Author: Jeremiah Genest

Quality professional with over 20 years of experience. Gamer and storyteller with forty years of practice.

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.