 12/02/2015 08:41 AM |
| Subject: | Fw: A quality audit checklist |
Dear Sir,
Very Good Morning sharing A quality audit checklist in that I have checked around 60% following under your guidance we shall reach 100%.
----- Forwarded by Dr Amarnath Giri/TS/KKD/NFCL/NAGARJUNA on 12/02/2015 08:40 AM -----
| From: | Amar Giri <goswami248@gmail.com> |
| To: | amarnathgiri <amarnathgiri@nagarjunagroup. |
| Date: | 12/02/2015 06:48 AM |
| Subject: | A quality audit checklist |
UTMOST REQUIRES TO DEVELOP WORK EFFICIENCY OF ALL WITH QUALITATIVE WAY
A quality audit checklist is a quality record that tracks the questions and responses during a quality audit. The quality audit is a valuable tool for continuous improvement. Audits ensure your quality assurance system is sound. Audits are also necessary for ISO 9001 registration.
To create an audit checklist, first reflect on the reason behind the audit. What kind of audit will it be? What audit category are you examining. See below.
Types of Audits
3rd Party Audits
2nd Party Audits
1st Party Audits
3rd Party Audit are done by an outside independent audit organization. In case of an ISO 9001 audit the independent organization is the registrar. They normally do not have an interest in the final outcome. The 3rd party could be a registrar, government employee, or a firm hired by the company. The result of the audit could be a certification, license, acceptance, or an award.
2nd Party Audit are Audits from those who have a deep interest in the final outcome. This could be you auditing your suppliers, or your customers auditing you. The audit could be called a survey or an assessment.
1st Party Audits are audits done internally. They are a management tool with the emphasis on continuous improvement. The auditor(s) must be independent of the audit area. The audit should be aligned with the company goals and metrics.
Audit Categories
System Audit
Conformance Audit
Compliance Audit
Process Audit
Product Audit
Department Audit
System Audits are looking at a particular system which includes multiple processes and can spread across several employees and departments. The audit of your calibration system can be consider a system audit. Your interaction chart lists your systems.
Conformance Audits are audits to define system requirements. These are global in nature. For example a 3rd party audit of your ISO 9001 system is a conformance audit.
Compliance Audit is an audit to regulatory requirements. This includes government agency audits.
Process Audit is a focused audit on a set of processes within your organization. It examines adherence to procedures and specifications during production or service activities.
Product Audit is a focus audit on the product itself. This may be an inspection activity or an out of the box audit.
Department Audit is a focus audit on one department that looks at the processes, specifications, and systems in one department only. It will look at the different operations with in that department. It will also examine department organization and training.
Quality Audit Checklist Stages
Determine the audit focus
Prepare for the audit
Perform the audit
Report the findings in the initial findings report
Determine the corrective action
Update the findings report with the corrective action
Conduct the corrective action
Update the findings report when actions are completed
Follow Up
Closure
The audit focus is dependent on the organization needs. If it is a system audit, use your interaction chart to determine the system focus. If there are many problems with a particular process then conduct a process audit on that process. If there is a department with many issues then conduct a department audit.
You may want to issue an internal audit engagement letter to the auditee.
During the audit preparation, determine the quality audit checklist. This checklist is the audit plan. During preparation, review the procedures, standards, specifications and / or work instructions. These documents help you determine the quality audit checklist. Record audit questions on the checklist.
During the audit performance follow these guidelines
Do not be biased
Keep an open mind
Do not be argumentive
Be patient
Remind the participant that the audit is for continuous improvement
Always state the facts
Do not correct the person on the spot.
Report accurately and clearly
Be familiar with the procedure
During the initial finding report, document the issues found. State the facts and provide evidence. Use names and demonstrate the findings. Show quality records for evidence. Apply the quality audit checklist as the basis for the findings report.
After the initial findings report, provide a copy to the corrective action team. Have a corrective action team meeting to issue the corrective actions. Document the corrective actions on the findings report. Be sure responsibilities and due dates are assign for the actions.
The team will then complete the corrective actions. Document the completion of the corrective actions on the findings report.
When all actions are completed, close out the report.
Audit Schedule
For ISO 9001 certification, predetermine the management systems audit schedule. Use your interaction chart to establish the necessary systems to schedule. I recommend not scheduling out all of the system audits. Instead keep a 3 to 6 month schedule and update this every month. This will allow you to audit the concerned areas.
I also recommend using a software application to track your audits. The software can track audit questions, schedule, results, and corrective action.
Quality Audit Benefits
It drives continuous improvement
Lets management know problems or potential problems
Provides input into management decisions
Accesses training and effectiveness
Shows management support of the quality program
Verifies compliance
Quality Audit Mistakes
These mistakes prevent an effective audit.
Auditing with the “gotcha” attitude
Finding faults and not facts
Not recognizing that the audit is people focused
Not properly defining the purpose and scope
Not using a quality audit checklist
Not issuing corrective action
Not conducting follow up on the corrective action
Not using a team approach to issuing corrective actions
internal Audit Plan
The internal audit plan consist of particular questions that you ask during the audit. These questions provide insight into your QA systems.
The audit plan could cover a system, process or department audit. The plan references your organization systems, or the ISO 9001 element for each question. The plan could cover an element from your interaction chart.
The audit plan is a document that list the planned questions. A final report references the internal audit plan and provides the answers to those questions.
Here are some questions that I like to quiz employees during an departmental ISO 9001 audit.
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Yes / No Questions
Do employees know the quality policy?
Do employees know the quality objectives and understand them with regards to their function?
Do employees know where their procedures are located?
Are all procedures and specifications controlled?
Are all forms current in the department?
Do employees know what is the most current revision of the document?
Can employee identify which documents cover inspection?
Can employee identify which documents contain the specifications?
Does employee know the specifications for the critical parameters?
Do employees know when changes are made to the process?
Do employees follow the inspection procedures?
Are the inspections documented?
Are inspection records completely filled in?
Do inspection records results agree with specification requirements?
Can employees locate the procedure for the equipment or process they are conducting?
Does the procedure for the equipment or process actually reflect employee’s methods?
Do employees send parts to MRB when inspection does not meet specifications?
Can the parts be tracked to all raw materials?Can employee describe how to select next work item?
Does employee know the process on ordering goods?
Does employee know the approval process for a purchase order?
Is the equipment in the PM (Preventive Maintenance) system? Are there records for PM?
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Are all critical raw materials labeled with accept stamps or traceable to an accept stamp?
Have all critical raw material been inspected and approved?
Are all measuring equipment labeled with measurement status?
Are all calibrations within due date?
Do employee know if testing equipment is OK to use?
Do calibration records reflect findings for the equipment?
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Do employees know what to do with non conforming parts?
Are production status labels properly used?
Are storage containers properly labeled?
Are there training records for each employee?
Is the training effective?
Are employee training needs determined?
Are training needs being addressed by the supervisor?
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Are employees involved in continuous improvement teams?
Do employees know what to do when an out of control condition exists?
Is department clean?
Does operator maintain cleanliness?
Are employees following safety procedures?
Do employees know where the MSDS are located?
Are employees properly storing tooling?
These are yes / no questions for the internal audit plan
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Internal Audit Plan Open End Questions
Tell me about the quality policy.
What quality objective do you affect?
How do you know these procedures are OK to follow?
Tell me about your work process.
Show me this process in your procedure.
What is the specification for this inspection?
What do you do when you find a defective part?
What is the traceability for this product?
Show me how you record the inspection.
How do you know this product is good?
What do you do when you see an out of control point?
How do you order supplies?
What do you do when you encounter a production problem?
What type of training have you received?
How do you know if this measuring equipment is ok to use?
What do you do when a piece of equipment breaks down?
These are open end questions for the internal audit plan
Read more: http://www.quality-assurance-
With best regards,
"Seven Billion Dreams. One Planet. Consume with Care."
(2015)
Dr. AMAR NATH GIRI
EHSQ , NFCL
M.Sc. -Environmental Science,Ph.D -Environmental Science law & DIPLOMA AS - P.G.D.E.P.L,CES, DCA,
EX IIM LUCKNOW FELLOW, EX RESEARCH SCIENTIST
IGIDR-MUMBAI
9912511918
amarnathgiri@nagarjunagroup.
http://www.nagarjunagroup.com
http://www.
EHSQ BLOG : http://dramarnathgiri.
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