When to implement the Development and Design Clause 7.3?

[JuhoS]

Dear all,

So far I have not been able to fully comprehend the scope of 7.3. Thanks to help of The Cove, I do have an understanding of the individual clauses but my problem pertains to when is it necessary to follow this process (from an audit perspective).

I have formulated this into a question specific to my organization. We are a non-profit based in New-Delhi, India, with a staff of approximately 50 people, working on a community based model of financial inclusion across South Asia. The implementation of this process consists of an extensive baseline study and a dozen or so different trainings and workshops (the product) and lasts approximately one year. We implement through a local partner who is our contact with the communities (customers) we work with.

1. Would the Development and Design clause be relevant to planning the entire 1-year process – our flow of interventions describing our interactions with the end-users (essentially the dozen or so 2-4 day training events and workshops);
2. Or would the Development and Design clause be relevant to the individual interactions (training events and workshops) which will be customized for each of the communities we work with based on the level of their understanding of relation with health and risk management, language requirements etc.;
3. Or should we use (and collect records) on two separate processes: Design and Development of the the entire 1-year process, and the Design and Development of the individual interactions (Training events and Workshops)?

Does the question(s) make any sense? What I am trying to say is that we constantly redevelop and redesign our model, practically on a daily basis. It seems daunting if all this needs to be recorded. At the end of the day if that's the case, 70 percent of our time would be spent on documentation.. Where do we draw the line?

Looking forward for any replies that would clear this up for me.


Thanks!

 

[somashekar]

Dear all,

So far I have not been able to fully comprehend the scope of 7.3. Thanks to help of The Cove, I do have an understanding of the individual clauses but my problem pertains to when is it necessary to follow this process (from an audit perspective).

I have formulated this into a question specific to my organization. We are a non-profit based in New-Delhi, India, with a staff of approximately 50 people, working on a community based model of financial inclusion across South Asia. The implementation of this process consists of an extensive baseline study and a dozen or so different trainings and workshops (the product) and lasts approximately one year. We implement through a local partner who is our contact with the communities (customers) we work with.

1. Would the Development and Design clause be relevant to planning the entire 1-year process – our flow of interventions describing our interactions with the end-users (essentially the dozen or so 2-4 day training events and workshops);
2. Or would the Development and Design clause be relevant to the individual interactions (training events and workshops) which will be customized for each of the communities we work with based on the level of their understanding of relation with health and risk management, language requirements etc.;
3. Or should we use (and collect records) on two separate processes: Design and Development of the the entire 1-year process, and the Design and Development of the individual interactions (Training events and Workshops)?

Does the question(s) make any sense? What I am trying to say is that we constantly redevelop and redesign our model, practically on a daily basis. It seems daunting if all this needs to be recorded. At the end of the day if that's the case, 70 percent of our time would be spent on documentation.. Where do we draw the line?

Looking forward for any replies that would clear this up for me.


Thanks!

Hi Juho.
Your question makes perfect sense. I will go with your question 2.
The extensive baseline study and a dozen or so different trainings and workshops (the product) is what you design and develop.
As you constantly redevelop and redesign your model, practically on a daily basis, these are design development changes and you are free to do them to the best of your requirements and as many times depending upon what new inputs you get, and what outputs you have to deliver to meet input requirement.
Just mark the revision change so that you know which exactly you will use where. Read the 7.3.7. It is simple even though you mention that you practically make several changes. This is the clause to address changes to already designed products.
You must put 70% or more time in the design changes thoughts and and have answers to 'why change'.
The documentation part of design and development changes control will be minimum and would hardly take 5 to 10 % of the time as I can visualize ....

 

[DrM2u]

I am a little confused but I'll try to take a stab at it. First I have to ask who is your customer? Is it the entire South Asia, specific countries or specific communities?

My second question is what is the 'product' that you are offering to your 'customer'? From here the path follows clause 7.3, as it applies to each 'product'. Sometimes a product can meet the needs of an entire region, other times you need to 'customize' or design the product for a specific community. Often times you'll find yourself taking one 'product' and modifying it as necessary, instead of designing a whole new product.

Now, here's my stab at it. From your post I conclude that you are looking at providing some sort of training to the communities. In order to achieve your ultimate objective (transfer the whole knowledge that brings about a change in behavior) you probably will have some enabling objectives. This means that instead of having one large training session you'll have smaller sessions that impart the pre'requisite knowledge for other classes. These being said you would have to have a plan/design for achieving the large objective as well as plans for each enabling objective. In conclusion I would have to say that the 3rd option is the proper approach if you choose to separate the design for the 'interventions' from the overall design, else the first option would apply.

For more information I would suggest reading more about Instructional Systems Design, in particular about project management as it relates to ISD.

 

[JuhoS]

Yes, your analysis of our product is correct. We mostly implement in the Indian subcontinent. Currently we have 7 implementation projects in various locations.

The product is the knowledge transfer, based on which the community (if they so choose) will set up a specific model of health insurance cooperative, eventually becoming their own health insurance provider. Now, this is the ultimate end-result, but as the cooperative is organized and registered by the community itself, I see that this per se is not the product we offer, and I have limited the definition of the product to the knowledge transfer activities.

All of the implementation projects are based on our “master model” but are customized to the specific community (the customer). The customization takes place at two levels.

First, at the level where we plan the ground-structure of the entire scheme with the partnering organization (representing the community). This means altering our master model to suit the context of the specific community, this is the road-map of the year long process. This might include leaving out some of the trainings or adding new trainings; changing the administrative structure of the scheme etc.

The second level pertains to the actual trainings. These need to be modified for each community – mostly for linguistic reasons. At minimum, what is required is the translation and back-translation of the training materials – usually in the form of PowerPoint presentations and an interactive game like tool – from the master versions (English) to vernacular language (Hindi, Kannada, Nepali etc.).

In conclusion I would have to say that the 3rd option is the proper approach if you choose to separate the design for the 'interventions' from the overall design, else the first option would apply.

This is precisely what I am struggling with. Can I choose to make this call, and only document the changes made to the road-map at the beginning of the project, and leave out the intervention specific design and development aspect? The reason I would like to do this, is that the interventions specific changes based on the master model are done on a daily basis by approximately by more than half of the staff. Documenting this would be a nightmare..

And I have no idea where to draw the line in the documentation. What constitutes a design and development activity that would need to be documented? A minor change in a PowerPoint slide? I guess so if this alters the product, which it would practically every time..

 

[somashekar]

The second level pertains to the actual trainings. These need to be modified for each community – mostly for linguistic reasons. At minimum, what is required is the translation and back-translation of the training materials – usually in the form of PowerPoint presentations and an interactive game like tool – from the master versions (English) to vernacular language (Hindi, Kannada, Nepali etc.).

If it is need based translation and delivery, then it can be best covered under the 6.2 and 7.5.1. If you are tailoring it, then competent persons who have authority to do so can and update the changes to the design change control.
Its like designing several boxes of various shapes and sizes and giving the authority to delivery people to color it the way it best suits.

 

[JuhoS]

If you are tailoring it, then competent persons who have authority to do so can and update the changes to the design change control.

Somashekar, thanks for the concrete example. So if I read you correctly, the changes to the training specific PPP slides would need to be documented to a change log of some sorts in any case?

Would it not be enough to have a defined person who has the authority to release the product, in this case review the slides, sign them off? Is it necessary for the Training Specialist to keep track of every change in a change log of some sorts?

The way the process is currently conducted:

A training is approaching in two weeks time (in a Nepal, so the material needs to me translated into Nepali).

1. Deputy Director of Training assigns Training Specialist X (Nepali speaker) to revise the training material for the training (at this training, the material would only consist of a set of PP presentations).
2. Some changes to the slides are made by Training Specialist X (e.g. if the ground-structure of the community in Nepal is different to that described in the Master PP presentation).
3. Training Specialist X sends the slides for translation to an external translation agency.
4. After the slides have been translated, Training Specialist X checks them for linguistic and contextual accuracy.
5. A mock training is conducted in the office (with other Training Specialist and Project Manager).
6. Any relevant changes suggested by Training Specialists and Project Manager are incorporated to the slides.
7. Deputy Director of Training reviews the final slides, and if need be, request changes. If happy with the slides, signs-off and saves the presentation to a specific folder as a reads-only version according to the Document Control procedure.
8. Training Specialist conducts the training in the field.
9. Feedback on the training is gathered and analysed.

It is still unclear to me what records and to which level of detail should we be gathering during this process?

 

[JaneB]

Would it not be enough to have a defined person who has the authority to release the product, in this case review the slides, sign them off?

Yes, in the sense that someone with authority signs off on the 'final' output.

Is it necessary for the Training Specialist to keep track of every change in a change log of some sorts?

No, I don't believe so, based on what you say. BUT you'd want to be able to demonstrate that a review took place. This WOULD be required when changes were to approved drawings, constructions, CAD designs etc, but not to training material in this kind of context. You're actually iteratively developing the material as you go.

You've got a very good description here of your process.

The way the process is currently conducted:

A training is approaching in two weeks time (in a Nepal, so the material needs to me translated into Nepali).

Deputy Director of Training assigns Training Specialist X (Nepali speaker) to revise the training material for the training (at this training, the material would only consist of a set of PP presentations).

OK - but where did the 'training specs' come from in the first place? ie, do you create from scratch each time, or is it previous material, delivered elsewhere, only customised for this client/delivery?

[*]Some changes to the slides are made by Training Specialist X (e.g. if the ground-structure of the community in Nepal is different to that described in the Master PP presentation).
Training Specialist X sends the slides for translation to an external translation agency.
After the slides have been translated, Training Specialist X checks them for linguistic and contextual accuracy.

And there'll be a record of this internal review, I hope? (Could be as easy as moving them into another folder on computer, for example).

A mock training is conducted in the office (with other Training Specialist and Project Manager).

Again, a review. Get this down as some kind of record, eg, their initials on a 'Review Form'?

Any relevant changes suggested by Training Specialists and Project Manager are incorporated to the slides.

Is the feedback verbal/written? If verbal, then keep the 'before' and 'after' training. The after one + the review form with initials form the 'record'. That's only one suggestion - the trick is for YOU to determine how you can most easily capture this information so you can later demonstrate that the activities were done to an independent person who wasn't present. You don't have to document every single little change though! As you point out, you'd then spend all your time in admin.

Deputy Director of Training reviews the final slides, and if need be, request changes. If happy with the slides, signs-off (how? where? need record) and saves the presentation to a specific folder as a reads-only version according to the Document Control procedure. Oh good - sounds fine.
Training Specialist conducts the training in the field.
Feedback on the training is gathered and analysed.
It is still unclear to me what records and to which level of detail should we be gathering during this process?

Empathise with your confusion... hope this helps straighten you out a bit?

A side note: Some (if not many) of the people in the Cove are more accustomed to manufacturing/scientific type applications of ISO 9001, and get (understnadably!) quite concrete about tracking design changes on engineering drawings and the like.

You are clearly providing a customised service rather than building physical widgets. The training material isn't your sole product (I assume), but is an important part of the service provided.

 

[DrM2u]

This is precisely what I am struggling with. Can I choose to make this call, and only document the changes made to the road-map at the beginning of the project, and leave out the intervention specific design and development aspect? The reason I would like to do this, is that the interventions specific changes based on the master model are done on a daily basis by approximately by more than half of the staff. Documenting this would be a nightmare...

OK, let me try to shine some more light on this by depicting a very general process flow for ISD design based on the ADDIE model:

1. Design planning (also known as analysis), is where the organization identifies a need (the gap between desired status vs. actual status) via analysis. In the case of ISD the analysis does not look only at the knowledge needs but also at aspects like logistics, environment, learners' knowledge levels, and any other factors that can impact the effectiveness of the training intervention. The results of the analysis are REVIEWED and they become the inputs (parameters) for the design phase.
2. Actual design is where the whole plan and individual courses are designed/outlined/drafted. The design is REVIEWED against the inputs and RECORDS should be retained, including decisions to make changes.
3. Development is where the actual courses are developed based on the design. This is the equivalent of developing prototypes for parts. Of course there is some REVIEW again and records should be retained.
4. Implementation is where the plan and courses are being piloted on a small scale. This is equivalent to the verification phase in 7.3 and this step focuses on making sure that all the 'components' are in place. Of course there is at least one more REVIEW to verifiy that the outcome matches the input.
5. Evaluation is the last major step in the design process, where the effectiveness and efficiency of the plan and courses is evaluated. In the case parts this is where any testing and inspection is performed. in the case of ISD this is where the courses are being taught on a small scale and the learners are evaluated if they have acquired any new knowledge and asked to provide feedback. This is usually done at levels 1 and 2, occasionaly at level 3 (reference Kirkpatrick's four levels of evaluation for more details). The results of this last step are REVIEWED again, of coursse. If the results are found to be acceptable then the plan and courses are rolled out to the whole application, the equivalent of a part being released for production.

As you have noted I highlighted the word REVIEW. The reason is that each review constitutes a decision making event/point. Based on the review the organization would decide if any changes are necessary or if should move forward as is. In accordance with ISO 9001 clause 7.3 and clause 4.2.4, records of reviews should be retained, including records of any changes made. It is up to the organization to be diligent about being compliant or not with every step.

I hope that I did not create more confusion with all my mumble-jumble.

 

[somashekar]

Would it not be enough to have a defined person who has the authority to release the product, in this case review the slides, sign them off? Is it necessary for the Training Specialist to keep track of every change in a change log of some sorts?

ISO 9001:2008 in 7.3.7 expects this :
Records of the results of the review of changes and any necessary actions shall be
maintained (see 4.2.4).
The training specialist can be authorized based on competency to make changes and he can maintain a log within the .ppt as a last slide perhaps. These must be defined as to who can make changes, verify them, validate them as necessary before the delivery

Deputy Director of Training assigns Training Specialist X (Nepali speaker) to revise the training material for the training (at this training, the material would only consist of a set of PP presentations).

Design and development changes shall be identified and records maintained. Here the deputy director of training identified a need to change

Some changes to the slides are made by Training Specialist X (e.g. if the ground-structure of the community in Nepal is different to that described in the Master PP presentation).

A change is made at this instant based on the need by a competent person.

Training Specialist X sends the slides for translation to an external translation agency.

Where an organization chooses to outsource any process that affects product conformity to requirements, the
organization shall ensure control over such processes. The type and extent of control to be applied to these
outsourced processes shall be defined within the quality management system.

After the slides have been translated, Training Specialist X checks them for linguistic and contextual accuracy.

determine the necessary competence for personnel performing work affecting conformity to product
requirements,
Is he competent to do this must be addressed by you.
If he is competent enough, then why out source ... ???

A mock training is conducted in the office (with other Training Specialist and Project Manager).

Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design
and development outputs have met the design and development input requirements. Records of the results of
the verification and any necessary actions shall be maintained (see 4.2.4).

Any relevant changes suggested by Training Specialists and Project Manager are incorporated to the slides.

Incorporate the changes

Deputy Director of Training reviews the final slides, and if need be, request changes. If happy with the slides, signs-off and saves the presentation to a specific folder as a reads-only version according to the Document Control procedure.

Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to
ensure that the resulting product is capable of meeting the requirements for the specified application or
intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or
implementation of the product. Records of the results of validation and any necessary actions shall be
maintained (see 4.2.4).
The changes are validated and the changed design is now made ready for delivery

Training Specialist conducts the training in the field.

This is the service provision

Feedback on the training is gathered and analysed.

This is the monitoring and measurement

You said ..

It is still unclear to me what records and to which level of detail should we be gathering during this process?

When you make a change that is significant enough to be improving the delivery quality, adds more value, updates with more data, may be make one or few new slides inclusion, just record them. Get a confidence first that this records is not something of a big burden. It is indeed not, and will just have to made as a good practice to be followed with appropriate identifications ...

 

[JuhoS]

Thank you all for the detailed the answers. I now definitely have a better understanding of how to address (and record) clause 7.3.

One related question. Going back to my first post.

Would clause 7.3 also be relevant for planning the entire 1-year process – our flow of interventions describing our interactions with the end-users (essentially the dozen or so 2-4 day training events and workshops)?

I feel that Clause 7: Product Realization is more relevant for the overall planning of the process. We have our standard road-map detailing the sequence of the trainings and workshops during the year, as well as a standard business process describing the administrative aspects of running the insurance scheme. We then look at these with our partnering organization (representing the end-users) and make some modifications to them, and start scoping for external service providers for some of the processes (research agency, translation agency, etc.)

I would not perceive this to be development/design, as it is mostly just changing the order of some of the interventions detailed in the standard road-map. So what I am hoping is that, I would not need to address the overall process in clause 7.3.