Example Report - Pro QC...

ISO 13485 Audit Report

* Example Report *

North America +1-813-252-4770

Latin America

+52-1-333-2010712

Europe & Middle-East +49-8122-552 9590

Asia & Asia Pacific +886-2-2832-2990

Email

[email protected]

www.proqc.com

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It is recommended that the client request a corrective action and/or improvement plan based on the results of the audit. The improvement plan should include: - Detailed description of action plan - Name of person responsible for the improvement activity - Date when the improvement will be completed

Each question is assessed for conformance to the requirements of ISO 13485, and the auditor's knowledge of the product and/or process This must be clear to the supplier at the opening meeting.

Complies with Requirements = - Has objective evidence to support the question, and - Has a written procedure (when required).Improvement Needed = - Has objective evidence but procedure needs improvement. - Has objective evidence, but no written procedure. - Has written procedure, but is lacking some objective evidence to support the question.Non-conformance = - No objective evidence to support the question (regardless of the procedure). - Lacking some objective evidence, and no written procedure.

RESULTS/RECOMMENDATIONS: (Automatically Calculated)The score is based upon the percent of questions that Conform to the Requirements, percent that Needs Improvement, and the percent that have a Major Non-conformance. Each client should review how the supplier was evaluated for each question and base their sourcing decisions upon factors which are important to them and their product.

AUDIT REPORT: - Scope of the Audit - Recommendations - Strengths of the Suppliers Quality System and Manufacturing Process - Opportunities for Improvement (weaknesses in the supplier's Quality System and/or Manufacturing Process)

RESULTS REVIEW WITH SUPPLIER:The auditor should review the audit results with the supplier, but cannot give the supplier a copy of the audit. The audit is the property of the client.

CORRECTIVE ACTIONS:

GUIDELINES FOR SCORING CONFORMANCE:

PURPOSE: Audit scores are rarely understood outside of the quality organization or the auditing company. This audit is based upon defined criteria for each element audited. Scoring is based upon the supplier's ability to meet the requirements. The audit focuses on factors which could result in increased costs or financial loss to the client due to poor performance by the supplier. The intent of the audit for suppliers is based on the requirements of ISO 13485, which is useful for making sourcing decisions and reducing associated risks.

SCORING:

Complies with the requirements = CImprovement Needed = INon-conformance found = NCN/A = does Not Apply to this supplier / process / product

ISO 13485 Quality System Audit Rev.GUIDELINES

Scores are to be assigned based on what is done for the Pro QC client regardless of what is done for other clients. For example, if control plans are developed for other clients but not for Pro QC's client, the score must be one 'NC' - Major Non-Conformance. Scoring must be explained to the supplier at the opening meeting.

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7. The factory should standardize the clothing and hand washing process.

9. The factory must re-evaluate the sterilization process in the new place and keep the record available at any time.

1. The factory could collect data and review the performance vs their defined quality objectives, on a monthly basis.2. The audit checklist must cover the section of internal audit and management review in the audit plan.3. The factory must develop a master list of quality records to be retained, specific to the retention location and period.4. The factory must use a documented method to send orders to suppliers (A), only by phone and MUST have a program to monitor them .5. The factory must have a procedure to require the implementation of order review prior to accepting the production.

8. The factory must update the calibration tags from the testing and measuring equipment.

Opportunities for Improvement:

6. The factory must improve the management of non-conforming parts in the workshop to avoid mix-up.

devices field, and lead by a devoted leader who is continuously progressing.4. The factory is ISO 13485 Certified and CE certified.5. Good manual lot traceability.

the device used to collect blood samples.

XXXXXXXXXXXXXXXXXX YYYY/MM/DD

ISO 13485 Quality System Audit Rev.AUDIT REPORT

Supplier Name Audit Date Report No.IMC00065030H

Scope of Audit:The intent of conducting a quality system audit based on ISO 13485:2003 requirement is to provide the client with information useful for making an initial assessment about business viability and reducing their sourcing risks.

Summary/Recommendations:XXXXXXX is located around 1 hour from Jinan, with around 200 employees. The factory is devoted to the manufacturing of

10. The factory could consider providing resources to maintain a back-up of the record of sterilization process.

At least 60% of people working there have been with the owner since the foundation over ten years ago.The factory was ISO certified in 2009 and plans are to extend this certification. The factory has mainly three processes:mold injection of plastic components, assembly and the sterilization process. The quality system is in place with a good command. Follow up and traceability is managed by skilled workers. However, the factory's presentweakness is in the aspect of management review, which includes review of performance as defined in the quality objectives. The factory also needs to maintain a recognizable system in the managementof NCF product during the manufacturing process in order to avoid mix-ups. We recommend the client motivate thissupplier to implement necessary corrections prior to moving forward.

Strengths:1. The factory has clean room running in respect to the standard YY 0033-2000.2. The factory has a sterilization process, fully and automatically controlled by the computer.3. The factory has valuable manpower, most employees having extensive experience working together in medical

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NAME : NAME :

ADDRESS : ADDRESS :

CITY : CITY :COUNTRY : COUNTRY :

PHONE : PHONE :FAX : FAX :

Mr./Mrs. Title: Email:










Scope :

Nb. Ques. %

93 73.2%

27 21.3%

7 5.5%

23

127

Not-compliant with Requirements (NC)

Not Applicable (N/A)

Audit according to ISO 13485

XXXXXX Reviewer

There are serious major issues noted with this supplier that could impact your business.The better solution will be to source from another supplier.

AUDIT RESULTS

RECOMMENDATIONS

XXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXX

Category

PRO QC PERSONNEL PARTICIPATING

XXXXXX

request immediate corrective action in case of long-term business.

IMC00065030H

XXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXX

XXXXXXXXXX

XXXXXXXX

SUPPLIER'S PERSONNEL PARTICIPATING

XXXXXXXXXXXXXXXXXX

XXXXXXXXXXXXXXXXXX

Improvement Needed ( I )

YYYY/MM/DD

XXXXXXXXXXXXXXXXXX

Complies with Requirements ( C )

XXXXXXXXXX

XXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXX

Auditor

supplier, and keep pushing for improvement.

System has several major issues. You could temporarily use this supplier and

XXXXXXXXXXXXXXXXXX

XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

Systems are effective. You could start or continue business with this supplier.

System is acceptable, with minor nonconformities. You could use this

XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

ISO 13485 Quality System Audit Rev.SUMMARY

Report No.Supplier Name Audit Date

XXXXXXXXXXXXXXXXXX

XXXXXXXX XXXXXXXXXX

XXXXXXXXXXXXXXXXXX XXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXX XXXXXXXXXX

CLIENT'S INFORMATIONSUPPLIER'S INFORMATION

XXXXXXXXXXXXXXXXXX

XXXXXXXXXXXXXXXXXX

XXXXXXXXXXXXXXXXXX

XXXXXXXXXXXXXXXXXX

73.2%&

21.3%&

5.5%&

2

SCORE

B1B1.1

C

B1.2

C

B1.3

I

B1.4

I

B1.5C

B1.6

C

B1.7

C

B1.8

C

B1.9

C

Yes, the factory has developed an organization chart in the Quality Manual, Page 7. Each position in the organization chart has a job description from Page 15 to 19.

Yes, the factory has enough manpower resources of around 200 employee, working in 20,000 square meter, in which includes ,3000 square meters allocation of cleanroom environment of class 10000, in respect to YY/ 0033-2000, the national standard for cleanroom.

Does the organization have a quality manual? Yes, LF/QM-ISO13485, Rev C.

The factory has developed all procedures (34) required by the ISO 13485, listed in the document LF-QP, rev. C.

Does the organization have the documented procedures required by ISO 13485:2003 and 21 CFR 820?

Rev.AUDIT CHECKLIST

Supplier Name Audit Date Report No.

Is there a company organization chart, and has the organization defined quality roles & responsibilities to the individual level?

The factory has developed all procedures (34) required by the ISO 13485, listed in the document LF-QP, rev. C of 2010/3/1. The quality objectives are not monitored and reviewed as explained in above question.

ISO 13485 Quality System Audit

The organization has defined two major quality goals in the Quality Manual: - Product Conformity Rate < 99.5% - Number of customer complaints < 1% The factory has also a distributed these quality goals per department in document Q/XK-ZLJL-074, but does not have a follow up record. Therefore, we are not able to see if they're consistent with policy.

Is the quality policy statement clearly defined to maintain the quality system effectiveness in accordance with ISO13485:2003 and/or 21 CFR 820?

Yes, the system clearly has the need to maintain it quality system effectiveness with regard to standard of Medical devices.

Management Responsibility

IMC00065030H

Are the organization's quality goals & objectives documented?. Are quality objectives measurable and consistent with the quality policy?

XXXXXXXXXXXXXXXXXX YYYY/MM/DD

Is the quality policy statement clearly posted, and is the policy communicated and understood throughout the organization? Take photo of where the policy is been posted.

C = Complies with the requirements, I = Improvement Needed, NC = Not Compliant, N/A = Not Applicable

Are adequate resources (Manpower, Equipments, workshops) provided for quality activities?

The factory XXXXXX has defined the Quality Policy in the Quality Manual LF/QM-ISO13485, Rev C. as following: - Ensure Safe medical System - comply with medical devices law - commit to maintain the system consistency. This policy is posted at various place within the factory.

Does the organization define a plan or strategy to meet the quality goals and objectives? Are quality objectives monitored and reviewed at reasonable intervals? Take a photo.

FINDINGSQUESTIONNAIRE

Can you show me a file for each type or model of medical device containing or identifying documents with product specifications and QMS requirements?

Yes, the factory has developed a file system for a range of medical devices in LF-C-02-05, including national specification required for this range of product. In total, 22 different national laws have been identified as critical in the manufacturing of the device.

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SCORE

Rev.AUDIT CHECKLIST



IMC00065030HXXXXXXXXXXXXXXXXXX YYYY/MM/DD


FINDINGSQUESTIONNAIREB1.10

C

B1.11

I

B1.12

C

B2

B2.1

C

B2.2

C

B2.3

C

B2.4

I

B2.5

C

B2.6

C

B3

Is there an individual assigned to the roles of management with executive responsibility & management representative?

Yes, the last time an internal audit was conducted was in 20XX/10/20. All records are available, such as Audit Plan in LF-C-01-07, Audit Checklist LF-C-01-08, etc.

Yes, We can see the signature in the record.

Yes, there is a report of NCF In form LF-C-01-09 found in section 4.1 and 4.2 document control. There is corrective action established and reviewed by the manager.

The factory has nominated Mr. XXX as Management Representative, and the nomination letter is visible in the Quality Manual . His job description is also visible in the document.

The factory has developed a Procedure LF/QP-5.6 as guideline to conduct the management review meeting. It requires conducting it once a year. The last management review meeting was conducted in 20XX/12/10, we can see the planning and attending people record LF-C-01-29. We cannot see any data to support the input or any action planned

Yes, as defined in the procedure LF/QP-4.2.3.

The factory has developed a Procedure LF/QP-8.2.2 as a guideline to conducting internal audits. It requires conducting the internal audit once per year. Non-conformities are to be followed closely.

Is there a documented management review procedure, and is it under revision control? Where is the most recent management review conducted? Does it demonstrate the suitability and effectiveness of the Quality System? Does the review cover all the required topics specified in the Quality Manual and/or management review procedure?

Are quality system procedures & work instructions documented and identified in a documented outline of the quality system structure?

Is there a documented procedure controlling internal audits? Does the audit procedure contain a provision for re-audits?

Have the quality system audits been scheduled & completed and audit documents on file?

Have internal auditors been trained and are they independent of the areas audited?

Does the audit plan/scope address all areas covered by the quality systems & cover all requirements of regulations?

Internal Audit

Are the results of internal audits reviewed by managers responsible for area audited?

Are audit findings properly documented, and is there evidence of actions taken?

Personnel (Training)

The auditors (4) have been trained by TUV. See photo 28. Removed from example.

According to the audit plan and checklist, the audit did not cover the section of internal audit and management review meeting. The content of the audit checklist is limited.

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SCORE

Rev.AUDIT CHECKLIST






C

B3.2

C

B3.3

C

B3.4

C

B4

B4.1

C

B4.2

C

B4.3

N/A

B4.4

C

B4.5

C

The factory has developed a procedure for the identification and implementation of employee training, LF/QP-6.2.2. There is training program, example of the year 2010, developed and approved in 2010/03/01. 6 topics were identified as training topics last year, records are available.

Has the organization identified training needs and developed a documented training plan?

Yes, trainings are evaluated with a written examination. We have checked record evaluation for XXX ( Rework), XXX (Injection) and GXXXa (Rework). See photo .

Does the factory maintain records of maintenance activities ? Yes, records of maintenance are properly kept.

Has the effectiveness of training been evaluated through any type of examination or test?

The factory is making medical devices to capture blood samples. The manufacturing of such devices uses: - Molding injection machine for plastic component molded together with ejector metal. - Sterilization process assisted with software. - and cleanroom environment. All these equipment are maintained in respect to the maintenance plan available on site.

What supporting services (such as transport or communication) are needed to ensure that products meet requirements? How are they maintained?

The factory uses external service for the transportation for delivery.

Does the factory have a documented requirement on how to maintain those facilities and equipment, including their frequency, responsibility? The organization shall establish documented requirements for maintenance activities, including their frequency, when such activities or lack thereof can affect product quality.

Yes, the factory has developed a maintenance program for all the machines and facility.

Are individual training records well established and properly maintained?

Yes, training record are available, See photo 29.

Infrastructure

Does employee training include the awareness that defects may occur from improper performance of their specific jobs? Specify the types of defect and related training received.

Yes.

Are the buildings, workspace and utilities appropriate to meet product requirements? How are they maintained?

The infrastructure and workplace are maintained in respect to the cleanroom standard YY / 0033-2000.

What kind of process equipment (both hardware and software) is necessary to conform to product requirements? How is the equipment maintained?

2

SCORE

Rev.AUDIT CHECKLIST






B5

B5.1

C

B5.2

I

B5.3

C

B5.4

C

B5.5

C

B6

B6.1

N/A

B6.2

N/A

The factory does not have any capability for the design of product, they receive product specifications and samples from their client. N/A

Work Environment

Are design planning requirements clearly explained in a revision controlled procedure? Is the referenced design plan included in significant elements such as design reviews, verification & validation, including responsibilities / interfaces?

IDEM

Design Control (Manufacturing of Product)Are design procedures documented under revision control?

Do the work environment conditions have an adverse effect on product quality? Do you have documented requirements for the work environment conditions and documented procedures or work instructions to monitor and control these work environment conditions? (see 7.5.1.2.1).

Yes, the conduction could affect the quality of product in terms of cleanliness. The factory has equipment to control the quantity of particles in air portion, see photo 17 and 1, and control temperature and humidity are controlled on a daily basis, See photo 11.

What kind of work environment is required to achieve conformity to product requirements? How is this environment managed and maintained?

The manufacturing of this product requires a clean room class 10,000. The factory has maintenance and control systems as required by the standard YY / 0033-2000 specific for the monitoring of a clean room, temperature and humidity are controlled on a daily basis. See photo 11.

Does the factory have documented requirements and work instructions for health, cleanliness and clothing of personnel if contact between such personnel and the product or work environment could adversely affect the quality of the product? See 7.5.1.2.1.

Yes, the factory has a documented procedure for health, cleanliness and clothing of personnel and it is visible along the entrance to the clean room. These documents are not identified as part of QMS with numbers and rev. As for cleanliness and clothing, the factory could use more pictures to describe this process.

Does the organization ensure that all personnel who are required to work temporarily under special environmental conditions within the work environment are appropriately trained or supervised by a trained person? See 6.2.2 b.

Yes, all personnel working in this area are trained, and have work permit visible with them during daily work period. There is a control device at the entrance of the cleanroom that can check automatically the permission of entrance of each worker and can detect if any worker is not allowed to go inside the clean room.

If appropriate, are special arrangements established and documented for the control of contaminated or potentially contaminated product in order to prevent contamination of other product, the work environment or personnel? See 7.5.3.1.

Each worker must be examined to make sure he does not have any potential contamination. Hands are required to be washed as visible in the photo 3. Product at the semi-finish stage are put in plastic bag and maintained inside the cleanroom to wait for sterilization.

2

SCORE

Rev.AUDIT CHECKLIST






N/A

B6.4

N/A

B6.5

N/A

B6.6

N/A

B6.7

N/A

B6.8

N/A

Does the procedure that defines & controls formal design reviews specify when reviews are required, participants, decisions made, and follow-up actions and is under revision control? Are formal design reviews performed and the documentation include all elements required by the procedure?

IDEM

IDEM

IDEM

IDEMAre design validation activities specified in a controlled procedure and performed per design plan and that procedures? Validation records confirm that intended use was satisfied, including documentation and disposition of discrepancies.

IDEM

IDEM

Are design verification activities defined by a revision controlled procedure, performed per the design plan and documented? Are verification records confirm that design inputs specifications were satisfied, including documentation and disposition of discrepancies?

Are design input documentation requirements clearly explained in a revision controlled procedure? Is design input documented under revision control, is up-to-date, and has it been reviewed and approved?

Are design output content, format and design output approval methods defined in a revision controlled procedure? Are design outputs included in acceptance criteria?

Are reviewed and approved documents available to demonstrate that the design output has satisfied the design input. In other words, parameters are traceable from input to output? .

2

SCORE

Rev.AUDIT CHECKLIST






C

B6.10

C

B6.11

C

B6.12

NC

B6.13

C

B7

B7.1

C

B7.2

I

Document ControlIs there a documented procedure in place that describes approval, distribution and change control for internal documents?

Has manufacturing process been verified/validated to meet the engineering specs (design DMR) for the audited project? Have the manufacturing procedures/work instructions been approved, implemented and are under change control?

Has organization established documented requirements for risk management throughout product realization? FMEA for software medical use - See ISO 14971:2007 for guidance related to risk management.

Is there a procedure controlling & defining design change control throughout the product design and life cycle is available and under revision control? Does the procedure covering change control include requirements for change approval and verification/validation?

The factory XXXX has evidence that the manufacturing process been verified and validated. The product inspection report # Y2009071507 of sample lot # 20090604, product range # 23 G, conducted from 20XX/8/10 to 20XX/9/17, by personnel # J3-11 and J3-09 working as representative members of National accredited inspection service for medicine and medical devices. The cleanroom process inspection report # H2009100908 conducted in 20XX/10/19 in respect to the standard YY 0033-2000. All the verification/validation was made before the factory moved to the new location. They must have done a verification, but some of the evidence is not visible at the factory at time of this audit

Yes, the factory has conducted a risk management along the product realization.

Yes, the procedure is developed.

Is there evidence that approval, distribution, and change is being followed in internal documentation?

We can see record of the distribution of document in the form LF-C-01-02, only for the procedures and Quality Manual, not for 3 level document such as On side work instruction and specification.

Does organization keep records on risk management throughout product realization?

Yes, the factory has conducted a risk management a long the product realization.

We cannot see any valid clinical evaluation, and the performance of the result from the clinic expect.

As part of design and development validation, the organization shall perform clinical evaluations and/or evaluation of performance of the medical device, as required by national or regional regulations. See Note 2.

Yes, the factory has a documented procedure for the control of document LF/QP-4.2.3. It specifies the control to be implemented for any internal and external document.

2

SCORE

Rev.AUDIT CHECKLIST






C

B7.4

C

B7.5

C

B7.6

C

B7.7

C

B7.8

C

B7.9

C

B8

B8.1

C

The procedure LF/QP-4.2.3, Paragraph 4.6 states that obsolete documents should be saved for at least five years after it has been obsolete.

Yes, the factory uses form LF-C-01-03 to apply for the modification, uses form LF-C-01-04 to review the reason of the modification, and uses the form LF-C-01-05 to communicate the modification.

Are appropriate documents available at all locations where they are used?

Are all obsolete documents removed or otherwise prevented from unintended use? How does the organization plan to prevent their unintended use?

Are changes to the documents reviewed and approved by an individual in the same function or organization that performed the original review and approval? Are change records maintained and do they include a description of change, signature of approving individual(s), approval date, and effective date?

Are approved changes communicated to the appropriate personnel in a timely manner?

The procedure LF/QP-4.2.3, Paragraph 4.6 states that obsolete documents should be saved for at least five years after it has been obsolete.

The factory has defined a process for the modification in case it happens in Step 4.4 of the procedure and also includes the need to control external documents.

Does the organization have a document defining how long each type of obsolete documents must be retained? The organization shall define the period for which at least one copy of obsolete controlled documents shall be retained.

Yes, the master List LF-C-01-01 is available with 36 procedures, 25 forms, etc.

Yes, it is specified in document control procedure LF/QP-4.2.3, Step 4.5.

Yes, the factory has a defined procedure LF/QP-7.4 Rev. C, as a guideline for the selection and management of suppliers.

Purchasing

Is a documented procedure in place that describes control for external documents and is there evidence that it is being followed?

Is there a documented procedure defining supplier evaluation and approval?

Is there is a master list of all controlled documents that includes current revision and distribution information?

Yes, documents are located at appointed place.

2

SCORE

Rev.AUDIT CHECKLIST






C

B8.3

C

B8.4

C

B8.5

I

B8.6

NC

B8.7

I

B8.8

C

B8.9

I

B9

Is there a procedure defining means to monitor supplier performance and the need for re-assessment and/or corrective action and is there is evidence of implementation? Is data relating to supplier performance review communicated to supplier?

Is there an agreement with supplier, in which the supplier agrees to notify customer of changes to the product or service so that the affect of the change on quality of the finished device can be evaluated?

Is there a process/procedure that requests to review and implement change requests made by suppliers and/or customers?

Is there a process that ensures that purchase order content, product requirements and supplier contracts, including changes, are approved?

Contract / Order Review

Yes, the procedure is developed but it has never been implemented so far.

The production will prepare the purchasing order and send it to the purchasing department in LF-C-07-02, but the purchasing department does not use any form to send order to supplier. Information for the purchases is communicated to the supplier via phone call. No record available.

Yes, the factory has defined an acceptance criteria for accept / reject supplier in BBJ-C-09-4.

There's a list of seven suppliers, approved in 20XX with four as significant suppliers (A) and three as lower level risk (B).

Are acceptance requirements for acceptable suppliers clearly defined?

Is there a list of approved suppliers of product related parts, services, consultants, subcontract, etc?

There is a record of initial evaluation of the supplier (No 1) in form BBJ-C-09-10.

Only incoming inspections are applied for suppliers that provide significant material, such as plastic material and ejector. Record of incoming inspection are visible.

No.

There is no document that requires this implementation, and even any of the contract signed by the factory with suppliers.

Is there documented evidence that suppliers have been evaluated for approval?

Are there documented procedures that define the type and extent of controls being applied to suppliers (i.e. source or receiving inspection, surveillance audits, test data/reports, etc.) and is there evidence of implementation?

2

SCORE

Rev.AUDIT CHECKLIST






I

B9.2

N/A

B9.3

N/A

B9.4

N/A

B9.5

I

B9.6

I

B10

B10.1

C

B10.2

C

B10.3

C

Yes, production process is documented in WI and correctly followed. See photos 4 and 12.

Does the contract review procedure define the processes used to assure order commitments can and are met on time, completely and is there evidence of proper implementation?

Does the contract review procedure define what records are retained, how and where these records readily accessible and accurate?

Yes, evidence is available, but there is no procedure to enforce this implementation.

Is there a written procedure that defines contract (customer order) review process and evidence of proper implementation?

There is no procedure that requires the contract review process, but there is evidence of the contract review process in Form LF-C-04-03, for the order No. JNLF20100105, and JNLF20110110.

Do documented quality plans exist for various products manufactured (process flowchart with tests / control or inspections Plan) , and are they correctly followed?

Production and Process ControlsYes, quality plans exist for products manufactured and are documented.

Are production process work instructions documented and correctly followed?

IDEM

IDEM

IDEM

Does the contract review procedure define review of orders (contracts) before acceptance/approval per documented criteria for all orders? Is there is evidence of proper implementation?

Yes, records are maintained in respect to each production lot, and are linked with raw material and sterilization lot. See photos 20 - 26.

Does the contract review procedure define how to resolve order conflicts/errors/etc. and is there evidence of proper implementation?

Does the contract review procedure define how order changes are processed/approved and is there evidence of proper implementation?

Yes, but it does not define how records must be retained.

Has the organization established and maintained a record for each batch of medical devices that provides traceability to the extent specified in 7.5.3 and identifies the amount manufactured and amount approved for distribution? Is the batch record verified and approved?

2

SCORE

Rev.AUDIT CHECKLIST






C

B10.5

C

B10.6

C

B10.7

C

B11

B11.1

C

B12

B12.1

N/A

B12.2

N/A

B12.3

N/A

B13

If reference standards are referenced in process documents, are the standards available, current and under revision control?

Is there a procedure in place that defines the requirements for the verification and validation of manufacturing process changes and is there evidence that manufacturing process changes have been verified and/or validated following procedural requirements?

Yes, for example injection of plastic material, mold temp, injection speed can affect the quality, these parameters are fixed and are properly monitored every two hours. Records are visible.

Is there another 3rd party in charge of installation and verification of the installation of medical device? If so, does the organization provide documented requirements for installation and verification if installation is performed by outside org?

IDEM

Does the organization establish documented requirements for cleanliness of product ifa) product is cleaned by the organization prior to sterilization and/or its use, orb) product is supplied non-sterile to be subjected to a cleaning process prior to sterilization and/or its use, orc) product is supplied to be used non-sterile and its cleanliness is of significance in use, ord) process agents are to be removed from product during manufacture?

The factory does not have any cleaning process. Products are manufactured in clean room. And the factory has a system (infrastructure for this cleaning), before sterilization.

Cleanliness of Product and Contamination Control

Servicing Activities

Installation Activities

If appropriate, does the organization establish documented requirements which contain acceptance criteria for installing and verifying the installation of the medical device?

Do records of installation and verification performed by the organization or its authorized agent get maintained? See 4.2.4.

IDEM

This section does not apply for the devices manufactured by XXXX.

Where process variation can effect product specifications, are there processes in place to monitor the variation and take action to maintain or reestablish control?

If process control limits have been exceeded, is it clearly defined what actions should be taken and how actions will be documented?

Yes, the reaction is written in the WI on-site.

Yes, standard are visible on-site, as in the example of the sterilization process.

Yes, there are subsequence verification of product along the manufacturing process and defined in the quality control plan.

2

SCORE

Rev.AUDIT CHECKLIST






N/A

B13.2

N/A

B14B14.1

C

B14.2

C

B14.3

C

B14.4

NC

B15

B15.1

C

B15.2

C

B15.3

C

Are validated processes revalidated where appropriate when changes or process deviations occur? Are the review and activities documented?

Does the organization provide repair and/or maintenance service to customer? If so, are there documented procedures, work instructions and reference materials and reference measurement procedures to conduct such services?

This section does not apply for the devices manufactured by XXXX.

IDEM

The factory is not able to show us the validation record for this process, since they confirm that service that makes this equipment and conducted the installation has effectively conducted this installation. This is a problem of record control.

Particular Requirements for Sterile Medical DevicesAre sterilization processes conducted? If so, are records of the process parameters for the sterilization process maintained? See 4.2.4.

Can sterilization records be traceable to each production batch of medical devices? See 7.5.1.1.

Does the product manufactured need to be sterilized prior to use ? If so, does the organization establish documented procedures for the validation of sterilization processes?

Are records of servicing activities carried out by the organization maintained? See 4.2.4.

Are records of validation of each sterilization process be maintained? See 4.2.4.

Yes, the factory conducts sterilization process. See photo 13. The parameters for the sterilization process are recorded in timely basis automatically by the software and followed by each lot. The lot is identified with the date of the sterilization.

Yes, the records are traceable to each production batch.

Yes, product must be sterilized. The validation process is documented, and it has been implemented by the external service that makes this machine and process, including the software.

Yes, the procedure requires it

Validation of Processes for Production and Service ProvisionIs there is a procedure that defines when process validation is to be done (non-verifiable/'special processes') and process controls/monitoring defined, and is there evidence of implementation?

For validated processes, are the monitoring and control methods and data, the date performed, and where appropriate individual(s) performing the process documented?

Yes, there is a clear document that defines when a validation must be conducted during the manufacturing, such as a period after the sterilization process, in order to verify the efficiency of the sterilization. Records are visible and well protected.

Yes, related information is visible on-site and the lab service.

2

SCORE

Rev.AUDIT CHECKLIST






C

B15.5

C

B15.6

I

B15.7

NC

B16

B16.1

C

B16.2

C

B16.3

C

B16.4

C

B16.5

N/A

Yes, the factory has developed a recall procedure for any problem found at the factory after product has been delivered to the client. There is no such evidence since this problem has not happened in past.

All calibrations are conducted by a qualified institute for calibration accredited by the local government. Therefore there is internal WI for calibration.

Are there procedures that define verification requirements for tools/fixtures/equipment used for inspection, measurement or test and evidence of these verifications being done?

Is there a procedure defining actions required if equipment is found out of calibration and is there evidence that these actions are recorded? Do actions include an evaluation of the possible adverse effect on the device's quality and are actions documented?

Are there specific equipment calibration instructions and records of calibrations performed (when and by who) kept?

Are there procedures in place for the verification & validation process in terms of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)?

Are there specification documents (approved and controlled) available for calibration of inspection, measurement and test equipment?

Are records of validation of the computer software application maintained? See 4.2.4.

No records available.

Yes, the master list is documented and contains all equipment used for the testing and inspection of product and process.

Inspection, Measuring and Test Equipment

Yes, there is documentation.

Yes, there are documents.

Is there a master list of inspection, measurement and test equipment, in which the calibration dates and expire dates are clearly stated?

Is there evidence of approval and sign-off for production release of processes and equipment including a V&V summary report/release letter?

Yes.

Yes, there is a report of performance qualification on record.

Does the organization use computer software? What software application is it? If so do they have documented procedures for the validation of the application of computer software (and changes to such software and/or its application) for production and service provision that affects the ability of the product to conform to specified requirements?

Yes, the computer software is used at the sterilization process but nobody knows what software it is.

2

SCORE

Rev.AUDIT CHECKLIST






I

B16.7

C

B16.8

I

B17

B17.1

`

B17.2

C

B17.3

C

B17.4

C

B17.5

C

B17.6

C

Yes, all information is visible, including signature, date, and the name of the personnel responsible for execution and review.

Yes, procedures have been developed. Each product on site has a label that identifies its status. See photo 6.

Are there procedures that define acceptable activity (inspections, tests, verifications) and record keeping requirements for in-process product? Is there evidence of compliance?

Are there procedures that define acceptable activity (inspections, tests, verifications) and record keeping requirements for final product? Is there evidence of compliance?

Yes, each release is authorized with a signature of the personnel.

Acceptance Activities

Yes, there are procedures for acceptable related activities at the factory, and records are available. Records are traceable to each lot number. See photos 23, 24 and 25.

Yes, there are procedures for acceptable related activities at the factory, and records are available. Records are traceable to each lot number. See photos 23, 24 and 25

Is release for shipment authorized by signature and date in compliance with the procedure?

Yes, procedures for acceptable related activities are at the factory, and records are available. Records are traceable to each lot number. See photos 23, 24 and 25.

Are there procedures that define acceptable activity (inspections, tests, verifications) and record keeping requirements for incoming product and material? Is there evidence of compliance?

Record as certificates are available for each equipment listed, but the tags on related equipment are not up-to-date. See photos 16 and 17. As shown on the tag, the equipment is expired, but their calibration certificates are on time.

Are records available to demonstrate that such equipment is calibrated, labeled and within defined intervals?

Yes, the factory uses computer software to monitor and measure the temperature and other parameters during the sterilization process, but due to the lack of verification records of this process, we cannot conform that it was confirmed.

When equipment is found to be out of calibration, how does the factory assess and record the validity of the previous measuring results? See ISO 10012-1 and ISO 10012-2.

The factory will recall all related products as required in the procedure and after verify that similar lot products are not the same.

Does factory use computer software for monitoring and measurement? If so, is its ability to perform that function confirmed prior to initial use and reconfirmed as necessary? See ISO 10012-1 and ISO 10012-2.

Do acceptance records include the acceptable activities performed, the date of performance, the acceptance result, the equipment used if appropriate as well as the signature of the individual(s) conducting the acceptance activities?

Are there procedures that define the identification of the acceptance status of product throughout the process, factory to field?

2

SCORE

Rev.AUDIT CHECKLIST






B18

B18.1

C

B18.2

C

B18.3

C

B18.4

C

B18.5

C

B18.6

C

B18.7

C

B18.8

C

B19B19.1

N/A

Yes, there is a procedure that defines the requirement of product identification, and there is evidence of implementation on-site. See photo 6.

Is the product manufactured by the organization an implantable medical device? If so, in defining the records required for traceability, are records of all components, materials and work environment conditions included?

Does the organization use agents or distributors for the sale of its product? if so, does the organization require that its agents or distributors maintain records of the distribution of medical devices to allow traceability. Are such records available for inspection?

Yes, there is a procedure that defines the requirement of product identification, and there is evidence of implementation on-site. See photo 6.

Identification and Traceability

Yes, product is in stock for finished part or as semi-finish are identified properly.

Yes, the lot number of identified product is visible in the label.

Yes, the procedure is documented and well implemented.

Is there a procedure that describes how product tracking data is to be captured, and is there evidence of compliance?

Yes, the factory is working with an agent for the distribution. There is a requirement for them to keep traceability. We are not able to check this implementation due to location.

Is the organization responsible for the final package of the product? If no, are records of the name and address of the shipping package consignee (shall) maintained? See 4.2.4.

The factory is the final packaging of the device they make. The product is sold to any client who will do the assembly and final packaging process.

Is there a procedure that defines the identification of product and materials throughout the manufacturing process and is there evidence of compliance?

Is there a procedure that defines the identification of product and materials in stores, and is there evidence of compliance?

Is there a procedure maintained for identifying each unit, lot or batch of finished devices and components?

Yes, the product is implantable, and there is a requirement to keep traceability to each component purchased. This system is well followed in the factory. Each finished product can be tracked back to the raw material, employee, machine, date. See record 20 to 26.

Customer propertyHow do you ensure that customer-owned property is identified, verified, protected and safeguarded?

Not applicable.

Is there a procedure that defines the identification of product and materials at receiving and incoming inspection, and is there evidence of compliance?

2

SCORE

Rev.AUDIT CHECKLIST






N/A

B20

B20.1

I

B20.2

I

B20.3

I

B20.4

I

B20.5

C

B20.6

C

B21

B21.1

C

B21.3

C

Is there a procedure that requires evaluation of nonconformities, including documentation of any needed investigation or decision not to investigate and guidance of when to investigate? Is evidence of compliance available?

Are there procedures / work instructions in place that describe how products are to be packaged for shipment?

Are labels examined for accuracy before they are released for use, and are signature and date of the individual performing the examination documented?

The procedure is written, but not implemented. Rejected products from production are not properly submitted to analysis and investigation.

Is there a procedure that covers feedback of nonconformance information to the problem source and is there evidence of compliance?

Yes, the product is written.Is there a procedure that defines disposition options and conditions of non-conforming materials (scrap, rework, return, use as is, deviate)? Is there evidence of compliance?

Is there a procedure that defines the marking and identification of non-conforming materials? Is there evidence of compliance?

Yes, there is a procedure as a guideline for the marking and identification of non-conforming materials, but we can see evidence of implementation, with blue boxes (same color as for conforming products) identified with white labels on which is written "NON-CONFORM." See photos 8 and 9. It could be subjected to the factory to use a red color boxes only for NCF product.

Nonconforming Product Control

There is only one visible area to keep NCF products at the warehouse. Only useful for products rejected by the client, this area is open. There is no such area inside the cleanroom.

Is there a physical segregation of nonconforming materials during subsequent storage & processing, and is there evidence of compliance?

Yes, there are procedures to describe the re-working.

Labeling and Packaging

Yes, products are to be packaged according to instructions provided by the client.

Yes, there is final inspection that is included the examination of all these information and records are visible.

Is there a procedure that describes how re-work will be accomplished and documented and is there evidence of compliance?

Yes, but rejected products are not submitted for accountability or even analysis.

Not applicable.If any customer property is lost, damaged etc., how is it reported to the customer? Can records regarding this be shown?

2

SCORE

Rev.AUDIT CHECKLIST






C

B22

B22.1

C

B22.2

C

B22.3

C

B23

B23.1

C

B23.2

I

B23.3

N/A

B23.4

NC

B24

B24.1

NC

B24.2

I

Has packaging design been validated and results recorded?

Are all quality records readily retrievable during the audit?

Yes, the methods are defined.

Are there procedures in place that specify material control activity/handling to and from stock locations to assure protection from mix-ups, damage, deterioration, contamination or other adverse effects, and is there evidence of compliance?

Packaging design is approved after the sterilization process.

Yes, the procedures for the handling materials and processes are defined.

Are those statistical techniques documented and based on sound statistical methods?

No, the procedure does not provide such detailed information.

Yes, but only to be used for sampling.

Data for the rejected products is not recorded or counted to be used as input for data analysis and statistical approach.

Statistics and data analysisAre procedures in place to identify valid statistical techniques for sampling or product characteristic/process control where necessary?

Are there any special storage conditions, and it this (shall) be controlled and recorded? See 4.2.4.

Yes, their storage conduction is well implemented. However, the stock place is not big enough at the moment and product has to be stored in the aisle of the factory.

Quality Records

Are procedures in place that define the content, location and retention of quality system records and process control records, and are records of compliance available?

Are retention periods for quality records equivalent to the design and expected life of the device but not less than two years from date of release to distribution?

Are procedures in place to define the content, location and retention of design records, and is evidence of compliance available?

Handling, Storage, preservation

Record of lot traceability for employee training, calibration, process control and validation were readily available for audit.

According to audited people, records are to be maintained for 5 years, since this product life is for 2 years. But there is no procedure in place.

Not applicable.

Have procedures been established that describe the methods for authorizing receipt from and dispatch to storage areas and stock rooms and is there evidence of compliance?

2

SCORE

Rev.AUDIT CHECKLIST






I

B24.4

I

B24.5

N/A

B24.6

I

B26

B26.1

NC

B26.3

N/A

B26.4

C

B26.5

C

B26.6

I

B26.7

I

N/A

Is there a documented and properly implemented process for handling of customer complaints?

Is there a documented and properly implemented process for the collection of defects found by or in the quality system?

Yes, the Sales Department is in charge of taking care of customer complaints and conducting investigations.

No, the procedure does not provide such detailed information.

Are there appropriate statistical techniques applied to defect data where necessary to detect recurring quality problems?

No.

Is there a procedure to ensure that sampling methods are adequate for their intended use and is there evidence of compliance?

No, there is not evidence that defects collected from production and the supplier are analyzed, only non-conformities from QMS.

No

Yes, internal .

Does the sampling procedure require review of sampling plans when changes occur?

Is there a documented and properly implemented process for the collection of production defects and supplier defects?

Corrective and Preventive Action

Is there a documented and properly implemented process for the collection of design related defects?

Is there evidence that the defect data is analyzed to identify opportunities for corrective or preventive action?

The sampling method used is based on GB 2828, a Chinese sampling standard from the international standard. This sampling is not reviewed and updated according to the feedback from the production

N/AWhat information does this analysis provide relating to:- (customer satisfaction) feedback (See 5.6) - conformity to product requirements (See 5.6)- characteristics and trends of processes and products (See 5.6)- suppliers (See 7.4.1)

What data is collected and analyzed to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual maintain of its effectiveness can be made? Can you show me documented procedures that describe this activity?

We can see information such as sterilization process and injection molding parameter has been collected, but are is not used for data analysis. Only an annual audit is conducted to identify abnormalities. Nothing is conducted in the process analysis.

2

SCORE

Rev.AUDIT CHECKLIST






I

B26.9

C

B26.11

C

B26.12

C

B26.13

C

B26.14

C

Is information relating to quality problems or nonconforming product disseminated to those directly responsible for assuring quality or preventing such problems?

Are results of corrective and preventive actions reviewed during management review?

Does each defect has a unique and traceable identification number?

Is there a procedure which documents the decision making process to pursue investigation and root cause corrective action?

Yes.

Yes.

Yes, there is such evidence.

Yes, there is such evidence.

Is there evidence that the corrective and preventive action has been fully documented, including problem statement, identified root cause, identification of action taken to eliminate root cause?

Does the evidence include verification that the corrective action has fixed root cause and resulted in no adverse effects?

Yes, there is such a procedure.

No.

2

5. "GOOD" Plastic Components Stored before Assembly 6. Labeling of "GOOD" Semi-Finished Product

1. Principal Gate, Office Building & Workshops 2. External View of Clean Room, Class 100000

3. Pro QC Auditor in Hand Washing Room 4. Plastic Injection Room

XXXXXXXXXXXXXXXXXX YYYY/MM/DD IMC00065030H

Photo Removed


ISO 13485 Quality System Audit Rev.FACTORY PHOTOS

2

XXXXXXXXXXXXXXXXXX YYYY/MM/DD IMC00065030HSupplier Name Audit Date Report No.


10. Equipment to Test the Leakage Function, not Used for the Product Online at the Audit Time.

9. Uses the Same Color Boxes Labeled "BAD PART" to Keep Rejected Product

6. Labeling of "GOOD" Semi-Finished Product 7. Assembly and Checking Room in Class 100000

8a. A Container with "BAD" Product Put in the Same Place of "GOOD". A risk of been mixed.

8b. A Container with "BAD" Product Put in the Same Place of "GOOD". A risk of been mixed.

BAD PART�

GOOD$PART�

2



13. Finished Product Packed & Waiting Sterilization

11. Temperature and Humidity Control Device Inside the Clean Room 12. Work Instruction On Site

13. Sterilization Process Automatically Controlled by Computer. Qualification Certificate of the employee.

14. Finished Product in Warehouse, Waiting for Delivery 15. Area to Maintain NCF Product from Client

2



21. Tracking Record of the EO Sterilization Process, Includes Daily Process Parameters, Result for the Lot

20110115.

17. Particle Counter in Cube Meter Air Sample

18. Equipment to Test the Mechanical Resistance of the Injector 19. Airborne Particle Counter

16. Particle Counter on Product Sample

20. Lab Testing Record for the Lot 20110115

2



24. Record of Incoming Inspection of Injector Lot 20100702. 25. Record of Incoming Inspection of Carton.

26. Record of In-process Inspection of the Injector After Molding 27. Sample of Product

22. Record of the Packaging of Lot 20110115 with the Carton # 23. Record of the Process Card for Lot 20110115

2



Photo Removed

28. ISO 13485, Internal Auditor 29. Examination After Training

Example Report - Pro QC...

Documents

Transcript of Example Report - Pro QC...