Check List For QMS Internal Audit [PDF]

Zitiervorschau

Date: 15/02/2019

ISO - 9001

ALM – QMS DOC # 09-E

Audit Checklist Date: _______________________

Section Contact Person Manpower:

Officers:

Staff /Worker: AUDIT CHECK LIST

A. HOUSE KEEPING No. Activity a. General Cleaning and House Keeping B. QUALITY MANAGEMENT SYSTEM (SECTION 4) No. Activity a. Is quality plan / process flow chart available? c. Is procedure for control of document available? d. Are work instructions available? e. Is procedure for control of record available? C MANAGEMENT RESPONSIBILITY (SECTION 5) No. Activity i. Is quality policy available? ii. Are employees know about quality policy? iii. Are job description available? iv. Is quality management representative appointed? v. Is organization chart available? vi. Is management review board formed? vii. Is record of management review meetings available? ix. Is internal communication Memo Verbal Phone system available? x. Is quality system manual available? xi. Are quality system procedures available? . xii. Are documents controlled? xiii. Is system of verification of approval of document and data exist? xiv System of distribution of document & data available. xvi Is system to incorporate changes in documents exist? xvii Is system to control & identify obsolete documents exist. xviii Is list of file / records maintained? xix Is the record retention period of record set up? C. RESOURCE MANAGEMENT (SECTION 6) No. Activity i. Is training plan available? Ii Is training attendance maintained? iii Is training material available? vii. Is maintenance of workplace, associated facilities and support services carried out. viii Is conducive work environment maintained? ix. Are first aid boxes available? xi. Are records of supporting services like transport and

Yes

No

Remarks

Yes

No

Remarks

Yes

No

Remarks

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Date: 15/02/2019

ISO - 9001

communication maintained. D. PRODUCT REALIZATION (SECTION 7) 7.1 PLANNING OF PRODUCT REALIZATION No. Activity i. Quality Objectives Department wise

ALM – QMS DOC # 09-E

Yes

No

Remarks

Section wise

ii. Are Contract records maintained? 7.2.1 DETERMINATION OF REQUIREMENT RELATED TO THE PRODUCT i. Is purchase order received form customer? ii. Is the purchase assessed? iv. Is customers defined regulatory requirements entertained? 7.2.2 REVIEW OF REQUIREMENT RELATED TO THE PRODUCT i. Is purchase order reviewed before acceptance? ii. Is records of review exists? iii. Is amendment (if any) communicated to customer? 7.2.3. CUSTOMER COMMUNICATION i. Is the customer is immediately communicated about purchase order compliance or etc.? iii. Is customer feedback system existing? iv. Is customer complaints handling procedures exists? 7.3 DESIGN DEVELOPMENT ………. Not applicable I Are records of all activities of design development maintained? 7.4 PURCHASING i. Is the record of indents available? ii. Is list of items available? iii. Is clear specifications defined on indent? iv. Is record of purchases made through cash available? v. Is the procedure for purchases available? vi. Is record of purchase orders / forecast available? 7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION i. Is availability of information about work to be performed available? iii. Are suitable equipment available? iv. Are list of measuring devices (balances) available? 7.5.2 Validation of processes for production & service provision … Not applicable 7.5.3 IDENTIFICATION AND TRACEABILITY i. Is system for product / service identification exist? ii. Is identification of purchased materials carried out? iii. Is identification of final product carried out? vi. Is traceability of service / product carried out? v. Is records of traceability of product maintained? 7.5.4 CUSTOMER PROPERTY ………. not applicable i Are records of customer property maintained? 7.5.5 PRESERVATION OF PRODUCT i. Are the appropriate step taken for storage of product? Ii Is the products handling carried throughout the process satisfactorily? iii. Is the storage area identified? v. Are the letter / reports / material dispatches are carried out Page 2 of 4

Date: 15/02/2019

ISO - 9001

ALM – QMS DOC # 09-E

satisfactorily? vi. Are the records of product delivery maintained? 7.6 CONTROL OF MONITORING AND MEASURING DEVICES i. Is there a control on test equipment’s exist? ii. Is there a master list of inspection and test equipment’s? iii Are the instruments / equipment’s / machines in calibrated conditions? iv. Is the calibration record maintained? v. Are calibrated instruments properly identified through Stickers? 8. MEASUREMENT, ANALYSIS AND IMPROVEMENT (SECTION 8) 8.1 GENERAL i. Is the production / service processes demonstrate conformity with customer requirement? 8.2.1 CUSTOMER SATISFACTION i. Is the customer satisfaction analyzed? ii. Is there any evidence on appropriate actions on customer feed backs / complaints? iii. Is the customer on tri-month basis are provided with feedback form for assessing the perception of organization? 8.22 INTERNAL AUDIT i. Is the internal audit procedures available? iii. Is the audit plan available? iv. Are audit performed by personnel independent of the activity being audited? vi. Are audit reports properly documented? 8.2.3 MEASUREMENT AND MONITORING OF PROCESS i. Is the inspection plan exist? ii. Is the specification / diagrams for process monitoring and measurement available? iv. Is in-process inspection carried out? V Is final inspection / checking carried out? vi. Is the record of inspection and checking maintained? vii. Is the record of corrective action taken to ensure the conformity of results are available? 8.2.3 MEASUREMENT AND MONITORING OF PRODUCTS i. Is the accuracy of the product verified? ii. Is the record of final inspection and inspection criteria maintained / iii. Is the service / production data are authenticated for issue before release? 8.3 CONTROL OF NON-CONFORMING PRODUCTS i. Is the non-conforming product identified & recorded? ii. Is re-checking of non-conforming product made? iii. Is the nonconforming product /data results segregated? 8.4 ANALYSIS OF DATA i. Is the customer satisfaction analyzed? ii. Is statistical techniques used for data analysis. iv. Are customers feed backs analyzed, recorded and maintained?

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Date: 15/02/2019

ISO - 9001

ALM – QMS DOC # 09-E

8.5 IMPROVEMENT 8.5.1 CONTINUAL IMPROVEMENT i. Is the quality policy and quality objectives are used for continuous improvement? ii. Is the audit finding are used for purpose of continuous improvement? 8.5.2 CORRECTIVE ACTION i. Is documented procedure available? ii. Is corrective action taken on internal nonconformity? iii. Is corrective action taken on customer complaints? iv. Is causes of non-conformities determined? v. Is record of corrective action is available? vi. Is evaluation of corrective action is made? 8.5.3 PREVENTIVE ACTION i. Is documented procedure available? ii. Is preventive action is properly followed up? iii. Is the record of preventive action maintained? iv. Are corrective and preventive actions discussed in management review meeting?

SIGNATURE OF AUDITOR:

_______________________________

SIGNATURE OF MR:

_______________________________

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