Clause 8 of ISO 9001:2008

Clause 8 of ISO 9001 covers customer satisfaction surveys, internal audits, non conforming product, analysis of data, continual improvements and corrective and preventive actions. We will only discuss a few of the areas which are otherwise difficult to handle in a company.

In ISO, internal audit tracking is quite difficult to manage as observations, non conformances have to be sent from the auditors to auditees and this involves a lot of back and forth emails. Using Touchbase, one can make the audit plan, set the auditor and auditee names in the product workflow and all documents will flow in the system through the workflow. At the end of the audit, one can compile the results in the form of a dashboard with clause wise summary and this can be presented to the management in the Management Review Meeting.

A similar dashboard can be prepared after completion of customer satisfaction survey and choosing of parameters to present  is quite easy. Data analysis is also easy using the dashboard feature of the product.

Handling of non conformities is done physically in the engineering industry by isolating the non conforming products but Touchbase has a defect tracking module to handle non conformities in a software development environment.

Corrective and Preventive action (CAPA) feature can be easily handled using the workflow feature of Touchbase.  CAPA can be collated from all the sources, tracked and presented in a dashboard and this will lead to continual improvements, if required.

Clause 7 of ISO 9001:2008

Clause 7 of the ISO 9001 standard is an important clause as it covers contract review, design and development activity, installation, commissioning, calibration  and release of product. Purchase activity and managing of non conformities is also also part of this clause.

Touchbase product manages the design clause very well. Design is an activity where many companies have non compliance issues as they cannot manage to keep all the design documentation due to paucity of time and non availibility of client / internal approvals. Touchbase allows companies to populate all the design documentation when the project is initiated and mandate some documents to be filled as part of the workflow. Design cannot proceed to the next step until the mandatory documents are filled in. This helps in meeting compliance requirements at the time of the audits and also ensuring delivery of a quality product. The project schedules can be filled in like MS project and monitored/ tracked with the timesheet feature of the product. All the design documentation is well managed as part of the documentation management system of Touchbase. Project Management module of the product is very robust.

In addition, there is a purchase module to take care of the end to end purchase activity , store inventory management and supplier management. Calibration has not been covered as there is a separate write up on calibration.

Clause 6 of ISO 9001:2008

Clause 6 of ISO 9001:2008 deals with managing resources which includes people and infrastructure. People issues are covered under clause 6.2 of the standard and Touchbase has a separate module for managing skill and competency matrix which has been covered in a separate knowledge series published by us. The net outcome of managing training needs is also managed through workflows and the DMS of Touchbase.

Clause 6.3 and 6.4 deal with managing infrastructure and this is well handled by the maintenance module of the product. The preventive maintenance schedule, equipment history and tracking maintenance are all handled as part of the maintenance module of Touchbase.

Clause 5 of ISO 9001:2008

Clause 5 of the standard deals with the formulating of a quality policy, objectives and conducting of management reviews. Where Touchbase product can be useful is for tracking of objectives using the dashboard feature of the product and also tracking of the management review meeting through workflows.

Creation of a dashboard in Touchbase is easy and one can change parameters for viewing very easily. This will help in tracking of the company objectives and presenting different views for the management. Management review meetings agenda can be set, meeting invites sent through workflows and minutes captured as part of the product include tracking of action items. This makes it easy to keep all the information in one location instead of having hard copies and creating different soft copy files.

Clause 4 of ISO 9001:2008

Continuing with the series of blogs on the TouchBase product and ISO 9001 standard, this blog will focus on clause 4 of the standard. The important sections of this clause are  the writing of a quality manual and supporting procedures, controlling those documents and records generated while filling in the formats.

Statistics show that the maximum number of non conformances in implementation of ISO 9001 is attributable to document control. The reason is that companies keep documents in hard and soft copies and one can find company personnel using obsolete copies of documents which result in non conformances when audits are carried out. What is useful is to have a document management system with appropriate access rights defined so that all the documentation- quality manual, procedures and formats are controlled. Companies have matured over the years after implementing ISO 9001 and many of them use a version control software to manage their documents.

TouchBase has a document management system module (DMS) which takes care of the version control aspect of storing documents. However, the benefit of using DMS is that one can define workflows for document creation and the approval cycles so that one does not have to search in emails to find approvals to new documents. During audits, one does find people searching for their document approvals and that also leads to non conformances. In DMS, one can define the document creator and approver as per the document control procedure and all approval records are stored as part of the DMS.

Companies who have implemented ISO 9001 should try the DMS module of TouchBase and life will be much easier for the Management Representative.

Series of blogs

We have written a blog on ISO 9001 and Touchbase product. This is going to be followed by a series of blogs on the TouchBase product and it’s link with different clauses of the standard. After that we will look at some of the verticals like Pharmaceutical, EPC, Engineering services and how TouchBase meets the specific requirements of these verticals beyond ISO 9001. So keep a lookout for our series of blogs. Happy reading.

Calibration requirements for companies

Control of monitoring and measuring equipment (calibration) is a requirement of clause 7.6 of ISO 9001:2008. The calibration is relevant where the equipment is used to measure the quality of the product from receipt to final inspection. While most companies have implemented this clause of the standard for meeting their own calibration requirements, there are some companies who have their own labs and offer calibration as a service. TouchBase product of ProductDossier has a module which caters to the requirements of both types of requirements given above.

Requirements of the ISO 9001:2008 standard

 Calibration is to be done at specified intervals
 Measurement standards to be traceable to National or International measurements standards
 The equipment should have adequate identification to determine its calibration status
 It should be safeguarded from adjustments and protected from damage

Key features of the Touchbase module

 Equipment master which gives all details of the equipment
 History card for each equipment
 Calibration frequency based on criticality of operations
 Calibration schedule and reminders
 Compliance for traceability to National or International standards
 Generation of reports after calibration (for companies offering calibration services)
 Verifying and storage of received reports
 Dashboards for showing calibration status

Companies having ISO certification should see a demo of the TouchBase calibration plug in module.

ISO 9001 and TouchBase product

ISO 9001 is a Quality Management System adopted across the globe by organizations of different sizes and across all verticals. Implementation of a standard like ISO 9001 gives companies the confidence that they can deliver to their clients consistently and thereby improve their competitive edge in the market. However, implementation of this standard requires a fair amount of documentation to support the certification by an external agency and also to give the confidence that a company can produce the desired output consistently. While smaller organizations keep their documentation and records in the form of hard copies, the mid tier and large organizations have resorted to some form of automation to keep track of their documents, records and manage their workflows. However, they still have some lacunae in the implementation which can make tracking of the Quality Management System quite difficult.

ProductDossier’s TouchBase makes it easy for companies to manage there ISO implementation. For different clauses of the standard, there are plug in modules like calibration, bug and issue tracking, skill matrix, risk management. The document management system of TouchBase takes care of version control and history of documents. Workflows are easy to set up and project life cycle, internal audit process can be managed through the product workflows without having documents moving back and forth through emails. Dashboards can be created with ease and that takes care of management oversight.

A white paper has been made which shows screen shots of the ISO process. ISO companies who have difficulty in managing their implementation should look at the product demo.

Integrated Project, Process & Product Lifecycle Management

As marketeers at ProductDossier we always try & make thing simple & logical. Today our concept of 3PLM (Project, Process & Product Lifecycle Management) is quite well accepted & appreciated. And why not? It makes perfect sense. At the heart of everything is Product. You may build your own product or provide a component or service to help your customer build the final product. So in either of the case, you will initiate a concept of project or program. Now during the execution of the project there will be multiple processes which will come into action to make the execution successful. So today all of us really need an integrated IT solution for Project, Process & Product. In the end its the product data which is required until its  obsolescence & Project/Process data may need to be kept more for compliance & regulatory purpose. Customers when asking for Project Management really need everything shown in the picture. It’s just that sometimes they are not able to articulate their needs so clearly but this is what creates opportunities for us to innovate in communication. Cheers!

Integrated Solution for Project, Process & Product Lifecycle Management

Need simpler way of Innovation, look beyond your industry!

One hour ago, as i was stepping out of my car in the parking lot, i saw a bunch of kids playing with color & water. This further told me that ‘Holi’ (a festival in India played by putting color & water on each other and with lots to drink & eat)  has arrived. I was almost tempted to join them & for a moment my childhood memories came alive. However as i look further,  i realize each one of them were carrying water pumps (read Pichkari). The pump was not new to me but i also saw that each one of them were carrying a water tank on their back and there was a constant water supply from this tank to the pump. The first reaction was “Wow”. Until now i only saw pumps which could carry from 200 ml to 2 l of water at a time. The water would finish in a jiffy and kids would again run towards nearby kept bucket and would fill the pump again. During this time, the target person would run away. But now with the constant supply of water from the back laid tank was several magnitudes of improvement and it looked neat on kids back. Obviously we all have seen this in pest control industry where the pest control person would fill the insect or pest replellant chemical in the tank, put it on his back and would spray it out across the street or farm or wherever else it is required. The 20 year old technique in one industry (read pest control)  is now a new innovation in another industry (Kids Toys). No rocket science, no Einsteins required to do this. All we need is to keep our eyes open and see how we can learn from one industry and apply some of those ideas in another industry. I know for sure that it Works.

Now coming back to my desk, i am able to easily associate with this kind of innovation culture at ProductDossier. We at ProductDossier are constantly doing this. Thanks to our product “TouchBase, an integrated software platform for Project, Process & Product Lifecycle Management”  which is used across industries right from Engineering Services, Automotive (OEM & Suppliers), Defence, Consumer Electronics, Pharmaceutical, EPC, Software & Technology, & so on. We have been constantly learning from one industry & applying that to another industry. Our customer may not exactly call this innovation but they see this as USP (unique selling proposition). To cite an example, we deployed in a pharmaceutical packaging industry, the concept of checklist for compliance purposes. Having learned and implemented this, while we were designing a solution for APQP for tier I supplier, we successfully deployed the checklist solution. In the case of APQP, each project has a certain checklist for each of the APQP phases. Each one of the checklist could be document (read TS or APQP documentation). Now it was easy for the APQP manager to see which checklists are done and which are pending. I won’t go into details of this but there are several such innovations are embedded in our solution. We are convinced that you need to look around & pick simple & powerful ideas to bring out innovations. You just need a lot of common sense and logical approach. However in reality when i go & sell the solution to the customer, he is only interested in other customers in his own industry and perhaps in his kind of business. Well,  I do give him references which satisfies him (thanks to the fact that we have customers in most domain) and i am tempted to tell him and customers in other industry also brings a lot of benefits to him.

Anyways, i am done for the innovation part for today.  I would have bought that neat looking  water pump ‘Pichkari’ for my daughter but she is just too young for that, perhaps i will call my sister and ask her to buy them for her kids who have the perfect age for such innovation. Long live the spirit of innovation!