Training As Is Analysis - Toluca Site

Questionnaire
January 2011
1 General Questions Answers

At Roche Toluca we have the following SOP's:

1) sop011861 Formación de Personal (Personnel training) - Describes theGMP training
system from onboarding process to the continual training program.
2) sop013471 Selección de instructores (Trainers selection) - Describes de minimum
internal criteria to be an instructor
3) sop014934 Inducción en Buenas Prácticas de Manufactura para Personal contratista
(GMP onboarding for contractors) Note: This sop is currently under HR responsibility. -
Describes the process to provide the GMP onboarding training for contractors.
4) sop012603 Competencia, formación y toma de conciencia (Competence, training and
awareness). Note: This sop is currently under SHE responsibility. - Describes the SHE
training and awareness activities for the site.
5) sop013000 Seguridad Industrial y Protección Ambiental para Personal Contratista (SHE
How many SOPs regarding training does your site have? What are their for contractors). Note: This sop is under SHE responsibility. - Describes the
1.1 titles and scope? SHEonboarding process for contractors.

Since it has been cascaded as part of a GMP requirement and compliance is part of our
1.2 Do you see training as an established part of your overall work culture? culture I would consider training as part of our culture.

We currently use for the GMP training a hard-document based system. We use this
system for the elaboration of training needs matrixes, training programs and training
What is your current Learning Management System? What do you use it records. No LMS is used for the GMP training, only an Access Data base is used for the
1.3 for? central administration of the training records.

Our GMP training SOP (sop011861) is periodically reviewed to make sure it is aligned with
current regulations as well as with corporate standards. In case any discrepancy is
identified during internal or external audits, an action plan is defined and followed for its
1.4 How do you manage issues of compliance risk related to training? completion by the audit system responsible.

Who at your site presents training system information to regulatory

1.5 officials? GMP Training system responsible, currently Tanya Mora (part of the Quality staff)

Has training ever received an observation or verbal notification from an There are no items related to training for the last inspections received at the site. (2010 -
1.6 inspection? today)

1.7 How is training tied into the budget process? Each area manager controls the budget for its department including the training expenses.

1
 Finance provides this figures and is responsible for the process. No further detail is
1.8 How are the costs of training calculated and included into the site budget? available from my standpoint.

Medium term, the 3 top challenges are the LMS implementation for the site in order to
ease the system administration, evolve in the training techniques we currently have in
1.9 What are your top 3 challenges for training? place for the site and establish a training effectiveness evaluation system.

2
2 Sponsorship Answers

A sponsor is the person responsible for something (in this case personnel training) to
2.1 How do you define sponsorship? happen as a whole process, from the planning and until the execution and measurement.

There is no formal process established but every area manager works as an sponsor for
2.2 Define the way sponsorship works at your site. the activies under his/her responsibility including training.

How does the Site Leadership Team demonstrate sponsorship toward the By supporting training efforts providing necessary resources such as time, people
2.3 training philosophy? availability, training program follow-up and budget.

Do training events need a local Sponsor? What is the role of that Sponsor
2.4 for training events? Who at the Site plays that role? There is no unique local sponsor for the site.

What is the role of a Sponsor within an initiative with training impact?

What are the accountabilities and responsibilities? Who at the Site plays
2.5 that role? There is no unique local sponsor for the site.

Is sponsorship demonstrated across all Operating Areas or just in small Each area manager sponsors the activities under their responsibiity, each one with
2.6 pockets? different leadership styles. No unified criteria is defined.

I have little iformation to provide a comparison. The best sponsor is consistent in his/her
2.7 Who are your best Sponsors? What makes them the best sponsors? attitude over time.

2.8 How are ineffective Sponsors held accountable? No information regarding the process is available from my standpoint.

Site Training Lead should be the overall coordinator of the training efforts for the site
What role does the Site Training Lead play with the Site Leadership working closely with area managers (sponsors). This role is being defined since it did not
2.9 Team? Why? exist before.

3
3 Training Roles and Partnerships Answers

A. Celio - Operational Excellence Manager

J.E. Morfin - Quality Manager
T.G. Mora - GMP Training Head
What are the different roles at your site of people supporting training? (List C.E. Fiscal - OD Manager
all roles, e.g. trainers, administrative support, training materials V. Badillo - OD Coordinator
3.1 developers, coordinators, etc.) Trainers (area supervisors / managers, safety supervisors)

Main roles are listed above with the curent person in charge. Trainers can be area
How many people are in each role? What is the percentage of time of that managers or supervisors (around 20 persons considering only production and QC
3.2 person working in that capacity? personnel)

No formal program for trainer development and certification. They are certified on their
3.3 How are these people in these roles trained and developed? roles considering their training, experience and education

3.4 What are the functional areas in which these people reside? Operational Excellence, Quality, Human Resources, Production and Safety.

Describe the level of partnership and collaboration between these

3.5 functions? Basic communication for information exchange, previously agreed and as needed.

3.6 Describe the partnership between the training team and the OE team? Basic communication for information exchange.

Describe the partnership between the training team and the site Quality
3.7 organization? GMP Training is part of Quality.

Describe the partnership between the training team and the site SHE Communication for information exchange, previously agreed and as needed and request
3.8 organization? for specific contractor trainings.

4
4 Training Selection Answers

GMP Training Head together with a representative per area (ideally manager and/or
supervisor) review the needs considering area objectives, failures, proejcts, new
Describe the process and methodology for identifying training needs and technologies, new requirements, etc. This is translated into a training needs assessment
4.1 opportunities? matrix.

Most of them are internal, where the trainer is the supervisor or manager and some other
are self-directed.
External training is selected considering recognized local suppliers as well as international
4.2 How are trainings identified and selected? ones when available.

Anyone can propose a training but it must be evaluated by area managers in order to
4.3 Who can propose trainings? What does it take to Sponsor a training? determine if it is aligned with current needs.

What percentages of projects are “internal, top-down”, “external-in” and This is not a classification we currently provide for each event, so no information is
4.4 “shop floor/analyst-driven up”? available regarding the percentages for each type.

How much advance notice do you generally receive between training

4.5 request and need for deployment? Ideally it must be at least 3 weeks before the training starts, at least for external events.

4.6 How are these trainings prioritized? According to preestablished program as well as area needs and priorities.

Not all requests for training are conducted. It depends on the definition area manager
4.7 Do you conduct all training courses that are requested of your site? gives for each request and event.

How is the list of training needs for your site developed, managed, and For GMP training, it is concentrated on a single person who supports the logistics and
4.8 maintained? gives follow up to previous commitments

5
5 Training Execution Answers

After training needs assessment, the training required is programmed per area and then
How is training deployed at your site? Please describe the process, tools the programs are executed. The follow up of the program is responsibility of each area
5.1 and systems, and people involved. with support of the GMP training function.

5.2 How are trainers currently qualified to be trainers? Currently there is no training certification at the site.

Procedure sop011861 requires to attach training material (when available) to the training
5.3 How do you store and manage training materials? record generated for the event.

When there is training to conduct, how is it communicated to the affected Mostly, it is the trainer who invites the involved people. In certain trainings, there is a
5.4 parties and by whom? coordinator who sends this invitation to the affected people.

Goals are part of the inputs required to perform the training needs assessment. This
5.5 How are training results related to site business goals and drivers? needs to be reviewed periodically as indicated in sop011861

How does training connect to other business metrics, e.g. discrepancies

5.6 due to human error, etc.? Discrepancies and failures are also inputs for the training needs assessment.

Support and conclude transition of the GMP function responsibility ensuring the contnuity
5.7 What were your training priorities for 2010? of current GMP training established process.

6
6 Training Metrics Answers

6.1 What are your metrics related to training? Training hours and training days per employee

Who sets the metrics for training? Are there department-specific

6.2 differences or are they the same across the site? Management sets the metrics. The same emtrics are used across the site.

How are the metrics discussed and analyzed for improvement? How often
6.3 and by whom? Quarterly, there is a report sent by GMP training head to management.

6.4 How are training quality and effectiveness measured at your site? No effectiveness measures are currently in place.

What reports exist that monitor completion and compliance requirements The completion and progress of the training programs is reviewed preiodically without a
6.5 for training, if any? clear measure as outcome.

To whom and how often are training metrics, reports, or a dashboard sent
6.6 to someone (either locally or within the network)? Quarterly, there is a report sent to local management.

How is the volume of training measured? (e.g. hours of training, number

6.7 of classes conducted etc.) Training hours and training days per employee are the defined metrics
There are 8700 training events (round number) registered in 2010 (including training in
How many training classes did your site complete in 2010? Please documents, internal and external courses) of which 90% was referred to a training in a
differentiate by WBT (web-based training), ILT (instructor-led training) and document, 7 % was internal training and 3% was external training. Currently we do not
6.8 OJT (on-the-job training). classify as WBT, ILT or OJT so no information with this differentiation is available.

7
7 Training Communication Answers

7.1 Which communication channels do you find work best at your site? Communication and instruction through supervisors and managers.

How often and using what methods is your Site Leadership and
7.2 management updated about training? Management is updated quarterly in topics related to training metrics.

Either through supervisors / managers or by informal communication to GMP training

How is feedback from shop floor and analyst personnel sent to the training personnel. There is a pilot effort in which for a specific program, effectiveness and
7.3 personnel? feedback is evaluated through a satisfaction questionnaire at the end of the session.

To make training programs pervasive, there needs to be an

understanding that everyone is achieving gains from the program. How
training results publicized to the Site Leadership and the general There is no communication to the general population regarding training results.
7.4 workforce? Management is informed through quarterly report.

7.5 How is your site website leveraged to support training? There is no link of the local website with the GMP training tasks.

8
8 Knowledge Sharing Answers

How do you currently receive information about best practices and

lessons learned from other sites? What specifically do you receive from Currently I only recieve what Alberto shares regarding the newly formed Global training
8.1 others? group.

At what point do you think something you have done is worth sharing with
8.2 others in the network? Sharing the global webinars suppliers might be useful in terms of global negotiations.

One of the current needs for the site is the implementation of an LMS that complies with
Tell us about a recent example of when you wished you could have applicable regulations, feedback on available options from the network would have been
8.3 reached out to the network for assistance, but did not. useful.