Release control process sipoc

Google does not share search terms for privacy reasons, so it is rare that a search term stands out on my blog.

So here you go.

SIPOC for disposition

This is purposefully a high level process.

Quality Review of Records: Batch Record, Packaging Record, the like

Lot Assessment: Evaluation of deviations, of change control and test results; but also of other inputs such as Critical Utilities and Environmental Monitoring Review. Ideally a holistic view.

Lot Disposition: Decision that the product meets all requirements of the GMPs and the market authorization.

Some important regulatory requirements:

  • United States: 21 CFR 211.22(a); 211.22(d)
  • EU: 1.4(xv); 1.9(vii); EU Annex 16
  • World Health Organization: Annex 3-GMP 1.2(g); Annex 3-GMP 9.11, 9.13, 9.15

 

One of the drivers for digital transformation, and a concept at route of the ICHs, is the idea of release by exception. Our systems will be tight enough, our design space robust enough, that most products are automatically released and sent into the market.

 

 

Quality Culture requires men being better allies to women

ISO 26000: Guidance on social responsibility defines social responsibility as:

The responsibility of an organization for the impacts of its decisions and activities on society and the environment, through transparent and ethical behavior that:

  • Contributes to sustainable development, including health and the welfare of society
  • Takes into account the expectations of stakeholders
  • Is in compliance with applicable laws and consistent with international norms of behavior
  • Is integrated throughout the organization and practiced in its relationships

ISO 26000 also defines seven key principles of socially responsible behavior:

  • Accountability
  • Transparency
  • Ethical behavior
  • Respect for stakeholder interests
  • Respect for the rule of law
  • Respect for international norms of behavior
  • Respect for human rights

One shouldn’t have to look for reasons for human rights and the drive towards to diversity, but let us simply say there are a ton of studies that show that diversity improves decision making, problem solving and even make us smarter.

In short diversity is critical towards a Quality Culture. Gender equality is a critical part of being a successful quality leader, and it behooves each and every one of us men to drive towards it. To figure out how to make our own workplaces more diverse.

There are many aspects of creating diverse culture but I want to discuss how it is critical that men support women, that we be allies. Too many organizations still miss the mark on gender equity efforts by focusing gender initiatives solely on changing women — from the way they network to the way the lead. Individualistic approaches to solving gender inequities overlook systemic structural causes and reinforce the perception that these are women’s issues — effectively telling men they don’t need to be involved. As always, it is always about the system thinking. Without the avid support of men progress toward ending gender disparities is unlikely and organizations cannot find reap the benefits.

Men need to become better allies by focusing on listening, support, and respect. We need to listen to women’s voices and bring all those core skills of  focus, sincerity, empathy, refusal to interrupt, and genuine valuing to systematically addressing inequities, whether the ubiquitous workplace sexual harassment or gender exclusion. End your silence and support and ally. No matter what level of your organization you are in.

By being a deliberate male ally, by actively promoting gender fairness and equity in the workplace we can drive systematic improvements. To lean on Deming, we can drive out fear. And isn’t that what Quality is all about?

FDA signals – no such thing as a planned deviation

The subject of planned deviations made for a raucous “Breakfast with the FDA” session Sept. 25 at the Parenteral Drug Association/FDA conference in Washington.

These are the deviations from standard operating procedures that workers carry out on purpose, typically to keep a pharmaceutical plant operating when for one reason or another they won’t be doing it the way the company said they would.

FDA Compliance Experts Advise Against Treating Minor Changes As ‘Planned Deviations’” – Bowman Cox, Pink Sheet

I wish I had gone to the PDA/FDA conference this year, if for nothing else to have been able to stand up and cheer wildly when this was said:

Brooke Higgins, a senior policy advisor in the FDA drug center’s Office of Compliance, agreed that “it’s a very strange term, and it kind of makes your skin crawl a little bit.”

There is a whole lot more good stuff over at the Pink Sheet’s summary.

I am a firm believer that there are no such things as planned changes. There are change controls, some of which are temporary, occasionally even ones that are retroactive (deviation identifies a change which is formalized in a change control). But all are through the same system, with the same evaluations and assessments and the same sorts of actions.

Keep all changes together. Its a true best practice.

 

India releases draft guideline on Good Distribution Practices (GDP)

The Indian regulatory authority CDSCO (Central Drugs Standard Control Organization) has published a 21-page draft on Good Distribution Practices (GDP) for pharmaceutical products.

The draft covers topics that are well aligned to other good distribution practices, and is aligned to the ICH framework.

It is good to see India moving ahead in adopting best practices. This is a huge market, a growing source of production and it will be a huge center of innovation in the near future. It is important for CDSCO to continue to push forward in a better regulatory regime and to tighten their quality practices.

The guidance contains some of my favorite themes of GDP (and other pharma) practices, including::

  • Each company must hold one person responsible for ensuring a quality system is implemented and maintained.
  • All distributors of pharmaceutical products have to establish and maintain a quality system supported by a documented quality system.
  • Senior management has to ensure that all parts of the quality system are adequately resourced with competent personnel and suitable and sufficient premises, equipment and facilities.

The responsible person/quality person model is one of the more problematic aspects of our field. Yes, there is someone who is responsible for quality, its called the officers of the company. But this idea that one person sits on the top of the pyramid and makes ALL the best decisions is a problematic thing that regulations tend to enshrine.

 

Change Management of multi-site implementations

A colleague asks in response to my post Group change controls:

… deploying a Learning + documentation system … all around the word [as a global deployment]  … do we I initiate a GLOBAL CC or does each site created a local CC.

The answer is usually, in my experience, both.

Change management is about process, organization, technology and people. Any change control needs to capture the actions necessary to successful implement the change.

so at implementation I would do two sets of changes. A global to capture all the global level changes and to implement the new (hopefully) harmonized system And then a local change control at each site to capture all the site impact.

System Element Global Local
Process Introduce the new global process

Update all global standards, procedures, etc

How will local procedures change? How will local system interactions change – clean up all the local procedures to ensure the point to the new global procedures and are harmonized as necessary.
Technology Computer system validation

Global interfaces

Global migration strategy

Local interfaces (if any) and configurations

Are local technologies being replaced? Plan for decommissioning.

Local migration (tactical)

People What do people do on the global level?

How will people interact within the system in the future?

Global training

What will be different for people at each individual site?

Localized training

Organization Will there be new organizational structures in place? Is this system being run out of a global group? How will communication be run.

System governance and change management

Site organization changes

How will different organizations and sub organizations adopt, adapt and work with the system

If you just have a global change control you are at real risk of missing a ton of local uniqueness and leaving in place a bunch of old ways of thinking and doing things.

If you just do local change controls you will be at risk of not seeing the big picture and getting the full benefits of harmonization. You also will probably have way too many change controls that regurgitate the same content, and then are at risk of divergence – a compliance nightmare.

This structure allows you better capture the diversity of perspectives at the sites. A global change control tends to be dominated by the folks at each site who own the system (all your documents and training folks in this example), while a site change will hopefully include other functions, such as engineering and operations. Trust me, they will have all sorts of impact.

This structure also allows you to have rolling implementations. The global implements when the technology is validated and the core processes are effective. each site then can implement based on their site deliverables. useful when deploying a document management system and you have a lot of migration.

Multisite changes

As part of the deployment make sure to think through matters of governance, especially change management. Once deployed it is easy to imagine many changes just needing a central change control. But be sure to have thought through the criteria that will require site change controls – such as impact other interrelated systems, site validation or different implementation dates.

I’ve done a lot of changes and a lot of deployment of systems. This structure has always worked well. I’ve never done just a global and been happy with the final results, they always leave too much unchanged elements behind that come back to haunt you. In the last year I’ve done 2 major changes to great success with this model, and seen one where the decision not to use this model has left us with lots of little messes to clean up.

As a final comment, keep the questions coming and I would love to hear other folks perspectives on these matters. I’m perpetually learning and I know there are lots of permutations to explore.