Lessons Garnered in the Quality Arena

Medical Device QA-RA Blog from the Experts

2011-11-04T20:52:00.000-07:00

An excellent blog from the experts on medical device regulations, Quality Assurance and related topics

http://medicaldevicesummit.com/Main/Blogs.aspx?taxonomy=DevineGuidance

It will take you a minute to create a Login Account- it is a minute well invested!!

Overview of Route to Regulatory Compliance to For Medical Device

2011-11-03T01:09:00.000-07:00

Hello!!

Writing after quite some time now!!!

I have been interacting with a friend whose organisation is developing a new medical device. A start up firm, they are keen on weaving in best practices right from start to ensure Regulatory Compliance. So I put together a small document to outline the route they could take in order to achieve that goal. I felt it was worth its while to share it here, considering that it keeps with the spirit of this blog- Quality Assurance for Novices (like me- smile)

Read on, it is pretty generic and does not cover ALL genres of medical devices (Category AP, APG, devices for Oxygen rich environments, Type A devices) but nevertheless a good start.
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Scope

This write-up is intended to give an overview of the logical steps to be followed during the Product Development Cycle of a Medical Device towards compliance to international Regulatory Requirements as dictated by the applicable Harmonized Standards for medical devices.

Target Reader Profile

The target reader is expected to have a minimum knowledge of the Product Development Life-cycle, some exposure to Risk Management in Medical Device Safety, an understanding of Risk Based Device Classification and the overall requirements to compliance.

Steps to Regulatory Compliance

1. Define the “Intended Use” and “Indications for use” of your device

a. The overall device concept
b. User profile, qualification etc.
c. Location of use
d. Max. Duration of use
e. Type of contact with patient
f. Method of powering the device
g. When NOT to use the device

Refer to Note A.2.4.2 and Annexe C of the ISO 14971 standard for more eye openers on this.

This should be a working document, under document control and will form an important part of your Technical Construction File

2. Based on “1” compile complete list of applicable Harmonised standards for medical devices available at

http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/

This compiled list will be under document control and will form an important part of your Technical Construction File

3. Conduct recursive Risk analysis exercises to identify Risks arising from
a. Functional aspects
b. Electrical
c. Mechanical
d. Biocompatibility
e. Usability
f. Ingress protection
g. Software Related Failures(if your device has some form of s/w)
h. Others

Your Risk managent Procedure, Risk Management Plan for a particular family of devices, the actual Risk Management file(identification, quantification, mitigation and requantification, residual risk handling) and a final Consolidated Risk Report for quick perusal will form your risk management file.

All these to be under document control and will form an important part of your Technical Construction File

4. Based on “1”, “2” and “3” and applying the guidelines of MDD document “classification 2_2_4-1part1_07-2001” and classification 2_2_4-1part2_07-2001 Classify your device.

Generate a clear flow-chart/ table showing which rules apply and why and the final Classification.

This classification along with the rationale for classification to be under document control and will form an important part of your Technical Construction File

5. Based on ANSI/AAMI/ISO 10993 guidelines and the characteristics identified in “1” identify the applicable Biocompatibility tests for the “Applied Part”.

a. This document showing identification of applicable Biocompatible tests along with the rationale to be under document control and will form an important part of your Technical Construction File

b. Providing cross Ref. to this document, your “Purchase” document for the applied part should identify that availability of MSDS certificate from the manufacturer of the raw material of the applied part is a REQUIREMENT for accepting the produced applied parts.

6. Classify the type of Applied Part as per IEC 60601-1 definition and classification.(Your NB may perform a test on a EUT to ascertain if your classification is justified)

7. Classify your device according to ISM standards.

"Emissions requirements
Devices shall comply with the relevant requirements of CISPR 11 that contains limits and methods of measurement of electromagnetic disturbance characteristics of industrial, scientific and medical (ISM) radio frequency equipment.

ISM equipment is classified into classes and groups:

Group 1: All ISM equipment in which there is internally generated and used, conductively coupled RF energy necessary for the internal functioning of the equipment.
Group 2: All ISM equipment in which RF energy is internally generated an/or used in the form of electromagnetic radiation for the treatment of material and spark erosion equipment
Class A: Equipment is suitable for use in other than domestic establishments and those connected to the domestic power supply
Class B: Equipment is suitable for use in domestic establishments."

This forms the basis for you to identify the applicable tests for Electrical Safety in compliance to IEC 60601-1-2.

8. Complete the following tables in IEC 60601-1-2 standard.

a. Table 1 – Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC EMISSIONS – for all ME EQUIPMENT and ME SYSTEMS (Fig. 1 for guidance)

b. Table 2 – Guidance and MANUFACTURER’S declaration –electromagnetic IMMUNITY –for all ME EQUIPMENT and ME SYSTEMS (Fig. 3 for Guidance)

c. Table 3 – Guidance and MANUFACTURER’S declaration –electromagnetic IMMUNITY –for LIFE-SUPPORTING ME EQUIPMENT and ME SYSTEMS (if applicable)

d. Table 4 – Guidance and MANUFACTURER’S declaration –electromagnetic IMMUNITY –for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING (if applicable)

Such a document with the completed tables will form the “Manufacturer’s Declaration” for the device. This will become

• a part of your final “Information to the User” documents
• The list against which your Testing Agency will perform the EMI/EMC tests.

Evidently, this will have to be under Document Control and becomes part of the Technical construction File via the IFU documents.

9. Similarly identify the applicable mechanical stability tests under IEC 60601-1 – Sec 9

10. Identify
a. The various labeling requirements per IEC 60601-1 Sec 7- specifically those required for safe installation, operation, maintenance, disposal(is any).
b. Identify the applicable symbols per EN 980 standard for medical device labeling.

Ideally there should be a working document showing what are the mandatory markings required for your device, where you intend to affix them, which EN 980 symbol(with Ref No. from the Std.) will be used etc.
This will be under Document control and will form a basis for
• Artwork for the labels
• Inclusion into the IFU to explain the various symbols found on the device to the end user.

And will be a part of your Technical Construction file

11. If your device incorporates some proprietary software, ensure that it is developed as per the ISO 62304 mandates in order to comply with IEC 60601-1-4 requirements.

a. Software Design Requirements Specification
b. Software Verification Plan
c. Software Verification Records
d. Software Validation Plan
e. Validation REcords

These will be under Document control and will be a part of your Technical Construction file

12. While designing the form factor and GUI adhere to the mandates of the IEC 60601-1-6 and maintain a working Usability File covering at a minimum the following.
a. Medical Purpose
b. Patient Population
c. Part of the body or type of tissue applied or interacted with
d. Intended Operator Profile
e. Physical Condition
f. Device Mobility
g. Primary Operating Functions (Critical, Frequently used, sparingly used)
h. Use Cases (what constitutes Pass and Failed use case)
i. Interface Requirements between user and device- GUI elements, alarms, annunciations, labels etc.
j. Safety information to be provided- symbols, labels, messages, warnings etc. On Device, in IFU etc. (ideally with ref. to the Risk management file where these needs have been identified), the symbol reference from the applicable standard etc.
k. Operator- User Interface Requirement Verification Checklist
l. Usability validation plan
m. Records of Usability Validation

These will be under Document control and will be a part of your Technical Construction file.

13. The requirements for Electrical safety, Mechanical safety and Biocompatibility identified under “5”, “6”, “7”, “8”, “9” should go into your DRS with some traceability from the DRS to those documents and if feasible- to the Risk File.

14. The Labeling and IFU requirements should be verified as fulfilled in a Review of the IFU and final Labeling of the device. An IFU validation Plan and associated records will ensure a good IFU quality

15. Clinical Evaluations/tests to prove the efficiency of the device should be performed as per ISO 14155 requirements. There should be
a. A Clinical Evaluation Plan
b. A roadmap of the Execution of such plan
c. Records of the evaluation
d. Final inferences drawn and conclusion of the Evaluations

16. It would be a good practice to populate the “Essential Requirements Checklist under MDD 93/42/EEC and do multiple reviews to ensure all requirements have been met.

17. MOST IMPORTANT- All documents to be under Document controls, dated, reviewed and cleared as Final and Acceptable for Release.

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This exercise would cover a good part of the REgulatory requirements for most regulatory approvals.

Remember this is only the ground work. Your actual design phase will incorporate the requirements you identified through this exercise. But you have the edge that you will not have to recursively repeat your design phase after finding that your design is non compliant as is the case when you do not identify the regulatory requirements early on. This reduces the time to market as also the astronomical costs associated with redegisning.

Do write in with your comments on whether at all you find this article useful. Good Day!!!

Translation of Medical Device Documentation

2010-08-06T01:28:00.000-07:00

Found this EXTREMELY USEFUL article on translation of medical device documentation on MDDIONLINE and wanted to share it on my blog..

http://www.mddionline.com/article/understanding-intricacies-medical-device-translation

Have YOU factored in translationexpenses into your bugdet yet?!!

Supplier QA- Why is it so difficult for startups??

2010-07-01T07:42:00.000-07:00

Having worked for start up organizations, I have observed a certain level of difficulty when it comes to complying with supplier Quality Assurance.

supplier QA typically should follow the following flow:

1. Come up with a complete specification of the product/service to be sourced
2. Scout for vendors/suppliers/sub contractors (V/S/SC)in the market who provide the specified product/service
3. If monopoly supplier/vendor, no questions asked- Go with it
4. Else: Evaluate the prospective V/S/SC against a list of requirements- some requirements may be generic, others may be specific to the product/service (For Example- being compliant to a particular standard)
5. If the V/S/SC passes the evaluation, add the V/S/SC to a master list of Approved Supplier/Vendor
6. Before finalising a purchase/contractual agreement etc. provide in black and white the Quality Requirements to be met by the V/S/SC (Provide a QA certificate for every consignment, provide COC for every batch and so on)and the consequence of quality lapses (return of goods, revoking the agreement and so on)
7. Schedule periodic re-evaluations and re-evaluations based on certain triggers (repeated quality problems- non conforming goods supplied, delay in shipment, wrong product sent etc. )
8. Always select V/S/SC from the approved supplier list

For a start up which does not have an experienced top level management which is particular about QA and has factored in supplier QA at some early stage of product develeopment planning the following is what normally happens:

As with all new products, the early stages of building proof of concept, prototyping and the first few production unit equivalents are built and tested before final production. The early stage product require the same (or near same) components, and these components are ordered in very few numbers at this stage.

At this stage only Step 1 of the above list is executed. The goal at this point is to obtain the components in very small quantities, at the most competitive price (we are talking start up). What happens is that the start up ends up assuring the V/S/SC of bulk purchase once production kicks in and thus try to get a good price.. For custom products, they may approach small time suppliers since their overhead would be the minimum and would drive the price down for the "few" units they need

In the meanwhile, nobody executed step 4/5 - nobody scouted for alternative sources or evaluated them.. So when the "Production units" stage is reached, the start up is stuck with the V/S/SC who provided the early stage supplies...

And at this stage the company is thinking QA/ ISO 9001 certification (at a minimum) to boost their market image (really- they weren't looking for process based functioning- I promise you!!!) and then the problem starts-

ISo 9001 wants you to select the supplier based on his ability to supply the goods your product requires, requires you to control the purchase product, requires you to monitor incoming goods, requires YOu to control the outsourced process.

Having given the supplier a free run in a state of " we cannot exist without you" it now becomes difficult to require the supplier to adhere to YOUR requirements-

1. You ask for material specifications- Supplier says My way or the Highway
2. You ask for QA Ok certificate- Supplier says- My product never failed in all these years how can you insult me!!!
3. You ask for equipment validation to be done - Supplier says Equipment "What???"

If the V/S/SC is a willing candidate to aid your QA effort although he it also start up- I should say you are blessed- this way the supplier gets better as you get better...

And this is the crux of the matter- Explaining to your supplier your QA requirements, explaining the role he plays in the larger scheme of your adherence to quality and his contribution. If you could achieve this, nothing like it..

But how many start ups have the time and means to have such a symbiotic relationship with the supplier???

Control Of Non- Conforming Product- An FDA Vs. MDD/13485 Perspective

2010-06-08T00:14:00.000-07:00

I found this very very useful link, which discusses "Control Of Non Conforming Product" in the light of FDA's QSR, MDD/ISO 13485- it brought in quite a bit of clarity to me.. Hope more novices find use in it!!

http://www.emdt.co.uk/article/complying-us-nonconforming-product-requirements

More on the Process Approach

2010-05-03T10:20:00.001-07:00

I just HAVE to thank Mr. Michael Hammer (Author of the book "The Agenda") on the immense amount of light he has thrown on the confusions surrounding the "Process Approach"

First off, a "Process Owner" is NOT someone who is supposed doing all the work related to a process... He is the one who "designs" a process. He draws up the process flowchart, determines the outcome of each and every step of the process, and generally creates the blueprint for a process..

Then comes the guy who has to "implement" the process that has been designed. He assigns the personnel responsible for each process step, and overall supervises whether the process is carried out as per the design..

One person may be responsible for "implementing" many processes.

Therefore, for example, if we take the process of say "Handling a customer Complaint"for an entertainment gadget, the process may say:

1. Customer service guy receives complaint from customer
2. If it is not in written form CS guy documents it and get a confirmation from customer
3. CS gets model number, year of purchase and other information
4. Technician visits customer, checks for origin of problem
5. Technician documents the findings and conveys them to customer
6. If customer wants to go ahead and repair, technician provides quote, Else he quotes the minimum trouble shooting charges, receives it, provides receipt to customer and leaves
7. If customer accepts quote, the repairs are done, gadget is operated and customer has to acknowledge that the issue has been resolved
8. Customer pays up, signs in the acknowledgement and get the receipt for payment
9. Technician leaves
10. In the back office, a data entry operator may update the information for that particular serial Number device with the details of the repairs for future reference
11. File closed for now.

In this example, the CS and technicians are NOT the process owners because they are executing the steps assigned to them.

The supervisor to whom the CS folks and technicians report is not the process owner because he is just checking if the process defined is being followed by the right folks at each process step.

So who is the process owner? The strategist who came up with the blueprint is. He thought out required outcome of the process, the need, the steps, the interaction of the steps, the metrics to check if a process is efficient enough and meeting its intended purpose and so on…

In most cases the process owner may not be a single mind- it would be a collection of minds including those that execute it, but ultimately the onus would lie with the one with executive authority to give the GO to the deployment of a process.

The process owner would be responsible to check if the process is performing as intended- the supervisor may collect data, analyse and present it to the owner, and again, the actual executors (for lack of correct word) who perform the steps provide the information for analysis.

Getting a grip on the science behind the process approach would make process based organisations a lot more comfortable with the idea and slowly wipe out the misconception that processes cause overheads.

Light on the Process Approach- Finally

2010-04-18T07:04:00.000-07:00

To begin with, I just realised what a flawed understanding i had had of "The Process Approach".

It was really one of those "aha" moments of my life...

Companies that adopt the process approach- one of the cardinal prnciples on which most Quality systems are based absolutely need to experience this Aha moment to make capital use of such an adoption.

A process approach is something completely different from the conventional "Department wise" approach, and it is a great mistake to adopt process "within departments" alone. Such an understanding not only does not add any value, because it is the same as having an organised department wise approach- but because it deludes top management that in spite of taking the process route nothing has changed and therefore it is a useless exercise.

Really a process approach should focus on the objective to be met and then consider all the input points- which would come in from various departments at the right time, in the right form and be managed so that the end objective is met.

For example- consider the process of creating a brochure for a product X.
Marketing may initiate the process and the following may be the steps:
1. Get the various technical specifications from the Tech. department
2. Get images of the product from Tech. department
3. Get the text written by a technical writer
4. Get the brochure laid out by someone in the Arts section
5. Document control assigns a control ID and number
6. Select the printer based on their approved vendor list
7. Purchase dept. may request for a quote and select the printer with the best quote
8. Place an order
9. Get initial proof printed
10. Marketing guys proof read for correctness of information and acceptability
11.Give the "GO" for final printing
12.Receiving goods section checks for correctness of ordered quantity, does a sampling Quality check
13. Accepts the brochure into stock
14. Stores updates records

The inputs came in from so many departments and each step can be deemed complete only if the responsible department completes it. All that one can say is that "Marketing DEpt." in this example owns the outcome of the "Brochure Creation" process.

It is now very clear to me that by adopting the process approach an organisation achieves the following:

1. Every department involved is accountable for the outcome of the process it is involved in
2. A well thought out process eliminates variation by ensuring that everything that should get done gets done
3. The approach fosters a sense of belonging and cohesiveness- departmental walls are broken down and flow of information happens unhindered
4. Everyone is a winner

PHEW!!! I know I will never be the mediocre QA person that I realise I have been (in retrospect) after this revelation!!!What a high I feel right now!!!!!

Unique Device Identification for Medical Devices- what is the business case?

2010-02-18T03:10:00.002-08:00

Current international regulatory requirements demand that medical devices be labeled with a minimum level of primary information (Product Name, Model No. Manufacturer Address) on the device and a certain level of secondary information (Expiry Date, Serial Number).

However, the concept of Unique Device Identification for medical devices has been under intensive consideration for quire sometime now, and the Global Harmonization task force has floated a document on this topic (UDI AHWG Draft Guidance for GHTF SC). The FDA has also discussed this topic in depth (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentifiers/ucm054169.htm)

Automatic Identification and Data Capture is not a new concept to the commercial world. We see bar codes on literally every product at every level of packaging- units, cartons containing multiple units, shipping containers etc. And then there is RFID, OCR for the more sophisticated businesses. These serve the purpose of coding in a lot of information which can be decoded using dedicated readers.

Implementing a Unique Device Identification would by no means be an inexpensive proposition.
A lot of time and effort need to be invested in selecting the method, in defining the coding, maintaining a database and making it really work when it is supposed to. Unless there is a strong business case and assured return on Investment (Tangible or intangible) UDI implementation would not be favored.

The two reasons that seem to favor UDI, based on my limited experience are:

The first and foremost compelling reason, to me seems to be that a well designed (complicated but well defined for decoding purposes)UDI system can overcome the distribution of duplicates in the market.
Tighter control over quality, more effective delivery through the supply chain

Finally it is the individual stakeholder that should decide on the need for UDI implementation. More and more clarity of UDI schemes and more visibility on the benefits will definitely drive more medical device manufacturers to embrace UDI as an integral part of their device labeling requirements.

Requirements to Set up a manufacturing Facility- As understood by a novice with empirical knowledge only

2009-12-29T00:53:00.000-08:00

Hello everybody

I am writing after a hiatus of almost 2 years!! Nevertheless, here I am, still alive and kicking!!!!

The stuff I am posting here is from a presentation I put together for a friend recently on his query regarding points to be considered in setting up a manufacturing utility for some electronic gadget. I know this is not exhaustive material by any measure, but it definitely gave me a chance to refresh my head on the issue at hand. So here goes.. Please feel free to append more information you may have.

Step 1 Company Induction

Form a company
Register the company under Company’s Act
Obtain CST, State ST, IT registrations

Step 2 License to Manufacture

Obtain the License for the company to manufacture from the appropriate ministry

Step 3 Product Study

National market/ International Market?
Projected demand
Are there existing manufacturing units?
If yes, what is the current combined manufacturing capacity of existing units?
What is the expected manufacturing capacity of the proposed manufacturing facility?

Step 4 Inputs Designer- Design Transfer Documentation

Costed Bill of Material- CBOM (Item tech. specification, )Vendor info for each item, cost based on lot size
Gerber file readable by commonly used s/w (PCB final design)
Autocad drawings of all mechanical parts with info of color, dimension, material used, commercial name of material etc.
Acceptance criteria for all items on CBOM, method of testing, AQL- including any test reports from vendors, approval certificates from vendors etc., quality plan
Manufacturing flowchart, detailed work instructions, test plans, testing procedures, test report outlines
Ideally a work time study of per unit production

Step 5-Identification

Identify the step by step operations to be performed in manufacturing per unit of the product
Identify machinery required for manufacturing operations along with any machine specific software required
Identify skill set/experience required for manufacturing operations
Empirical work time study and machine capacity to find out the optimum number of personnel per operation, no. of identical machinery required etc.

Step 6- Real Estate Requirements

Total land area requirement depends on the complete set of manufacturing operations to be performed and also support operations (Doesthis include warehousing?)
Consider size and number of machinery to be installed (minimum distance between subsequent operations to reduce delay due to material movement)
Consider proximity to raw material sourcing/ transport- closeness to port/rail yard etc.

Step 7-Hardware/ Software Requirements

Hardware includes computer terminals, machinery
Software includes basic computer software for administration and specialized software required for automated machinery ( Ex. Pick and Place machinery for PCB, software for reading Gerbers, Autocad file inputs etc.)

Step 8- Power/ Water Requirements

Work out total power required per full running shift of manufacturing facility and calculate Electricity requirements
Calculate water requirement and needs to arrange for auxiliary sources if need be
Very importantly set up ESD safety Earth connection points

Machinery Selection

Ensure that the total production capacity if the machinery is in agreement with the projected production requirement – Investing in a higher capacity machinery right away causes reduced machine efficiency and also unnecessary consumption of power
Ensure that machinery is a tested and proven model as against newer models

Work- Time Study

Required to ensure that there are no bottlenecks in the production assembly line
This is done by taking into consideration the time taken for each step in the production process
Steps that take more time to perform are done by having more personnel parallely make more units
Steps that take lesser time to perform are done by fewer personnel

QA/QC Operations

Ensure vendors are established in their products and can supply Quality checked OK reports, safety certificates etc.
Ensure that Inventory Receiving facility is supplied with correct Quality criteria to check incoming inventory and accept them based on AQL
Ensure that minimum Quality check points are established in the production assembly line

Establish a Process based System

Documentation Control and Records control
Inventory Control
Human Resource management and Training
Purchase control
Equipment maintenance
Product Identification and traceability
Handling, storage, Packaging, Storage and Delivery
Control of Limited Shelf Life Parts
Control of Monitoring and Measuring Equipment
Monitoring and Measurement of Products
Control of Non-conforming Products
Corrective and Preventive Actions

Document Control

Identification means to differentiate for Internal and External Documents
Master List of documents
Distribution control of documents
Change control of documents
Control of obsolete documents
Authority for all of above processes

Control of Records

Identification of required Records
Templates for records (If repetitive process outcomes are recorded) and their distribution control
Training for creating and maintaining records
Authorisation of records
Identification, Storage and Retrieval of records
Destruction of obsolete records

Equipment Maintenance

Identification for all equipment including

Internal Equipment ID (If any)
Manufacturer
Purchase proof No. (if any)
Model No.

Whether any calibration/periodic servicing Required
Whether calibration/service is internal/External
Date of Last Service
Details of Calibration/service done with a certificate and Report to be maintained
If equipment is under repair, means of quarantining and identification needed
If equipment is portable, suitable means for transporting to be followed to ensure that intended use of the equipment is not affected
Calibration activities to be carried out in prompt manner and traceable to national or international standards
If equipment is under repair, means of quarantining and identification needed
If equipment is portable, suitable means for transporting to be followed to ensure that intended use of the equipment is not affected

Identification and Traceability

Method of identifying parts, sub-assemblies and assemblies to be established
Identification must be maintained right from purchasing, storage, release to production, assembly, testing, release to warehousing and in all records generated in the interim
Training to personnel for understanding and using such identification should be provided and evaluated

Handling, Packaging, Storage and Delivery

Methods for handling parts, assemblies, sub assemblies, packaged goods, measuring equipment etc. to be established
Provisions like trolleys, gravity-based conveyance of products to be made for movement of goods and materials
Storage conditions for raw materials of different types to be determined and arranged for
Packaging standards should be adhered to
All specifications for packaging materials including drawings, master samples and material specifications to be maintained by the Engg. Department
Any final Quality check operations before delivery including AQL should be defined and adhered to- Records to be maintained

Control of Limited Shelf life Parts

Identify shelf life of all purchased raw materials
Record shelf life alongside during storage
Storage conditions to be maintained as per manufacturer recommendation
Stores should release parts on a FIFO (First In-First Out) basis
Clear Directions on disposal of Products with expired shelf life to be documented and adhered to

Control of Monitoring and Measuring Equipment

Identification including

Internal Equipment ID (If any)
Manufacturer
Purchase proof No. (if any)
Model No.

Whether any calibration/periodic servicing Required
Whether calibration/service is internal/External
Date of Last Service
Master list of such equipment to be maintained
Details of Calibration/service done with a certificate and Report to be maintained

Monitoring and Measurement of Products

Identify stages at which product should be tested (sub assembly/ sub assembly/ final etc.)
Method of testing to be established and documented
Acceptance Criteria and Acceptable and unacceptable results of testing to be demarcated and testing personnel trained to identify the same
Acceptable Quality level in case of lot testing should be determined

Control of Non-conforming Products

Products (sub assemblies/ assemblies/ final products) Tested OK and Not OK should be clearly identified and segregated
Non- conforming product handling should be clearly defined and documented and adequate training provided (Accept with concession/ Repair/ Rework/ Scrap)
Non- conforming product handling should be adhered to and proper records of any repair/rework maintained to avoid inadvertent supply of faulty product to customer

Corrective and Preventive Actions

Product corrective actions and system corrective actions to be identified clearly
Product fault conditions/method of identifying the existance of fault and the corrective action to be taken should be clearly document and personnel should be trained
All corrected products should be thoroughly retested and certified OK by authorised signatory and corrective action records maintained
System corrective actions to be implemented by authorised personnel
Performance of system to be checked after corrective action and adequate updates to procedures and work instructions made and distributed accordingly
Preventive Actions to be implemented by authorised personnel
Documentation of the preventive action, expected outcome and any contra-indications expected
Preventive action to be implemented on full scale only after a successful trial run
Adequate records to be maintained

Human Resource Management and Training and Evaluation

Identification of personnel required- skill set, experience, No.
Method of personnel evaluation- written testing, interpersonal interviews, hands-on testing
Evaluators- thrid party consultants/ SME/s?
Maintenance of hired personnel records
Maintenance of skill matrix for constant updating
Regular evaluation of personnel (Evaluation indices to be identified and documented)
Regular training areas to be identified and training provided, documented and personnel evaluated for level of benefit derived from training
Modes of training ro be identified( class room/field trip/ hands-on?)

Example: In case of manual assembly operations, an adept should train the semi-skilled work force in their respective operations, and evaluate them after a brief practice period and certify them fit for production assembly

Periodic evaluation is necessary
Similarly, in case of new machinery being deployed, personnel should be trained by representative of machinery manufacturer and then certified fit for operating the machinery

Workshop on Bar-code Implementation

2008-07-11T07:30:00.000-07:00

Yesterday, I attended a workshop on Bar code implementation which was conducted by GS1 India.

Today, if you are an observant shopper, you will notice that every single product you buy comes with a bar code- be it a book, your tooth paste, pickle bottle, medicine- anything- bar code is the universal language through which a number of details are presented. It is this bar code that makes it easy for the person at the check-out counter at the shopping mall get the bill across to you real quick.

Although I am already aware of the EAN-13 standard for bar coding and am experienced in allottingbar codes to items in my organisation, this workshop was an eye opener.

For example, I did not know there was an EAN-8 system- neither did i know that the logic behind EAN-8 and EAN-13 is totally unrelated...

And then there is the GTIN-13 for retail units of a saleableproduct, the GTIN-14 for cartons of packed wholesale items and the EAN-128 for logistics packaging!!! whew!!!

The best part of the workshop was a 20 minute long presentation of a study conducted by AC Neilson's at South Africa, on the mistakes made in bar coding..It is fantastic really.. The color of the bars and the background, the white space around the bar code required to ensure bar code readers red the code righ the first time, every time, the position in which the artwork should be placed on a product, the heigh to width ratio and the results of truncating either of these dimensionsand a host of other factors to be considered to avoidbar coding mistakes-for a newbee to bar coding, these were lessons that woulkd hold me in great steed!

I know this is a little bit of a digression from the purpose of this blog.. But a little bit ofadditional knowledgewill always help yopu see.

Google for GS1 and download the presentation therein and look through the same.. You will be wiser on bar coding!!!

The Cost Of Quality

2008-06-01T08:22:00.000-07:00

We all know that any company is created with the foremost objective of generating income. Many of us would also know that "Income " is the difference between the Revenue to the company and the expenses incurred by the company for creating a product or service.

In order to create a product, a company has to incur many expenses- Quality is one of them, if proper care is not taken to invest in quality. Sounds enigmatic, does it not??

Well, lets take a simple example of baking a cake. The preparatory steps would be to buy the flour, butter, eggs, sugar, flavoring etc., read the instructions for baking carefully, mix the ingredients in the right proportion, set the oven at the right temperature, put the baking dish into the oven and monitor the baking till the cake is done as it should be done.

Scenario A: You went to the shop and picked up ingredients at random, without checking for the quantity needed for the recipe, and without checking the "Best Before" date on the labels, you mixed the ingredients without heeding the steps in the recipe, set the oven ad hoc, and did not bother to monitor the baking- End REsult at hand- Either unbaked or completely burnt mass of flour which can be called "Cake" only out of politeness- Now you have to redo the entire exercise if you absolutely have to deliver the cake -- buy correct quantity of the right ingredients, mix properly, bake properly and monitor the baking to ensure you get the right cake- What did this exercise cost you?? Loss of time, loss of money and loss of your temper.

Scenario B: You read the cake recipe thoroughly, buy the correct ingredients, mix, check for consistency, set the oven, bake the dish as instructed, and you get a wonderful cake that you can be proud of.

In scenario A, your initial output- the "Bad" cake, came out pretty fast, since you did not bother to spend your time and energy to plan and do it right.. As a consequence, you lost double the amount of time and money. You probably tried saving a part of the burnt cake that looked"OK" or tried to recook parts of the unbaked cake. All this rework on the cake and checking which part is OK and which is not took a good deal of time and your patience.The additional time and money were tangible components of the "COST OF QUALITY" of your "Second time right" Cake. The patience yout lost and the tension were the intangible components

In Scenario B, you spent a certain amount of time initially understanding what you need for the cake and planned the purchases and did the mixing and baking right. As a result, you gained the following- the next time you need to bake the cake, you are armed with the knowledge of baking the cake right, you know where to look for the correct ingredients at the right price and you will not have to go through any "Salvation operation" to save parts of a baking debacle. Although you spent some appreciable amount of time in understanding the requirements for the cake and the right procedure to bake it, and to tell if the cake has come out as it should, it is an investment for life and not an "Expense".

The situation is no different in a company that may manufacture millions of units of product A or B. If adequate measures are not taken to draw out the requirements of the product- features and functionalities, if the complete procedure of making the product is not charted out early on, if the materials required to make the products are not bought from a vendor of repute, if the manufacturing process is not set to produce product units without defects, if periodic maintenance activities are not defined and undertaken to keep machinery in top shape to produce a high first pass number- ( all of which pertain to Quality Assurance- Remember??), the result would be that every unit of product produced will have to be inspected, to check for form, fitness and function. The costs are high in this case- the company needs more inspection personnel, there is no assurance on what coule be acceptable number of units in any given period of time. REpair, Rework and scrap of rejected goods (All Quality Control Activities) again are costly to the company in terms of the time wasted and in terms of productivity- In short, all these are unproductive activities.Add to that one more- the risk of a Non- conforming unit of product reaching a customer, and thereeby setting the stage for a loss of reputation of the company!!!

Quality is a costly thing..it has to be got right first time on. If a company has carried out it Quality Assurance activities right, which is a one time investment in terms of time and money, possibly a high one , the Cost of their Quality will be considerably reduced, by means of reductions in redoing a same activity many times due to failure to do it right the first time, in terms of reduction in the inspection levels, in terms of reduction of repair, rework and scrap, and above all the RISK of losing a standing reputation in the market. A shrewd company will see that a one time high investment always brings rich dividends by reducing recurring expenses which are many times greater in magnitude and detrimental effect. And as any finance Geek will tell you, a reduction in COST always translates to an INCREASE in income!!!

It pays to be Quality Conscious!!!

The difference between Quality Assurance and Quality control

2008-05-30T02:17:00.000-07:00

One of the very first doubts that tormented me from the day I was made part of the "Quality" team in my company is- what is the difference between Quality Assurance and Quality control???? And it has taken me a little less than 3 years to really understand the difference!!! I want to present the essence of this understanding to you, dear reader, so you have a good understanding early on.

Generally, any organization is set up to provide either products or services to its customers. For my explanation, i am going to choose as an example, ABC Inc., an organization that makes a simple thing as a ball point pen.

In order to make the body of the pen, ABC inc. has to procure the plastic for making the body of the pen, machinery to mould the body of the pen and so on.

Before ABC Inc. buys the plastic, they should (ideally) have researched on which plastic will best suit the features of the pen, and then look at who are the raw material manufacturers in the market who can provide this particular plastic. Then, after listing out potential raw material vendors, ABC Inc. would see, shich of them has a reputation of standing, which of them have established processes to supply the correct plastic everytime, on time and at the most competitive price and a host of other considerations. Once such a thorough evaluation is done, ABC Inc. decides to go for Trans- Plastics as their vendor. Similar exercise follows for all items obtained from other vendors. AS for machinery, they would list out the specifications of the machinery that can make the exact pen they have designed, look for machinery manufacturers, evaluate the manufacturer and machinery cost etc. and then zero down on a particular machine.

Then ABC Inc. would run a trial production run to see if the machinery and plastic together product the pen that will meet all the quality requirements listed out during the design of the pen. Once all concerned authorities accept that the pen prototype meets all requirements, a GO will be given for mass production.

All these activities- namely, systematic listing of specifications of the plastic and machinery, scouting for the right supplier and accepting a supplier after objective evaluation, and the prototype production to validate the production process- all happen before the actual marketable pens are made. All these are done to ensure that the pens can be produced to be acceptable for sale. These activities can all be termed as Quality Assurance Activities.

Now, everything is set up and ABC Inc. begins production run. they produce 10 batches of the pen- each batch containing 500 pens. AS soon as the plastic body is created by the machinery, a mechanism is put in place to check if the plastic body is in perfect shape- no deformations, no discolorations, threading on the bottom edge of the plastic is proper etc. (this list of things to be checked are all pre-listed). Suppose a specimen is found with some feature that makes it unusable, the specimen is termed as "Non-conforming" and is separated from the acceptable specimens. This exercise is repeated for the pen cap, the refill, the Ball point tip and so on.
Only those pen parts that meet all the specified list of criteria for acceptance will be put together into a complete pen, which again will be checked for acceptance-( is the ink flow just right?, for example).

These activities, during and after the actual making of the product can be collectively called as Quality Control Activities.

Activities such as the maintenance of the machinery also fall under Quality Assurance, because, this activity ensures that the machine is in proper health to produce the acceptable product.

In short,

Activities that precede the actual making of the tangible product, which activities are undertaken so that all of man and machinery required for the making of the product are of the best quality, to ensure that the end product is one of acceptable quality are all QA.

Activities that follow the making of the actual tangible product, to check that all criteria for the acceptability of the product are met, and to undertake a next course of action in case of unacceptable product fall under QC.

A peek at what you can expect to read here

2008-05-04T11:01:00.000-07:00

Hello everyone,

I am Priya Darshini, and am a Quality Assurance/Control Engineer working for an organisation that is into Design and DEvelopment of Medical Devices. You may know that "Quality" is perceived as very vital in two industries in particular, specifically from the point of view of safety to the user- The automobile industry and the medical device industry.

I have "learnt" the strings of Quality Assurance/Control from the grassroot level, and want to share the lessons I have learnt. This blogspot is not for the expert QA personnel to read and sneer at me for "writing such absolutely commonsense stuff".This is for the clueless first time novice QA person to read my experiences, the way I understood the nuances of this stream and the way implement quality practices in his/her organisation.

I hope you are able to relate to my posts and derive guidance and reassurance therefrom!! Keepcoming back for new posts!!