Subject Matter Experts (SME) | Getting the best from your Experts

The therapeutics goods industry is stuffed to the gunnels with very smart people; those who know the inside and out of all the processes and procedures in their field. They are the people that you want on board to ensure a thorough and educated approach to document writing and are commonly referred to as Subject Matter Experts (SME).

When do you need Subject Matter Experts (SME)?

Subject Matter Experts can be invaluable:

  • During projects
  • For document writing*
  • When conducting root cause analysis and investigations
  • Whenever there is a knowledge gap you need to fill

* We will use this example throughout this blog

Identifying appropriate participants

As with any team, recruiting SMEs into an activity (SME engagement) ensures that the required expertise in a specific topic is available. This is particularly important when process mapping (new blog coming soon) during the early phases of document development.

When you are identifying potential team members:

  • Ensure they are relevant to the content. Do/will they directly use the process?
  • Request a functional manager to suggest a potential SME
  • Be sure to include project functions as well, such as a QA representative, a technical writer and a project team leader

Whilst it’s important to seek contribution from all appropriate sources:

  • Try to keep the number of team members manageable and to scale appropriate to the size of your company – one SME may be all you need.
  • Too many SMEs can make it a challenge to get decisions made.
  • Don’t double-up – individual SMEs can identify their proxy in case of absence.
  • Only invite those with significant involvement in the process.

Example: An equipment management process might involve personnel from:

  • Purchasing
  • Validation
  • Quality
  • Users or manager at individual manufacturing sites
  • Calibration/maintenance/engineering

Selling the process

It’s likely that document development or technical writing is not part of an SME’s normal job function, and they may be unable (or unwilling) to contribute much of their time to it. Your process writing is never going to be as important to them as it is to you.

You may need to persuade an SME that it’s to their advantage to contribute to the process. Which, of course, it is. In our example, they or their team are likely to be using the process document you’re preparing and if it’s incomplete, incorrect, or overly complicated this could heavily impact their work.

It is also a regulatory requirement to produce suitable documentation:

PIC/S PE 009-15, Part 1, Chapter 4: Documentation
4.2 Documents should be designed, prepared, reviewed, and distributed with care. They should comply with the relevant parts of Product Specification Files, Manufacturing and Marketing Authorisation dossiers, as appropriate.

4.3 Documents containing instructions should be approved, signed and dated by appropriate and authorised persons.

Defining their role – managing expectations

Everyone is more comfortable when they know what’s going to happen: the better an SME understands their role in the process, the more chance you have of getting their best contribution.

Let them know about:

  • Hours they need to commit – when and for how long
  • The expected duration of the project
  • Attending meetings
  • Voicing their opinion/requirements – and letting others do the same
  • Providing feedback on the timeline requested

Considering individuals’ needs

In addition to helping them understand the benefit of their contribution, it is worth considering an individual’s working style if you want to get the best out of them.

  • Do they like to talk on the phone … or hate being interrupted by it?
  • Do they contribute more when working in a team … or prefer solitary contemplation?
  • Are they happy to make their opinion known … or do they hold back their thoughts?
  • Would they like to have a scheduled time for documentation … or can fit it in whenever needed?

You might ask them directly about how they like to work, but also watch out for tell-tale clues: When you email them, do they call you back? Are they quiet during a team meeting, preferring to listen and provide their feedback at a later date? Do they repeatedly miss meetings?

Having some understanding of their preferences will help make their contribution less demanding and make your life easier too.

Asking for input

The first step may be developing a process map (The role of process mapping in SOP writing – new blog coming soon) can help you with the details of this process.

PharmOut also has several blogs to support the technical writer during the procedure drafting process:

Once a map or procedure draft is ready for review, when trying to seek opinion and input from your SMEs, ensure they understand what they are expected to contribute:

  • Help define the scope of the review process
  • Provide background information about the process
  • Define all steps of the process within their area of expertise
  • Confirm departmental roles and responsibilities for these steps
  • Identify discrepancies or contradictions
  • Ensure compliance requirements are met
  • Communicate appropriately and effectively with the rest of the team
  • Respond within the required timeframe

Equally important, define what they won’t be required to do, such as: write the SOP, host meetings, or create reports or records.

Tips for providing effective feedback for SMEs

It is also important for your SMEs to understand how to provide effective feedback. Below are some tips for SMEs when reviewing and providing feedback on written documents:

  • Try not to make comments such as ‘this is wrong’ or ‘missing a step’ as this is not effective, and the technical writer is unlikely to know what the missing step is.
  • Provide details of the correction or communicate the change effectively to the technical writer.
  • Ensure that all technical information and/or terminology are correct.
  • Try not to make any fundamental changes to the document template without discussing this with the technical writer or the Quality department.

Remember, all documents can (and should be) continuously improved.

Managing feedback

Whilst you might have a separate project lead in place, the technical writer could be best placed to process the feedback received about a process map or document draft.

Either way:

  • Ensure a deadline is included in the request for review
  • Track responses from all SMEs – and give them a second or third chance to do so, outlining the benefit to them, and the risks if they don’t
  • Incorporate changes that have been agreed by all members to the document
  • Highlight disagreements and raise them as items for the next discussion
  • Don’t let the review cycle go on too long – perhaps 2-3 cycles for the process map, and 2 for the SOP and its supporting documents. More than this suggests there is something more fundamentally wrong with the project and should be addressed. e.g. are the right people involved?

Face-to-face and remote working

Thanks to COVID, more personnel are working remotely than ever before. You may have to accommodate both remote and local team members when developing your document.


  • How best to use available technology e.g. Sharepoint for document sharing, Teams for videoconferencing
  • Giving those who are online specific opportunities to voice their thoughts
  • Provide meeting minutes to confirm actions and responsibilities

Dealing with conflict

There’s a chance that the team will not agree on an approach to the process – perhaps one option is more onerous to one department than another; perhaps they disagree about the scope of the process.

Of course, it’s always best to reach a consensus but be prepared to step in and make a decision – it might be wise to justify your decision in a document (email or minutes) based on the available evidence and reasoned thinking.

Finalising the document

Once the documents have been agreed upon by the team, they will be ready to publish through your document management system. Not every SME needs to sign as the reviewer – just the primary user or document owner as per your SOP. Hopefully you’ve created a compliant process that is easy to use and meets everyone’s needs. That’s always the goal!

Further reading

PharmOut has several other blogs to help you make the best of your QMS:

Support from PharmOut

PharmOut can offer document writing assistance, ongoing advice, mentoring and/or support as you develop and implement your PQS at your site; we have a team of experienced GMP technical writers who can help.

Or if you’d like some training, please visit our website: Technical Writing Training Courses